Michela Starace, Luca Rapparini, Francesca Pampaloni, Stephano Cedirian, Federico Quadrelli, Francesca Bruni, Ginevra Martelli, Giampiero Girolomoni, Francesco Bellinato, Paolo Gisondi, Giuseppe Gallo, Simone Ribero, Michela Ortoncelli, Pietro Quaglino, Luigi Gargiulo, Carlo Alberto Vignoli, Alessandra Narcisi, Francesca Ambrogio, Caterina Foti, Raffaele Dante Caposiena, Iris Zalaudek, Angelo Valerio Marzano, Andrea Sechi, Mauro Barbareschi, Luca Valtellini, Silvia Mariel Ferrucci, Laura Diluvio, Enrico Matteini, Luca Bianchi, Mariateresa Cantelli, Paola Nappa, Carolina D’Elia, Valeria Boccaletti, Carola Romanò, Elisabetta Fulgione, Anna Balato, Giuseppe Argenziano, Emanuele Trovato, Elisa Cinotti, Pietro Rubegni, Federica Dall’Oglio, Francesco Lacarrubba, Giuseppe Micali, Elena Pezzolo, Francesca Caroppo, Anna Belloni Fortina, Giacomo Caldarola, Ketty Peris, Lorenzo Maria Pinto, Calogero Pagliarello, Riccardo Balestri, Carlo Tomasini, Stefania Barruscotti, Laura Atzori, Silvia Sanna, Lorenzo Ala, Giulio Bortone, Giovanni Pellacani, Alfredo Rossi, Serena Lembo, Annunziata Raimondo, Flavia Manzo Margiotta, Valentina Dini, Marco Romanelli, Andrea Megna, Francesca Prignano, Gianmarco Silvi, Oriana Simonetti, Edoardo De Simoni, Michela Magnano, Natale Schettini, Alessandro Borghi, Francesca Satolli, Maria Beatrice De Felici Del Giudice, Franco Rongioletti, Stefania Guida, Gianmarco Diego Bigotto, Cesare Filippeschi, Teresa Oranges, Greta Tronconi, Bianca Maria Piraccini
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. 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. 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. 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. In this multicentre real-world study, ritlecitinib 50 mg/day was an effective and well-tolerated treatment option for severe alopecia areata. Alopecia areata is a common autoimmune disease that causes hair loss on the scalp and other parts of the body, such as eyebrows, eyelashes, and body hair. It affects people of any age, including adolescents, and often has a strong psycho-emotional impact, reducing quality of life. A new medication for severe alopecia areata, called ritlecitinib, was approved in 2023. Ritlecitinib is a Janus kinase inhibitor that modulates the immune response involved in the pathogenesis of the disease, promoting hair regrowth. However, data on its efficacy in everyday clinical practice have remained limited. To address this, we carried out a retrospective clinical study in Italy involving 20 university dermatology departments. We evaluated 102 adults and adolescents (≥ 12 years) with severe alopecia areata, treated with ritlecitinib 50 mg/day for 24 weeks. After 6 months of treatment, about 40% of patients had major hair regrowth on the scalp (with 80% of the scalp covered by hair). The treatment worked better in adolescents than in adults (48.6 vs 21.9%). Significant improvements were also noted in eyebrows, eyelashes, nail involvement, and quality of life parameters. Ritlecitinib was generally safe and well tolerated. Adverse effects were mild, and only one patient stopped treatment because of anaemia. Overall, our study showed that ritlecitinib was an effective and safe treatment for severe alopecia areata in real-world practice, particularly among adolescents.