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    Stelara (Ustekinumab)

    STELARA Messaging Exploration

    Message Topic Efficacy/ Head To Head Trial

    Core Claim- Directly From PI Two multicenter, randomized, double blind,

    placebo controlled (Study 1 and Study 2)

    enrolled a total of 1996 subjects 18 years of age

    and older with plaque psoriasis who had aminimum body surface area of involvement of

    10%, and Psoriasis Area and Severity Index

    (PASI) score of 12, and who were candidates for

    photo therapy or systemic therapy. Subjects

    with guttate, erythrodermic or pustular psoriasis

    were excluded from the studies

    (PI/pg14/sec14/table3)

    In the comparator study, 68 and 74 percent of

    patients receiving subcutaneous injections of

    Stelara (45 mg or 90 mg) at weeks 0 and 4

    achieved at least a 75 percent reduction inpsoriasis as measured by the Psoriasis Area and

    Severity Index (PASI 75) at week 12, the primary

    endpoint, compared with 57 percent of patients

    subcutaneous injections of 50 mg of etanercept

    twice a week for 12 weeks (P=0.01 for Stelara

    45mg ; P

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    Patient benefit Achieve superior skin clearance with Stelara.

    See real clearance after just 2 doses.

    Two doses of Stelara work better than 24 doses

    of Enbrel.

    Notice a 75 percent reduction in your symptoms

    in just 12 weeks.

    You could achieve higher levels of skin clearance

    quicker.

    Physician benefit Achieve robust clearance in significantly more

    patients than with Enbrel.

    Choose superior clearance for your patients.

    Superior clearance your patients will appreciate.

    You can prescribe with confidence.

    Human truth Feel more like yourself.

    You can get back to being yourself faster.

    You dont have to wait longer than you need to.

    Waiting for psoriasis to clear can seem like an

    eternity.

    Promotional headline Two doses of Stelara beat 24 doses of Enbrel.

    Two doses to superior clearance.

    The choice is clear.

    The clear choice for superior results.

    Feel better in your own skin.

    Put the shame away.

    Its time to get over it.

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    Its time to take control.

    Visual ideas People in T shirts with the PASI # on the shirt.

    People in sweat shirts and then the same people

    in T shirts (as they take of the sweat shirts their

    faces go from sad or flat to happy and joyous

    and laughing/ smiling).

    Messaging From Every Angle: Superiority

    Message Topic Superiority to Etanercept

    Core Claim- Directly From PI At week 12, a total of 67.5% of patients whoreceived 45 mg of ustekinumab and 73.8% of

    patients who received 90 mg of ustekinumab hadat least 75% improvement in the PASI score, ascompared with 56.8% of those who received high-dose etanercept (P=0.01 and P

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    Say it in as few words as possible Stelara out performed Enbrel at PASI 90.

    Patient Benefit Your best chance for complete clearance.

    Physician Benefit Give more of your patients the complete

    clearance they want.

    Clearer patients are happier patients.

    Human Truth Psoriasis patients deserve their best chance at

    complete clearance.

    When you choose a biologic therapy, you expect

    the most.

    You need to get the most from an injectable

    therapy.

    Anything less would be a waste of time.

    There is no room for disappointment when using

    an injectable therapy.

    Promotional Headline Go ahead, feel comfortable in your own skin.

    Its like it never happened.

    We all have our flaws, our skin doesnt have to be

    one of them.

    Clearance on a different scale.

    The light at the end of the tunnel.

    Clearly, the results you want.

    The answer has never been so clear.

    Waiting for clearance can feel like forever.

    Visual ideas A womans hand on her bare shoulder.

    A soft light on a woman/ mans face with clear

    skin.

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    A clear sky vs/ cloudy sky.

    A stormy sea vs/ a calm flat sea.

    Messaging From Every Angle: MOA

    Message Topic MOA

    Core Claim- Directly From PI Ustekinumab is a human IgG1k monoclonal

    antibody that binds with high affinity and

    specificity to the p40 protein subunit used by

    both interleukin (IL)-12 and IL-23 cytokines. IL-12

    and IL- 23 are naturally occurring cytokines that

    are involved in inflammatory and immune

    responses, such as natural killer cell activation

    and CD4+ T-cell differentiation and activation. In

    in- vitro models, Ustekinumab was shown to

    disrupt IL-12 and IL-23 mediated signaling and

    cytokine cascades by disrupting the interaction of

    these cytokines with a shared cell- surface

    receptor chain, IL-12B1. (PI/pg11,12/sec12.1)

    Hierarchy and active voice Stelara works to disrupt the production IL-12 and

    IL-23 cytokines by blocking the receptor sites.

    Say it in as few words as possible Stelara blocks inflammatory cytokines of IL-12

    and 23.

    Patient benefit By blocking the cause of plaque psoriasis at thecellular level, it really reduces the amount of

    plaque formation.

    Physician Benefit Because Stelara works to block receptor sites

    used by IL-12 and IL-23 there is less of a cytokine

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    cascade. In turn reducing the amount of plaque

    psoriasis and reducing the formation of more.

    IL-12 and 23 are key agents in the inflammatory

    cascade that causes psoriasis plaques.

    Targeting IL-12 and 23 allows you to interrupt the

    psoriasis cascade with fewer downstream effects

    than TNF.

    Human truth Why suppress the entire immune system when

    you dont have to?

    Promotional headline We stop it before it starts.

    Visual ideas Stelara on a cell surface blocking IL-12 and 23.

    A key that doesnt fit a lock.

    Time lapse of a subject with less and less plaque.

    A quick flip picture book of a person with less and

    less plaque.

    Stop sign.

    Dont walk light at intersection