Adalimumab for nail psoriasis: Efficacy and safety over 52 weeks from a phase-3, randomized, placebo-controlled trial
Journal of the European Academy of Dermatology and Venereology Jul 19, 2019
Elewski BE, et al. - Researchers conducted this phase-3, randomized, placebo-controlled trial to assess the effectiveness and safety of adalimumab (ADA) (Humira [AbbVie Inc, North Chicago, IL]) long-term treatment (52 weeks) in patients with moderate-to-severe plaque psoriasis and concomitant moderate-to-severe psoriasis of the fingernail. Reporting results from the first 26 weeks (Period A). In the following 26-week open-label extension (OLE) period, patients receiving 40 mg ADA every other week or placebo in Period A persisted or switched to 40 mg ADA every other week. Of the initially randomized 217 patients in Period A, 188 entered the OLE after completion or early escape from Period A. According to findings, long-term effectiveness and enhancement in signs and symptoms of nail disease were shown after therapy with ADA every other week in this psoriasis patients population with concomitant, moderate to severe nail psoriasis; including incremental improvements in the frequency of total clearance of nail disease. For patients receiving at least one dose of ADA over 52 weeks, no new safety hazards have been recognized. Data reported that serious adverse event and serious infection rates for the All-ADA Population were 6.9% and 3.4%, respectively.
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