Baricitinib 4 mg plus topical steroids bests placebo in moderate to severe AD

A 4 mg dose of baricitinib plus topical corticosteroids was associated with significant improvement over placebo in a phase 3 study of patients with moderate to severe atopic dermatitis, according to a study.

“Baricitinib, an oral selective [Janus kinase (JAK)]1 and JAK2 inhibitor, was shown to improve the signs and symptoms of moderate to severe atopic dermatitis (AD),” Thomas Bieber, MD, PhD, MDRA, of the department of dermatology and allergy at University Hospital in Bonn, Germany, and the Christine Kühne Center of Allergy Research and Education in Davos, Switzerland, and colleagues wrote.

Bieber and colleagues assessed the efficacy and safety of baricitinib when administered with background topical corticosteroids in patients for whom cyclosporine A is not an option, either because of poor response, intolerance or contraindication.

The analysis was a double-blind, randomized, placebo-controlled study that included 93 patients treated with baricitinib 1 mg, 185 patients treated with baricitinib 2 mg, 92 patients treated with baricitinib 4 mg and 93 patients in the placebo arm. All patients received background corticosteroids.

The proportion of patients in the 2 mg or 4 mg dosing groups who achieved at least a 75% improvement from baseline in the EASI at week 16 served as the primary outcome measure. The study also included safety assessments.

Results showed that 32% of patients in the baricitinib 4 mg plus steroid group reached EASI 75, compared with 17% of patients in the placebo group (P = .031). This dosing rate also was associated with at least a 4-point improvement in a number of parameters at various time points compared with placebo, including itch, skin pain and number of nighttime awakenings due to itch, according to the findings.

The researchers noted that the efficacy outcomes for the 4 mg dose were maintained through 52 weeks of treatment.

Safety findings showed that treatment-emergent adverse events were reported more frequently in the study drug group compared with placebo. The 4 mg dose of baricitinib was associated with nasopharyngitis in 37%, followed by herpes simplex, influenza and headache, which each occurred in fewer than 20% of patients.

The 4 mg and 1 mg baricitinib doses yielded the most frequent adverse events.

There were no treatment-emergent fatalities or deep vein thromboses, according to the findings.

“Baricitinib 4 mg plus topical corticosteroids improved the signs and symptoms of moderate to severe AD through 52 weeks of treatment in patients with inadequate response, intolerance or contraindication to cyclosporine A,” the researchers concluded. “The safety profile was consistent with previous studies of baricitinib in moderate to severe AD.”