Espondiloartritis Tratamiento

Dr. Julio Ramírez García

AEs leading to discontinuation (2.2%

vs 3.2%), serious AEs (1.1% vs 1.1%)

Infections (20.4% and 27.7%)

ABSTRACT NUMBER: 2728Efficacy and Safety of Upadacitinib in a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2/3 Clinical Study ofPatients with Active Ankylosing SpondylitisDésirée van der Heijde

• This study assessed the efficacyand safety of UPA in DMARD naive AS.

• Phase 2/3 study (SELECT-AXIS 1)

• 1:1 UPA 15 mg/placebo W14.

• Primary efficacy endpoint

• ASAS 40 response at wk 14.

• MRI spine (secondary outcome)

• 187 p

ABSTRACT NUMBER: 2729Ixekizumab in Non-Radiographic Axial Spondyloarthritis: Primary Results from a Phase 3 TrialAtul Deodhar

• COAST-X was a 52-wk, randomized, double-blind, PBO-controlled

• axSpA who met ASAS classification (but notmodified New York) criteria,

• BASDAI ≥4, back pain ≥4, inflammation [sacroiliitis onMRI or elevated CRP >5 mg/L], and inadequate response orintolerance to NSAIDs

• 1:1:1 80 mg IXE Q4W, 80 mg IXE Q2w, PBO

Primary endpoints ASAS40 at 16w

303 subjects

ABSTRACT NUMBER: 2729

ABSTRACT NUMBER: L01Comparative Risk of Hospitalized Serious Infection in Patients with Psoriasis and Psoriatic Arthritis: A Population-Based Multi-Database StudyYinzhu Jin

• Aim: To compare the risk of infection among UST, SEC, IXE, APR vs TNFi in patients with PsO or PsA.

• Methods: Cohort study using two large US claims databases, MarketScan (9/25/2009–12/31/2017) and Optum (9/25/2009–12/31/2018)

• Primary outcome was a composite endpoint of hospitalizedserious infection including bacterial, viral, or opportunisticinfection.

• 123,383 PsO/PsA patients• 61% PsO

• 22% PsA

• 17% PsO+PsA.

ABSTRACT NUMBER: L01

ABSTRACT NUMBER: L14Tofacitinib as Monotherapy Following Methotrexate Withdrawalin Patients with Psoriatic Arthritis Previously Treated with Open-label Tofacitinib + Methotrexate: A Randomized, Placebo-controlled Sub-study of OPAL BalancePeter Nash

• OPAL Balance: open-label long-term extension study of TOFA in pts with PsA from OPAL Broaden, OPAL Beyond.

• Multicenter, 12-month, randomized, double-blind, placebo (PBO)-controlled, parallel group, estimation study of pts with TOFA+MTX before sub-study entry.

• 1:1 to receive

• PBO (tofacitinib monotherapy)

• MTX (tofacitinib + MTX)

• 12 months.

• Primary endpoints: changes from sub-study baseline (BL; ∆) in PASDAS and HAQ-DI at 6m.

180 patients

ABSTRACT NUMBER: L14Tofacitinib as Monotherapy Following Methotrexate Withdrawalin Patients with Psoriatic Arthritis Previously Treated with Open-label Tofacitinib + Methotrexate: A Randomized, Placebo-controlled Sub-study of OPAL BalancePeter Nash

Largest study in nr AxSpA

555 pts

Naive or prior 1 TNFi(10%)>50% female

ABSTRACT NUMBER: L21Secukinumab 150 mg Significantly Improved Signs and Symptomsof Non-radiographic Axial Spondyloarthritis: Results from a Phase3 Double-blind, Randomized, Placebo-controlled StudyAtul Deodhar

ABSTRACT NUMBER: L20A Head-to-Head Comparison of Ixekizumab and Adalimumab in Biologic-Naïve Patients with Active Psoriatic Arthritis: Efficacy and Safety Outcomes from a Randomized, Open-Label, BlindedAssessor Study Through 52 WeeksJosef Smolen

• IXE was superior to ADA at Wk24 for simultaneous achievementof ACR50 and PASI100 (SPIRIT-H2H) (Mease et al, Ann Rheum Dis2019)

• We report final 52-wk efficacy and safety, and efficacy in subgroups defined by concomitant MTX use in SPIRIT-H2H.

• 87% (246/283) and 84% (237/283) of pts randomized to IXE and ADA, respectively, completed Wk 52.

• Simultaneous ACR50 + PASI100 response was numerically greaterwith IXE than ADA, regardless of concomitant MTX use

ABSTRACT NUMBER: L20

ABSTRACT NUMBER: L20

AEs 73.9% IXE and 68.6% ADA.

Serious AEs 4.2% IXE and 12.4% ADA

ABSTRACT NUMBER: L20