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 Oct 09, 2019
Elewski BE, Baker CS, Crowley JJ, et al. - Researchers tested the safety and effectiveness 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. Outcomes from the first 26 weeks (Period A) were reported. In the subsequent 26-week open-label extension (OLE) period, individuals 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 individuals in Period A, 188 entered the OLE after completion or early escape from Period A. According to this phase-3, randomized, placebo-controlled trial, 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 identified. 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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