Phase III study of Stelara (J&J Janssen Cilag) shows significant benefit at endpoint for Active Psoriatic Arthritis

Results from a Phase III study show patients with Active Psoriatic Arthritis who received Stelara (ustekinumab), from J&J Janssen Cilag, achieved significant improvement in symptoms at the study's primary endpoint compared with placebo. According to findings from the PSUMMIT I study, treatment with Stelara every 12 weeks led to improvements in signs and symptoms of active disease and symptoms through one year. Patients were randomized to receive subcutaneous Stelara 45 mg or 90 mg or placebo at weeks 0, 4 and then every 12 weeks.

At week 24, 42.4 percent and 49.5 percent of patients receiving Stelara 45 mg and 90 mg, respectively, achieved at least 20% improvement in signs and symptoms according to the American College of Rheumatology criteria (ACR 20), the primary endpoint, compared with 22.8% of patients receiving placebo. ACR 50 and ACR 70 response rates also increased over time among patients receiving Stelara. Improvement continued to increase after week 24, with 31.4% and 37% of patients in the Stelara 45 mg and 90 mg groups, respectively, demonstrating ACR 50 response at week 52. Results were published in The Lancet. See: "Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial." Iain B McInnes et al. The Lancet early Online Publication, 13 June 2013 doi:10.1016/S0140-6736(13)60594-2