Background: Ritlecitinib, an oral selective inhibitor of Janus kinase 3 and the TEC family of kinases, has recently been approved for the treatment of severe alopecia areata, but real-world data are still limited. Objective: The aim was to evaluate the effectiveness and tolerability of ritlecitinib 50 mg/day after 24 weeks in patients with severe alopecia areata in clinical practice. Methods: We performed an Italian observational, retrospective, multicentre study with 24 weeks of follow-up. Patients ≥ 12 years of age with severe alopecia areata (Severity of Alopecia Tool [SALT] ≥ 50) and a disease duration ≥ 6 months who were candidates for systemic therapy were enrolled. Ritlecitinib 50 mg/day was administered according to national guidelines. The primary endpoint was to evaluate the achievement of SALT ≤ 20 at week 24. Secondary endpoints included achievement of SALT ≤ 10; mean change in SALT; trichoscopic improvement; quality of life; psychological impact; efficacy in eyebrows, eyelashes, and nails; and safety profile. Results: A total of 102 patients were included. At week 24, 40.2% of patients achieved SALT ≤ 20, with a greater response in adolescents (48.6%) than in adults (21.9%). The mean SALT score decreased from 86.2 ± 18.5 to 40.8 ± 37.1. Significant improvements were observed in trichoscopic signs and quality of life. The treatment was also effective on eyebrows, eyelashes, and nails. Adverse events were mild (e.g., acne, headache). Ritlecitinib had to be discontinued in only one case of severe anaemia. Conclusions: In this multicentre real-world study, ritlecitinib 50 mg/day was an effective and well-tolerated treatment option for severe alopecia areata.

Ritlecitinib for Severe Alopecia Areata: A 24-Week, Multicentre, Real-World Study / Starace, M., Rapparini, L., Pampaloni, F., Cedirian, S., Quadrelli, F., Bruni, F., Martelli, G., Girolomoni, G., Bellinato, F., Gisondi, P., Gallo, G., Ribero, S., Ortoncelli, M., Quaglino, P., Gargiulo, L., Vignoli, C., Narcisi, A., Ambrogio, F., Foti, C., Caposiena Caro, R.D., et al.. - In: AMERICAN JOURNAL OF CLINICAL DERMATOLOGY. - ISSN 1175-0561. - 27:3(2026), pp. 621-630. [10.1007/s40257-026-01022-5]

Ritlecitinib for Severe Alopecia Areata: A 24-Week, Multicentre, Real-World Study

Rongioletti F.;Guida S.;Bigotto G. D.;
2026-01-01

Abstract

Background: Ritlecitinib, an oral selective inhibitor of Janus kinase 3 and the TEC family of kinases, has recently been approved for the treatment of severe alopecia areata, but real-world data are still limited. Objective: The aim was to evaluate the effectiveness and tolerability of ritlecitinib 50 mg/day after 24 weeks in patients with severe alopecia areata in clinical practice. Methods: We performed an Italian observational, retrospective, multicentre study with 24 weeks of follow-up. Patients ≥ 12 years of age with severe alopecia areata (Severity of Alopecia Tool [SALT] ≥ 50) and a disease duration ≥ 6 months who were candidates for systemic therapy were enrolled. Ritlecitinib 50 mg/day was administered according to national guidelines. The primary endpoint was to evaluate the achievement of SALT ≤ 20 at week 24. Secondary endpoints included achievement of SALT ≤ 10; mean change in SALT; trichoscopic improvement; quality of life; psychological impact; efficacy in eyebrows, eyelashes, and nails; and safety profile. Results: A total of 102 patients were included. At week 24, 40.2% of patients achieved SALT ≤ 20, with a greater response in adolescents (48.6%) than in adults (21.9%). The mean SALT score decreased from 86.2 ± 18.5 to 40.8 ± 37.1. Significant improvements were observed in trichoscopic signs and quality of life. The treatment was also effective on eyebrows, eyelashes, and nails. Adverse events were mild (e.g., acne, headache). Ritlecitinib had to be discontinued in only one case of severe anaemia. Conclusions: In this multicentre real-world study, ritlecitinib 50 mg/day was an effective and well-tolerated treatment option for severe alopecia areata.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.11768/206376
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