Stelara Approved for New Indication
The approval for the expanded indication is based on findings from two Phase 3 Multicenter, Randomised, Double-blind, Placebo-controlled trials of Ustekinumab, a Fully Human anti–IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis (PSUMMIT I and PSUMMIT II). These two trials evaluated the efficacy and safety of subcutaneous Stelara 45mg or 90mg at Weeks 0, 4, and then every 12 weeks (N=927).
Results from PSUMMIT I showed that at Week 24, 42% and 50% of patients receiving Stelara 45mg and 90mg, respectively, achieved >20% improvement in signs and symptoms according to the ACR 20 criteria. Results from PSUMMIT II showed that at Week 24, 44% of patients receiving Stelara 45mg and 90mg achieved ACR 20 .
Stelara is a human interleukin (IL)-12 and IL-23 antagonist currently approved for the treatment of adults (>18 years) with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
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