Gated page parent

SKYRIZI is a selective IL-23/p19 inhibitor with:

UltIMMa-1 and UltIMMa-2 were replicate Phase 3 studies

PASI 90 and PASI 100 clearance of psoriatic lesions at Week 52 vs ustekinumab was a ranked secondary endpoint.^1,2

UltIMMa-1 and UltIMMa-2: Missing data were imputed as nonresponders (NRI) for categorical endpoints and by last observation carried forward for continuous endpoints.

Co-primary endpoints: Proportion of patients who achieved PASI 90 response and an sPGA score of clear or almost clear (sPGA 0 or 1) at Week 16 vs placebo.

Ranked secondary endpoints: sPGA 0 (clear), PASI 100, Dermatology Life Quality Index (DLQI) of 0 or 1, Psoriasis Symptom Scale (PSS) score of 0, PASI 75, and change from baseline in PSS total score at Week 12, Week 16, or Week 52.

Dosing: SKYRIZI 150 mg (two 75-mg subcutaneous injections) at Week 0, Week 4, and every 12 weeks thereafter. Ustekinumab 45 mg or 90 mg (weight-based per label). Ustekinumab is dosed every 12 weeks after 2 starter doses at Week 0 and Week 4.

Important contextual safety information

Tuberculosis: Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB.

Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Lab monitoring: SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Patients treated with SKYRIZI should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and SKYRIZI should not be administered until the infection resolves.