Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study.

IF 3.5 3区 医学 Q1 DERMATOLOGY
Dermatology and Therapy Pub Date : 2024-12-01 Epub Date: 2024-11-08 DOI:10.1007/s13555-024-01292-z
Richard B Warren, Lev Pavlovsky, Antonio Costanzo, Michael Bukhalo, Neil J Korman, Yu-Huei Huang, Georgios Kokolakis, Andreas Pinter, Nadia Ibrahim, Yanbing Zheng, Leonidas Drogaris, Vassilis Stakias, Ahmed M Soliman, Simone Rubant, Diamant Thaçi
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引用次数: 0

Abstract

Introduction: Risankizumab has demonstrated superior efficacy compared to other psoriasis treatments, including secukinumab, adalimumab, and ustekinumab; switching to risankizumab from other psoriasis treatments has shown superior clinical and quality of life (QoL) outcomes. We evaluated the efficacy and safety of directly switching patients with moderate-to-severe plaque psoriasis and a suboptimal response to interleukin (IL)-17 inhibitors (secukinumab or ixekizumab) to risankizumab.

Methods: This 52-week, phase 3b study enrolled patients (≥ 18 years) with moderate-to-severe plaque psoriasis who had previously been treated with the recommended dose of secukinumab or ixekizumab for ≥ 6 months but did not achieve an optimal response (static Physician's Global Assessment [sPGA] 2/3; body surface are [BSA] 3- < 10%). Patients received subcutaneous risankizumab (150 mg) without washout. The primary endpoint was the proportion of patients achieving sPGA of 0/1 at week 16. Secondary endpoints included sPGA 0/1 at week 52, sPGA 0, Dermatology Life Quality Index (DLQI) 0/1, and Psoriasis Symptoms Scale (PSS) 0 at weeks 16 and 52. Safety was monitored throughout the study.

Results: The study included 244 patients. sPGA 0/1 was achieved by 57.4% and 62.3% at week 16 and 52. At week 16, sPGA 0, DLQI 0/1, and PSS 0 were achieved by 20.5%, 40.2%, and 20.9%, respectively. At week 52, these proportions increased to 27.1% for sPGA 0, 47.2% for DLQI 0/1, and 27.5% for PSS 0. Most frequently reported adverse events (reported in ≥ 5% of patients) in risankizumab-treated patients were COVID-19 infection (8.6%) and nasopharyngitis (5.7%). No new safety signals were observed.

Conclusions: Directly switching to risankizumab improved outcomes and QoL in patients with moderate-to-severe psoriasis who had suboptimal responses to anti-IL-17 inhibitors (secukinumab or ixekizumab). The safety results are consistent with previously reported safety of risankizumab. This study supports the efficacy of risankizumab in patients previously treated with biologics, including IL-17 inhibitors, and suggests a direct switch to risankizumab for improved clinical outcomes and QoL.

Clinical trials: ClinicalTrials.gov identifier: NCT04102007.

对塞库单抗或伊克珠单抗疗效不佳的银屑病患者使用利抗珠单抗的疗效和安全性:3b期开放标签单臂(aIMM)研究结果。
简介与其他银屑病治疗方法(包括secukinumab、阿达木单抗和乌斯特库单抗)相比,利赞珠单抗的疗效更优;从其他银屑病治疗方法转用利赞珠单抗的临床和生活质量(QoL)结果更佳。我们评估了中重度斑块状银屑病且对白介素(IL)-17抑制剂(secukinumab或ixekizumab)反应不佳的患者直接转用利桑单抗的疗效和安全性:这项为期52周的3b期研究招募了中重度斑块状银屑病患者(≥18岁),这些患者曾接受推荐剂量的secukinumab或ixekizumab治疗≥6个月,但未获得最佳应答(静态医生总体评估[sPGA] 2/3;体表面积[BSA] 3- 结果):在第16周和第52周,分别有57.4%和62.3%的患者达到sPGA 0/1。在第 16 周,分别有 20.5%、40.2% 和 20.9% 的患者达到了 sPGA 0、DLQI 0/1 和 PSS 0。利坦珠单抗治疗患者最常报告的不良事件(≥5%的患者报告)是COVID-19感染(8.6%)和鼻咽炎(5.7%)。未观察到新的安全信号:结论:对于对抗IL-17抑制剂(secukinumab或ixekizumab)反应不佳的中重度银屑病患者,直接改用利抗珠单抗可改善疗效和生活质量。安全性结果与之前报道的利桑珠单抗的安全性一致。这项研究支持利坦珠单抗对既往接受过生物制剂(包括IL-17抑制剂)治疗的患者的疗效,并建议直接改用利坦珠单抗以改善临床疗效和生活质量:临床试验:ClinicalTrials.gov identifier:临床试验:ClinicalTrials.gov 标识符:NCT04102007。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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