Effectiveness and safety of baricitinib in severe alopecia areata: 48-week results

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.