P131 A multicentre real-world evaluation of ritlecitinib in severe alopecia areata: safety and treatment persistence

Abstract

Ritlecitinib has demonstrated efficacy for severe alopecia areata in randomized controlled trials; however, real-world safety and treatment persistence remain less well characterized. We conducted a retrospective, multicentre review of patients treated with ritlecitinib (n = 54), summarizing clinician-recorded adverse events (AEs) and rates of treatment interruption and discontinuation. Outcomes were benchmarked against published safety data from the 50-mg once-daily arm of pivotal clinical trials. Adverse events were documented in 31 of 54 (57%) patients. Laboratory abnormalities occurred in 9 of 31 (29%), most commonly anaemia (n = 3) and dyslipidaemia (n = 3). Less frequent abnormalities included elevated white cell count or neutrophils, transaminitis, raised alkaline phosphatase, thrombocytosis, and elevated creatine kinase or urea. Nonlaboratory AEs were predominantly mild and included fatigue or malaise (n = 8), gastrointestinal symptoms (n = 7), acne (n = 5), infective episodes (n = 5) and headache (n = 4). Additional reported events were heterogeneous. Only two patients experienced treatment interruption or discontinuation: one permanent discontinuation at 3 months due to cumulative adverse-event burden and one temporary interruption related to a pharyngeal abscess. Overall AE reporting was lower than in the reference trial population (57% vs. 75%; Fisher’s exact test, P = 0.02). Permanent discontinuation rates were comparable between cohorts (1.9% vs. 1.5%; P > 0.99). Temporary interruptions were numerically lower in routine practice but did not reach statistical significance (1.9% vs. 10.0%; P = 0.07). Combined interruption or discontinuation rates were similarly low (3.7% vs. 11.5%; P = 0.16). Our study demonstrates that ritlecitinib has a favourable real-world tolerability and safety profile in severe alopecia areata, with low rates of clinically meaningful adverse events and treatment discontinuation, supporting sustained treatment persistence in routine clinical practice. Differences in AE frequency compared with trial data likely reflect less intensive surveillance and protocol-driven reporting.