Maui Derm for Dermatologists
Maui Derm for Dermatologists
Source:

King B, et al. Efficacy and safety of baricitinib in the treatment of patients with severe or very severe alopecia areata: Phase 2 portion of BRAVE-AA1 randomized controlled trial. Presented at: Maui Derm for Dermatologists; Jan. 25-29, 2021; Maui, Hawaii (hybrid meeting).

Disclosures: King reports he has been a clinical trial investigator for Concert Pharmaceuticals, Eli Lilly and Company, and Pfizer; has received honoraria and/or consulting fees from Aclaris, Arena Pharmaceuticals, Bristol Myers Squibb, Concert Pharmaceuticals, Dermavant Sciences, Eli Lilly and Company, Pfizer, Regeneron, Sanofi Genzyme and Viela Bio; and is on the speakers bureau for Regeneron and Sanofi Genzyme. Please see the study for all other authors’ relevant financial disclosures.
February 16, 2021
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Positive results reported for baricitinib in alopecia areata

Source:

King B, et al. Efficacy and safety of baricitinib in the treatment of patients with severe or very severe alopecia areata: Phase 2 portion of BRAVE-AA1 randomized controlled trial. Presented at: Maui Derm for Dermatologists; Jan. 25-29, 2021; Maui, Hawaii (hybrid meeting).

Disclosures: King reports he has been a clinical trial investigator for Concert Pharmaceuticals, Eli Lilly and Company, and Pfizer; has received honoraria and/or consulting fees from Aclaris, Arena Pharmaceuticals, Bristol Myers Squibb, Concert Pharmaceuticals, Dermavant Sciences, Eli Lilly and Company, Pfizer, Regeneron, Sanofi Genzyme and Viela Bio; and is on the speakers bureau for Regeneron and Sanofi Genzyme. Please see the study for all other authors’ relevant financial disclosures.
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Patients with alopecia areata had greater improvements with baricitinib treatment compared placebo, according to an interim analysis presented at Maui Derm for Dermatologists.

Brett King, MD, PhD, and colleagues wrote in the poster that the objective of the phase 2 portion of the study was “to identify up to two doses of baricitinib for use in the phase 3 portion of the trial” investigating alopecia areata, a condition that currently has no FDA-approved treatments.

In the BRAVE-AA1 ongoing, multicenter, randomized, double-blind, placebo-controlled, operationally seamless, adaptive phase 2/3 trial, researchers enrolled adults with a current episode of alopecia areata between 6 months and 8 years with a Severity of Alopecia Tool (SALT) score of 50 or higher. Researchers randomly assigned 28 patients to treatment with 1 mg baricitinib, a JAK inhibitor, 27 patients to 2 mg baricitinib, 27 patients to 4 mg baricitinib and 28 patients to placebo. At week 12, patients in the 1 mg group transitioned to receiving 4 mg; however, these data were not included in the interim analysis.

The study’s primary endpoint was the percentage of patients who achieved a SALT score of 20 or less at week 36. Other efficacy outcomes included scalp, eyebrow and eyelash loss.

At week 36, 52% of patients in the 4 mg group and 33% in the 2 mg group achieved a SALT score of 20 or less compared with 4% in the placebo group. Thirty-seven percent of patients in the 4 mg group and 33% of patients in the 2 mg group also met the endpoint for Scalp Hair Assessment Patient-Reported Outcome score compared with 4% of patients in the placebo group.

The 4 mg group had the highest proportion of patients who achieved both clinician-reported outcomes for eyebrow loss (39% vs. 29% for 2 mg and 4% for placebo) and eyelash loss (60% vs. 40% for 2 mg and 6% for placebo), as well as patient-reported outcomes for eyebrow loss (46% vs. 40% for 2 mg and 0% for placebo) and eyelash loss (58% vs. 28% for 2 mg and 0% for placebo).

There were no serious adverse events, thromboembolic events or new safety concerns.

“These results support the potential use of baricitinib in the treatment of patients with AA with [equal to or greater than] 50% of scalp hair loss,” they wrote.