Law Ernest H, Hanson Kent A, Harries Matthew, Korver Dane, Sherif Bintu, Chirila Costel
Pfizer Inc, New York, NY, USA.
Department of Pharmacy Systems, Outcomes and Policy, University of Illinois Chicago, Chicago, IL, USA.
J Dermatolog Treat. 2025 Dec;36(1):2460577. doi: 10.1080/09546634.2025.2460577. Epub 2025 Feb 3.
Alopecia areata (AA), an autoimmune disorder characterized by non-scarring hair loss, is detrimental to the psychological health and quality of life of people living with AA. Clinically meaningful hair regrowth is possible, but the relationship with downstream patient-reported outcomes (PROs) is complex. This post hoc analysis of ALLEGRO-2b/3 (NCT03732807) longitudinal data from Weeks 24-48 compared improvements in PROs between patients who achieved (responders) or did not achieve (non-responders) clinically meaningful scalp hair regrowth. Responders were defined by a Week 24 Severity of Alopecia Tool (SALT) score ≤20 (SALT20) or ≤10 (SALT10). Across 6 PROs assessing multiple AA-related health domains, response proportions and mean changes from baseline were estimated for Weeks 24-48. Among 650 included participants, 114 (17.5%) were SALT20 responders, of which 76 (11.7%) were also SALT10 responders. Generally, more responders than non-responders reported improvements in AA and related symptoms or limitations and satisfaction with hair regrowth. Responders additionally reported greater improvement from baseline than non-responders for measures of AA-related emotional symptoms, mental health, and work or activity limitations. These results support a positive relationship between scalp hair regrowth and downstream PROs-including satisfaction and psychosocial burden-demonstrating an association between clinically meaningful hair regrowth and patient-reported treatment benefits.
斑秃（AA）是一种以非瘢痕性脱发为特征的自身免疫性疾病，对斑秃患者的心理健康和生活质量有害。临床上实现有意义的头发生长是可能的，但与下游患者报告结局（PROs）的关系很复杂。这项对ALLEGRO-2b/3（NCT03732807）研究第24至48周纵向数据的事后分析，比较了实现（有反应者）或未实现（无反应者）临床上有意义的头皮毛发生长的患者之间PROs的改善情况。有反应者的定义为第24周脱发严重程度工具（SALT）评分≤20（SALT20）或≤10（SALT10）。在评估多个与斑秃相关健康领域的6项PROs中，估计了第24至48周的反应比例和相对于基线的平均变化。在650名纳入的参与者中，114名（17.5%）是SALT20有反应者，其中76名（11.7%）也是SALT10有反应者。一般来说，与无反应者相比，更多有反应者报告斑秃及相关症状或局限性有所改善，对毛发生长感到满意。有反应者还报告，在斑秃相关情绪症状（measures of AA-related emotional symptoms）、心理健康以及工作或活动受限等指标方面，相对于基线的改善程度大于无反应者。这些结果支持头皮毛发生长与下游PROs之间存在正相关关系，包括满意度和心理社会负担，表明临床上有意义的毛发生长与患者报告的治疗益处之间存在关联。
