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FDA Approves Stelara (Ustekinumab) to Treat Psoriatic Arthritis

First anti-interleukin therapy for adult patients with the disease (September 23)

The FDA has approved Stelara (ustekinumab, Janssen Biotech), alone or in combination with methotrexate, for the treatment of adult patients (18 years of age or older) with active psoriatic arthritis — a chronic autoimmune disease characterized by both joint inflammation and psoriasis skin lesions.

Stelara is administered as a 45-mg subcutaneous (SC) injection at weeks 0 and 4, and then every 12 weeks thereafter. For patients with co-existing moderate-to-severe plaque psoriasis who weigh more than 220 lb (100 kg), the recommended dose is a 90-mg SC injection at weeks 0 and 4, and then every 12 weeks thereafter.

The agency’s approval is based on findings from two pivotal Phase III Multicenter, RandomiSed, Double-Blind, Placebo-Controlled Trials of Ustekinumab, a Fully Human anti–IL-12/23p40 Monoclonal Antibody, AdMinistered Subcutaneously, In Subjects With Active Psoriatic ArThritis (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of Stelara 45 mg SC or 90 mg SC at weeks 0 and 4, and then every 12 weeks. The trials included a total of 927 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 despite previous treatment with conventional therapy. PSUMMIT II also included 180 patients with previous exposure to one to five tumor necrosis factor (TNF) inhibitors.

Results from the PSUMMIT I trial showed that at week 24, 42% and 50% 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 for both studies. In PSUMMIT II, 44% of patients receiving Stelara 45 mg and 44% of patients receiving Stelara 90 mg achieved ACR 20 at week 24. In addition, Stelara improved soft-tissue components of the disease, including dactylitis and enthesitis.

Stelara (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of adult patients (18 years of age or older) with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in inflammatory conditions, such as psoriasis and psoriatic arthritis.

Source: Johnson & Johnson; September 23, 2013.

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