Baricitinib Shows Effectiveness, Safety for Severe AA With Room for Further Exploration

Hair loss in brush and medicine on table | Image Credit: Viktoriia M - stock.adobe.com

The safety profile of baricitinib, an oral Janus kinase (JAK) inhibitor that has been approved for the treatment of severe alopecia areata (AA), was comparable with other real-world experiences on JAK inhibitors for atopic dermatitis, but more long-term trials are needed to further assess the effectiveness and safety of the drug.

A retrospective study aimed to assess the effectiveness and safety of baricitinib in severe AA, typically defined as alopecia cases with a Severity of Alopecia Tool (SALT) score of greater than or equal to 50 or more than 50% scalp hair loss.

Alopecia is a widespread, long-lasting condition where the immune system attacks the hair follicles, causing nonscarring hair loss; it can affect any hair-bearing area of the body. The cause of alopecia is linked to an abnormal immune response, leading to inflammation and damage to the hair follicles influenced by molecules like interferon-γ, IL-15, and JAK.

Study dosing was 4 mg of baricitinib once daily and evaluated at baseline, week 16, week 24, and week 36. By week 36, effectiveness was measured by the average SALT score reduction in comparison with their baseline score. The percentage of patients with a SALT score of less than or equal to 20 at each visit was also observed.

A total of 50 patients from 4 separate dermatology units in Milan, Italy, were analyzed. Patients underwent routine blood tests to calculate blood cell count, hepatic enzymes, and lipid profiles following the first 4 weeks and then every 16 weeks after.

Out of 50 patients, 34 completed 16 weeks of treatment, with only 26.5% achieving a SALT score of less than or equal to 20. This percentage increased to 38.1% and 54.6% at weeks 24 and 36, out of 24 and 11 patients, respectively.

The average SALT score decreased at weeks 8, 16, 24, and 36 to 70.1, 56.24, 41.86, and 32.27, respectively. The percentage change from baseline to week 36 in the SALT score was –61.6%. Compared with phase 3 clinical trials, patients achieved comparable or slightly better SALT scores at weeks 16 and 24.

Patients who achieved a SALT score of less than or equal to 20 included 15.8% early responders (between 4 and 12 weeks), 68.4% gradual responders (between 12 and 36 weeks), and 15.8% late responders (more than 36 weeks).

The most common adverse events (AEs) included hypercholesterolemia among 10 patients and creatine phosphokinase elevation in only 3 patients. There were no AEs that led to discontinuation or serious AEs.

Study limitations included the retrospective nature and limited sample size design that hindered the generalizability applicable to the results.

Baricitinib showed comparability to other real-world experiences with JAK inhibitors for atopic dermatitis, but more extensive research is required to assess the effectiveness and safety profiles of the drug in patients with severe AA, the authors concluded.

Reference

Gargiulo L, Ibba L, Vignoli CA, et al. Effectiveness and safety of baricitinib in patients with severe alopecia areata: a 36-week multicenter real-world experience. J. Dermatolog Treat. 2023;34(1):2268764. doi:10.1080/09546634.2023.2268764