Oral Icotrokinra for Plaque Psoriasis in Adults and Adolescents

作者：Robert Bissonnette, Jennifer Soung, Adelaide A. Hebert, Andrew Pink, Andreas Pinter, Angela Moore, Yuling Shi, Wenhui Wang, Darryl Toth, Megan Miller-Kassamali, Joseph Cafone, Jingzhi Jiang, Shu Li, Cynthia Marie Carver DeKlotz, Fabio P. Nunes, Mark Lebwohl · 发表于：New England Journal of Medicine · 年份：2025 · DOI：10.1056/nejmoa2504187 · 被引用次数：24 · 研究领域：Psoriasis: Treatment and Pathogenesis、Dermatology and Skin Diseases、Spondyloarthritis Studies and Treatments

BACKGROUND: Icotrokinra, a targeted oral peptide that selectively binds the interleukin-23 receptor, is under investigation for the treatment of plaque psoriasis. METHODS: We conducted a phase 3, double-blind, randomized, placebo-controlled trial involving adults and adolescents (≥12 years of age) with moderate-to-severe plaque psoriasis, as defined by all the following: a total body-surface area of psoriasis involvement of at least 10%, a Psoriasis Area and Severity Index (PASI) score of at least 12 (range, 0 to 72, with higher scores indicating a greater extent or severity of psoriasis), and an Investigator's Global Assessment (IGA) score of at least 3 (range, 0 [clear skin] to 4 [severe disease]). Participants were assigned in a 2:1 ratio to receive icotrokinra at a dose of 200 mg once daily through week 24 or placebo through week 16 followed by transition to icotrokinra. The coprimary end points were an IGA 0/1 response (IGA score of 0 or 1 with ≥2-point reduction from baseline) and a PASI 90 response (≥90% reduction from baseline in the PASI score) at week 16. RESULTS: A total of 684 participants underwent randomization (456 to the icotrokinra group and 228 to the placebo group). At week 16, a total of 65% of the participants receiving icotrokinra and 8% of those receiving placebo had an IGA 0/1 response, and 50% and 4%, respectively, had a PASI 90 response (P<0.001 for both comparisons). Complete clearance of skin at week 16 was significantly more likely with icotrokinr...