New Phase 3 Findings Show STELARA® Significantly Reduced Signs and Symptoms of Active Psoriatic Arthritis
Janssen Research & Development, LLC (Janssen) announced today new findings from PSUMMIT II, a Phase 3 investigational study that showed patients with active psoriatic arthritis, including those previously treated with one to five tumor necrosis factor (TNF) inhibitors, receiving the interleukin (IL)-12/23 inhibitor STELARA^® (ustekinumab) demonstrated significant improvements in signs and symptoms of the disease. Significantly more patients receiving either STELARA 45 mg or 90 mg achieved at least a 20 percent improvement in signs and symptoms according to American College of Rheumatology criteria (ACR 20) at week 24, the primary endpoint, than did patients receiving placebo regardless of background methotrexate use. During a late-breaker session of PSUMMIT 1, the initial Phase 3 study, investigators will present 52-week data that showed improvement in efficacy of STELARA over time in treating signs and symptoms of the disease. These data are being presented at the 2012 Annual Meeting of the American College of Rheumatology.
In the Phase 3 Multicenter, Randomized, Double-blind, Placebo‑controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis Including Those Previously Treated with Biologic Anti-TNF-alpha Agent(s) (PSUMMIT II) study, patients with active psoriatic arthritis despite treatment with disease-modifying antirheumatic drugs (DMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs) and/or anti-TNF-alpha therapy (not intended as a superiority or comparative claim versus TNF inhibitors) 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, the primary endpoint was met as statistically significantly greater proportions of patients achieving ACR 20 responses (a standard measure of improvement in disease activity) were observed in patients receiving STELARA 45 mg (43.7 percent of patients) or STELARA 90 mg (43.8 percent of patients) compared with 20.2 percent of patients receiving placebo (P < 0.001 for both comparisons). Among patients previously treated with TNF inhibitors, 36.7 percent of patients and 34.5 percent of patients receiving STELARA 45 mg or 90 mg, respectively, achieved ACR 20 at week 24 compared with 14.5 percent of patients receiving placebo (P = 0.006 for STELARA 45 mg, P = 0.011 for STELARA 90 mg).
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