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Adalimumab Approved in Japan for Plaque Psoriasis, Psoriatic Arthritis NEW YORK -- January 20, 2010 -- Adalimumab (Humira) pre-filled syringe 40 mg/0.8 mL for subcutaneous injection has received approval for the additional indications of plaque psoriasis (PS) and psoriatic arthritis (PSA) in Japan. Post-marketing observation survey (PMOS) will be conducted in all patients treated with the drug over a given period of time in order to promote its effective and safe use in treating psoriasis. The approval was based on a 24-week, multicentre, double-blind, placebo-controlled study in 169 patients from Japan with moderate to severe psoriasis, including patients with psoriatic arthritis with joint symptoms. The study compared 3 different dosages of adalimumab against placebo (primary efficacy was evaluated up until week 16). The percentages of patients achieving Psoriasis Area and Severity Index (PASI) >= 75% at week 16 was 57.9 %, 62.8 %, and 81.0 % in patients receiving adalimumab 40 mg every other week, 40 mg every other week plus a 80 mg loading dose at the initial administration, and 80 mg every other week, respectively, with a significantly higher number of patients treated with adalimumab experiencing improvement compared with the placebo group (4.3%). The percentage of patients with PASI 75 among those treated with adalimumab was significantly higher at week 4 and thereafter, indicating rapid onset of efficacy. Patients treated with adalimumab showed significant improvement in quality of life compared with those who were treated with placebo. The safety profile of adalimumab in this study was consistent with that seen in studies in patients with rheumatoid arthritis. SOURCE: Eisai Co., Ltd. E-mail this page to a friend or colleague! To print, use this version