Janssen announced 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.
The PSUMMIT II trial was a multicenter, randomized, double-blind, placebo‑controlled study including 312 adults. 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 vs. TNF inhibitors) were randomized to receive subcutaneous Stelara 45mg or 90mg 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 were observed in patients receiving Stelara 45mg (43.7% of patients) or Stelara 90mg (43.8% of patients) compared with 20.2% of patients receiving placebo (P<0.001 for both comparisons). Among patients previously treated with TNF inhibitors, 36.% of patients and 34.5% of patients receiving Stelara 45mg or 90mg, respectively, achieved ACR 20 at Week 24 compared with 14.5% of patients receiving placebo (P=0.006 for Stelara 45mg, P=0.011 for Stelara 90mg).
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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