Background: Alopecia areata (AA) is an autoimmune condition leading to hair loss. Baricitinib, a Janus kinase (JAK) inhibitor, has demonstrated efficacy in controlled clinical trials, but real-world data on its long-term effectiveness and safety remain limited. Objectives: This study aimed to assess the real-life effectiveness and safety of baricitinib 4 mg daily in Italian adult patients with severe AA over a 48-week treatment period. Methods: We conducted a 48-week retrospective, observational, multicenter study across 27 Italian university hospitals. Adult patients (18–65 years) with severe AA (Severity of Alopecia Tool [SALT] score ≥ 50) who initiated baricitinib 4 mg daily treatment between November 2022 and October 2023 were included. Effectiveness was measured by the percentage of patients achieving SALT ≤20 at week 48. Secondary outcomes included changes in mean SALT score, trichoscopic findings, patient-reported quality of life (Skindex-16, Hospital Anxiety and Depression Scale [HADS]), and Clinician-Reported Outcomes (ClinRO) for eyebrows and eyelashes. Adverse events were also documented. Results: A total of 253 patients (66.8% females, mean age 40.0 ± 12.6 years) were included. By week 48, 63.2% achieved SALT ≤20, and 75.5% achieved SALT ≤30. The mean SALT score significantly decreased from 93.7 ± 14.1 at baseline to 26.5 ± 33.0 at week 48 (p < 0.001). Trichoscopic assessment showed a decline in yellow dots (97.6%–50.2%), black dots (43.5%–9.1%), and dystrophic hairs (14.6%–4.3%), whilst regrowing hairs increased (7.1%–80.2%). Skindex-16 scores improved significantly (57.1 ± 25.0 to 30.0 ± 17.8, p < 0.001), as did HADS Anxiety (8.21 ± 9.38 to 4.62 ± 4.21, p < 0.001) and HADS Depression (6.36 ± 4.55 to 3.70 ± 4.11, p < 0.001). Adverse events were reported in 9.4% of patients. Conclusions: This real-world study confirms the effectiveness of baricitinib in achieving significant hair regrowth and improving psychological well-being in severe AA patients.
Effectiveness and safety of baricitinib in severe alopecia areata: 48‐week results / Piraccini, Bianca Maria; Cedirian, Stephano; Pampaloni, Francesca; Rapparini, Luca; Quadrelli, Federico; Bruni, Francesca; Ala, Lorenzo; Acri, Maria Cristina; Rossi, Alfredo; Pellacani, Giovanni; Lacarrubba, Francesco; Dall'Oglio, Federica; Micali, Giuseppe; Foggia, Luciano; Cantelli, Mariateresa; Nappa, Paola; Diluvio, Laura; Bianchi, Luca; Luigi, Naldi; Bolzon, Anna; Peris, Ketty; Caldarola, Giacomo; Girolomoni, Giampiero; Marangoni, Francesca; Bellinato, Francesco; Gisondi, Paolo; Silvi, Gianmarco; Prignano, Francesca; Pimpinelli, Nicola; Tomasini, Carlo; Barruscotti, Stefania; Simonetti, Oriana; de Simoni, Edoardo; Ambrogio, Francesca; Foti, Caterina; Boccaletti, Valeria; Fraghì, Alessandro; Marzano, Angelo Valerio; Mattioli, Maria Alessandra; Ferrucci, Silvia; Sechi, Andrea; Valtellini, Luca; Barbareschi, Mauro; Gallo, Giuseppe; Ribero, Simone; Quaglino, Pietro; Di Corteranzo, Isotta Giunipero; Balestri, Riccardo; Pagliarello, Calogero; Caposiena, Raffaele Dante; Zalaudek, Iris; Vagnozzi, Emanuele; Fargnoli, Maria Concetta; Caponio, Chiara; Rubegni, Pietro; Cinotti, Elisa; Trovato, Emanuele; Romanelli, Marco; Dini, Valentina; Manzo Margiotta, Flavia; Feliciani, Claudio; De Felici Del Giudice, Maria Beatrice; Atzori, Laura; Sanna, Silvia; Lembo, Serena; Raimondo, Annunziata; Magnano, Michela; Argenziano, Giuseppe; Babino, Graziella; Fulgione, Elisabetta; Rongioletti, Franco; Pesce, Nazario; Guida, Stefania; Guglielmo, Alba; Schettini, Natale; Starace, Michela. - In: JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY. - ISSN 0926-9959. - STAMPA. - 40:(2026), pp. 224-231. [10.1111/jdv.70067]
Effectiveness and safety of baricitinib in severe alopecia areata: 48‐week results
Piraccini, Bianca Maria;Luigi, Naldi;Silvi, Gianmarco;Prignano, Francesca;Pimpinelli, Nicola;Foti, Caterina;Rubegni, Pietro;Cinotti, Elisa;Dini, Valentina;Sanna, Silvia;Starace, Michela
2026
Abstract
Background: Alopecia areata (AA) is an autoimmune condition leading to hair loss. Baricitinib, a Janus kinase (JAK) inhibitor, has demonstrated efficacy in controlled clinical trials, but real-world data on its long-term effectiveness and safety remain limited. Objectives: This study aimed to assess the real-life effectiveness and safety of baricitinib 4 mg daily in Italian adult patients with severe AA over a 48-week treatment period. Methods: We conducted a 48-week retrospective, observational, multicenter study across 27 Italian university hospitals. Adult patients (18–65 years) with severe AA (Severity of Alopecia Tool [SALT] score ≥ 50) who initiated baricitinib 4 mg daily treatment between November 2022 and October 2023 were included. Effectiveness was measured by the percentage of patients achieving SALT ≤20 at week 48. Secondary outcomes included changes in mean SALT score, trichoscopic findings, patient-reported quality of life (Skindex-16, Hospital Anxiety and Depression Scale [HADS]), and Clinician-Reported Outcomes (ClinRO) for eyebrows and eyelashes. Adverse events were also documented. Results: A total of 253 patients (66.8% females, mean age 40.0 ± 12.6 years) were included. By week 48, 63.2% achieved SALT ≤20, and 75.5% achieved SALT ≤30. The mean SALT score significantly decreased from 93.7 ± 14.1 at baseline to 26.5 ± 33.0 at week 48 (p < 0.001). Trichoscopic assessment showed a decline in yellow dots (97.6%–50.2%), black dots (43.5%–9.1%), and dystrophic hairs (14.6%–4.3%), whilst regrowing hairs increased (7.1%–80.2%). Skindex-16 scores improved significantly (57.1 ± 25.0 to 30.0 ± 17.8, p < 0.001), as did HADS Anxiety (8.21 ± 9.38 to 4.62 ± 4.21, p < 0.001) and HADS Depression (6.36 ± 4.55 to 3.70 ± 4.11, p < 0.001). Adverse events were reported in 9.4% of patients. Conclusions: This real-world study confirms the effectiveness of baricitinib in achieving significant hair regrowth and improving psychological well-being in severe AA patients.
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