FDA approves Stelara for Psoriatic Arthritis in adults

The FDA has approved Stelara (ustekinumab), from Janssen Biotech, alone or in combination with methotrexate for the treatment of adult patients (18 years or older) with active Psoriatic Arthritis. The approval is supported by findings from two pivotal Phase 3 trials (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of subcutaneously-administered Stelara 45 mg or 90 mg at weeks 0, 4 and then every 12 weeks.

Results from PSUMMIT 1 showed that at week 24, 42 percent and 50 percent of patients receiving Stelara 45 mg and 90 mg, respectively, achieved at least 20 percent improvement in signs and symptoms according to the American College of Rheumatology criteria (ACR 20), the primary endpoint for both studies. In PSUMMIT II, 44 percent of patients receiving Stelara 45 mg and 44 percent of patients receiving Stelara 90 mg achieved ACR 20 at week 24.