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New research suggests the Janus kinase 1 and 2 inhibitor relieves symptoms of atopic dermatitis at a daily dose of 4 mg.
Baricitinib (Olumiant) appears to improve the symptoms of moderate to severe atopic dermatitis (AD) in combination with topical corticosteroids, according to a new randomized clinical trial.
The findings suggest some patients with AD might be able to benefit from a wider array of therapies than is currently available.
Corresponding author Kristian Reich, MD, of the University Medical Center Hamburg-Eppendorf, in Germany, and colleagues wrote that the standard treatment for patients with AD is topical corticosteroids (TCSs) and emollients.
However, they said new research has led to a better understanding of the pathogenesis of the disease, which in turn has led to new treatment possibilities, including the human anti-interleukin 4 receptor α antibody, dupilumab (Dupixent), which is approved in both the U.S. and Europe for moderate to severe AD.
Baricitinib is a Janus kinase 1 and 2 (JAK1/JAK2) inhibitor which inhibits several cytokines involved in AD. Earlier research has suggested the drug is effective for patients with inadequate responses to TCS as monotherapy.
In this new study, Reich and colleagues wanted to understand how the drug would perform when used in combination with TCSs, since they said that better reflects how the real-world clinical usage patterns.
The investigators set up a double-blind, placebo-controlled phase 3 trial, dubbed BREEZE-AD7, enrolling patients ages 18 and older at 68 medical centers in 10 countries. The patients were treated between November 2018 and August 2019 for moderate to severe AD which had not been sufficiently managed with TCSs.
A total of 329 patients were enrolled and randomly assigned to one of 3 groups: 109 received baricitinib at a once-daily dose of 2 mg; 111 received daily 4-mg doses of the drug; the remaining 109 patients received placebo. The patients received 16 weeks of intervention, during which they were allowed to use low- to moderate-potency TCSs.
At week 16, patients were scored using the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), in which scores of 0 and 1 mean the patient is “clear” or “almost clear” respectively. The investigators found 34 patients (31%) in the 4-mg cohort and 26 patients (24%) in the 2-mg cohort achieved scores of 0 or 1, versus just 16 patients (15%) in the placebo group.
Adverse event rates were similar in the 4-mg and 2-mg groups (58% and 56%, respectively), the most common of which were nasopharyngitis, upper respiratory tract infections, and folliculitis. A total of 10 patients had serious adverse events (4 in the 4-mg group, 2 in the 2-mg group, and 4 in the placebo group).
“Treatment with 4 mg of baricitinib plus TCSs achieved a statistically significant improvement compared with placebo plus TCSs in the proportion of patients achieving a vIGA-AD score of 0 or 1 with a 2-point or greater improvement from baseline at week 16 (primary endpoint) and successfully improved signs and symptoms of AD,” Reich and colleagues wrote.
The investigators noted baricitinib appeared to improve patients’ itchiness by the second day of therapy and the drug also appeared to improve skin pain and sleep, both of which are common effects of AD.
“Baricitinib may represent a potential novel oral treatment option in combination with background TCSs for patients with moderate to severe AD,” they concluded.
The study, "Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis," was published online in JAMA Dermatology.