Ritlecitinib for Severe Alopecia Areata: A 24-Week, Multicentre, Real-World Study

IF 11.4 1区 医学 Q1 DERMATOLOGY
Michela Starace, Luca Rapparini, Francesca Pampaloni, Stephano Cedirian, Federico Quadrelli, Francesca Bruni, Ginevra Martelli, Giampiero Girolomoni, Francesco Bellinato, Paolo Gisondi, Giuseppe Gallo, Simone Ribero, Michela Ortoncelli, Pietro Quaglino, Luigi Gargiulo, Carlo Vignoli, Alessandra Narcisi, Francesca Ambrogio, Caterina Foti, Raffaele Dante Caposiena Caro, Iris Zalaudek, Angelo Valerio Marzano, Andrea Sechi, Mauro Barbareschi, Luca Valtellini, Silvia Mariel Ferrucci, Laura Diluvio, Enrico Matteini, Luca Bianchi, Mariateresa Cantelli, Paola Nappa, Carolina D’Elia, Valeria Boccaletti, Carola Romanò, Elisabetta Fulgione, Anna Balato, Giuseppe Argenziano, Emanuele Trovato, Elisa Cinotti, Pietro Rubegni, Federica Dall’Oglio, Francesco Lacarrubba, Giuseppe Micali, Elena Pezzolo, Francesca Caroppo, Anna Belloni Fortina, Giacomo Caldarola, Ketty Peris, Lorenzo Maria Pinto, Calogero Pagliarello, Riccardo Balestri, Carlo Tomasini, Stefania Barruscotti, Laura Atzori, Silvia Sanna, Lorenzo Ala, Giulio Bortone, Giovanni Pellacani, Alfredo Rossi, Serena Lembo, Annunziata Raimondo, Flavia Manzo Margiotta, Valentina Dini, Marco Romanelli, Andrea Megna, Francesca Prignano, Gianmarco Silvi, Oriana Simonetti, Edoardo De Simoni, Michela Magnano, Natale Schettini, ⁠⁠Alessandro Borghi, Francesca Satolli, Maria Beatrice de Felici del Giudice, Franco Rongioletti, Stefania Guida, Gianmarco Diego Bigotto, Cesare Filippeschi, Teresa Oranges, Greta Tronconi, Bianca Maria Piraccini
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引用次数: 0

Abstract

Background

Ritlecitinib, an oral selective inhibitor of Janus kinase 3 and the TEC family of kinases, has recently been approved for the treatment of severe alopecia areata, but real-world data are still limited.

Objective

The aim was to evaluate the effectiveness and tolerability of ritlecitinib 50 mg/day after 24 weeks in patients with severe alopecia areata in clinical practice.

Methods

We performed an Italian observational, retrospective, multicentre study with 24 weeks of follow-up. Patients ≥ 12 years of age with severe alopecia areata (Severity of Alopecia Tool [SALT] ≥ 50) and a disease duration ≥ 6 months who were candidates for systemic therapy were enrolled. Ritlecitinib 50 mg/day was administered according to national guidelines. The primary endpoint was to evaluate the achievement of SALT ≤ 20 at week 24. Secondary endpoints included achievement of SALT ≤ 10; mean change in SALT; trichoscopic improvement; quality of life; psychological impact; efficacy in eyebrows, eyelashes, and nails; and safety profile.

Results

A total of 102 patients were included. At week 24, 40.2% of patients achieved SALT ≤ 20, with a greater response in adolescents (48.6%) than in adults (21.9%). The mean SALT score decreased from 86.2 ± 18.5 to 40.8 ± 37.1. Significant improvements were observed in trichoscopic signs and quality of life. The treatment was also effective on eyebrows, eyelashes, and nails. Adverse events were mild (e.g., acne, headache). Ritlecitinib had to be discontinued in only one case of severe anaemia.

Conclusions

In this multicentre real-world study, ritlecitinib 50 mg/day was an effective and well-tolerated treatment option for severe alopecia areata.

利来替尼治疗重度斑秃:一项24周、多中心、真实世界研究
背景:利来替尼(Ritlecitinib)是一种口服选择性Janus激酶3和TEC家族激酶抑制剂,最近已被批准用于治疗严重斑秃,但实际数据仍然有限。目的:评价利来替尼50 mg/天治疗重度斑秃患者24周后的临床疗效和耐受性。方法:我们进行了一项意大利观察性、回顾性、多中心研究,随访24周。纳入年龄≥12岁的严重斑秃患者(严重程度[SALT]≥50),病程≥6个月,适合接受全身治疗。Ritlecitinib 50mg /天按照国家指南给药。主要终点是评估第24周时SALT≤20的实现情况。次要终点包括SALT≤10;盐均值变化;trichoscopic改善;生活质量;心理影响;眉毛、睫毛和指甲的功效;还有安全概况。结果:共纳入102例患者。在第24周,40.2%的患者达到SALT≤20,青少年(48.6%)的应答率高于成人(21.9%)。平均SALT评分由86.2±18.5降至40.8±37.1。观察到trichoscopy体征和生活质量的显著改善。这种疗法对眉毛、睫毛和指甲也有效。不良事件轻微(如痤疮、头痛)。只有一例严重贫血患者需要停用利来替尼。结论:在这项多中心真实世界的研究中,利来替尼50mg /天是治疗严重斑秃的有效且耐受性良好的选择。
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
CiteScore
15.20
自引率
2.70%
发文量
84
审稿时长
>12 weeks
期刊介绍: The American Journal of Clinical Dermatology is dedicated to evidence-based therapy and effective patient management in dermatology. It publishes critical review articles and clinically focused original research covering comprehensive aspects of dermatological conditions. The journal enhances visibility and educational value through features like Key Points summaries, plain language summaries, and various digital elements, ensuring accessibility and depth for a diverse readership.
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