EU approves Stelara for Psoriatic Arthritis in adults
The European Commission has approved the use of Stelara (ustekinumab), from J&J Janssen Cilag, alone or in combination with methotrexate, for the treatment of active Psoriatic Arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. approval based on a review of data from two pivotal Phase III multicenter, randomised, double-blind, placebo-controlled trials of ustekinumab (PSUMMIT I and PSUMMIT II.)
The primary endpoints for both studies were the proportion of patients demonstrating at least a 20 percent improvement in arthritis signs and symptoms (ACR20) at week 24. The studies also captured improvements in enthesitis and dactylitis scores for patients with enthesitis and/or dactylitis at baseline.
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