Patient-reported outcome improvements following scalp hair regrowth among patients with Alopecia Areata: analysis of the ALLEGRO-2b/3 trial.

Purpose: 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. Materials and methods: 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. Results: 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. Conclusions: 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.