Janssen Submits sBLA Application for Stelara for Psoriatic Arthritis
Janssen announced the submission of a supplemental Biologics License Application (sBLA) to the FDA requesting approval of Stelara (ustekinumab) for the treatment of adult patients with active psoriatic arthritis. Stelara is a human interleukin (IL)-12 and IL-23 antagonist.
The applications are supported by findings from Phase 3 Multicenter, Randomized, 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), which evaluated the efficacy and safety of subcutaneously administered Stelara 45mg or 90mg at Weeks 0, 4 and then every 12 weeks. The trials included patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and C-reactive protein (CRP) levels of ≥0.3mg/dL in spite of previous treatment with conventional therapy. PSUMMIT II also included patients with previous exposure to tumor necrosis factor (TNF) inhibitors. The primary endpoints for both studies were the proportion of patients demonstrating ≥20% improvement in arthritis signs and symptoms [American College of Rheumatology (ACR) 20] at Week 24.
Stelara is approved for the treatment of adult patients (≥18 years) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
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