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Ustekinumab Approved in Canada for Moderate to Severe Plaque Psoriasis NEW YORK -- December 15, 2008 -- Ustekinumab (Stelara) has been approved in Canada for adults with moderate to severe plaque psoriasis. Ustekinumab, which is self-injected every 12 weeks following 2 starter doses at weeks 0 and 4, has demonstrated significant efficacy in studies involving more than 3,000 patients. "This is an exciting new advancement in the management of psoriasis with approximately two-thirds of adults receiving [ustekinumab] having achieved at least 75% improvement in their psoriasis within the first 12-week course of dosing in clinical trials," said Richard Langley, MD, Dermatology Research, Dalhousie University, Halifax, Nova Scotia. "Every 12-week dosing makes [ustekinumab] a much-anticipated therapeutic option for patients living with moderate to severe psoriasis." The approval is based on 2 phase 3 trials in which the majority of patients with moderate to severe plaque psoriasis who received ustekinumab sustained clinically significant improvement in their disease severity. At week 12, the primary endpoint of both studies, 66% to 76% of patients who received just 2 doses of ustekinumab, 45 or 90 mg, at weeks 0 and 4, achieved 75% improvement on the Psoriasis Activity and Severity Index compared with 3% to 4% of patients receiving placebo (P < .001). Rates of serious adverse events, including serious infections, malignancies, and cardiovascular events, were low and consistent with the expected background rates. The most common adverse events in phase 3 trials were arthralgia, cough, headache, injection-site erythema, nasopharyngitis, and upper respiratory tract infection. SOURCE: Janssen-Ortho Inc. E-mail this page to a friend or colleague! To print, use this version