Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme.

IF 8.4 2区医学 Q1 DERMATOLOGY

Journal of the European Academy of Dermatology and Venereology Pub Date : 2025-02-17 DOI:10.1111/jdv.20547

B King, P Mirmirani, K Lo Sicco, Y Ramot, R Sinclair, L Asfour, K Ezzedine, C Paul, M Ohyama, R A Edwards, G Bonfanti, U Kerkmann, D Wajsbrot, R Ishowo-Adejumo, S H Zwillich, A Lejeune

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引用次数: 0

Abstract

Background: Ritlecitinib, an oral JAK3/TEC family kinase inhibitor, demonstrated efficacy over 48 weeks in patients with alopecia areata (AA) in the ALLEGRO phase 2b/3 study.

Objectives: This post hoc analysis evaluated individual Severity of Alopecia Tool (SALT) score trajectories in patients who received ritlecitinib 50 mg and rolled over from Phase 2b/3 into the ongoing, open-label, Phase 3 ALLEGRO-LT study to describe long-term response patterns and associated baseline disease characteristics.

Methods: Patients aged ≥12 years with ≥50% scalp hair loss received ritlecitinib 50 mg once daily in both studies. SALT score trajectories from baseline to Month 24 were used to categorise patients as early (SALT score ≤20 at Week 24 and Months 12 and 24), middle (≤20 at Months 12 and 24) or late responders (≤20 by Month 24) or as partial responders (maintained 30% improvement), relapsers (achieved but did not maintain 30% improvement) or non-responders (did not achieve 30% improvement). The proportions of patients achieving sustained response (achieved and maintained SALT score ≤20 at all subsequent available time points through Month 24) and complete response (SALT score 0 at ≥1 time point through Month 24) were evaluated. Multivariable logistic regression assessed variables associated with response.

Results: Of 191 patients treated with ritlecitinib 50 mg, 87 (45.5%) were responders (SALT score ≤20), 24 (12.6%) were partial responders, 24 (12.6%) were relapsers and 56 (29.3%) were non-responders. Of 87 patients categorised as responders, 81 (93.1%) sustained their clinical response and 47 (46.0%) achieved complete response. Factors associated with treatment response included female sex and less extensive and shorter duration of hair loss.

Conclusions: Approximately 45% of patients were SALT score responders, with up to 11% requiring >1 year of ritlecitinib treatment to achieve response, highlighting the importance of extended treatment duration.

Clinicaltrials:

Gov registration: ALLEGRO phase 2b/3 study (NCT03732807); ALLEGRO-LT study (NCT04006457).

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背景：利特西替尼是一种口服JAK3/TEC家族激酶抑制剂，在ALLEGRO 2b/3期研究中对斑秃（AA）患者的疗效超过48周：这项事后分析评估了接受利特西替尼50毫克治疗并从2b/3期转入正在进行的开放标签3期ALLEGRO-LT研究的患者的脱发严重程度工具（SALT）评分轨迹，以描述长期反应模式和相关的基线疾病特征：在两项研究中，年龄≥12岁、头皮脱发≥50%的患者均接受利特西替尼50毫克，每日一次。从基线到第24个月的SALT评分轨迹用于将患者分为早期应答者（第24周及第12个月和第24个月时SALT评分≤20分）、中期应答者（第12个月和第24个月时≤20分）或晚期应答者（第24个月时≤20分），或部分应答者（维持30%的改善）、复发者（达到但未维持30%的改善）或无应答者（未达到30%的改善）。评估了获得持续应答（在第 24 个月之前的所有可用时间点获得并保持 SALT 评分≤20）和完全应答（在第 24 个月之前的≥1 个时间点 SALT 评分为 0）的患者比例。多变量逻辑回归评估了与应答相关的变量：在191名接受利特西替尼50毫克治疗的患者中，87人（45.5%）为应答者（SALT评分≤20分），24人（12.6%）为部分应答者，24人（12.6%）为复发者，56人（29.3%）为无应答者。在被归类为应答者的 87 名患者中，81 人（93.1%）保持了临床应答，47 人（46.0%）实现了完全应答。与治疗反应相关的因素包括女性、脱发范围较小且持续时间较短：约45%的患者为SALT评分应答者，其中多达11%的患者需要接受超过1年的利特西替尼治疗才能获得应答，这凸显了延长治疗时间的重要性：Gov 注册：ALLEGRO2b/3期研究（NCT03732807）；ALLEGRO-LT研究（NCT04006457）。

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

Journal of the European Academy of Dermatology and Venereology 医学-皮肤病学

CiteScore

10.70

自引率

8.70%

发文量

874

审稿时长

3-6 weeks

期刊介绍： The Journal of the European Academy of Dermatology and Venereology (JEADV) is a publication that focuses on dermatology and venereology. It covers various topics within these fields, including both clinical and basic science subjects. The journal publishes articles in different formats, such as editorials, review articles, practice articles, original papers, short reports, letters to the editor, features, and announcements from the European Academy of Dermatology and Venereology (EADV). The journal covers a wide range of keywords, including allergy, cancer, clinical medicine, cytokines, dermatology, drug reactions, hair disease, laser therapy, nail disease, oncology, skin cancer, skin disease, therapeutics, tumors, virus infections, and venereology. The JEADV is indexed and abstracted by various databases and resources, including Abstracts on Hygiene & Communicable Diseases, Academic Search, AgBiotech News & Information, Botanical Pesticides, CAB Abstracts®, Embase, Global Health, InfoTrac, Ingenta Select, MEDLINE/PubMed, Science Citation Index Expanded, and others.