Approximately 40% of adults with alopecia areata treated with baricitinib achieved significant hair regrowth within 52 weeks
Nearly 40% of adults with alopecia areata treated with the Janus kinase (JAK) 1 and 2 inhibitor baricitinib orally achieved significant hair regrowth within 52 weeks, according to updated results from two phased studies III presented to the congress.American Academy of Dermatology (ADA) 2022.
The results indicate improved response rates and hair growth in study participants, said the study’s lecturer and senior author. Brett King, associate professor of dermatology at Yale University School of Medicine in New Haven, Connecticut. At the European Academy of Dermatology and Venereology (EADV) 2021, King presented the results at 36 weeks, recently published in the New England Journal of Medicine.
Pooled data at 52 weeks from 2 clinical trials
All patients included in the two studies, called BRAVE-AA1 and BRAVE-AA2, phase III, randomized and placebo-controlled, had severe alopecia areata, defined by a SALT (Severity of Alopecia Tool) score ≥ 50, which means up to at 50% presence of hair (coverage of the scalp). The score ranges from 0 (no hair loss) to 100 (complete hair loss). The primary endpoint was a SALT score ≤ 20, corresponding to 80% scalp coverage.
For the 52-week results presented at the congress, the researchers pooled data from the two clinical trials, for a total of 1,200 patients. After 36 weeks, the placebo group was randomly reassigned to receive baricitinib at a dose of 2 or 4 mg once daily.
Further improvement in hair regrowth
At baseline, patients enrolled in the study had an average SALT score of 85.5. After 52 weeks, 39.0% of subjects treated with 4 mg of baricitinib had at least 80% scalp coverage. Of these, nearly three in four (74.1%) had at least 90% scalp coverage or a SALT score ≤ 10.
In patients who received the 2 mg dose, after 52 weeks, 22.6% had a SALT score ≤ 2, corresponding to at least 80% scalp coverage, and two-thirds (67.5%) at less than 90% coverage.
By comparison, after 36 weeks, 35.2% of BRAVE-AA1 participants and 32.5% of BRAVE-AA2 participants receiving 4 mg baricitinib had at least 80% scalp coverage. In the lower dose group, 21.7% and 17.3% of patients in the BRAVE-AA1 and BRAVE-AA2 studies, respectively, achieved at least 80% scalp coverage (these rates differ slightly from published works due to a different analysis of the missing data, the speaker pointed out).
In summary, the results indicate that 5% more patients achieved their primary endpoint during the additional 16 weeks of the study, King said.
Adverse events at 52 weeks were consistent with those at 36 weeks and did not occur in more than 10% of participants. The most common were headaches, acne, and increased muscle-related blood markers. The most frequently reported infections were pneumonia, shingles and urinary tract infections. Other opportunistic infections reported during the study included tuberculosis, multiderma zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus.
Regrowth of eyelashes and eyebrows as well
L’alopecia areata it is an autoimmune disease in which immune cells attack hair follicles, causing hair loss, and is associated with emotional and psychological stress.
“Many underestimate the impact of this disease on patients,” he commented. Adam Friedman, a professor of dermatology at George Washington University, Washington DC, who was not involved in the study. “The burden of disease, which is certainly emotional in nature but also physical, absolutely must be treated with FDA-approved drugs, which is the goal of these studies.”
Alopecia can attack any hair follicle, but it rarely destroys it, so hair can grow back. The BRAVE-AA1 and AA2 trials focused on hair regrowth, but eyebrow and eyelash growth, two secondary outcomes, also improved between 36 and 52 weeks in both groups, calculated using the proportion of participants who had achieved complete regrowth or regrowth with minimal deviations. After 36 weeks, approximately 31-35% of patients who received 4 mg baricitinib grew eyebrows and eyelashes and by 52 weeks, more than two out of five patients grew back (eyebrows 44.1%, eyelashes 45.3% ).
“This is a fantastic result and an important step forward in alopecia areata, especially for patients with the most severe and refractory cases,” he said. Arash Mostaghimidirector of hospital dermatology at Brigham and Women’s Hospital (BWH) in Boston, Massachusetts.
In February 2022, the FDA granted priority review to baricitinib for the treatment of severe alopecia areata. Ely Lilly, which is developing the therapy, expects a regulatory decision by the end of the year.
American Academy of Dermatology 2022. Presented March 26, 2022.
King B et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022 Mar 26.