Baricitinib shows long-term efficacy in severe alopecia areata treatment

Key Takeaways:

• In two phase 3 trials, the efficacy of baricitinib for severe alopecia areata continued to improve over 52 weeks.
• Baricitinib has the potential for long-term treatment of severe alopecia areata.

Prolonged use of baricitinib increased the drug’s efficacy in the treatment of adults with severe alopecia areata, according to two phase 3 trials.

Severe alopecia areata (AA) is defined as an autoimmune disorder causing more than 50% non-scarring scalp hair loss. According to Ohsang Kwon, MD, PhD, professor of dermatology at Seoul National University Hospital in Seoul, Korea, and colleagues, Janus kinase (JAK) inhibitors have been proven to interrupt inflammatory pathways that contribute to the immunopathogenesis of AA, but long-term use of these inhibitors is still relatively unknown.

Baricitinib, an oral, selective and reversible JAK1/JAK2 inhibitor, is the first FDA-approved treatment for adults with severe AA. Kwon and colleagues assessed efficacy and safety of baricitinib in long-term extension periods of BRAVE-AA1 and BRAVE-AA2, two recently published phase 3 studies that showed the drug’s superiority in hair growth compared with placebo over a 36-week treatment period.

During these extension periods, the 465 patients (mean age, 37 years; 58.9% women) in BRAVE-AA1 and 390 patients (mean age, 38.4 years; 63.3% women) in BRAVE-AA2 originally randomly assigned to baricitinib continued their dosage through 52 weeks. The average Severity of Alopecia Tool (SALT) scores at baseline were 85.9 and 85.1, respectively. The primary endpoint was the proportion of patients achieving a SALT score less than or equal to 20.

Results showed that the response rate of hair regrowth continued to increase over the 52-week period, implying that baricitinib’s efficacy rates improve with prolonged use. Overall, 40.9% of patients treated with baricitinib 4 mg and 21.2% treated with baricitinib 2 mg achieved the primary endpoint in BRAVE-AA1. Similarly, of the BRAVE-AA2 patients, 36.8% and 24.4% achieved the same, respectively.

Among the patients with very severe AA, defined as having a SALT score between 95 and 100 at baseline, 27.7% of the 4 mg group and 10.3% of the 2 mg group in BRAVE-AA1 achieved a SALT score less than or equal to 20. In BRAVE-AA2, 27.7% and 15.1% also exhibited these SALT scores, respectively.

“In both studies, numerically greater proportions of patients achieved efficacy endpoints with baricitinib 4 mg vs. 2 mg, and these differences were sustained over time,” Kwon and colleagues wrote.

The study extension did not reveal any new adverse events compared with the 36-week study. The most common adverse events included upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection, CPK elevation and COVID-19 infection.

“These results confirm the potential for baricitinib in the treatment of severe AA,” the researchers concluded.