Reich K, Sullivan J, Arenberger P, Jazayeri S, Mrowietz U, Augustin M, Elewski B, You R, Regnault P, Frueh J A
Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Skinflammation® Center, Hamburg, Germany.
Br J Dermatol. 2021 Mar;184(3):425-436. doi: 10.1111/bjd.19262. Epub 2020 Dec 16.
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.
To report the long-term (2·5-year) efficacy and safety of secukinumab in nail psoriasis.
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.
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.
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.
司库奇尤单抗是一种全人源单克隆抗体，可选择性中和白细胞介素-17A（银屑病的关键细胞因子），在银屑病的全谱表现中显示出持久的疗效和安全性。
报告司库奇尤单抗治疗甲银屑病的长期（2.5年）疗效和安全性。
TRANSFIGURE是一项双盲、随机、安慰剂对照、平行组、多中心IIIb期研究，纳入198例中重度甲银屑病患者，研究了司库奇尤单抗150mg和300mg的疗效。
在第16周时，达到了主要终点甲银屑病严重程度指数（NAPSI），表明司库奇尤单抗优于安慰剂。这种效果在2.5年中持续存在，对指甲清除有很大益处，司库奇尤单抗300mg和150mg组的平均NAPSI改善分别为-73.3%和-63.6%。在2.5年时，司库奇尤单抗使银屑病和银屑病关节炎指甲评估（NAPPA）总平均生活质量（QoL）评分持续显著降低，分别为-52.4%和-18.1%，司库奇尤单抗300mg和150mg组分别有70%和71%的患者达到加权NAPPA患者获益指数全球评分≥2。患者在2.5年时欧洲五维健康状况调查问卷中显示出相当大的改善，报告疼痛和不适有所减轻。未观察到新的安全发现。
司库奇尤单抗在甲银屑病中显示出长达2.5年的强大且具有临床意义的疗效，生活质量持续显著改善，安全性良好。
