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Ustekinumab Approved in EU for Moderate to Severe Plaque Psoriasis NEW YORK -- January 22, 2009 -- The European Commission has approved ustekinumab (Stelara) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, and psoralen plus ultraviolet A light (PUVA). The approval is based on data from 2 large, pivotal phase 3 multicentre, randomised, double-blind, placebo controlled trials (PHOENIX 1 & 2) involving nearly 2,000 patients in whom the efficacy and safety of ustekinumab in the treatment of moderate-to-severe plaque psoriasis were evaluated. Two-thirds or more of patients achieved the primary endpoint of each trial. At least 75% improvement in psoriasis was seen at week 12 using the Psoriasis Area and Severity Index (PASI 75), after receiving just 2 doses of ustekinumab 45 mg or 90 mg at weeks 0 and 4. At week 12, 66% to 76% of patients receiving ustekinumab 45 mg or 90 mg doses achieved PASI 75 compared with 3% to 4% of patients receiving placebo (P<.001). The majority of responders receiving injections every 12 weeks maintained PASI 75 response through up to 18 months. 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 reactions in phase 3 trials were arthralgia, cough, headache, injection site erythema, nasopharyngitis, and upper respiratory tract infection. Most were considered to be mild and did not necessitate discontinuation of therapy. SOURCE: Johnson&Johnson E-mail this page to a friend or colleague! To print, use this version