塞库金单抗
医学
银屑病
皮肤科生活质量指数
银屑病性关节炎
银屑病面积及严重程度指数
皮肤病科
安慰剂
临床终点
随机对照试验
生活质量(医疗保健)
钉子(扣件)
中止
内科学
病理
材料科学
替代医学
冶金
护理部
作者
Kristian Reich,John Sullivan,Petr Arenberger,S. Jazayeri,Ulrich Mrowietz,Matthias Augustin,Boni E. Elewski,R. You,P. Regnault,Jennifer Frueh
摘要
Background Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A, a cornerstone cytokine in psoriasis, has shown long-lasting efficacy and safety in the complete spectrum of psoriasis manifestations. Objectives To report the long-term (2·5-year) efficacy and safety of secukinumab in nail psoriasis. Methods TRANSFIGURE, a double-blind, randomized, placebo-controlled, parallel-group, multicentre phase IIIb study in 198 patients, investigated secukinumab 150 mg and 300 mg in patients with moderate-to-severe nail psoriasis. Results At week 16, the primary endpoint Nail Psoriasis Severity Index (NAPSI) was met, demonstrating superiority of secukinumab to placebo. The effect was sustained over 2·5 years with a large benefit for nail clearance, with mean NAPSI improvement of −73·3% and −63·6% with secukinumab 300 mg and 150 mg, respectively. At 2·5 years, secukinumab demonstrated sustained clinically significant reductions in total mean Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) quality-of-life (QoL) scores of −52·4% and −18·1%, and 70% and 71% of patients achieved a weighted NAPPA Patient Benefit Index global score of ≥ 2 with secukinumab 300 mg and 150 mg, respectively. Patients showed considerable improvements in the EuroQol 5-Dimension health status questionnaire at 2·5 years, reporting a decrease in pain and discomfort. No new safety findings were observed. Conclusions Secukinumab demonstrated strong and clinically meaningful efficacy for up to 2·5 years in nail psoriasis, with significant sustained QoL improvements and a favourable safety profile.
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