Combination of Baricitinib and Phototherapy in Adults With Active Vitiligo: A Randomized Clinical Trial.

IF 11.5 1区 医学 Q1 DERMATOLOGY
Julien Seneschal, Mathilde Guyon, Ribal Merhi, Juliette Mazereeuw-Hautier, Nicolas Andreu, Sarah Cazenave, Khaled Ezzedine, Thierry Passeron, Katia Boniface
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引用次数: 0

Abstract

Importance: Vitiligo is a chronic autoimmune disorder leading to skin depigmentation and reduced quality of life (QOL). Patients with extensive and very active disease are the most difficult to treat.

Objective: To assess the efficacy and adverse events of baricitinib combined with narrowband UV-B in adults with severe, active, nonsegmental vitiligo.

Design, setting, and participants: This academic, multicenter, double-blind, noncomparative randomized clinical trial was conducted at 4 dermatology departments between July 2021 and April 2023 and included adult patients with extensive and active nonsegmental vitiligo. The study was designed to evaluate the effect of baricitinib plus narrowband UV-B based solely on the results from this experimental group. The placebo group was used as a calibration group. Data were analyzed from August to November 2023.

Interventions: Participants were randomized 3:1 to baricitinib, 4 mg per day, or placebo for 36 weeks alone for the first 12 weeks and then in combination with narrowband UV-B twice a week from weeks 12 to 36.

Main outcomes and measures: The primary outcome was mean percentage change in total Vitiligo Area Scoring Index (VASI) score from baseline to week 36 (baricitinib group). The prespecified aim of the study was to show that the reduction in the baricitinib plus narrowband UV-B was significantly greater than 42.9%, a repigmented surface threshold previously observed in patients treated with narrowband UV-B alone. Adverse events and secondary outcomes of change in disease activity and QOL were assessed. Post hoc analyses were additionally performed.

Results: Of 49 included patients, 35 (71%) were female, and the median (IQR) age was 49.9 (38.4-59.8) years. A total of 37 patients were randomized to the baricitinib group and 12 to the placebo group. The mean change in total VASI at week 36 was -44.8% (95% CI, -58.4% to -31.3%) for the baricitinib group and -9.2% (95% CI, -27.7% to 24.7%) for the placebo group. This was not significantly greater than the sufficient repigmented surface threshold of 42.9%. Post hoc analyses showed a significant difference at week 36 for total VASI score in the baricitinib plus narrowband UV-B group compared with placebo plus narrowband UV-B (-44.8% vs -9.2%, respectively; P = .02). There was a greater improvement in disease activity and QOL in the baricitinib group vs placebo group and no significant difference in the number of adverse events.

Conclusions and relevance: This proof-of-concept randomized clinical trial confirmed the efficacy of baricitinib combined with narrowband UV-B in the treatment of patients with extensive and active vitiligo.

Trial registration: ClinicalTrials.gov Identifier: NCT04822584.

Baricitinib联合光疗治疗成人活动性白癜风:一项随机临床试验。
重要性:白癜风是一种慢性自身免疫性疾病,导致皮肤色素沉着和生活质量(QOL)下降。病情广泛且非常活跃的患者是最难治疗的。目的:评价巴西替尼联合窄带UV-B治疗成人重度活动性非节段性白癜风的疗效和不良事件。设计、环境和参与者:这项学术性、多中心、双盲、非比较随机临床试验于2021年7月至2023年4月在4个皮肤科进行,包括患有广泛性和活动性非节段性白癜风的成年患者。本研究旨在仅基于该实验组的结果来评估巴西替尼加窄带UV-B的效果。安慰剂组作为校正组。数据分析时间为2023年8月至11月。干预措施:参与者以3:1的比例随机分配到baricitinib,每天4mg,或安慰剂,在前12周单独使用36周,然后在第12周至第36周每周两次与窄带UV-B联合使用。主要结局和测量:主要结局是白癜风区域评分指数(VASI)总评分从基线到第36周的平均百分比变化(巴西替尼组)。该研究的预先设定目的是显示baricitinib加窄带UV-B治疗的降低率显著大于42.9%,这是先前在单独使用窄带UV-B治疗的患者中观察到的重着色表面阈值。评估不良事件和疾病活动性和生活质量变化的次要结局。此外还进行了事后分析。结果:49例患者中,女性35例(71%),中位(IQR)年龄为49.9(38.4 ~ 59.8)岁。共有37名患者被随机分配到baricitinib组,12名患者被随机分配到安慰剂组。在第36周,baricitinib组总VASI的平均变化为-44.8% (95% CI, -58.4%至-31.3%),安慰剂组为-9.2% (95% CI, -27.7%至24.7%)。这并不显著高于42.9%的充分重着色表面阈值。事后分析显示,与安慰剂加窄带UV-B组相比,巴西替尼加窄带UV-B组在第36周的VASI总评分有显著差异(分别为-44.8%和-9.2%;p = .02)。与安慰剂组相比,baricitinib组在疾病活动性和生活质量方面有更大的改善,不良事件的数量没有显著差异。结论和相关性:这项概念验证的随机临床试验证实了巴西替尼联合窄带UV-B治疗广泛性和活动性白癜风患者的有效性。试验注册:ClinicalTrials.gov标识符:NCT04822584。
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
JAMA dermatology
JAMA dermatology DERMATOLOGY-
CiteScore
14.10
自引率
5.50%
发文量
300
期刊介绍: JAMA Dermatology is an international peer-reviewed journal that has been in continuous publication since 1882. It began publication by the American Medical Association in 1920 as Archives of Dermatology and Syphilology. The journal publishes material that helps in the development and testing of the effectiveness of diagnosis and treatment in medical and surgical dermatology, pediatric and geriatric dermatology, and oncologic and aesthetic dermatologic surgery. JAMA Dermatology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. It is published online weekly, every Wednesday, and in 12 print/online issues a year. The mission of the journal is to elevate the art and science of health and diseases of skin, hair, nails, and mucous membranes, and their treatment, with the aim of enabling dermatologists to deliver evidence-based, high-value medical and surgical dermatologic care. The journal publishes a broad range of innovative studies and trials that shift research and clinical practice paradigms, expand the understanding of the burden of dermatologic diseases and key outcomes, improve the practice of dermatology, and ensure equitable care to all patients. It also features research and opinion examining ethical, moral, socioeconomic, educational, and political issues relevant to dermatologists, aiming to enable ongoing improvement to the workforce, scope of practice, and the training of future dermatologists. JAMA Dermatology aims to be a leader in developing initiatives to improve diversity, equity, and inclusion within the specialty and within dermatology medical publishing.
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