Stelara Approved for New Indication

Janssen announced that the FDA has approved Stelara (ustekinumab) alone or in combination with methotrexate for the treatment of adults with active psoriatic arthritis.

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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