P151 A multicentre real-world evaluation of ritlecitinib in severe alopecia areata: patient-reported outcome measures

Abstract

Ritlecitinib has shown clinically meaningful efficacy in trials for alopecia areata (AA). However, real-world effectiveness may differ due to greater population heterogeneity and less standardized outcome measures. In ALLEGRO-2b/3, patient-reported outcome measures (PROMs) were measured using the Alopecia Areata Patient Priority Outcomes instrument, which assesses patient-reported hair loss and its emotional and functional impacts. The Severity of Alopecia Tool (SALT) is widely used to assess disease severity; however, this does not consider the psychosocial burden. In the UK, ritlecitinib is licensed for the treatment of severe AA, defined as a SALT score of 21–49 plus a negative impact on psychological functioning. Demonstrating the psychological impact of AA can be facilitated through use of PROMs. The objective of this analysis was to compare real-world treatment success with published efficacy using a trial-aligned definition of response, and to describe patient-reported change at 6 months. Treatment success was defined as achieving a SALT score ≤ 20. In our cohort, 14 of 52 patients (27%, 95% confidence interval 15.6–41) achieved treatment success, and this did not differ significantly from the trial reference proportion on two-sided exact binomial testing (P = 0.52). A two-sample comparison against the trial cohort using Fisher’s exact test showed no significant difference (odds ratio 1.21, 95% confidence interval 0.53–2.67; P = 0.70). Patient-reported global impression of change at 6 months was available for 32 patients and showed a median score of 2 (interquartile range 2–3, range 1–4), consistent with overall patient-perceived improvement. PROMs are central to the comprehensive assessment of patients with AA, capturing the psychosocial impact, which is not otherwise reflected by traditional clinical measures. Interpretation of our findings should consider differences in case mix, prior or concomitant therapies, adherence and follow-up between trial and real-world settings. Larger, prospective studies using trial-aligned endpoints and validated PROMs (as used in ALLEGRO) are needed to refine real-world effectiveness estimates.