Department of Dermatology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Department of Dermatology, Chang Gung Memorial Hospital, and College of Medicine, Chang Gung University, Taoyuan, Taiwan.
J Dermatol. 2019 Sep;46(9):752-758. doi: 10.1111/1346-8138.15004. Epub 2019 Jul 25.
The 52-week results from the CLEAR (NCT02074982) study showed high and superior efficacy of secukinumab versus ustekinumab in clearing skin and improving patient-reported outcomes, with comparable safety profile in subjects with moderate to severe psoriasis. Here, we analyzed the efficacy and safety of secukinumab in Asian subjects from the CLEAR study. In this double-blind, phase IIIb study, eligible subjects with moderate to severe plaque psoriasis were randomized (1:1) to receive s.c. injection of secukinumab 300 mg or ustekinumab as per label. Of 62 subjects included in Asian subanalyses, 23 were randomized to secukinumab and 39 to ustekinumab. A significantly higher proportion of subjects achieved 90% or more improvement in Psoriasis Area and Severity Index (PASI 90) with secukinumab versus ustekinumab at week 16 (78.3% vs 35.9%, P = 0.0010) and at week 52 (60.9% vs 33.3%, P = 0.0196). Similarly, a higher proportion of subjects achieved PASI 100 with secukinumab versus ustekinumab at week 16 (43.5% vs 10.3%, P = 0.0029) and at week 52 (30.4% vs 12.8%, P = 0.0704). The median time to achieve 50% improvement in baseline PASI was 2.8 weeks in the secukinumab group versus 6.3 weeks in the ustekinumab group. The safety profile of secukinumab was in line with the known profile and no deaths occurred. Overall, 95.7% and 84.6% of subjects remained on secukinumab and ustekinumab, respectively. Similar to the core study, secukinumab showed sustained and superior efficacy with faster response versus ustekinumab, and no new or unexpected safety concerns were identified, in Asian subjects with moderate to severe plaque psoriasis.
CLEAR(NCT02074982)研究的 52 周结果表明,司库奇尤单抗在清除皮肤和改善患者报告的结果方面比乌司奴单抗具有更高和更好的疗效,在中重度银屑病患者中具有相似的安全性。在这里,我们分析了 CLEAR 研究中亚洲受试者的疗效和安全性。在这项双盲、IIIb 期研究中,符合条件的中重度斑块状银屑病患者按 1:1 随机(双盲)接受司库奇尤单抗 300mg 或乌司奴单抗皮下注射。在亚洲亚组分析中纳入的 62 名受试者中,23 名随机分配至司库奇尤单抗组,39 名随机分配至乌司奴单抗组。与乌司奴单抗相比,司库奇尤单抗在第 16 周(78.3% vs. 35.9%,P = 0.0010)和第 52 周(60.9% vs. 33.3%,P = 0.0196)时达到银屑病面积和严重程度指数(PASI)90%或更高改善的受试者比例显著更高。同样,与乌司奴单抗相比,司库奇尤单抗在第 16 周(43.5% vs. 10.3%,P = 0.0029)和第 52 周(30.4% vs. 12.8%,P = 0.0704)时达到 PASI 100 的受试者比例更高。司库奇尤单抗组达到基线 PASI 改善 50%的中位时间为 2.8 周,乌司奴单抗组为 6.3 周。司库奇尤单抗的安全性与已知安全性一致,未发生死亡事件。总体而言,分别有 95.7%和 84.6%的受试者继续接受司库奇尤单抗和乌司奴单抗治疗。与核心研究相似,在中重度斑块状银屑病的亚洲受试者中,司库奇尤单抗表现出持续和更好的疗效,与乌司奴单抗相比,起效更快,且未发现新的或意外的安全性问题。