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Core Messages

Two phase 3 studies, each running for 36 weeks, have proven the efficacy of the Janus kinase inhibitor baricitinib (Olumiant) for patients with alopecia areata. Almost a quarter of participants achieved the therapeutic aim of 80% hair coverage at the low dose, while this figure was significantly more than one third for the high dose.

Background

Patchy hair loss (alopecia areata) is a relapsing autoimmune disease that can only be treated (inadequately) with the topical use of steroids or immunosuppressants. One new approach is the relatively specific inhibition of the interferon gamma and interleukin 15 cytokines with baricitinib, a Janus kinase inhibitor, which has already been used off-label many times.

Design

The two randomized, panadol 16 placebo-controlled, phase 3 studies BRAVE-AA1 and BRAVE-AA2 included 654 adult patients. The average age was about 38 years, and women accounted for 60% of the population. The duration of illness was about 12 years, and the current episode had lasted 4 years. The studies were designed by the sponsor, Eli Lilly, and the inclusion criteria were upper age limits of 60 years for men and 70 years for women, aiming to limit the risk of extensive androgenic alopecia. In addition, patients had to have a severity of at least 50 out of 100 points on the Severity of Alopecia Tool (SALT). Patients were randomly assigned to daily oral administration of 4 mg or 2 mg of baricitinib or placebo.

Results

The primary endpoint of a maximum SALT value of 20 (corresponding to around 80% hair coverage) at week 36 was achieved in both studies as follows:

  • With 4 mg baricitinib: 38.8% / 35.9%

  • With 2 mg baricitinib: 22.8% / 19.4%

  • With placebo: 6.2% / 3.3%

In both studies, the difference between the two dosages and the placebo was statistically highly significant (P < .001).

The 10 most important secondary parameters, including the patient’s assessment of head hair growth and the clinician’s assessment of the eyebrows, tended to only be superior to placebo at the higher dosage.

Frequently observed side effects with use of the study drug were acne, increased creatinine kinase levels, and elevated LDL and HDL levels.

Clinical Significance

The proportion of patients who achieved significant hair growth with baricitinib within 36 weeks was significantly greater than with placebo and was more than a third of those receiving the higher dosage. The authors acknowledge that longer studies would be required to evaluate the efficacy and safety of this substance.

Sponsor: Eli Lilly under license from Incyte.

This article was translated from  Univadis Germany .

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