Stelara (J&J Janssen Cilag/Janssen Biotech) filed with FDA and EMA to treat adults with active Psoriatic Arthritis

Janssen Biotech and J&J Janssen Cilag have submitted a supplemental Biologics License Application (sBLA) to the FDA and a Type II Variation to the EMA requesting approval of Stelara (ustekinumab) for the treatment of adult patients with active Psoriatic Arthritis. These applications are supported by findings from Phase III multicenter, randomised, double-blind, trials of ustekinumab 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.

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 at least 0.3 mg/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 at least a 20 percent improvement in arthritis signs and symptoms [American College of Rheumatology (ACR) 20] at week 24.