IN ACTIVE PSORIATIC ARTHRITISPROVEN SAFETY PROFILE

Study Design

PSUMMIT I was a multicenter, randomized, double-blind, placebo-controlled study in 615 adult patients with active PsA for ≥6 months despite treatment with NSAID or DMARD therapy; patients were biologic-naïve. PSUMMIT II was a multicenter, randomized, double-blind, placebo-controlled study in 312 adult patients with active PsA for ≥6 months, despite current or previous DMARD and/or NSAID therapy, and who may have been previously treated with biologic anti-TNF agent(s). In both studies, active PsA was defined as ≥5 swollen joints, ≥5 tender joints, and C-reactive protein ≥0.3 mg/dL. Patients had active plaque psoriasis, or a documented history of plaque psoriasis, and could be categorized in at least 1 of the PsA subsets (distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis). Subjects who previously had been treated with anti-TNFα therapy, or received systemic therapy, received systemic immunosuppressives, or DMARDs other than methotrexate (MTX) within 4 weeks prior to the first study dose, were to be excluded from participation. Stable doses (≤25 mg/week) of MTX at study entry, stable oral corticosteroid doses equivalent to ≤10 mg/day of prednisone, and NSAIDs were permitted. Patients were randomized to receive STELARA® 45 mg, STELARA® 90 mg, or placebo as a subcutaneous injection at Weeks 0 and 4 and every 12 weeks thereafter. At Week 16, subjects with <5% improvement from baseline in both tender and swollen joint counts in the 45-mg and placebo groups were eligible for early escape and received STELARA® 90 mg and 45 mg, respectively. Patients randomized to placebo who did not qualify for early escape were to cross over to receive STELARA® 45 mg at Weeks 24 and 28, followed by injections every 12 weeks thereafter. The primary endpoint was the percentage of patients achieving ACR20 response at Week 24. Patients were followed for efficacy through Week 100 and for safety through Week 108. Investigative study sites and patients remained blinded to treatment assignment until the last enrolled subject completed Week 108. Although treatment failure rules were the same, criteria for a treatment failure changed after Week 52 because the protocol allowed concomitant use of DMARDs besides MTX, systemic immunosuppressant, or additional corticosteroids starting at Week 52. Those medications were therefore not considered prohibited after Week 52 defining of treatment failures.^1-4