RA PsA AS - Kropcache.krop.com/seminara-571738371d466e5.pdf · SUMMARY PsA Psoriatic arthritis...
Transcript of RA PsA AS - Kropcache.krop.com/seminara-571738371d466e5.pdf · SUMMARY PsA Psoriatic arthritis...
Copyright © 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ, USA. All rights reserved. RHEU-1070841-0001 02/13
RA Rheumatoid arthritis
EFFICACY
QoL
SAFETY
EXPERIENCE
SUMMARY
PsA Psoriatic arthritis
EFFICACY
QoL
SAFETY
EXPERIENCE
SUMMARY
ASAnkylosing spondylitis
EFFICACY
QoL
SAFETY
EXPERIENCE
SUMMARY
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps deliver a sustained reduction in the
signs and symptoms of RA1
xxxxxxxEFFICACY xxxxxxxxxxxxxxx
RA
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
ACR response at Week 522
Placebo + MTX (n=39; switched to SIMPONI 50 mg monthly + MTX at Week 16)
SIMPONI 50 mg monthly + MTX (n=70)
90
60
30
0
Patients
, %
ACR20 ACR50 ACR70
82.9
57.1
31.4
59.0
30.8
17.9
HAQ-DI scoreWeek 14
ACR
improvements
were sustained
over 2 years.3
SIMPONI helps deliver a sustained reduction in the
signs and symptoms of RA1
ACR
improvements
were sustained
over 2 years.3
xxxxxxxEFFICACY xxxxxxxxxxxxxxx
RA
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
ACR response at Week 141
Placebo (n=133)
SIMPONI 50 mg (n=89)
90
60
30
0
Patients
, %
ACR20 (PE) ACR50 ACR70
55.1
34.8
13.5
33.1
9.83.8
P=0.0001
P=0.0001
P=0.008
Week 52 HAQ-DI scoreWWeeeekk 1144
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps deliver a sustained reduction in the
signs and symptoms of RA1
ACR
improvements
were sustained
over 2 years.3
xxxxxxxEFFICACY xxxxxxxxxxxxxxx
RA
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Almost 3 times more improvement in
HAQ-DI scores vs placebo + MTX alone at
Week 24 (0.38 vs 0.13, P<0.001)
Week 52 HHAAQQ-DDII ssccoorreeWeek 14
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
RA = rheumatoid arthritis; ACR = American College of Rheumatology; MTX = methotrexate;
PE = primary end point; HAQ-DI = Health Assessment Questionnaire Disability Index.
References
1. Keystone EC, et al. Ann Rheum Dis. 2009;68(6):789–796. Erratum in: Ann Rheum Dis. 2011;70(1):238.
2. Keystone EC, et al. Ann Rheum Dis. 2010;69(6):1129–1135.
3. SIMPONI. Summary of Product Characteristics. March 2012.
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the
effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in
a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus
placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered
subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement in
the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps achieve and maintain clinical remission1
DAS28 remission rates were
maintained through Week 104.2
RA
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
DAS28 (CRP) remission at Week 241
Placebo + MTX
(n=133)
60
40
20
0
Patients
, %
27.0
6.8
SIMPONI 50 mg + MTX
monthly (n=89)
P<0.001
Week 52WWeekk 2244
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps achieve and maintain clinical remission1
DAS28 remission rates were
maintained through Week 104.2
RA
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
DAS28 (CRP) remission at Week 241
Placebo + MTX
(n=133)
60
40
20
0
Patients
, %
27.0
6.8
SIMPONI 50 mg + MTX
monthly (n=89)
P<0.001
Week 52WWeekk 2244
4 times as many patients achieved DAS28 remission vs
MTX alone (27.0% vs 6.8%; P<0.001) at Week 24.1
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
DAS28 remission rates were
maintained through Week 104.2
WWeekk 5522Week 24
SIMPONI helps achieve and maintain clinical remission1RA
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Remission was sustained through Week 52—
61% of patients initially receiving
SIMPONI 50 mg + MTX achieved
DAS28 (CRP) remission.3
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
MTX = methotrexate; DAS28 = Disease Activity Score 28; CRP = C-reactive protein; RA = rheumatoid arthritis;
ACR = American College of Rheumatology; HAQ-DI = Health Assessment Questionnaire Disability Index.
References
1. Keystone EC, et al. Ann Rheum Dis. 2009;68(6):789–796. Erratum in: Ann Rheum Dis. 2011;70(1):238.
2. SIMPONI. Summary of Product Characteristics. March 2012.
3. Keystone EC, et al. Ann Rheum Dis. 2010;69(6):1129–1135.
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the
effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in
a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus
placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered
subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement
in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
SIMPONI helps achieve early and sustained reduction in
pre-erosive lesions1,2,a,b
MRI synovitis and bone marrow edema osteitis in early RA
can predict later radiographic progression.3
Radiographic data for SIMPONI supported by MRI substudies1,2:
In a substudy of GO-BEFORE (N=318), signifi cant improvements in synovitis (P<0.001),
osteitis (P<0.001), and bone erosions (P<0.05) vs placebo + MTX were observed as early as
Week 12.1,c
In a substudy of GO-FORWARD (n=240), signifi cant reductions in synovitis and osteitis vs
MTX alone were observed despite low levels of disease activity in the total study population
(P<0.001).2,d
Improvements in synovitis, osteitis, and bone erosions were maintained to Week 24.1
RA
Synovitis
improvement
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
RA
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Example of improvements in synovitis after treatment with SIMPONIe
Baseline Week 12 Week 24
STIR Postcontrast T1
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Example of improvements in synovitis after treatment with SIMPONIe
STIR Postcontrast T1
Baseline Week 12 Week 24
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Example of improvements in synovitis after treatment with SIMPONIe
STIR Postcontrast T1
Baseline Week 12 Week 24
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Example of improvements in synovitis after treatment with SIMPONIe
STIR Postcontrast T1
Baseline Week 12 Week 24
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Example of improvements in synovitis after treatment with SIMPONIe
STIR Postcontrast T1
Baseline Week 12 Week 24
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Example of improvements in synovitis after treatment with SIMPONIe
STIR Postcontrast T1
Baseline Week 12 Week 24
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Example of improvements in synovitis after treatment with SIMPONIe
STIR Postcontrast T1
Baseline Week 12 Week 24
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Example of improvements in synovitis after treatment with SIMPONIe
STIR Postcontrast T1
Baseline Week 12 Week 24
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Example of improvements in synovitis after treatment with SIMPONIe
STIR Postcontrast T1
Baseline Week 12 Week 24
a Early defi ned as treatment response at Week 12. Sustained defi ned as maintained improvements at Week 24.
bPre-erosive = synovitis and osteitis.
cGO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active
RA naïve to MTX. Radiographic progression was a primary end point.
dGO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) in patients with
active RA despite MTX therapy. Primary end points were the proportion of patients with ≥20% improvement in
the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24.
ePlease note that treatment with SIMPONI 100 mg should only be considered in patients weighing over 100 kg
who have not achieved adequate clinical response with SIMPONI 50 mg. The increased risk of certain serious
adverse drug reactions with the 100-mg dose compared with the 50-mg dose should be taken into account.
MRI = magnetic resonance imaging; MTX = methotrexate; RA = rheumatoid arthritis; ACR = American College of
Rheumatology; HAQ-DI = Health Assessment Questionnaire Disability Index.
References
1. Østergaard M, et al. Arthritis Rheum. 2011;63(12):3712–3722.
2. Conaghan PG, et al. Ann Rheum Dis. 2011;70(11):1968–1974.
3. Boyesen P, et al. Ann Rheum Dis. 2011;70(3):428–433.
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-FORWARD: MRI of the wrist at baseline, Week 12, and Week 24 of a patient randomized to receive SIMPONI
100 mg plus placebo. Coronal short tau inversion recovery (STIR) images (A–C) show extensive bone edema at
baseline (A). The bone edema has markedly decreased at Week 12 (B) and has nearly resolved at Week 24 (C).
Corresponding postcontrast T1-weighted images with fat suppression (D–F) show substantial synovitis at baseline
(D) and markedly reduced synovitis at Week 12 (E) and Week 24 (F). Precontrast T1-weighted images without
fat suppression (G–I) show no progression of bone erosion during the 24-week follow-up period. Note: Series of
consecutive images were evaluated; the images displayed here are representative but not exhaustive.
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps to significantly inhibit progression of
structural damage1
SIMPONI, in combination with MTX, has been shown to
reduce the rate of progression of joint damage as measured
by x-ray and to improve physical function—leading to
potential improvements in patient QoL.3
SIMPONI 50 mg + MTX signifi cantly inhibited radiographic progression at Week 52 in previously
MTX-naïve patients, as measured by SHS.1
Nearly half the radiographic progression seen vs MTX alone.
Benefi ts demonstrated even in patients with disease duration >3 years (established RA).
In MTX-experienced patients with active disease, SIMPONI 50 mg + MTX signifi cantly limited
radiographic progression at Week 24 and reduced RA signs and symptoms as measured by
ACR20 responses at Weeks 14 and 24.2
RA
MTX naive
MTX
experienced
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
p
In MTX-experienced patients with active disea
radiographic progression at Week 24 and redu
ACR20 responses at Weeks 14 and 24.2
Change in SHS from baseline1,2RA
3.5
3
2.5
2
1.5
1
0.5
0
Mean c
hang
e f
rom
baselin
e
0.74
1.37
MTX naïve (Week 52)a
P=0.015
Placebo + MTX
(n=160)
SIMPONI 50 mg monthly
+ MTX (n=159)
MTX naive
MTX
experienced
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Change in SHS from baseline1,2RA
3.5
3
2.5
2
1.5
1
0.5
0
Mean c
hang
e f
rom
baselin
e
0.74
1.37
MTX naïve (Week 52)a
P=0.015
Placebo + MTX
(n=160)
SIMPONI 50 mg monthly
+ MTX (n=159)
46% less progression
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
MTX naive
MTX
experienced
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Change in SHS from baseline1,2RA
3.5
3
2.5
2
1.5
1
0.5
0
Mean c
hang
e f
rom
baselin
e
MTX experienced (Week 24)b
P=0.020
1.05
2.51
Placebo + MTX
(n=105)
SIMPONI 50 mg monthly
+ MTX (n=101)
MTX naive
MTX
experienced
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Change in SHS from baseline1,2RA
3.5
3
2.5
2
1.5
1
0.5
0
Mean c
hang
e f
rom
baselin
e
MTX experienced (Week 24)b
P=0.020
1.05
2.51
Placebo + MTX
(n=105)
SIMPONI 50 mg monthly
+ MTX (n=101)
58% less progression
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
MTX naive
MTX
experienced
aCoprimary end point at Week 52.
bWeek 24 data.
MTX = methotrexate; SHS = Sharp/van der Heijde score (higher SHS scores indicate greater radiographic
progression); RA = rheumatoid arthritis; QoL = quality of life.
References
1. Emery P, et al. Arthritis Rheum. 2011;63(5):1200–1210.
2. Tanaka Y, et al. Ann Rheum Dis. 2011;Epub ahead of print.
3. SIMPONI. Summary of Product Characteristics. March 2012.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active
RA naïve to MTX. Radiographic progression was a primary end point.
Tanaka, et al: a multicenter, randomized, double-blind, placebo-controlled study in Japanese patients (N=261)
with active RA despite MTX therapy. Patients were randomized to SIMPONI 50 mg, SIMPONI 100 mg, or placebo,
subcutaneously, every 4 weeks. The primary end point was the proportion of patients achieving ACR20 at
Week 14. Radiographic progression was assessed by change from baseline in SHS at Week 24.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and
symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage
Effective once-monthly treatment that helps improve
physical function and QoL1,2
Signifi cantly improved health-related QoL as measured
by SF-36 physical component score.3
SIMPONI 50 mg + MTX signifi cantly improved HAQ scores vs placebo + MTX1,2:
HAQ scores were maintained through Week 104.3
RA
HAQ
Physical functionQoL Summary
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Improvement in HAQ from baseline
Week 24 Week 52
Placebo + MTX (switched to SIMPONI 50 mg monthly + MTX at Week 16)
SIMPONI 50 mg + MTX
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
Med
ian
im
pro
vem
ent
in H
AQ
-DI
0.38
0.13
0.63
P<0.001
n=133 n=89
0.38
n=81 n=70
RA
Physical functionQoL Summary
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
QoL = quality of life; MTX = methotrexate; HAQ = Health Assessment Questionnaire; HAQ-DI = HAQ Disability Index;
RA = rheumatoid arthritis; ACR = American College of Rheumatology; SF-36 = Short Form-36 Health Survey.
References
1. Keystone EC, et al. Ann Rheum Dis. 2009;68(6):789–796. Erratum in: Ann Rheum Dis. 2011;70(1):238.
2. Keystone EC, et al. Ann Rheum Dis. 2010;69(6):1129–1135.
3. SIMPONI. Summary of Product Characteristics. March 2012.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Physical functionQoL Summary
GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the
effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in
a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus
placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered
subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement
in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24.
Physical functionQoL Summary
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Efficacy with monthly SC SIMPONI
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Reduced
disease activity2,4–6
Reduced signs
and symptoms1–3
Provided proven
clinical remission2,3
RA
Physical functionQoL Summary
Efficacy with monthly SC SIMPONI
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Reduced
disease activity2,4–6
Reduced signs
and symptoms1–3
Almost twice as many
patients achieved an ACR50
response vs MTX alone
ACR response maintained
through 2 years
Provided proven
clinical remission2,3
RA
Physical functionQoL Summary
Efficacy with monthly SC SIMPONI
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Reduced
disease activity2,4–6
Reduced signs
and symptoms1–3
Almost twice as many
patients achieved an ACR50
response vs MTX alone
ACR response maintained
through 2 years
Provided proven
clinical remission2,3
DAS28 remission rates
sustained through Week 52
and Week 104
RA
Physical functionQoL Summary
Efficacy with monthly SC SIMPONI
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Reduced
disease activity2,4–6
Signifi cantly reduced pre-
erosive lesions
Resulted in nearly half the
radiographic progression
vs MTX alone
Reduced signs
and symptoms1–3
Almost twice as many
patients achieved an ACR50
response vs MTX alone
ACR response maintained
through 2 years
Provided proven
clinical remission2,3
DAS28 remission rates
sustained through Week 52
and Week 104
RA
Physical functionQoL Summary
ACR = American College of Rheumatology; MTX = methotrexate; SC = subcutaneous; DAS28 = Disease
Activity Score 28 (DAS28 remission was compiled using C-reactive protein [CRP]); HAQ = Health Assessment
Questionnaire; SF-36 = Short Form-36 Health Survey.
References
1. Keystone EC, et al. Ann Rheum Dis. 2009;68(6):789–796. Erratum in: Ann Rheum Dis. 2011;70(1):238.
2. SIMPONI. Summary of Product Characteristics. March 2012.
3. Keystone EC, et al. Ann Rheum Dis. 2010;69(6):1129–1135. Erratum in: Ann Rheum Dis. 2011;70(1):238–239.
4. Østergaard M, et al. Arthritis Rheum. 2011;63(12):3712–3722.
5. Conaghan PG, et al. Ann Rheum Dis. 2011;70(11):1968–1974.
6. Emery P, et al. Arthritis Rheum. 2011;63(5):1200–1210.
Physical functionQoL Summary
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Safety profile of SIMPONI after 3 years1,2
In Phase 3 trials through 3 years1:
7.4% of patients receiving injections of SIMPONI 50 mg discontinued therapy
because of adverse events vs 4.9% of those receiving placebo injections.
SIMPONI has over 8 years of worldwide
clinical trial experience and has been
used in over 80,000 patients.2,3
3-year safety data SAFETYComprehensively
tested
Adverse
event data
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
RA
An analysis of pooled data from the long-term extensions of randomized,
double-blind, placebo-controlled studies in RA, PsA, and AS.1
Adverse event2 (Pooled data) SIMPONI 50 mg +/– MTX Placebo +/– MTX
Patients treated (n) 1,317 674
Deathsa 0.30 0.28
All serious infectionsa 3.03 5.31
Tuberculosis (TB)a 0.17 0.00
Opportunistic infections other than TBa
0.13 0.00
Malignancy Nonmelanoma skin cancersTotal patient-years of follow-upIncidence/100 patient-years
2,3050.43
3561.40
LymphomaTotal patient-years of follow-upIncidence/100 patient-years
2,3130.04
3580.00
Other malignanciesTotal patient-years of follow-upIncidence/100 patient-years
2,3080.78
3570.56
Includes SIMPONI SC
Phase 2b studies in
addition to Phase 3 RA,
PsA, and AS studies.
3-year safety data SAFETYComprehensively
tested
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aIncidence per 100 patient-years.
RA = rheumatoid arthritis; PsA = psoriatic arthritis; AS = ankylosing spondylitis; MTX = methotrexate.
References
1. Kay J, et al. ACR 2011; abstract 2227.
2. Data on fi le. MSD SIMPONI PSUR 05.
3. http://clinicaltrials.gov/ct2/show/NCT00207714?term=cnto+148&rank=8. Accessed 31/01/12.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI —comprehensively tested in worldwide trials
SIMPONI has been extensively
tested in a worldwide clinical
trial program in more than 2,300
patients, including different RAa
patient groups, as well as those
with PsAb or ASc.1–6
A comprehensive development program:
Phase 3 clinical trials in over 2,300 rheumatology patients1–6
Trial Indication Patient type Subjects, N
GO-BEFORE Active RA MTX naïve 637
GO-FORWARD Active RA MTX nonresponders 444
GO-AFTER Active RA Anti-TNF experienced 461
GO-REVEAL Active PsADMARD
nonresponders405
GO-RAISE Active ASConventional therapy
nonresponders356
3-year safety data SAFETYComprehensively
tested
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active
RA naïve to MTX. Radiographic progression was a primary end point. ACR50 at Week 24 was a primary end point.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the
effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in
a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus
placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered
subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement in
the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-AFTER: a double-blind, placebo-controlled trial (N=461) to evaluate the effi cacy and safety of SIMPONI in
patients with active rheumatoid arthritis (RA) who had previously received one or more TNFα inhibitors. Patients
with active RA were randomly assigned (1:1:1) to placebo or SIMPONI 50 mg or 100 mg. The primary end point
was the proportion of patients who achieved 20% or higher improvement in ACR criteria for assessment of RA
(ACR20) at Week 14. At Week 16, patients who had less than 20% improvement in tender and swollen joint
counts were given rescue therapy in a double-blinded manner: patients in the placebo group received
SIMPONI 50 mg, patients in the SIMPONI 50-mg group had a dose escalation to 100 mg, and patients in the
SIMPONI 100-mg group continued to receive 100 mg.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active
PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4
weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria
at Week 14.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy
and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or
100 mg, or placebo every 4 weeks.
The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. At Week 16,
patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients
in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a
dose escalation to 100 mg, and patients in the SC SIMPONI 100-mg group continued to receive 100 mg of
SC SIMPONI. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aSIMPONI, in combination with MTX, is indicated for:
• the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to DMARD therapy
including MTX has been inadequate.
• the treatment of severe, active, and progressive rheumatoid arthritis in adults not previously treated with MTX.
SIMPONI, in combination with MTX, has been shown to reduce the rate of progression of joint damage as
measured by x-ray and to improve physical function.
bSIMPONI, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in
adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has been shown
to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular
symmetrical subtypes of the disease and to improve physical function.
cSIMPONI is indicated for the treatment of severe, active AS in adults who have responded inadequately to
conventional therapy.
RA = rheumatoid arthritis; MTX = methotrexate; TNF = tumor necrosis factor; PsA = psoriatic arthritis;
DMARD = disease-modifying antirheumatic drug; AS = ankylosing spondylitis.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Keystone EC, et al. Ann Rheum Dis. 2009;68(6):789–796. Erratum in: Ann Rheum Dis. 2011;70(1):238.
3. Emery P, et al. Arthritis Rheum. 2009;60(8):2272–2283. Erratum in: Arthritis Rheum. 2010;62(10):3005.
4. Smolen JS, et al. Lancet. 2009;374(9685):210–221.
5. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.
6. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenience and features that fit with everyday life
Developed for convenience with only 1 injection per month.1–6
Features citric acid–free formulationa and low injection volume (0.5 mL).1
Low level of ISRs, including pain1:
5.8% of patients on SIMPONI (50 mg and 100 mg) experienced ISRs vs
2.2% on placebo.1
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Dosing
information
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
✔ Monthly SIMPONI autoinjector 50 mg
✔ Monthly SIMPONI prefi lled syringe 50 mg
✘ Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
✔ Etanercept autoinjector 50 mg
✔ Etanercept prefi lled syringe 25 mg
✔ Certolizumab prefi lled syringe 200 mg
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Citric acid–free formulationa Injection volume
✔ Monthly SIMPONI autoinjector 50 mg
✔ Monthly SIMPONI prefi lled syringe 50 mg
✘ Adalimumab autoinjector 40 mg
and prefi lled syringe 40 mg
✔ Etanercept autoinjector 50 mg
✔ Etanercept prefi lled syringe 25 mg
✔ Certolizumab prefi lled syringe 200 mg
Citric acid–free formulationa Injection volume
0.5 mL
0.5 mL
0.8 mL
1.0 mL
1.0 mL
0.5 mL
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aA comparison of injection media found that a solution containing citrate as a buffer caused more pain
immediately after SC injection than did a solution with histidine as a buffer, which did not cause more pain
than the control saline solution.6
ISR = injection site reaction; SC = subcutaneous.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Humira. Summary of Product Characteristics. January 2012.
3. Enbrel. Summary of Product Characteristics. September 2011.
4. Cimzia. Summary of Product Characteristics. December 2011.
5. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.
6. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.
Brands mentioned are trademarks of their respective owners.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Only SC anti-TNF with monthly dosing1-6
Injections
per month
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1-6
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1-6
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per month
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1-6
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per month
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1-6
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per month
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1-6
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per month
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1-6
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per year
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1-6
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per year
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1-6
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per year
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1-6
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per year
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1-6
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per year
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1-6
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Injections
per year
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Humira. Summary of Product Characteristics. January 2012.
3. Enbrel. Summary of Product Characteristics. September 2011.
4. Cimzia. Summary of Product Characteristics. December 2011.
5. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.
6. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.
Brands mentioned are trademarks of their respective owners.
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
State-of-the-art SmartJect® autoinjector pen
Developed to help simplify administration
Also available as 0.5-mL,
single-use prefi lled syringe
Easy to handle
Easy-grip body
Large side button
Easy-twist cap
Easy to administer
2 audible clicks
Large observation window
Secure
Autoretract needle
Security seal
Built-in safety sleeve
In RA, SIMPONI has a recommended dose of 50 mg,
in combination with MTX, given once a month, on
the same date each month.1
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenient, single-use prefilled syringe
Developed to help simplify administration
Also available as 0.5-mL, single-use,
state-of-the-art SmartJect® autoinjector pen
Secure
Sturdy needle cover
Extra-fi ne needle
Easy to administer
Clear observation window
Easy-to-read labelEasy to handle
Needle guard
Thumb-sized plunger head
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
In RA, SIMPONI has a recommended dose of 50 mg,
in combination with MTX, given once a month, on
the same date each month.1
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
RA = rheumatoid arthritis; MTX = methotrexate.
Reference
1. SIMPONI. Summary of Product Characteristics. March 2012.
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Carefully tailored SIMPONI® for Me™ patient support program
Patient support program designed to complement the patient-doctor relationship:
Developed to help give patients on therapy with SIMPONI the confi dence they need to self-inject
Personalized, ongoing educational advice and support
Tailored to meet needs of treatment-naïve and biologic-experienced patients
Program includes A starter kit
Personalized
monthly reminder-
to-inject service
FREE
help line
Online
information
resource
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Any patients with medical questions concerning their condition
are advised to contact their health care professional.
Registering for
SIMPONI for Me
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
How patients can register for SIMPONI® for Me™
Complete and
return enrollment
form provided with
starter kit
Call
SIMPONI for Me at
<0000 0000 0000>
Visit
simponiforme.com
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
RA
SIMPONISUMMARYREMICADE®
(infl iximab)
Convenience
and support1
Proven and sustained
clinical effi cacy1,2
Rigorous clinical
trial program1,3,4
Helps get patients back to everyday life in a monthly SC dose
Clinical effi cacyffi Clinical experience Conveniencei
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Proven and sustained
clinical effi cacy1,2
Provided sustained ACR50 response
Achieved and maintained DAS28
remission
Inhibited radiographic progression
Signifi cantly improved HAQ scores
Helps get patients back to everyday life in a monthly SC dose
Clinical effi cacyffi Clinical experience Conveniencei
SIMPONISUMMARYREMICADE®
(infl iximab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenience
and support1
Rigorous clinical
trial program1,3,4
Proven and sustained
clinical effi cacy1,2
Provided sustained ACR50 response
Achieved and maintained DAS28
remission
Inhibited radiographic progression
Signifi cantly improved HAQ scores
Rigorous clinical
trial program1,3,4
Effi cacy in RA demonstrated in
three Phase 3 trials
Over 8 years of worldwide clinical
trial experience across indications
Over 80,000 patients treated
globally across indications
Helps get patients back to everyday life in a monthly SC dose
Clinical effi cacyffi Clinical experience Conveniencei
SIMPONISUMMARYREMICADE®
(infl iximab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenience
and support1
Convenience
and support1
Only SC anti-TNF with monthly
dosing
Choice of prefi lled autoinjector
pen or syringe
Carefully tailored patient support
program
Clinical effi cacyffi Clinical experience Conveniencei
Proven and sustained
clinical effi cacy1,2
Provided sustained ACR50 response
Achieved and maintained DAS28
remission
Inhibited radiographic progression
Signifi cantly improved HAQ scores
Rigorous clinical
trial program1,3,4
Effi cacy in RA demonstrated in
three Phase 3 trials
Over 8 years of worldwide clinical
trial experience across indications
Over 80,000 patients treated
globally across indications
Helps get patients back to everyday life in a monthly SC dose
SIMPONISUMMARYREMICADE®
(infl iximab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Effi cacy sustained through Week 52 with more than
half of patients achieving an ACR50 response.2Effi cacy sustained through Week 52 with more than
half of patients achieving an ACR50 response.2
Clinical efficacy
Effi cacy sustained through Week with more than
half of patients achieving an ACR50 response.5
Almost times more improvement in HAQ-DI
scores vs placebo + MTX alone at Week 24 (P<0.001).2
14 4224 52
2 43 5
2 43 5
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
times as many patients achieved DAS28
remission vs MTX alone (P<0.001) at Week 24.2
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical efficacy
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
RAClinical efficacy
Effi cacy sustained through Week 52 with more than
half of patients achieving an ACR50 response.5
Almost times more improvement in HAQ-DI
scores vs placebo + MTX alone at Week 24 (P<0.001).2
14 4224
2 43 5
2 43 5
times as many patients achieved DAS28
remission vs MTX alone (P<0.001) at Week 24.2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
RAClinical efficacy
Effi cacy sustained through Week 52 with more than
half of patients achieving an ACR50 response.514 4224
2 3 5
2 43 5
4 times as many patients achieved DAS28
remission vs MTX alone (P<0.001) at Week 24.2
Almost times more improvement in HAQ-DI
scores vs placebo + MTX alone at Week 24 (P<0.001).2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
RAClinical efficacy
Effi cacy sustained through Week 52 with more than
half of patients achieving an ACR50 response.5
Almost 3 times more improvement in HAQ-DI
scores vs placebo + MTX alone at Week 24 (P<0.001).2
14 4224
2 3 5
2 4 5
4 times as many patients achieved DAS28
remission vs MTX alone (P<0.001) at Week 24.2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical experience
Over patients treated globally.3,4
Over years of clinical trial experience.3,4
70,000 90,00080,000 100,000
3 85 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Over 80,000 patients treated globally.3,4
Over years of clinical trial experience.3,4
70,000 90,000 100,000
3 85 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical experience
Over 80,000 patients treated globally.3,4
Over 8 years of clinical trial experience.3,4
70,000 90,000 100,000
3 5 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical experience
Which of these products is NOT a citric acid–free formulation?1,6–10,a
Monthly SIMPONI autoinjector 50 mg
Monthly SIMPONI prefi lled syringe 50 mg
Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
Etanercept autoinjector 50 mg
Etanercept prefi lled syringe 25 mg
Certolizumab prefi lled syringe 200 mg
✘
Convenience
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Which of these products is NOT a citric acid–free formulation?1,6–10,a
Monthly SIMPONI autoinjector 50 mg
Monthly SIMPONI prefi lled syringe 50 mg
Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
Etanercept autoinjector 50 mg
Etanercept prefi lled syringe 25 mg
Certolizumab prefi lled syringe 200 mg
✔
✔
✔
✔
✔
✘
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
Convenience RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aA comparison of injection media found that a solution containing citrate as a buffer caused more pain
immediately after SC injection than did a solution with histidine as a buffer, which did not cause more pain
than the control saline solution.10
SC = subcutaneous; RA = rheumatoid arthritis; TNF = tumor necrosis factor;
ACR = American College of Rheumatology; MTX = methotrexate; DAS28 = Disease Activity Score 28;
HAQ= Health Assessment Questionnaire; HAQ-DI = Health Assessment Questionnaire Disability Index.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Keystone EC, et al. Ann Rheum Dis. 2009;68(6):789–796. Erratum in: Ann Rheum Dis. 2011;70(1):238.
3. Data on fi le. MSD SIMPONI PSUR 05.
4. http://clinicaltrials.gov/ct2/show/NCT00207714?term=cnto+148&rank=8. Accessed 01/31/12.
5. Keystone EC, et al. Ann Rheum Dis. 2010;69(6):1129–1135.
6. Humira. Summary of Product Characteristics. January 2012.
7. Enbrel. Summary of Product Characteristics. September 2011.
8. Cimzia. Summary of Product Characteristics. December 2011.
9. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.
10. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.
Brands mentioned are trademarks of their respective owners.
SIMPONISUMMARYREMICADE®
(infl iximab)
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
REMICADE provides an appropriate solution for patients with
active, uncontrolled disease who are at risk of noncompliance
and/or who have a preference for IV
REMICADE helps you deliver rapida relief, proven remission, and close management for patients with RA
In-offi ce infusion allows for closer patient monitoring and support
Improved signs and symptoms2
Weight-based dose optimization4
Helped prevent joint damage5
Improved quality of life1
Helped achieve biologic-free remission3REMICADE
rapida relief,
proven remission
REMICADE offers speeda and power
to help achieve sustained remission
in early and established RA.
Patient profi les
SIMPONISUMMARYREMICADE®
(infl iximab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
The patient at risk
of noncompliance
or who prefers
IV treatment
The patient
with active,
uncontrolled
disease
High CRP levels
Signs of erosive disease
High infl amed
joint count
Unable to understand and/
or follow treatment regimen
Unwilling or unable
to self-inject
Needs the reassurance of
regular contact with an HCP
SIMPONISUMMARYREMICADE®
(infl iximab)
RA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
IV = intravenous; RA = rheumatoid arthritis; CRP = C-reactive protein; HCP = health care professional.
References
1. Klarenbeek NB, et al. Ann Rheum Dis. 2011;70(6):1039–1046.
2. Maini R, et al. Lancet. 1999;354(9194):1932–1939.
3. Van der Kooij SM, et al. Ann Rheum Dis. 2009;68(6):914–921.
4. REMICADE. Summary of Product Characteristics. March 2012.
5. St Clair EW, et al. Arthritis Rheum. 2004;50(11):3432–3443.
SIMPONISUMMARYREMICADE®
(infl iximab)
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Copyright © 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ, USA. All rights reserved. RHEU-1070841-0003 02/13
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
RA Rheumatoid arthritis
EFFICACY
QoL
SAFETY
EXPERIENCE
SUMMARY
PsA Psoriatic arthritis
EFFICACY
QoL
SAFETY
EXPERIENCE
SUMMARY
ASAnkylosing spondylitis
EFFICACY
QoL
SAFETY
EXPERIENCE
SUMMARY
SIMPONI helps to provide proven reduction in disease
activity in PsA patients1,2
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n = 113)
SIMPONI 50 mg (n = 292)
ACR20 ACR50 ACR70
80
60
40
20
0
Patients
, %
9.0
30.0
2.0 1.0
P < 0.05
P < 0.05
P < 0.05
12.0
51.0
ACR response at Week 141,2
Week 24 Week 52 Week 104WWeeeekk 1144
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI 50 mg signifi cantly reduced signs and symptoms across all ACR criteria1,2:
The safety profi le
of SIMPONI in
PsA was
consistent with
that of other
anti-TNF agents.2
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n = 113)
SIMPONI 50 mg (n = 292)
ACR20 ACR50 ACR70
80
60
40
20
0
Patients
, %
12.0
32.0
4.0
19.0
1.0
P < 0.05
P < 0.05
P < 0.05
52.0
ACR response at Week 241,2
Week 52 Week 104Week 14
SIMPONI 50 mg signifi cantly reduced signs and symptoms across all ACR criteria1,2:
SIMPONI helps to provide proven reduction in disease
activity in PsA patients1,2
The safety profi le
of SIMPONI in
PsA was
consistent with
that of other
anti-TNF agents.2
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n =113)
SIMPONI 50 mg (n=146)
67.165.5
48.638.9
19.5
ACR20 ACR50 ACR70
35.6
80
60
40
20
0
Patients
, %
ACR response at Week 521– 3
Week 24 WWeeeekk 5522 Week 104Week 14
SIMPONI 50 mg signifi cantly reduced signs and symptoms across all ACR criteria1,2:
The safety profi le
of SIMPONI in
PsA was
consistent with
that of other
anti-TNF agents.2
SIMPONI helps to provide proven reduction in disease
activity in PsA patients1,2
Week 24 Week 52 WWeeeekk 110044Week 14
SIMPONI 50 mg signifi cantly reduced signs and symptoms across all ACR criteria1,2:
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Clinical improvements across all ACR
criteria were maintained through Week 104.2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps to provide proven reduction in disease
activity in PsA patients1,2
The safety profi le
of SIMPONI in
PsA was
consistent with
that of other
anti-TNF agents.2
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
PsA = psoriatic arthritis; ACR = American College of Rheumatology; SC = subcutaneous;
TNF = tumor necrosis factor.
References
1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
2. SIMPONI. Summary of Product Characteristics. March 2012.
3. Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: 10.1002/art.34436. [Epub ahead of print]
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N = 405) in patients with active
PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every
4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement
criteria at Week 14.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps provide proven reduction in disease activity
in PsA patients1,2
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Placebo
(n=113)
SIMPONI 50 mg monthly
(n=146)
2
1.5
1
0.5
0Imp
rove
ments
in D
AS
28
0.1
1.5P < 0.001
Week 52 Week 104
DAS28 scores
were maintained
through 2 years.2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
DAS28 scores at Week 241,a
SIMPONI helped achieve a signifi cant improvement in DAS28 scores at Week 24 (P<0.001)1,a
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Week 24 WWeeeekk 5522 Week 104
DAS28-CRP response of good/moderate
was achieved by
82% of patients treated with
SIMPONI 50 mg at Week 52.3
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps provide proven reduction in disease activity
in PsA patients1,2
SIMPONI helped achieve a signifi cant improvement in DAS28 scores at Week 24 (P<0.001)1,a
DAS28 scores
were maintained
through 2 years.2
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Week 24 Week 52 WWeeeekk 110044
DAS28 scores were
maintained through 2 years.2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps provide proven reduction in disease activity
in PsA patients1,2
SIMPONI helped achieve a signifi cant improvement in DAS28 scores at Week 24 (P<0.001)1,a
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
aDAS28 remission was compiled using CRP; lower score equals improvement.
PsA = psoriatic arthritis; DAS28 = Disease Activity Score 28; CRP = C-reactive protein; SC = subcutaneous;
ACR = American College of Rheumatology.
References
1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
2. SIMPONI. Summary of Product Characteristics. March 2012.
3. Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: 10.1002/art.34436. [Epub ahead of print]
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N= 405) in patients with
active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo
every 4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement
criteria at Week 14.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps inhibit structural damage in active PsA
Helps prevent long-term damage
SIMPONI signifi cantly inhibited structural damage in active PsA through Week 24
(–0.16 vs 0.27 for placebo; P= 0.011).1
Prevention of structural damage was maintained through Week 52 and Week 104,
with 77% of patients experiencing no progression from baseline.1
PsA
Radiographic
progression
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
0.4
0.2
0
-0.2
-0.4Mean c
hang
e in S
HS
fro
m b
aselin
e
0 Weeks
0.00 Weeks
0.0
SIMPONI 50 mg monthly
(n=146)
Placebo
(n=113)
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Change in radiographic progression to Week 241,2
Week 52Week 24WWeekk 00
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
0.4
0.2
0
-0.2
-0.4Mean c
hang
e in S
HS
fro
m b
aselin
e
24 Weeks
-0.16
24 Weeks
0.27 P=0.011
SIMPONI 50 mg monthly
(n=146)
Placebo
(n=113)
All patients randomized to placebo received
SIMPONI 50 mg monthly from Week 24
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Change in radiographic progression to Week 241,2
Week 52WWeekk 2244Week 0
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
WWeekk 5522Week 24Week 0
0.4
0.2
0
-0.2
-0.4Mean c
hang
e in S
HS
fro
m b
aselin
e
52 Weeks
-0.22
52 Weeks
0.22
SIMPONI 50 mg monthly
(n=146)
Placebo
(n=113)
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Change in radiographic progression to Week 521,2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
PsA = psoriatic arthritis; SHS = Sharp/van der Heijde score; SC = subcutaneous;
ACR = American College of Rheumatology.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: 10.1002/art.34436. [Epub ahead of print]
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active
PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every
4 weeks through Week 20. All patients, including those randomized to placebo, received SIMPONI from Week 24
through Week 104. The primary end point was the proportion of patients meeting the ACR20 improvement criteria
at Week 14. Radiographs of the hands and feet were obtained at Weeks 0, 24, 52, and 104.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps improve signs and symptoms of psoriasis
SIMPONI helped to signifi cantly reduce severity of skin psoriasisa (PASI50, 75, and 90; P<0.001)1
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Nail
appearance
Improvement in PASI scores at Week 241
Placebo (n=113)
SIMPONI 50 mg monthly (n=146)
80
60
40
20
0
Patients
, %
PASI50 PASI75 PASI90
76.0
8.0
56.0
1.0
32.0
0.0
P < 0.001
P < 0.001
P < 0.001
Week 52WWeekk 2244
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Nail
appearance
Improvement in PASI75 score at Week 522
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=113)
SIMPONI 50 mg monthly (n=146)
80
60
40
20
0
Patients
, %
62.448.1
Week 24
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps improve signs and symptoms of psoriasis
SIMPONI helped to signifi cantly reduce severity of skin psoriasisa (PASI50, 75, and 90; P<0.001)1
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
aAmong the 74% of patients in whom ≥3% of body surface area was affected by psoriasis at baseline.
PASI = Psoriasis Area and Severity Index; PsA = psoriatic arthritis; SC = subcutaneous;
ACR = American College of Rheumatology.
References
1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
2. Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: 10.1002/art.34436. [Epub ahead of print]
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N = 405) in patients with
active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo
every 4 weeks through Week 20. All patients, including those randomized to placebo, received SIMPONI from
Week 24 through Week 52. The study was unblinded at Week 52. The primary end point was the proportion
of patients meeting the ACR20 improvement criteria at Week 14.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps restore normal appearance to nails1
NAPSI
improvements
were sustained
through
Week 52.2
SIMPONI helped to signifi cantly improve psoriatic nail disease as measured by NAPSI (P=0.015
Week 14; P<0.001 Week 24)1:
Improvement in NAPSI score1
Placebo (n=113)
SIMPONI 50 mg monthly (n=146)
40
20
0Med
ian c
hang
e in
NA
PS
I sco
re, %
25.0
0.0 0.0
33.0P<0.001
P=0.015
Week 14 Week 24
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
NAPSI = Nail Psoriasis Severity Index; PsA = psoriatic arthritis; SC = subcutaneous;
ACR = American College of Rheumatology.
References
1. Kavanaugh A, et al. Arthritis Rheum. 2009;60:976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
2. Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: 10.1002/art.34436. [Epub ahead of print]
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active
PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every
4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement
criteria at Week 14.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps reduce the signs and symptoms
of enthesitis
SIMPONI has shown signifi cant
effi cacy against most of the
manifestations associated with PsA.1–4
In GO-REVEAL, SIMPONI signifi cantly improved enthesitis and reduced the
proportion of patients with enthesitis vs placebo at Week 241,a:
5 times greater improvement in PsA-modifi ed MASES score vs placebo at
Week 24 (60% vs 12%, P<0.001)
PsA
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA.
Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks
through Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria
at Week 14.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptoms
of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis
aSIMPONI 50 mg monthly.
MASES = Maastricht Ankylosing Spondylitis Enthesitis Score; PsA = psoriatic arthritis; SC = subcutaneous;
ACR = American College of Rheumatology.
References
1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
2. Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: 10.1002/art.34436. [Epub ahead of print]
3. Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):1387−1394.
4. SIMPONI. Summary of Product Characteristics. March 2012.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps improve patient QoL
10 times more improvement in QoL score with SIMPONI 50 mg vs placebo1:
Mean improvement in PCS component of SF36 of 6.5 in the group receiving
SIMPONI 50 mg vs 0.6 for placebo at Week 14 (P<0.001).
Improvement was maintained through Week 52.2
PsA
Improved QoLQoL Summary
Improvement in QoL
Placebo (n=113)
SIMPONI 50 mg monthly (n=146)
Week 14 Week 52
12
10
8
6
4
2
0Mean c
hang
e f
rom
baselin
e
in S
F36 P
CS
sco
re
6.5
0.6
9.98.3P<0.001
Safety
profi le
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
PsA
Improved QoLQoL Summary
Safety profi le through Week 52:
Safety fi ndings through Week 52 were consistent with Week 24 results and with
other biologic agents, including anti-TNF agents.2
The most commonly reported AEs at Weeks 24 and 52 were respiratory infections
and nasopharyngitis (at Week 24, 9% SIMPONI vs 6% placebo, and 9% SIMPONI
vs 4% placebo, respectively).1,2
No patient developed active tuberculosis or an opportunistic infection
through Week 52.2
3% of the group receiving SIMPONI and 4% of the placebo group discontinued
treatment before Week 24.1
ISRs occurred in 3% of the groups receiving either placebo or SIMPONI at
Week 24. No ISR was severe, serious, or resulted in discontinuation of treatment.1
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N = 405) in patients with active
PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every
4 weeks through Week 20. All patients, including those randomized to placebo, received SIMPONI from Week
24 through Week 52. The study was unblinded at Week 52. The primary end point was the proportion of patients
meeting the ACR20 improvement criteria at Week 14.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Improved QoLQoL Summary
QoL = quality of life; SF36 PCS = Short Form-36 physical component summary score; PsA = psoriatic arthritis;
SC = subcutaneous; ACR = American College of Rheumatology; TNF = tumor necrosis factor; AE = adverse
event; ISR = injection site reaction.
References
1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
2. Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: 10.1002/art.34436. [Epub ahead of print]
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Improved QoLQoL Summary
PsA
Improved most
PsA-associated
comorbidities2,3
Reduced signs
and symptoms1,2
Reduced
disease activity1,2
Improved QoLQoL Summary
Efficacy with monthly SC SIMPONI
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
PsAEfficacy with monthly SC SIMPONI
Improved QoLQoL Summary
Reduced signs
and symptoms1,2
8 times more patients achieved
an ACR50 response at Week 24a
ACR response maintained
through 2 yearsb
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Improved most
PsA-associated
comorbidities2,3
Reduced
disease activity1,2
PsA
Reduced signs
and symptoms1,2
8 times more patients achieved
an ACR50 response at Week 24a
ACR response maintained
through 2 yearsb
Reduced
disease activity1,2
Signifi cant improvement in
DAS28 scores at Week 24,
maintained over 2 years
Helped to prevent structural
damage through Week 52 and
Week 104 to help maintain
everyday functioning
Efficacy with monthly SC SIMPONI
Improved QoLQoL Summary
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Improved most
PsA-associated
comorbidities2,3
PsA
Improved most
PsA-associated
comorbidities2,3
Signifi cant improvement in
skin response (PASI), nail
disease (NAPSI), and enthesitis
(PsA-modifi ed MASES)
Efficacy with monthly SC SIMPONI
Improved QoLQoL Summary
Reduced signs
and symptoms1,2
8 times more patients achieved
an ACR50 response at Week 24a
ACR response maintained
through 2 yearsb
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Reduced
disease activity1,2
Signifi cant improvement in
DAS28 scores at Week 24,
maintained over 2 years
Helped to prevent structural
damage through Week 52 and
Week 104 to help maintain
everyday functioning
aACR50 response at Week 24: 32% for SIMPONI 50 mg vs 4% for placebo.
bACR50 response at Week 104 of 46% for SIMPONI 50 mg.
ACR = American College of Rheumatology; PsA = psoriatic arthritis; PASI = Psoriasis Area and Severity Index;
NAPSI = Nail Psoriasis Severity Index; MASES = Maastricht Ankylosing Spondylitis Enthesitis Score;
DAS28 = Disease Activity Score 28; SC = subcutaneous; SF36 PCS = Short Form-36 physical component
summary score.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
3. Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):138−1394.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Improved QoLQoL Summary
Safety profile of SIMPONI after 3 years1,2
In Phase 3 trials through 3 years1:
7.4% of patients receiving injections of SIMPONI 50 mg discontinued therapy
because of adverse events vs 4.9% of those receiving placebo injections.
SIMPONI has over 8 years of worldwide
clinical trial experience and has been
used in over 80,000 patients.2,3
3-year safety data SAFETYComprehensively
tested
Adverse
event data
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
PsA
An analysis of pooled data from the long-term extensions of randomized,
double-blind, placebo-controlled studies in AS, RA, and PsA1:
Adverse event2 (Pooled data) SIMPONI 50 mg +/– MTX Placebo +/– MTX
Patients treated (n) 1,317 674
Deathsa 0.30 0.28
All serious infectionsa 3.03 5.31
Tuberculosis (TB)a 0.17 0.00
Opportunistic infections other than TBa
0.13 0.00
Malignancy Nonmelanoma skin cancersTotal patient-years of follow-upIncidence/100 patient-years
2,3050.43
3561.40
LymphomaTotal patient-years of follow-upIncidence/100 patient-years
2,3130.04
3580.00
Other malignanciesTotal patient-years of follow-upIncidence/100 patient-years
2,3080.78
3570.56
Includes SIMPONI SC
Phase 2b studies in
addition to Phase 3
AS, RA, and PsA.
3-year safety data SAFETYComprehensively
tested
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aIncidence per 100 patient-years.
MTX = methotrexate; AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis.
References
1. Kay J, et al. ACR 2011; abstract 2227.
2. Data on fi le. MSD SIMPONI PSUR 05.
3. http://clinicaltrials.gov/ct2/show/NCT00207714?term=cnto+148&rank=8. Accessed 01/31/12.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI —comprehensively tested in worldwide trials
SIMPONI has been extensively
tested in a worldwide clinical
trial program in more than 2,300
patients, including different RAa
patient groups, as well as those
with PsAb or ASc.1–6
A comprehensive development program:
Phase 3 clinical trials in over 2,300 rheumatology patients1–6
Trial Indication Patient type Subjects, N
GO-BEFORE Active RAa MTX naïve 637
GO-FORWARD Active RAa MTX nonresponders 444
GO-AFTER Active RAa Anti-TNF experienced 461
GO-REVEAL Active PsAbDMARD
nonresponders405
GO-RAISE Active AScConventional therapy
nonresponders356
3-year safety data SAFETYComprehensively
tested
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N= 637) in patients with active
RA naïve to MTX. Radiographic progression was a primary end point. ACR50 at Week 24 was a primary end point.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the
effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in
a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus
placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered
subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement in
the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-AFTER: a multicenter, double-blind, placebo-controlled Phase III trial (N=461) to evaluate the effi cacy
and safety of SIMPONI in patients with active rheumatoid arthritis (RA) who had previously received one or
more TNFα inhibitors. Patients with active RA were randomly assigned (1:1:1) to placebo, SIMPONI 50 mg, or
SIMPONI 100 mg. The primary end point was the proportion of patients who achieved 20% or higher improvement
in ACR criteria for assessment of RA (ACR20) at Week 14. At Week 16, patients who had <20% improvement in
tender and swollen joint counts were given rescue therapy in a double-blinded manner: patients in the placebo
group received SIMPONI 50 mg, patients in the SIMPONI 50-mg group had a dose escalation to 100 mg, and
patients in the SIMPONI 100-mg group continued to receive 100 mg.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-REVEAL: a randomized, double-blind, placebo-controlled study (N=405) in patients with active PsA. Patients
were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks to Week 20.
The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy
and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or
100 mg or placebo, every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20
response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape
in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group
receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to
receive 100 mg. All other patients in the placebo group were switched in Week 24 to SC SIMPONI 50 mg.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aSIMPONI, in combination with MTX, is indicated for:
• The treatment of moderate to severe, active rheumatoid arthritis in adults when the response to DMARD
therapy including MTX has been inadequate.
• The treatment of severe, active, and progressive rheumatoid arthritis in adults not previously treated with MTX.
SIMPONI, in combination with MTX, has been shown to reduce the rate of progression of joint damage as
measured by x-ray and to improve physical function.
bSIMPONI, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in
adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has been shown
to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular
symmetrical subtypes of the disease and to improve physical function.
cSIMPONI is indicated for the treatment of severe, active AS in adults who have responded inadequately to
conventional therapy.
RA = rheumatoid arthritis; MTX = methotrexate; TNF = tumor necrosis factor; PsA = psoriatic arthritis;
DMARD = disease-modifying antirheumatic drug; AS = ankylosing spondylitis.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Keystone EC, et al. Ann Rheum Dis. 2009;68(6):789–796. Erratum in: Ann Rheum Dis. 2011;70(1):238.
3. Emery P, et al. Arthritis Rheum. 2009;60(8):2272–2283. Erratum in: Arthritis Rheum. 2010;62(10):3005.
4. Smolen JS, et al. Lancet. 2009;374(9685):210–221.
5. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.
6. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenience and features that fit with everyday life
Developed for convenience with only 1 injection per month.1–5
Features citric acid–free formulationa and low injection volume (0.5 mL).1
Low level of ISRs, including pain:
5.8% of patients on SIMPONI (50 mg and 100 mg) experienced ISRs vs
2.2% on placebo.1
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Dosing
information
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
✔ Monthly SIMPONI autoinjector 50 mg
✔ Monthly SIMPONI prefi lled syringe 50 mg
✘ Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
✔ Etanercept autoinjector 50 mg
✔ Etanercept prefi lled syringe 25 mg
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Citric acid–free formulationa Injection volume
✔ Monthly SIMPONI autoinjector 50 mg
✔ Monthly SIMPONI prefi lled syringe 50 mg
✘ Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
✔ Etanercept autoinjector 50 mg
✔ Etanercept prefi lled syringe 25 mg
0.5 mL
0.5 mL
0.8 mL
1.0 mL
0.5 mL
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Citric acid–free formulationa Injection volume
aA comparison of injection media found that a solution containing citrate as a buffer caused more pain
immediately after SC injection than did a solution with histidine as buffer, which did not cause more pain
than the control saline solution.5
ISR = injection site reaction; SC=subcutaneous.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Humira. Summary of Product Characteristics. January 2012.
3. Enbrel. Summary of Product Characteristics. September 2011.
4. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.
5. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.
Brands mentioned are trademarks of their respective owners.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Only SC anti-TNF with monthly dosing1 –5
Injections
per month
Injections
per year
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1–5
Injections
per year
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1–5
Injections
per year
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Injections
per month
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1–5
Injections
per year
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Injections
per month
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1–5
Injections
per year
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Injections
per month
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1–5
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Injections
per year
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1–5
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Injections
per year
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1–5
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Injections
per year
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1–5
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Injections
per year
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
Only SC anti-TNF with monthly dosing1–5
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Injections
per year
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Injections
per month
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Humira. Summary of Product Characteristics. January 2012.
3. Enbrel. Summary of Product Characteristics. September 2011.
4. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.
5. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.
Brands mentioned are trademarks of their respective owners
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
State-of-the-art SmartJect® autoinjector pen
Developed to help simplify administration
Also available as 0.5-mL,
single-use prefi lled syringe
Easy to handle
Easy-grip body
Large side button
Easy-twist cap
Easy to administer
2 audible clicks
Large observation window
Secure
Autoretract needle
Security seal
Built-in safety sleeve
In PsA, SIMPONI 50 mg is given once a month,
on the same date each month.1
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenient, single-use prefilled syringe
Developed to help simplify administration
Also available as 0.5-mL, single-use,
state-of-the-art SmartJect® autoinjector pen
Secure
Sturdy needle cover
Extra-fi ne needle
Easy to administer
Clear observation window
Easy-to-read labelEasy to handle
Needle guard
Thumb-sized plunger head
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
In PsA, SIMPONI 50 mg is given once a month,
on the same date each month.1
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
PsA = psoriatic arthritis.
Reference
1. SIMPONI. Summary of Product Characteristics. March 2012.
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Carefully tailored SIMPONI® for Me™ patient support program
Patient support program designed to complement the patient–doctor relationship:
Developed to help give patients on therapy with SIMPONI the confi dence they need to self-inject
Personalized, ongoing educational advice and support
Tailored to meet needs of treatment-naïve and biologic-experienced patients
Program includes A starter kit
Personalized
monthly reminder-
to-inject service
FREE
help line
Online
information
resource
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Any patients with medical questions concerning their condition
are advised to contact their health care professional.
Registering for
SIMPONI for Me
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
PsA
How patients can register for SIMPONI® for Me™
Complete and
return enrollment
form provided with
starter kit
Call
SIMPONI for Me at
<0000 0000 0000>
Visit
simponiforme.com
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ConvenienceEXPERIENCEState-of-the-art
devicesMonthly dosing
Patient support
program
PsA
SIMPONISUMMARYREMICADE®
(infl iximab)
Helps get patients back to everyday life in a monthly SC dose
Clinical effi cacyffi Safety Conveniencei
Convenience and support1
Proven and sustained
clinical effi cacy1–3
Rigorous clinical
trial program1
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Helps get patients back to everyday life in a monthly SC dose
Clinical effi cacyffi Safety Conveniencei
SIMPONISUMMARYREMICADE®
(infl iximab)
Convenience and support1
Proven and sustained
clinical effi cacy1–3
Sustained improvements in ACR
response criteria
Effi cacy against key manifestations
associated with PsA, including skin
and nail disease
Improved QoL
Rigorous clinical
trial program1
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Helps get patients back to everyday life in a monthly SC dose
Clinical effi cacyffi Safety Conveniencei
SIMPONISUMMARYREMICADE®
(infl iximab)
Convenience and support1
Proven and sustained
clinical effi cacy1–3
Sustained improvements in ACR
response criteria
Effi cacy against key manifestations
associated with PsA, including skin
and nail disease
Improved QoL
Rigorous clinical
trial program1
Approval for PsA, RA, and
AS at launch
Trials in wide range of patient
types and treatment experience
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenience and support1
Only SC anti-TNF with
monthly dosing
Carefully tailored patient
support program
Clinical effi cacyffi Safety Conveniencei
Proven and sustained
clinical effi cacy1–3
Sustained improvements in ACR
response criteria
Effi cacy against key manifestations
associated with PsA, including skin
and nail disease
Improved QoL
Rigorous clinical
trial program1
Approval for PsA, RA, and
AS at launch
Trials in wide range of patient
types and treatment experience
Helps get patients back to everyday life in a monthly SC dose
SIMPONISUMMARYREMICADE®
(infl iximab)
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical efficacy
Clinical improvements across all ACR criteria were
maintained through Week .1
times more improvement in QoL score with
SIMPONI 50 mg vs placebo.2
24 7652 104
37 7753 85
4 86 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
Prevention of structural damage was maintained
through Week 52 and Week 104, with % of
patients experiencing no progression from baseline.1
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical efficacy
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
Clinical efficacy PsA
Clinical improvements across all ACR criteria were
maintained through Week 104.1
times more improvement in QoL score with
SIMPONI 50 mg vs placebo.2
24 7652
37 7753 85
4 86 10
Prevention of structural damage was maintained
through Week 52 and Week 104, with % of
patients experiencing no progression from baseline.1
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
Clinical efficacy PsA
Clinical improvements across all ACR criteria were
maintained through Week 104.1
times more improvement in QoL score with
SIMPONI 50 mg vs placebo.2
24 7652
37 53 85
4 86 10
Prevention of structural damage was maintained
through Week 52 and Week 104, with 77% of
patients experiencing no progression from baseline.1
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
Clinical efficacy PsA
Clinical improvements across all ACR criteria were
maintained through Week 104.1
10 times more improvement in QoL score with
SIMPONI 50 mg vs placebo.2
24 7652
37 53 85
4 86
Prevention of structural damage was maintained
through Week 52 and Week 104, with 77% of
patients experiencing no progression from baseline.1
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Over patients treated globally.4,5
Over years of clinical trial experience.4,5
70,000 90,00080,000 100,000
3 85 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
Clinical experience PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Over 80,000 patients treated globally.4,5
Over years of clinical trial experience.4,5
70,000 90,000 100,000
3 85 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical experience
Over 80,000 patients treated globally.4,5
70,000 90,000 100,000
3 5 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
PsA
Over 8 years of clinical trial experience.4,5
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical experience
Which of these products is NOT a citric acid–free formulation?1,6–9,a
Monthly SIMPONI autoinjector 50 mg
Monthly SIMPONI prefi lled syringe 50 mg
Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
Etanercept autoinjector 50 mg
Etanercept prefi lled syringe 25 mg
✘
Convenience
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Which of these products is NOT a citric acid–free formulation?1,6–9,a
Monthly SIMPONI autoinjector 50 mg
Monthly SIMPONI prefi lled syringe 50 mg
Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
Etanercept autoinjector 50 mg
Etanercept prefi lled syringe 25 mg
✔
✔
✔
✔
✘
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
Convenience PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
a A comparison of injection media found that a solution containing citrate as a buffer caused more pain
immediately after SC injection than did a solution with histidine as a buffer, which did not cause more pain than
the control saline solution.9
SC = subcutaneous; ACR = American College of Rheumatology; QoL = quality of life;
AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis; TNF = tumor necrosis factor.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
3. Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):1387–1394.
4. Data on fi le. MSD SIMPONI PSUR 05.
5. http://clinicaltrials.gov/ct2/show/NCT00207714?term=cnto+148&rank=8.
6. Humira. Summary of Product Characteristics. January 2012.
7. Enbrel. Summary of Product Characteristics. September 2011.
8. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.
9. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.
Brands mentioned are trademarks of their respective owners
SIMPONISUMMARYREMICADE®
(infl iximab)
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
REMICADE provides an appropriate solution for patients with
high disease activity who are at risk of noncompliance and/or
have a preference for IVREMICADE helps you deliver rapida relief, sustained improvement, and close management for patients with PsA
In-offi ce infusion allows for closer patient monitoring and support
Improvements in PsA manifestations2–6
Long-term inhibition of radiographic progression8
Recommended by GRAPPA for all PsA manifestations9
Rapida relief of articular symptoms1–3
Sustained improvement in structural damage7REMICADE:
rapida relief,
proven remission
REMICADE offers speeda and power
to help achieve sustained remission
in early and established PsA.
Patient profi les
SIMPONISUMMARYREMICADE®
(infl iximab)
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
The patient at risk
of noncompliance
or who prefers
IV treatment
The patient
with active,
uncontrolled
disease
High CRP levels
Signs of erosive disease
High infl amed
joint count
Unable to understand and/
or follow treatment regimen
Unwilling or unable
to self-inject
Needs the reassurance of
regular contact with an HCP
SIMPONISUMMARYREMICADE®
(infl iximab)
PsA
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aRapid and speed are defi ned as response by Week 2.
IV = intravenous; GRAPPA = Group for Research and Assessment of Psoriasis and Psoriatic Arthritis;
PsA = psoriatic arthritis.
References
1. Baranauskaite A, et al. Ann Rheum Dis. 2012;71(4):541–548.
2. Antoni C, et al. Arthritis Rheum. 2005;52(4):1227–1236.
3. Antoni C, et al. J Rheumatol. 2008;35(5):869–876.
4. Reich K, et al. Lancet. 2005;366(9494);1367–1374.
5. Antoni C, et al. Ann Rheum Dis. 2005;64(8):1150–1157.
6. Kavanaugh A, et al. Ann Rheum Dis. 2007;66(4):498–505.
7. Van der Heijde D, et al. Ann Rheum Dis. 2007;56(8);2698–2707.
8. Kavanaugh A, et al. Ann Rheum Dis. 2006;65(8):1038–1043.
9. Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):1387–1394.
SIMPONISUMMARYREMICADE®
(infl iximab)
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Copyright © 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ, USA. All rights reserved. RHEU-1070841-0002 02/13
RA Rheumatoid arthritis
EFFICACY
QoL
SAFETY
EXPERIENCE
SUMMARY
PsA Psoriatic arthritis
EFFICACY
QoL
SAFETY
EXPERIENCE
SUMMARY
ASAnkylosing spondylitis
EFFICACY
QoL
SAFETY
EXPERIENCE
SUMMARY
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps to significantly reduce signs and symptoms of AS
SIMPONI 50 mg helped achieve a greater ASAS20 response 4 weeks after
the fi rst injection vs placebo1: 59% of patients receiving SIMPONI 50 mg achieved the primary end
point of an ASAS20 response vs 22% of placebo patients by Week 14
(P<0.001).1,2
ASAS40
response data
Clinical improvements in ASAS20 and ASAS40 were
maintained through 2 years, and 32% of patients receiving
SIMPONI 50 mg were in ASAS partial remission.3
AS
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
100
80
60
40
20
0
Patients
, %
Week 64 76 88 104
EEPE XO
20161440 8 12 24 28 32 36 40 44 48 52
ASAS40 response at Week 1043
Week 104Week 28Week 14Week 4
AS
Signs and symptomsEFFICACY Spinal infl ammationFunctioningSigns and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
100
80
60
40
20
0
Patients
, %
Week 64 76 88 104
EEPE XO
20161440 8 12 24 28 32 36 40 44 48 52
Week 104Week 28Week 14Week 4
ASAS40 response at Week 1043
Greaateer proportions of patients in theroppp opop
SIMMPOONI grouups achieved an ASAS40 g pON
respponnse 4 weeeks after the fi rst injection.resporere pp
ASAS40 response at Week 41
AS
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
100
80
60
40
20
0
Patients
, %
Week 64 76 88 104
EEPE XO
20161440 8 12 24 28 32 36 40 44 48 52
Week 4
ASAS40 response at Week 1043
43.5%% of SIMPONI patientsof43.5% S43 5% of S% of %% ofof
15.4%% of placebo patients4%
(switchhed to SIMPONI 50 mg (s((s
at Weeek 16 or Week 24)
ASAS40 response at Week 141
AS
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Week 104Week 28Week 14
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
100
80
60
40
20
0
Patients
, %
Week 64 76 88 104
EEPE XO
20161440 8 12 24 28 32 36 40 44 48 52
Week 104Week 28Week 14Week 4
ASAS40 response at Week 1043
54% of SIMPONI patients54% of SIMPONI patients% S M I nt% of SIMPONI patients4% of SIMM%% oo SS
48% of placebo patients484
(switched to SIMPONI 50 mg ( it h d t SIMPONI 50
at Week 16 or Week 24)
ASAS40 response at Week 281
AS
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
100
80
60
40
20
0
Patients
, %
Week 64 76 88 104
EEPE XO
20161440 8 12 24 28 32 36 40 44 48 52
Week 104Week 28Week 14Week 4
ASAS40 response at Week 1043
75% of SIMPONI patientsPONI patientststspp
79% of placebo patients79% f l b ti t% of pl% of pla79% o%% ofof99
(switched to SIMPONI 50 mg (
at Week 16 or Week 24)
ASAS40 response at Week 1043
AS
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
AS = ankylosing spondylitis; ASAS = ASsessment in AS international working group criteria;
PE = primary endpoint; EE = early escape; XO = crossover; SC = subcutaneous.
References
1. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.
2. SIMPONI. Summary of Product Characteristics. March 2012.
3. Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy
and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or
100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20
response at Week 14. Observed data are presented without imputation. At Week 16, patients who had failed
to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group
received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to
100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group
were changed over in Week 24 to SC SIMPONI 50 mg.
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps to achieve sustained improvements in functioning,
pain, and stiffness over time
SIMPONI 50 mg helped improve disease activity (BASDAI50) and physical function
(BASFI) scores at Week 24 vs placebo (P<0.001)1:
Half of patients achieved BASDAI50 at Week 24 (51% vs 15% placebo; P<0.001).1
AS
Clinical improvements in disease activity and physical
function were maintained through 2 years with
SIMPONI 50 mg (both <3 at Week 104).2
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
BASDAI50
response data
BASFI
response data
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
10
8
6
4
2
0
Mean B
AS
DA
I sco
re
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
PE XOEE
0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104
Week 104Week 28Week 14Week 4
BASDAI50 response at Week 1042AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
10
8
6
4
2
0
Mean B
AS
DA
I sco
re
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
PE XOEE
0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104
Week 28Week 14Week 4
BASDAI50 response at Week 1042
A ggreaater prooportion of patients in A greater proportion of patients inA greaAA grgreaea
thee SIIMPONI group achieved a ≥50% MPOMPMPOO
impproovemennt in BASDAI score 4 weeksimprovement in BASDAI score 4 weeksimp ovemeimprovemeent inntnt inin
afteer tthe fi rsst injection.st in e tiont injectionction.titionon
BASDAI50 response at Week 42
AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Week 104
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
10
8
6
4
2
0
Mean B
AS
DA
I sco
re
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
PE XOEE
0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104
Week 28Week 14Week 4 Week 104
BASDAI50 response at Week 1042
45.9%% of SIMPONI patients4
15.4%% of placebo patients15 4% of placebo patients4% %%
(switcched to SIMPONI 50 mg ched to S MPON mched to SIMPONI 50 mg o SIMPONI toto SS MMPPONON
at Week 16 or Week 24)at Week 16 or Week 24)
BASDAI50 response at Week 141
AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
10
8
6
4
2
0
Mean B
AS
DA
I sco
re
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
PE XOEE
0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104
Week 14Week 4 Week 104
BASDAI50 response at Week 1042
53% of SIMPONI patients
50% of placebo patients5050
(switched to SIMPONI 50 mg ched to P 0hed to SIMPONI 50 mgtched to SIMPONI 50 mgwiwi hheded toto PP 00
at Week 16 or Week 24)
BASDAI50 response at Week 282
AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
10
8
6
4
2
0
Mean B
AS
DA
I sco
re
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
PE XOEE
0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104
Week 28Week 14Week 4 Week 104
BASDAI50 response at Week 1042
72% of SIMPONI patients
74% of placebo patients74% of placebo patients77
(switched to SIMPONI 50 mg ( tched o O mwitched to SIMPONI 50 mgitched to SIMPONI 50 mg tctchehed d to o OO mm
at Week 16 or Week 24)W k 16 W k 24)
BASDAI50 response at Week 1042
AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
10
8
6
4
2
0
Mean B
AS
FI sco
re
Week
EEPE XO
0 4 8 12 14 16 202428323640444852 64 76 88 104
AS
Week 104Week 28Week 14Week 4
BASFI response at Week 1042AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
10
8
6
4
2
0
Mean B
AS
FI sco
re
Week
EEPE XO
0 4 8 12 14 16 202428323640444852 64 76 88 104
Week 14Week 4
BASFI response at Week 1042
Moore patieents in the SIMPONI group More pMMororee
achhieeved iimprovements in BASFI achieved improvements in BASFIimpd iimmpmp
scoorees 4 wweeks after the fi rst injection.4 weeks after the fi rst injection4 weeks a ter he fi eafter the fi rst aa teter r hehe fifi
BASFI response at Week 41
AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Week 104Week 28
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
10
8
6
4
2
0
Mean B
AS
FI sco
re
Week
EEPE XO
0 4 8 12 14 16 202428323640444852 64 76 88 104
Week 14Week 4 Week 104Week 28
BASFI response at Week 1042
3.6—SIMPONI patients3
5.0—placebo patients5 0—placepp acaceb
(swwitched to SIMPONI 50 mg o SIMPONI 50 mgt S MPON mgMPONI 50 mgSS MIMPPONON mgmg
at WWeek 16 or Week 24)
BASFI response at Week 141
AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
10
8
6
4
2
0
Mean B
AS
FI sco
re
Week
EEPE XO
0 4 8 12 14 16 202428323640444852 64 76 88 104
Week 14Week 4 Week 104Week 28
BASFI response at Week 1042
Patients who switched from placebo
to SIMPONI experienced substantial to toto
improvement in BASFI within ment in BASFI withinp me B went in BASFI withinme BB ww
4–12 weeks.
BASFI response at Week 282
AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=107 at Week 104)
10
8
6
4
2
0
Mean B
AS
FI sco
re
Week
EEPE XO
0 4 8 12 14 16 202428323640444852 64 76 88 104
Week 14Week 4 Week 104Week 28
BASFI response at Week 1042
SIMPONI maintained BASFI responsemaintained BASFI responsepONI m S paintained BASFI responseNINI nene SS pp
from Week 52 to Week 104.
BASFI response at Week 1042
AS
BASDAI50
response data
BASFI
response data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
BASDAI = Bath AS Disease Activity Index; BASFI = Bath AS Functional Index; PE = primary endpoint;
EE = early escape; XO = crossover; AS = ankylosing spondylitis.
References
1. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.
2. Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy
and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or
100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20
response at Week 14. Observed data are presented without imputation. At Week 16, patients who had failed
to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group
received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to
100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group
were changed over in Week 24 to SC SIMPONI 50 mg.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
SIMPONI helps achieve improvement in spinal inflammation1
SIMPONI 50 mg helped achieve a signifi cant improvement in MRI-detected
spinal infl ammation1:
5.9 reduction in mean ASspiMRI-a score with SIMPONI vs 2.5 with
placebo at Week 14 (P<0.05).
59% of patients receiving SIMPONI 50 mg with infl ammation at baseline
demonstrated minimal infl ammation at Week 104.1
Improvements in MRI-detected spinal infl ammation were
sustained through Week 104 with a mean reduction in
ASspiMRI-a score of 7.1.1
AS
MRI data
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Changes in MRI-detected spinal infl ammation1,aAS
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
MRI scan at baseline
Active lesions at multiple
vertebral units (C7/T1 and T6/T7)
MRI scan at Week 14 MRI scan at Week 104
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
AS
MRI scan at baseline
Active lesions at multiple
vertebral units (C7/T1 and T6/T7)
MRI scan at Week 14
Spinal activity
markedly decreased
MRI scan at Week 104
Changes in MRI-detected spinal infl ammation1,a
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
AS
MRI scan at baseline
Active lesions at multiple
vertebral units (C7/T1 and T6/T7)
MRI scan at Week 14
Spinal activity
markedly decreased
MRI scan at Week 104
Spinal activity
almost fully resolved
Changes in MRI-detected spinal infl ammation1,a
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aPlease note that treatment with SIMPONI 100 mg should only be considered in patients weighing over 100 kg
who have not achieved adequate clinical response with SIMPONI 50 mg. The increased risk of certain serious
adverse drug reactions with the 100-mg dose compared with the 50-mg dose should be taken into account.
MRI = magnetic resonance imaging; ASspiMRI-a = AS spine MRI-activity (assesses the presence of bone marrow
edema but not the degree of edema); AS = ankylosing spondylitis; SC = subcutaneous; ASAS = assessment in
AS international working group criteria.
Reference
1. Braun J, et al. Ann Rheum Dis. 2011 (Nov 29); Epub ahead of print.
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy
and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or
100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20
response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape
in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group
receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to
receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
SIMPONI helps improve patient quality of life
27% improvement from baseline in SF-36 PCS with
SIMPONI vs 7% with placebo at Week 24 (P<0.001).1
Patients who switched from placebo to SIMPONI 50 mg
at Week 24 demonstrated a quality-of-life bounce back,
achieving a 7-fold improvement in SF-36 PCS score
by Week 52.1,2
Improvements in health-related quality of life, as assessed
by SF-36 PCS scores, were sustained through 104 weeks.1,2
AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
SF-36 PCS data
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Sustained improvement in SF-36 PCS1,2
P<0.001
0 24 52 76 104
XO18
16
14
12
10
8
6
4
2
0
Mean c
hang
e f
rom
baselin
e
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=113 at Week 104)
Week 104Week 76Week 52Week 24
AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
P<0.001
0 24 52 76 104
XO18
16
14
12
10
8
6
4
2
0
Mean c
hang
e f
rom
baselin
e
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=113 at Week 104)
Sustained improvement in SF-36 PCS1,2
Week 104Week 76Week 52Week 24
001 7.9 —SIMPONI patients9 SIMPONI iSIMPMP
2.0—placebo patients (switched to p p (2 —p
SIMPONI 50 mg at Week 16 or Week 24). g )SIM
Numbers are for mean change fromNumbers are for mean change fromN
baseline in SF-36 PCSbaseline in SF 36 PCS
0
Sustained improvement at Week 241
AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
P<0.001
0 24 52 76 104
XO18
16
14
12
10
8
6
4
2
0
Mean c
hang
e f
rom
baselin
e
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=113 at Week 104)
Sustained improvement in SF-36 PCS1,2
Week 104Week 76Week 52Week 24
12.8 —SIMPONI patientsS O
d to hed14.1—placebo patients (switchp p (
Week 24). r WSIMPONI 50 mg at Week 16 org
om e froNumbers are for mean changeNumbers are for mean change
baseline in SF-36 PCS.baseline in SF 36 PCS
Sustained improvement at Week 521
AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
P<0.001
0 24 52 76 104
XO18
16
14
12
10
8
6
4
2
0
Mean c
hang
e f
rom
baselin
e
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=113 at Week 104)
Sustained improvement in SF-36 PCS1,2
Week 104Week 76Week 52Week 24
P<P 0 001
1133.44—SSIIMMPPOOONI patients
15.2—placebbo patients (switched to 15.2 placebo patients (switched toientss (sPP<<PP 00....000011
SIMPONI 50 mg at Week 16 or Week 24). SIMPONI 50 mg at Week 16 or Week 24)0 mg We0 m
Numbers aree for mean change from Numbers are for mean change fromrs a me
baseline in SF-36 PCSbaseline in SF 36 PCSseli -3
Sustained improvement at Week 762
AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
P<0.001
0 24 52 76 104
XO18
16
14
12
10
8
6
4
2
0
Mean c
hang
e f
rom
baselin
e
Week
Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65)
SIMPONI 50 mg (n=113 at Week 104)
Sustained improvement in SF-36 PCS1,2
Week 104Week 76Week 52Week 24
001
14.2—SIMPONI patientsPONI patientsMPO
15.5—placebo patients (switched to 15 5 placebo patients (switched to5.5—pl
SIMPONI 50 mg at Week 16 or Week 24).SIMPONI 50 mg at Week 16 or Week 24)MPO
Numbers are for mean change from Numbers are for mean change fromNu
baseline in SF-36 PCS.baseline in SF 36 PCS
0
Sustained improvement at Week 1042
AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SF-36 = Short Form-36 Health Survey; PCS = physical component score, assessed on a 0 to 50 scale (higher
score represents improvement); AS = ankylosing spondylitis; XO = crossover.
References
1. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.
2. Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy
and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or
100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20
response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape
in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group
receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to
receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.
Signs and symptomsEFFICACY Spinal infl ammationFunctioning
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI helps reduce night back pain and improve sleep1,2
Signifi cant reduction in night back pain with SIMPONI vs placebo at
Weeks 14 and 24 (P<0.001).1,2
Signifi cantly greater reduction in sleep disturbance with SIMPONI vs
placebo at Weeks 14 and 24 (P<0.001), as measured by the JSEQ.1
Changes in JSEQ scores signifi cantly correlated with
changes in SF-36 summary scores, BASFI scores, night
back pain, total back pain, BASDAI scores, and infl ammation
(morning stiffness).2
AS
VAS scores
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Week 24Week 14Baseline
Improvement in night back pain at Week 24
8
7
6
5
4
3
2
1
0
VA
S (0
–10 c
m)
Baseline
7.1Baseline
7.4
SIMPONI 50 mg monthly
(n=138)
Placebo
(n=78)
AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Week 14
4.1P<0.001
Week 14
7.1
8
7
6
5
4
3
2
1
0
VA
S (0
–10 c
m)
SIMPONI 50 mg monthly
(n=138)
Placebo
(n=78)
Improvement in night back pain at Week 24 AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Week 24Week 14Baseline
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Week 24
4.0P<0.001
Week 24
7.0
8
7
6
5
4
3
2
1
0
VA
S (0
–10 c
m)
SIMPONI 50 mg monthly
(n=138)
Placebo
(n=78)
Improvement in night back pain at Week 24 AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Week 24Week 14Baseline
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
VAS = visual analogue scale; AS = ankylosing spondylitis; SC = subcutaneous; ASAS = ASsessment in AS
international working group criteria; JSEQ = Jenkins Sleep Evaluation Questionnaire; SF-36 = Short Form-36
Health Survey (physical component score assessed on a 0 to 50 scale [higher score represents improvement]);
BASFI = Bath AS Functional Index; BASDAI = Bath AS Disease Activity Index.
References
1. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.
2. Deodhar A, et al. Arthritis Care Res. 2010;62(9):1266–1271.
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy
and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or
100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20
response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape
in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group
receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to
receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Improved
patient QoLQoL Summary
Night back
pain & sleep
4 weeks 2 years1.5 years44 weeks14 weeks
Reduced signs
and symptoms1
Sustained
improvements2
Reduced
disease activity1
AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Efficacy with monthly SC SIMPONI
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
4 weeks 2 years1.5 years44 weeks14 weeks
Sustained
improvements2
Reduced
disease activity1
AS
Reduced signs
and symptoms1
Almost half of patients
achieved an ASAS20
response just 4 weeks
after the fi rst injection.
Efficacy with monthly SC SIMPONI
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
4 weeks 2 years
Reduced signs
and symptoms1
Almost half of patients
achieved an ASAS20
response just 4 weeks
after the fi rst injection.
1.5 years44 weeks14 weeks
Reduced
disease activity1
43% of patients achieved
BASDAI50 by Week 14.
Sustained
improvements2
Efficacy with monthly SC SIMPONI AS
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
4 weeks 2 years
Sustained
improvements2
Improvements in signs
and symptoms, physical
function, and quality of
life were maintained
through 2 years.
1.5 years1 5 years44 weeks44 weeks14 weeks
SIMPONI can help
to improve quality of
life and functionality
4 times greater improvement
in SF-36 physical component
scores at Week 24 with
SIMPONI 50 mg compared
with placebo.1
Efficacy with monthly SC SIMPONI AS
Reduced signs
and symptoms1
Almost half of patients
achieved an ASAS20
response just 4 weeks
after the fi rst injection.
Reduced
disease activity1
43% of patients achieved
BASDAI50 by Week 14.
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASAS = ASsessment in AS international working group criteria; SC = subcutaneous; BASDAI = Bath AS Disease
Activity Index; SF-36 = Short Form-36 Health Survey (physical component score assessed on a 0 to 50 scale
[higher score represents improvement]).
References
1. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.
2. Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.
Improved
patient QoLQoL Summary
Night back
pain & sleep
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Safety profile of SIMPONI after 3 years1,2
In Phase 3 trials through 3 years1:
7.4% of patients receiving injections of SIMPONI 50 mg discontinued therapy
because of adverse events vs 4.9% of those receiving placebo injections.
AS
3-year safety data SAFETYComprehensively
tested
Adverse
event data
SIMPONI has over 8 years of worldwide
clinical trial experience and has been
used in over 80,000 patients2,3
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
An analysis of pooled data from the long-term extensions of randomized,
double-blind, placebo-controlled studies in AS, RA, and PsA1:
Adverse event2 (Pooled data) SIMPONI 50 mg +/– MTX Placebo +/– MTX
Patients treated (n) 1,317 674
Deathsa 0.30 0.28
All serious infectionsa 3.03 5.31
Tuberculosis (TB)a 0.17 0.00
Opportunistic infections other than TBa
0.13 0.00
Malignancy Nonmelanoma skin cancersTotal patient-years of follow-upIncidence/100 patient-years
2,3050.43
3561.40
LymphomaTotal patient-years of follow-upIncidence/100 patient-years
2,3130.04
3580.00
Other malignanciesTotal patient-years of follow-upIncidence/100 patient-years
2,3080.78
3570.56
AS
Includes SIMPONI SC
Phase 2b studies in
addition to Phase 3
AS, RA, and PsA.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aIncidence per 100 patient-years.
MTX = methotrexate; AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis.
References
1. Kay J, et al. ACR 2011; abstract 2227.
2. Data on fi le. MSD SIMPONI PSUR 05.
3. http://clinicaltrials.gov/ct2/show/NCT00207714?term=cnto+148&rank=8.
Accessed 01/31/12.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONI —comprehensively tested in worldwide trials
SIMPONI has been extensively
tested in a worldwide clinical
trial program in more than 2,300
patients, including different RAa
patient groups, as well as those
with PsAb or ASc.1–6
A comprehensive development program:
Phase 3 clinical trials in over 2,300 rheumatology patients1–6
Trial Indication Patient type Subjects, N
GO-BEFORE Active RA MTX naïve 637
GO-FORWARD Active RA MTX nonresponders 444
GO-AFTER Active RA Anti-TNF experienced 461
GO-REVEAL Active PsADMARD
nonresponders405
GO-RAISE Active ASConventional therapy
nonresponders356
AS
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-BEFORE: A multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active
RA naïve to MTX. Radiographic progression was a primary end point. ACR50 at Week 24 was a primary end point.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-FORWARD: A multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the
effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in
a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus
placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered
subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement in the
ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-AFTER: a multicenter, randomized, double-blind, placebo-controlled, Phase III trial (N=461) to evaluate the
effi cacy and safety of SIMPONI in patients with active rheumatoid arthritis (RA) who had previously received one
or more TNFα inhibitors. Patients with active RA were randomly assigned (1:1:1) to placebo or SIMPONI 50 mg or
100 mg. The primary end point was the proportion of patients who achieved 20% or higher improvement in ACR
criteria for assessment of RA (ACR20) at Week 14. At Week 16, patients who had less than 20% improvement in
tender and swollen joint counts were given rescue therapy in a double-blinded manner: patients in the placebo
group received SIMPONI 50 mg, patients in the SIMPONI 50-mg group had a dose escalation to 100 mg, and
patients in the SIMPONI 100-mg group continued to receive 100 mg.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-REVEAL: A multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active
PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4
weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria
at Week 14.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
GO-RAISE: A multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy
and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or
100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20
response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape
in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group
receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to
receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aSIMPONI, in combination with MTX, is indicated for:
• the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to DMARD therapy
including MTX has been inadequate.
• the treatment of severe, active, and progressive rheumatoid arthritis in adults not previously treated with MTX.
SIMPONI, in combination with MTX, has been shown to reduce the rate of progression of joint damage as
measured by x-ray and to improve physical function.
bSIMPONI, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in
adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has been shown
to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular
symmetrical subtypes of the disease and to improve physical function.
cSIMPONI is indicated for the treatment of severe, active AS in adults who have responded inadequately to
conventional therapy.
RA = rheumatoid arthritis; MTX = methotrexate; TNF = tumor necrosis factor; PsA = psoriatic arthritis; DMARD =
disease-modifying antirheumatic drug; AS = ankylosing spondylitis.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Keystone EC, et al. Ann Rheum Dis. 2009;68(6):789–796. Erratum in: Ann Rheum Dis. 2011;70(1):238.
3. Emery P, et al. Arthritis Rheum. 2009;60(8):2272–2283. Erratum in: Arthritis Rheum. 2010;62(10):3005.
4. Smolen JS, et al. Lancet. 2009;374(9685):210–221.
5. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.
6. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.
3-year safety data SAFETYComprehensively
tested
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenience and features that fit with everyday life
Developed for convenience with only 1 injection per month.1–5
Features citric acid–free formulationa and low injection volume.1
Low level of ISRs including pain:
5.8% of patients on SIMPONI (50 mg and 100 mg) experienced ISRs vs
2.2% on placebo.1
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
AS
Dosing
information
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
✔ Monthly SIMPONI autoinjector 50 mg
✔ Monthly SIMPONI prefi lled syringe 50 mg
✘ Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
✔ Etanercept autoinjector 50 mg
✔ Etanercept prefi lled syringe 25 mg
AS
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Citric acid–free formulationa Injection volume
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
✔ Monthly SIMPONI autoinjector 50 mg
✔ Monthly SIMPONI prefi lled syringe 50 mg
✘ Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
✔ Etanercept autoinjector 50 mg
✔ Etanercept prefi lled syringe 25 mg
0.5 mL
0.5 mL
0.8 mL
1.0 mL
0.5 mL
AS
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Citric acid–free formulationa Injection volume
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aA comparison of injection media found that a solution containing citrate as a buffer caused more pain
immediately after SC injection than did a solution with histidine as buffer, which did not cause more pain
than the control saline solution.5
ISR = injection site reaction; SC = subcutaneous.
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Humira. Summary of Product Characteristics. January 2012.
3. Enbrel. Summary of Product Characteristics. September 2011.
4. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.
5. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.
Brands mentioned are trademarks of their respective owners.
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Only SC anti-TNF with monthly dosing1–5AS
Injections
per month
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASOnly SC anti-TNF with monthly dosing1–5
Injections
per month
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASOnly SC anti-TNF with monthly dosing1–5
Injections
per month
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASOnly SC anti-TNF with monthly dosing1–5
Injections
per month
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASOnly SC anti-TNF with monthly dosing1–5
Injections
per month
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASOnly SC anti-TNF with monthly dosing1–5
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Injections
per month
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASOnly SC anti-TNF with monthly dosing1–5
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Injections
per month
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASOnly SC anti-TNF with monthly dosing1–5
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Injections
per month
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASOnly SC anti-TNF with monthly dosing1–5
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Injections
per month
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
ASOnly SC anti-TNF with monthly dosing1–5
Injections
per year
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Injections
per month
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
References
1. SIMPONI. Summary of Product Characteristics. March 2012.
2. Humira. Summary of Product Characteristics. January 2012.
3. Enbrel. Summary of Product Characteristics. September 2011.
4. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.
5. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.
Brands mentioned are trademarks of their respective owners.
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
State-of-the-art SmartJect® autoinjector pen
Developed to help simplify administration
Also available as 0.5-ml,
single-use prefi lled syringe
Easy to handle
Easy-grip body
Large side button
Easy-twist cap
Easy to administer
2 audible clicks
Large observation window
Secure
Autoretract needle
Security seal
Built-in safety sleeve
In AS, SIMPONI 50 mg is given once a month,
on the same date each month.1
AS
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenient single-use prefilled syringe
Developed to help simplify administration
Also available as 0.5-ml, single-use,
state-of-the-art SmartJect® autoinjector pen
Secure
Sturdy needle cover
Extra-fi ne needle
Easy to administer
Clear observation window
Easy-to-read labelEasy to handle
Needle guard
Thumb-sized plunger head
AS
In AS, SIMPONI 50 mg is given once a month,
on the same date each month.1
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
AS = ankylosing spondylitis.
Reference
1. SIMPONI. Summary of Product Characteristics. March 2012.
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Carefully tailored SIMPONI® for Me™ patient support program
Patient support program designed to complement the patient–doctor relationship:
Developed to help give patients on therapy with SIMPONI the confi dence they need to self-inject
Personalized, ongoing educational advice and support
Tailored to meet needs of treatment-naïve and biologic-experienced patients
Program includes A starter kit
Personalized
monthly reminder-
to-inject service
FREE
help line
Online
information
resource
Any patients with medical questions concerning their condition
are advised to contact their health care professional.
AS
Registering for
SIMPONI for Me
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
How patients can register for SIMPONI® for Me™
Complete
and return
enrollment form
provided with
starter kit
Call
SIMPONI for Me at
<0000 0000 0000>
Visit
simponiforme.com
AS
ConvenienceEXPERIENCEState-of-the-
art devicesMonthly dosing
Patient support
program
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
SIMPONISUMMARYREMICADE®
(infl iximab)
Convenience and support3
Proven and sustained
clinical effi cacy1–4
Rigorous clinical
trial program3,5,6
Helps get patients back to everyday life in a monthly SC dose AS
Clinical effi cacyffi Clinical experience Conveniencei
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Proven and sustained
clinical effi cacy1–4
Sustained improvement in ASAS
response, BASDAI50, and BASFI
Signifi cant improvement in
MRI-detected spinal infl ammation
Signifi cant improvement in
SF-36 quality-of-life scores
ASHelps get patients back to everyday life in a monthly SC dose
Clinical effi cacyffi Clinical experience Conveniencei
SIMPONISUMMARYREMICADE®
(infl iximab)
Convenience and support3
Rigorous clinical
trial program3,5,6
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Rigorous clinical
trial program3,5,6
Approval for AS, RA, and PsA
at launch
Over 8 years of worldwide clinical
trial experience
Over 80,000 patients treated
globally
ASHelps get patients back to everyday life in a monthly SC dose
Clinical effi cacyffi Clinical experience Conveniencei
SIMPONISUMMARYREMICADE®
(infl iximab)
Proven and sustained
clinical effi cacy1–4
Sustained improvement in ASAS
response, BASDAI50, and BASFI
Signifi cant improvement in
MRI-detected spinal infl ammation
Signifi cant improvement in
SF-36 quality-of-life scores
Convenience and support3
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Convenience and support3
Only SC anti-TNF with monthly
dosing
Choice of prefi lled autoinjector pen
or syringe
Innovative patient support program
Clinical effi cacyffi Clinical experience Conveniencei
Rigorous clinical
trial program3,5,6
Approval for AS, RA, and PsA
at launch
Over 8 years of worldwide clinical
trial experience
Over 80,000 patients treated
globally
ASHelps get patients back to everyday life in a monthly SC dose
SIMPONISUMMARYREMICADE®
(infl iximab)
Proven and sustained
clinical effi cacy1–4
Sustained improvement in ASAS
response, BASDAI50, and BASFI
Signifi cant improvement in
MRI-detected spinal infl ammation
Signifi cant improvement in
SF-36 quality-of-life scores
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical efficacy
Sustained improvement in ASAS response,
BASDAI50, and BASFI for weeks.1
of patients receiving SIMPONI 50 mg with
infl ammation at baseline demonstrated minimal
infl ammation at Week 104.4
24 7652 104
25% 59%38% 70%
2-fold 6-fold5-fold 7-fold
AS
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
Patients who switched from placebo to SIMPONI 50 mg
at Week 24 demonstrated a quality-of-life bounce back,
achieving a improvement in SF-36 PCS score by
Week 52.1,2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical efficacy
Sustained improvement in ASAS response,
BASDAI50, and BASFI for 104 weeks.1
24 7652
25% 59%38% 70%
2-fold 6-fold5-fold 7-fold
AS
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
of patients receiving SIMPONI 50 mg with
infl ammation at baseline demonstrated minimal
infl ammation at Week 104.4
Patients who switched from placebo to SIMPONI 50 mg
at Week 24 demonstrated a quality-of-life bounce back,
achieving a improvement in SF-36 PCS score by
Week 52.1,2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical efficacy
Sustained improvement in ASAS response,
BASDAI50, and BASFI for 104 weeks.1
24 7652
25% 38% 70%
2-fold 6-fold5-fold 7-fold
AS
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
59% of patients receiving SIMPONI 50 mg with
infl ammation at baseline demonstrated minimal
infl ammation at Week 104.4
Patients who switched from placebo to SIMPONI 50 mg
at Week 24 demonstrated a quality-of-life bounce back,
achieving a improvement in SF-36 PCS score by
Week 52.1,2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical efficacy
Sustained improvement in ASAS response,
BASDAI50, and BASFI for 104 weeks.1
24 7652
25% 38% 70%
2-fold 6-fold5-fold
AS
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
59% of patients receiving SIMPONI 50 mg with
infl ammation at baseline demonstrated minimal
infl ammation at Week 104.4
Patients who switched from placebo to SIMPONI 50 mg
at Week 24 demonstrated a quality-of-life bounce back,
achieving a 7-fold improvement in SF-36 PCS score by
Week 52.1,2
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical experience
Over patients treated globally.5,6
Over years of clinical trial experience.5,6
70,000 90,00080,000 100,000
3 85 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
AS
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical experience
Over 80,000 patients treated globally.5,6
Over years of clinical trial experience.5,6
70,000 90,000 100,000
3 85 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
AS
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Clinical experience
Over 80,000 patients treated globally.5,6
Over 8 years of clinical trial experience.5,6
70,000 90,000 100,000
3 5 10
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
AS
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Which of these products is NOT a citric acid–free formulation?3,7–10,a
Monthly SIMPONI autoinjector 50 mg
Monthly SIMPONI prefi lled syringe 50 mg
Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
Etanercept autoinjector 50 mg
Etanercept prefi lled syringe 25 mg
✘
Convenience AS
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
Which of these products is NOT a citric acid–free formulation?3,7–10,a
Monthly SIMPONI autoinjector 50 mg
Monthly SIMPONI prefi lled syringe 50 mg
Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg
Etanercept autoinjector 50 mg
Etanercept prefi lled syringe 25 mg
Convenience
✔
✔
✔
✔
✘
Clinical
experience
Clinical
effi cacy
Convenience
SIMPONISUMMARYREMICADE®
(infl iximab)
AS
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aA comparison of injection media found that a solution containing citrate as a buffer caused more pain immediately
after SC injection than did a solution with histidine as buffer, which did not cause more pain than the control
saline solution.10
SC = subcutaneous; ASAS = ASsessment in AS international working group criteria; BASDAI = Bath AS Disease
Activity Index; BASFI = Bath AS Functional Index; MRI = magnetic resonance imaging; SF-36 = Short Form-36
Health Survey; AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis; TNF = tumor
necrosis factor.
References
1. Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.
2. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.
3. SIMPONI. Summary of Product Characteristics. March 2012.
4. Braun J, et al. Ann Rheum Dis. 2011 (Nov 29); Epub ahead of print.
5. Data on fi le. MSD SIMPONI PSUR 05.
6. http://clinicaltrials.gov/ct2/show/NCT00207714?term=cnto+148&rank=8.
7. Humira. Summary of Product Characteristics. January 2012.
8. Enbrel. Summary of Product Characteristics. September 2011.
9. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.
10. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.
Brands mentioned are trademarks of their respective owners.
SIMPONISUMMARYREMICADE®
(infl iximab)
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
REMICADE provides an appropriate solution
for patients with axial disease and the EAMs of AS
REMICADE helps you deliver rapida relief, sustained improvement, and close management for patients with AS.
In-offi ce infusion allows for closer patient monitoring and support
Sustained improvement in axial symptoms2,3
Reduced IBD fl ares5
Reduced AU fl ares6
Rapida improvement in axial symptoms1
Helped resolve spinal infl ammation4
REMICADE
the only IV anti-TNF
to provide speeda
and power
REMICADE offers speeda and power to help achieve
early and sustained improvements in AS patients with
current, or a history of, EAMs.
Patient profi les
SIMPONISUMMARYREMICADE®
(infl iximab)
AS
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
The patient at risk
of noncompliance
or who prefers
IV treatment
The patient with
concomitant, or a
history of, EAMs
Uveitis
IBD
Psoriasis
Unable to understand and/or
follow treatment regimen
Unwilling or unable
to self-inject
Needs the reassurance of
regular contact with an HCP
SIMPONISUMMARYREMICADE®
(infl iximab)
AS
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)
aRapid and speed are defi ned as response by Week 2.
AS = ankylosing spondylitis; EAM = extra-articular manifestation; IV = intravenous; TNF = tumor necrosis factor;
IBD = infl ammatory bowel disease; AU = anterior uveitis; HCP = health care professional.
References
1. Braun J, et al. Lancet. 2002;359(9313):1187−1193.
2. Braun J, et al. Ann Rheum Dis. 2008;67(3):340−345.
3. Baraliakos X, et al. Rheumatology. 2011;50(9):1690−1699.
4. Braun J, et al. Arthritis Rheum. 2006;54(5):1646−1652.
5. Braun J, et al. Arthritis Rheum. 2007;57(4):639−647.
6. Braun J, et al. Arthritis Rheum. 2005;52(8):2447−2451.
SIMPONISUMMARYREMICADE®
(infl iximab)
Indications and Select Safety InformationSummary of Product Characteristics
SIMPONI® (golimumab)