Ritlecitinib Demonstrates Meaningful Improvement in Psychosocial Impact of Alopecia Areata, Extended Analysis Shows
New analysis of data from the ALLEGRO-2b/3 trial reveals that ritlecitinib, a therapeutic agent for alopecia areata, considerably reduces the psychosocial burden experienced by patients, but these improvements may take time too fully manifest. The findings, published online October 9, 2025, in the International Journal of Dermatology, highlight a potential lag between clinical hair regrowth and patient-reported improvements in emotional well-being and daily activities.
Researchers examined 48-week data from 325 participants treated with either a 50-mg once-daily (QD) maintenance dose of ritlecitinib (with or without a 200-mg, 4-week loading dose) or a subtherapeutic 10-mg dose - used as a proxy for placebo. The analysis focused on changes from baseline in scores from the Alopecia areata Priority Outcomes (AAPPO) questionnaire, specifically the emotional symptoms and activity limitation domains.
Results showed that while improvements in both domains where generally observed for all groups receiving the 50-mg dose, the 10-mg group experienced a plateau or slight worsening of scores. Statistically significant differences between the 50-mg and 10-mg groups emerged starting at week 34 for emotional symptoms and week 40 for activity limitations.
By week 48, the 50-mg group demonstrated a statistically significant improvement compared to the 10-mg group in both emotional symptoms (least squares mean difference, -0.41; 95% CI, −0.63 to −0.18; P* = .0004) and activity limitations (least squares mean difference, -0.17; 95% CI, −0.34 to −0.00; *P = .0469).
Further item-level analysis pinpointed specific areas of benefit,with the largest improvements linked to reduced feelings of self-consciousness and embarrassment (emotional symptoms) and improved interactions with others (activity limitations).
“Since hair regrowth can precede patient-reported outcome (PRO) improvement, individuals with a clinical response at week 24 may need additional follow-up time to capture any delayed PRO effects,” explained the authors, led by Law EH, Sherif B, and Mostaghimi A.
The study acknowledges limitations including exclusion criteria within the ALLEGRO-2b/3 trial – specifically excluding patients with less than 50% scalp hair loss or those experiencing alopecia areata for longer than 10 years – and limited sample sizes. However, the authors state the findings complement the primary ALLEGRO-2b/3 analysis.
The authors concluded, “By week 48, ALLEGRO-2b/3 participants reported greater improvements in [emotional symptoms] and [activity limitations] due to hair loss with the 50-mg ritlecitinib QD maintenance dose (+/− 200-mg 4-week loading dose) than with the subtherapeutic 10-mg QD ritlecitinib dose. these findings show item-level AAPPO differences and may demonstrate improvements in psychosocial burden following hair regrowth with ritlecitinib.”
