Nearly 40% of adults with alopecia areata taking baricitinib, an oral Janus kinase (JAK) 1 and 2 inhibitor, see significant hair regrowth over 52 weeks, according to updated results from two phase 3 Studies presented at the 2022 American Academy of Dermatology Annual Meeting in Boston, Massachusetts.
The results indicate improved response rates and hair growth among study participants, said Brett King, MD, PhD, associate professor of dermatology at Yale University School of Medicine in New Haven, Connecticut. He is the lead author of the analyzes and presented the research.
King presented the 36-week clinical trial results at the 2021 European Academy of Dermatology and Venereology (EADV) Annual Meeting. The same findings were also published in the New England Journal of Medicine on March 26, 2022.
“Every bit of data that we have is extremely important,” King said in an interview with Medscape Medical News. “Each time we add 16-week data from hundreds of patients, we take a big step towards the goal of FDA approval for a drug for alopecia areata.”
All patients enrolled in both studies BRAVE-AA1 and BRAVE-AA2 had severe alopecia areata, defined as a Severity of Alopecia Tool (SALT) score of ≥ 50, representing 50% or less scalp coverage. The score ranges from 0 (no hair loss) to 100 (complete hair loss). The primary endpoint was a SALT score ≤ 20 (80% scalp hairiness).
The researchers pooled data from both clinical trials, involving a total of 1200 participants, for the 52-week results presented at the meeting. The placebo group ended after 36 weeks, and these patients were randomly assigned to either the once-daily 4 mg or 2 mg baricitinib treatment groups.
At baseline, patients enrolled in the study had a mean SALT score of 85.5. At 52 weeks, 39.0% of patients receiving baricitinib 4 mg had at least 80% scalp coverage. In this group, nearly three out of four (74.1%) had at least 90% scalp coverage or a SALT score of ≤10.
Of the patients receiving baricitinib 2 mg, 22.6% had a SALT score ≤20 (at least 80% scalp hair coverage) at 52 weeks and two-thirds of this group (67.5%) had at least 90% scalp hair coverage at 52 weeks .
In comparison, at 36 weeks, 35.2% of participants in BRAVE-AA1 and 32.5% of participants in BRAVE-AA2 who received baricitinib 4 mg 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, had achieved at least 80% scalp coverage at 36 weeks. (These percentages differ slightly from the NEJM article due to another analysis of missing data, King said. EADV percentages are used above to compare results at 36 and 52 weeks.)
The results show that 5% more patients met the primary endpoint over the additional 16 weeks of the study, King said.
Alopecia areata is an autoimmune disease in which immune cells attack hair follicles, causing hair to fall out, and is associated with emotional and psychological distress. Any hair follicle can be attacked, but it is rarely destroyed, allowing hair to grow back. The BRAVE-AA1 and BRAVE-AA2 studies focused on scalp hair regrowth.
Eyebrow and eyelash growth, secondary outcomes, also improved between 36 and 52 weeks in both groups, calculated based on the proportion of participants who achieved complete regrowth or regrowth with minimal gaps. After 36 weeks, eyebrow and eyelash hair grew back in about 31% to 35% of patients who received baricitinib 4 mg. After 52 weeks, eyebrow (44.1%) and eyelash hair (45.3%) grew back in more than two out of five patients.
“It’s a fantastic achievement and a huge step forward in alopecia areata, especially for patients with the most severe and refractory cases,” said Arash Mostaghimi, MD, MPH, the director of inpatient dermatology at Brigham and Women’s Hospital (BWH) in Boston. Massachusetts. Mostaghimi is a member of the Advisory Board of Eli Lilly and Company (Lilly), which makes baricitinib, and BWH was one of the study’s clinical sites.
Adverse events at 52 weeks were consistent with data from 36 weeks, which revealed that none of these adverse events occurred in more than 10% of participants. The most common adverse events were headache, acne and increases in muscle blood markers. The most commonly reported infections were pneumonia, herpes zoster and urinary tract infections. Other opportunistic infections reported during the study were tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus.
In February 2022, the U.S. Food and Drug Administration granted priority review to baricitinib for the treatment of severe alopecia areata. Lilly expects a regulatory decision by the end of the year, a press release said.
Lilly funded the BRAVE-AA1 and BRAVE-AA2 studies. King has disclosed financial relationships with Aclaris, Arena Pharmaceuticals, Bristol Myers Squibb, Concert Pharmaceutics, Dermavant, Lilly, Pfizer, Regeneron, Sanofi Genzyme and Viela Bio. Mostaghimi has reported that he is a member of an advisory board for Lilly.
American Academy of Dermatology 2022. Presented March 26, 2022.
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