Investigation of plaque psoriasis relapse after secukinumab withdrawal in patients from two Phase 3 studies

塞库金单抗 中止 医学 安慰剂 银屑病 银屑病面积及严重程度指数 内科学 皮肤病科 银屑病性关节炎 病理 替代医学
作者
Mark Lebwohl,Lars Iversen,Liv Eidsmo,James G. Krueger,Mayte Suárez‐Fariñas,Lewis Tomalin,Konstantin Frank,Ruquan You,M. Milutinovic
出处
期刊:Clinical and Experimental Dermatology [Oxford University Press]
标识
DOI:10.1093/ced/llad329
摘要

Secukinumab is effective against a range of psoriatic manifestations. Investigating psoriasis (PsO) relapse following secukinumab discontinuation could provide insights into long-term PsO remission.To examine PsO relapse rates upon treatment discontinuation following one year of secukinumab treatment.This study (NCT01544595) is an extension of the Phase 3 ERASURE/FIXTURE studies in patients with moderate-to-severe plaque PsO. After one year of secukinumab 300 mg or 150 mg treatment, Week 52 PASI75 responders were randomly assigned to receive placebo. Upon relapse, patients receiving placebo were switched to their previous secukinumab dose. The study primary outcome was non-relapse rate after secukinumab withdrawal.Following the last dose of secukinumab 300 mg, 21% and 10% of patients who switched to placebo did not relapse at one and two years after discontinuation, respectively. Patients who received secukinumab 150 mg for one year showed a lower proportion of non-relapse following treatment discontinuation (14% and 6%) at one and two years, respectively). Non-relapsing patients maintained low mean PASI (2.8) at one year drug-free versus baseline (20.9); 1.7 at two years drug-free versus baseline (19.2). Disease duration (P=0.017) and severity (P=0.022) were significantly associated with time-to-relapse in patients initially treated with secukinumab 300 mg; patients with shorter disease duration and lower baseline PASI remained relapse-free for longer.Following discontinuation of secukinumab, a proportion of patients stayed relapse-free. Further, patients with shorter disease duration remained relapse-free for longer, suggesting that earlier treatment with secukinumab may result in long-term clinical control of moderate-to-severe PsO.
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