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. Conclusion: This real-world study confirms the effectiveness of baricitinib in achieving significant hair regrowth and improving psychological well-being in severe AA patients.
Piraccini, B. M., Cedirian, S., Pampaloni, F., Rapparini, L., Quadrelli, F., Bruni, F., Ala, L., Acri, M. C., Rossi, A., Pellacani, G., Lacarrubba, F., Dall'Oglio, F., Micali, G., Foggia, L., Cantelli, M., Nappa, P., Diluvio, L., Bianchi, L., Luigi, N., Bolzon, A., Peris, K., Caldarola, G., Girolomoni, G., Marangoni, F., Bellinato, F., Gisondi, P., Silvi, G., Prignano, F., Pimpinelli, N., Tomasini, C., Barruscotti, S., Simonetti, O., De Simoni, E., Ambrogio, F., Foti, C., Boccaletti, V., Fraghì, A., Marzano, A. V., Mattioli, M. A., Ferrucci, S., Sechi, A., Valtellini, L., Barbareschi, M., Gallo, G., Ribero, S., Quaglino, P., Di Corteranzo, I. G., Balestri, R., Pagliarello, C., Caposiena, R. D., Zalaudek, I., Vagnozzi, E., Fargnoli, M. C., Caponio, C., Rubegni, P., Cinotti, E., Trovato, E., Romanelli, M., Dini, V., Manzo Margiotta, F., Feliciani, C., De Felici Del Giudice, M. B., Atzori, L., Sanna, S., Lembo, S., Raimondo, A., Magnano, M., Argenziano, G., Babino, G., Fulgione, E., Rongioletti, F., Pesce, N., Guida, S., Guglielmo, A., Schettini, N., Starace, M., Effectiveness and safety of baricitinib in severe alopecia areata: 48-week results, <<JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY>>, 2025; (n/a): N/A-N/A. [doi:10.1111/jdv.70067] [https://hdl.handle.net/10807/323737]
Effectiveness and safety of baricitinib in severe alopecia areata: 48-week results
Peris, Ketty;Caldarola, Giacomo;Pagliarello, Cologero;Zalaudek, Iris;Fargnoli, Maria Concetta;Romanelli, Margherita;Dini, Veronica;
2025
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. Conclusion: 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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