Stelara (Ustekinumab)

STELARA Messaging Exploration

Message Topic Core Claim- Directly From PI Efficacy/ Head To Head Trial 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 a minimum 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 in psoriasis 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<0.001 for STELARA 90mg, each compared with etanercept (Christopher E.M. Griffiths, M.D., Bruce E. Strober, M.D., Ph.D., Peter van de Kerkhof, M.D. et al. N Engl J Med 2010; 362:118-128January 14, 2010DOI: 10.1056/NEJMoa0810652) In a head to head study, Stelara demonstrated superior plaque psoriasis clearance to etanercept.

Hierarchy and active voice

Say it in as few words as possible

Stelara shows greater efficacy than etanercept.

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.

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 Core Claim- Directly From PI Superiority to Etanercept
At week 12, a total of 67.5% of patients who received 45 mg of ustekinumab and 73.8% of patients who received 90 mg of ustekinumab had at least 75% improvement in the PASI score, as compared with 56.8% of those who received highdose etanercept (P=0.01 and P<0.001, respectively). A 90% improvement in the PASI score was achieved at week 12 by a higher proportion of patients who received 45 mg or 90 mg of ustekinumab (36.4% and 44.7%, respectively) than by patients who received etanercept (23.1%) (P<0.001 for both comparisons) (Christopher E.M. Griffiths, M.D.,

Bruce E. Strober, M.D., Ph.D., Peter van de Kerkhof, M.D. et al. N Engl J Med 2010; 362:118128January 14, 2010DOI: 10.1056/NEJMoa0810652)

Hierarchy and Active Voice

Stelara delivered significantly better PASI 90 results versus etanercept at 12 weeks.

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.

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 the cellular 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

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