Senna Maryanne M, Kwon Ohsang, Piraccini Bianca M, Sinclair Rodney, Ball Susan, Ding Yuxin, Chen Yun-Fei, Dutronc Yves, King Brett
Lahey Dermatology, Burlington, MA, USA.
Harvard Medical School, Boston, MA, USA.
Dermatol Ther (Heidelb). 2023 Dec;13(12):3209-3220. doi: 10.1007/s13555-023-01063-2. Epub 2023 Nov 22.
The present analyses report integrated results from BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259) on the clinical benefits of baricitinib treatment on the basis of the amount of scalp hair regrowth through 52 weeks of treatment.
This post hoc analysis was conducted with data from patients who were treated continuously for 52 weeks with baricitinib 4 mg or 2 mg. Clinical outcomes were assessed using the Severity of Alopecia Tool (SALT) and Clinician-Reported Outcome (ClinRO) for Eyebrow (EB) and Eyelash (EL) hair. Secondary measures included the Hospital Anxiety and Depression Scale and Skindex-16 adapted for alopecia areata. At week 52, patients were classified into three subgroups: SALT ≤ 20 response, intermediate response (achieved a 30% improvement from baseline (SALT) without a SALT score ≤ 20), or nonresponse (never achieved SALT). The criterion of SALT approximates a minimal clinical meaningful response to therapy.
At week 52, with baricitinib 4 mg treatment, the greatest (70%) improvement in EB and EL was observed in responders, but approximately 50% of patients with intermediate response and 20% of nonresponders experienced complete/nearly complete EB and EL regrowth. Improvement in emotional distress was directionally related to improvements in scalp hair regrowth, while impact on quality of life was proportionately greater for the responder subgroup.
Clinically meaningful regrowth in eyebrow and eyelash hair can occur in the absence of complete scalp hair regrowth after treatment with baricitinib. Emotional distress and quality of life improvement is most associated with obtaining a clinical meaningful improvement in scalp hair.
BRAVE-AA1, ClinicalTrials.gov number, NCT03570749, start date, 24 September 2018; BRAVE-AA2, ClinicalTrials.gov number, NCT03899259, start date, 8 July 2019.
本分析报告了BRAVE - AA1（NCT03570749）和BRAVE - AA2（NCT03899259）的综合结果，内容为巴瑞替尼治疗52周后基于头皮毛发再生量的临床获益情况。
本事后分析使用了接受4毫克或2毫克巴瑞替尼持续治疗52周患者的数据。使用脱发严重程度工具（SALT）以及针对眉毛（EB）和睫毛（EL）毛发的临床医生报告结局（ClinRO）评估临床结局。次要指标包括医院焦虑抑郁量表以及适用于斑秃的Skindex - 16。在第52周时，患者被分为三个亚组：SALT≤20反应组、中度反应组（从基线（SALT）改善30%但SALT评分＞20）或无反应组（从未达到SALT标准）。SALT标准近似于对治疗的最小临床有意义反应。
在第52周时，接受4毫克巴瑞替尼治疗的患者中，反应组的EB和EL改善最为显著（70%），但约50%的中度反应患者和20%的无反应患者出现了完全/几乎完全的EB和EL再生。情绪困扰的改善与头皮毛发再生的改善呈正向相关，而反应组亚组对生活质量的影响更大。
使用巴瑞替尼治疗后，即使头皮毛发未完全再生，眉毛和睫毛毛发也可能出现具有临床意义的再生。情绪困扰和生活质量的改善与头皮毛发获得临床有意义的改善最为相关。
BRAVE - AA1，ClinicalTrials.gov编号，NCT03570749，开始日期，2018年9月24日；BRAVE - AA2，ClinicalTrials.gov编号，NCT03899259，开始日期，2019年7月8日。
