Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS)

医学 安慰剂 耐受性 银屑病 银屑病面积及严重程度指数 剂量范围研究 内科学 临床终点 人口 随机对照试验 不利影响 胃肠病学 皮肤病科 双盲 病理 替代医学 环境卫生
作者
Richard B. Warren,Lars E. French,Andrew Blauvelt,Richard Langley,Alexander Egeberg,Ulrich Mrowietz,H.J.A. Hunter,Melinda Gooderham,Per Soelberg Soerensen,Philippe Andrès,Morten Otto Alexander Sommer,Anna Carlsson,Kim D. Kjøller,Bruce Strober
出处
期刊:Journal of The American Academy of Dermatology [Elsevier BV]
卷期号:90 (3): 494-503 被引量:10
标识
DOI:10.1016/j.jaad.2023.11.005
摘要

Background Orismilast is a novel oral phosphodiesterase 4 (PDE4) B/D inhibitor being investigated as a potential treatment for moderate-to-severe psoriasis. Objective To evaluate efficacy and safety of orismilast modified-release formulation in moderate-to-severe psoriasis. Methods This multicenter, randomized (1:1:1:1 to 20, 30, 40 mg orismilast or placebo, twice daily), double-blinded, placebo-controlled, parallel-group, phase 2b, 16-week, dose-ranging study evaluated orismilast in adults with moderate-to-severe plaque psoriasis (NCT05190419). Efficacy endpoints were analyzed using multiple imputation. Results Of 202 randomized patients, baseline characteristics were balanced across arms, except greater severe disease proportions for orismilast versus placebo. Orismilast showed significant improvements in the primary endpoint, percentage change in Psoriasis Area and Severity Index (PASI), from baseline to week 16 (orismilast –52.6% to –63.7%; placebo, –17.3%; all P<0.001). Greater proportions receiving orismilast achieved PASI75 (39.5% to 49.0%; P<0.05) and PASI90 (22.0% to 28.3%; P<0.05 for 20 and 40 mg) versus placebo (PASI75, 16.5%; PASI90, 8.3%) at week 16. Safety findings were as expected with PDE4 inhibition; dose-dependent tolerability effects observed. Limitations Small sample size, disease severity imbalance between groups, limited duration and diversity in study population. Conclusion Orismilast demonstrated greater efficacy versus placebo and a safety profile in line with PDE4 inhibition.
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