Impact of Previous Alopecia Areata Treatment on Efficacy Responses up to Week 48 Following Ritlecitinib Treatment: A Post Hoc Analysis

IF 3.5 3区医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-09-10 DOI:10.1007/s13555-024-01260-7

Jennifer Fu, Alexander Egeberg, Susan Holmes, Sergio Vano-Galvan, Martin Steinhoff, Roger Edwards, Gianluca Bonfanti, Ranjit Nagra, Robert Wolk, Helen Tran, Ernest Law

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Abstract

Introduction

Patients with alopecia areata (AA) may have received several therapies for management of AA during their lives. In the ALLEGRO phase 2b/3 (NCT03732807) study, the oral JAK3/TEC family kinase inhibitor ritlecitinib demonstrated efficacy and an acceptable safety profile in patients aged ≥ 12 years with AA and ≥ 50% scalp hair loss. This post hoc analysis investigated associations between prior use of AA therapies and Severity of Alopecia Tool (SALT) responses in patients receiving ritlecitinib for AA.

Methods

Patients receiving ritlecitinib 30 mg or 50 mg once daily with or without an initial 4-week 200-mg daily loading dose were grouped by previous exposure to AA treatments, including topicals, intralesional corticosteroids (ILCS), topical immunotherapy, and systemic immunosuppressants or any prior AA treatment. Multivariable logistic regression analyses evaluated the association between response based on a SALT score of ≤ 20 and any prior treatment for AA at weeks 24 and 48.

Results

Of 522 patients, 360 (69.0%) had previous exposure to any AA treatment. At Week 24, SALT ≤ 20 response was positively associated with prior use of ILCS (odds ratio [OR], 2.12; 95% confidence interval [CI], 1.23–3.65; P < 0.05) and negatively associated with prior use of systemic immunosuppressants (OR 0.50; 95% CI 0.28–0.88; P < 0.05). Prior use of topicals or topical immunotherapy was not associated with SALT ≤ 20 response at Week 24. By Week 48, no association was identified between SALT ≤ 20 response and prior use of topicals, ILCS, topical immunosuppressants, or systemic immunosuppressants (all P > 0.05). Previous exposure to any AA therapy was not associated with SALT ≤ 20 response at weeks 24 or 48 (all P > 0.05).

Conclusions

Prior AA treatment history had no effect on longer-term treatment response to ritlecitinib.

Trial Registration Number

NCT03732807.

Graphical Abstract

Abstract Image

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曾接受过的脱发治疗对瑞替西尼治疗第 48 周疗效反应的影响：事后分析

导言：斑秃（AA）患者一生中可能接受过多种治疗方法。在ALLEGRO 2b/3期（NCT03732807）研究中，口服JAK3/TEC家族激酶抑制剂利特西替尼对年龄≥12岁、头皮脱发≥50%的AA患者具有良好的疗效和可接受的安全性。本事后分析调查了接受利特西替尼治疗的 AA 患者之前使用 AA 治疗与脱发严重程度工具（SALT）反应之间的关系。方法将接受利特西替尼 30 毫克或 50 毫克、每天一次，或不接受初始 4 周 200 毫克、每天一次负荷剂量治疗的患者按之前接受 AA 治疗的情况分组，包括外用药、局部皮质类固醇 (ILCS)、局部免疫疗法和全身免疫抑制剂或之前接受过的任何 AA 治疗。多变量逻辑回归分析评估了第24周和第48周SALT评分≤20分的反应与既往接受过任何AA治疗之间的关系。结果在522名患者中，360人（69.0%）既往接受过任何AA治疗。在第 24 周，SALT ≤ 20 反应与之前使用 ILCS 呈正相关（几率比 [OR]，2.12；95% 置信区间 [CI]，1.23-3.65；P <；0.05），与之前使用全身性免疫抑制剂呈负相关（OR 0.50；95% CI 0.28-0.88；P <；0.05）。在第24周时，曾使用外用药或局部免疫疗法与SALT≤20反应无关。第48周时，未发现SALT≤20反应与之前使用外用药、ILCS、局部免疫抑制剂或全身免疫抑制剂有关（均为P >0.05）。结论先前的AA治疗史对瑞替西尼的长期治疗反应没有影响。试验注册号NCT03732807.图文摘要

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来源期刊

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.