瑞莎珠单抗治疗中度至重度斑块状银屑病的长期安全性和有效性：LIMMitless 3期最终开放标签扩展试验结果

Long-Term Safety and Efficacy of Risankizumab to Treat Moderate-to-Severe Plaque Psoriasis: Final LIMMitless Phase 3, Open-Label Extension Trial Results.

作者信息

Papp Kim A, Lebwohl Mark G, Puig Lluís, Ohtsuki Mamitaro, Beissert Stefan, Gooderham Melinda, Amin Ahmad Z, Wu Tianshuang, Rubant Simone, Bialik Brenton, Ashley Doug, Soliman Ahmed M, Chen Michael M, Blauvelt Andrew

机构信息

Alliance Clinical Trials and Probity Medical Research, Inc., 135 Union Street East, Waterloo, ON, N2J 1C4, Canada.

Division of Dermatology, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

出版信息

Am J Clin Dermatol. 2025 Jul 29. doi: 10.1007/s40257-025-00964-6.

DOI:10.1007/s40257-025-00964-6

PMID:40728772

Abstract

BACKGROUND

Psoriasis is a chronic, inflammatory disease requiring long-term therapy. Risankizumab, an anti-interleukin-23 monoclonal antibody, is approved to treat moderate-to-severe plaque psoriasis in adults.

OBJECTIVE

The aim was to assess the long-term safety and efficacy of continuous risankizumab treatment through 6 years in adults with moderate-to-severe plaque psoriasis.

METHODS

LIMMitless, a phase 3, open-label extension study, evaluated the long-term safety and efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis following multiple phase 2/3 base studies. Patients randomized to risankizumab 150 mg at baseline of the base studies (≤ 52 weeks) were eligible to enroll in the LIMMitless study, in which they received risankizumab 150 mg subcutaneously every 12 weeks for an additional 252 weeks. This final analysis assessed safety (treatment-emergent adverse events [TEAEs]) through 324 weeks and efficacy (including proportions of patients who achieved ≥ 90%/100% improvement from baseline in Psoriasis Area and Severity Index [PASI 90/PASI 100], static Physician's Global Assessment of clear or almost clear [sPGA 0/1], or Dermatology Life Quality Index of no effect on patient's quality of life [DLQI 0/1]) through 304 weeks.

RESULTS

Of 897 patients enrolled in the LIMMitless study, 661 completed the study for a total of 4921.2 patient years of exposure to risankizumab. Rates of TEAEs, TEAEs leading to discontinuation, and TEAEs of safety interest were low and consistent with rates observed in previous studies. During the base studies, risankizumab treatment demonstrated high rates of rapid and durable efficacy through 52 weeks; risankizumab treatment also maintained or further improved efficacy and quality-of-life outcomes in the LIMMitless study. At week 304, 86.0% of patients achieved PASI 90, 54.2% achieved PASI 100, 84.7% achieved sPGA 0/1, and 76.3% achieved DLQI 0/1 (using modified nonresponder imputation).

CONCLUSIONS

Long-term risankizumab was well tolerated and demonstrated high and durable efficacy through 6 years of continuous treatment.

CLINICAL TRIAL REGISTRATION

NCT03047395.

摘要

背景

银屑病是一种需要长期治疗的慢性炎症性疾病。瑞莎珠单抗是一种抗白细胞介素-23单克隆抗体，已被批准用于治疗成人中度至重度斑块状银屑病。

目的

旨在评估连续使用瑞莎珠单抗治疗6年对成人中度至重度斑块状银屑病的长期安全性和疗效。

方法

LIMMitless是一项3期开放标签扩展研究，在多项2/3期基础研究之后，评估了瑞莎珠单抗对中度至重度斑块状银屑病患者的长期安全性和疗效。在基础研究（≤52周）基线时随机接受150mg瑞莎珠单抗的患者有资格参加LIMMitless研究，在该研究中，他们每12周皮下注射150mg瑞莎珠单抗，持续252周。这项最终分析评估了324周的安全性（治疗中出现的不良事件[TEAE]）和304周的疗效（包括达到银屑病面积和严重程度指数[PASI 90/PASI 100]较基线改善≥90%/100%、静态医师整体评估为清除或几乎清除[sPGA 0/1]、或皮肤病生活质量指数对患者生活质量无影响[DLQI 0/1]的患者比例）。

结果

在LIMMitless研究纳入的897例患者中，661例完成了研究，瑞莎珠单抗的总暴露患者年数为4921.2。TEAE、导致停药的TEAE和安全性关注的TEAE发生率较低，与先前研究中观察到的发生率一致。在基础研究期间，瑞莎珠单抗治疗在52周内显示出快速且持久的高疗效；瑞莎珠单抗治疗在LIMMitless研究中也维持或进一步改善了疗效和生活质量结果。在第304周时，86.0%的患者达到PASI 90，54.2%的患者达到PASI 100，84.7%的患者达到sPGA 0/1，76.3%的患者达到DLQI 0/1（使用改良的无反应者插补法）。