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Data from a pair of phase 3 trials concluded that oral baricitinib was superior to placebo for patients with severe alopecia areata for hair regrowth at 36 weeks.
Data from 2 phase 3 trials shoed that oral baricitinib was superior to placebo for patients with severe alopecia areata for hair regrowth at 36 weeks.
The new findings, presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston, MA, featured data from the randomized, placebo-controlled, phase 3 trials BRAVE-AA1 and BRAVE-AA2.
Alopecia areata is an autoimmune disorder known for non-scarring hair loss in various hair-bearing sites including the scalp, eyebrows, and eyelashes.
The pathogenesis of the disorder involves genetic and immune factors. However, previous research suggested that baricitinib could be involved in the interruption of cytokine signaling in the pathogenesis of alopecia areata.
As such, Brett King, MD, PhD, Yale School of Medicine, New Haven, and fellow investigators conducted 2 phase 3 trials of the oral inhibitor for adult patients with alopecia areata.
A total of 169 centers from 10 countries were included in both the BRAVE-AA1 and BRAVE-AA2 trials. Both trials were identical in eligibility criteria and featured identical primary and secondary outcomes for the 36-week placebo-controlled treatment periods.
In both trials, the first patients included in the trial began receiving either baricitinib or a placebo in June and May 2020, respectively.
Recruitment was performed by clinicians at trials sites and through various advertisement methods. Eligible male patients were 18-60 years old, and female patients were 18-70 years old.
Inclusion criteria also involved a Severity of Alopecia Tool (SALT) score of 50 or higher an a current episode of alopecia areata lasting more to 6 months and to less than 8 years without improvement in the previous 6 months.
Patients who were treated with topical glucocorticoids within 1 week before randomization, systemic or intralesional glucocorticoids within 8 weeks before randomization, and topical or oral JAK inhibitors within 4 or 8 weeks before randomization were excluded from the study.
Patients were randomly assigned in a 3:2:2 ratio to receive either a once-daily oral baricitinib dose of 4 mg or 2 mg or placebo for 36 weeks.
However, treatments for alopecia areata were prohibited, though treatment with finasteride and with oral or topical minoxidil was permitted if patients had been receiving a dose for 12 months prior to randomization.
A total of 654 patients were evaluated.
King and colleagues estimated that the percentage of patients with SALT scores of 20 or less by week 36 was 38.8% with 4 mg baricitinib, 22.8% with 2 mg baracitinib, and 6.2% with placebo in BRAVE-AA1.
Regarding BRAVE-AA2, investigators estimated that the percentages were 35.9% with 4 mg baracitinib, 19.4% with 2 mg baracitinib, and 3.3% with placebo.
Additionally, the differences between 4-mg baracitinib and placebo was 32.6 percentage points (95% CI, 25.6 - 39.5), and the difference between 2-mg baricitinib and placebo was 16.6 percentage points (95% CI, 9.5 - 23.8) (P <.001 for each dose vs. placebo).
For BRAVE-AA2, the corresponding values were 32.6 percentage points (95% CI, 25.6 - 39.6) and 16.1 percentage points (95% CI, 9.1 - 23.2) (P <.001 for each dose vs. placebo).
Regarding secondary outcomes for higher dose baricitinib, the team noted that secondary outcomes generally favored baracitinib to placebo. However, acne, elevated levels of creatine kinase, and increased levels of low- and high-densitylipoprotein cholesterol were observed more with baricitinib than with placebo.
“Longer trials are necessary to determine the efficacy and safety of baricitinib for alopecia areata, and the current trials are ongoing and are planned to remain randomized and blinded for up to 200 weeks,” the team wrote.
The study, "Two Phase 3 Trials of Baricitinib for Alopecia Areata," was published online in the New England Journal of Medicine.