In adults with moderate to severe atopic dermatitis (AD), the use of baricitinib combined with topical corticosteroids (TCS) is associated with a significant reduction in cutaneous inflammation and pruritus, according to the results of a recent phase 2, randomized, placebo-controlled, multiple-dose study (ClinicalTrials.gov identifier: NCT02576938) conducted in the United States and Japan and published in the Journal of the American Academy of Dermatology.
The investigators sought to evaluate the efficacy and safety of baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, which modulates pro-inflammatory cytokine signaling in adult patients with moderate to severe AD.
A total of 124 patients applied TCS for 4 weeks prior to being randomly assigned to 1 of 3 treatment groups: once-daily placebo (n=49), once-daily baricitinib 2 mg (n=37), or once-daily baricitinib 4 mg (n=38). All groups were treated for 16 weeks. TCS use was allowed throughout the study. The primary study outcome was the proportion of baricitinib-treated patients who achieved ≥50% reduction in the Eczema Area and Severity Index (EASI-50) score compared with placebo-treated participants.
At 16 weeks, significantly more patients in the baricitinib 4-mg group had reduced EASI-50 score vs the placebo group (61% vs 37%, respectively; P =.027). The proportion of participants in the baricitinib 2-mg arm and the baricitinib 4-mg arm who achieved reduction in EASI-50 score, compared with placebo, was statistically significant as early as 4 weeks after beginning treatment. The use of baricitinib was also associated with improvements in pruritus and sleep loss.
Treatment-emergent adverse events were reported in 46% of the baricitinib 2-mg arm, 71% of the baricitinib 4-mg arm, and 49% of patients in the placebo group. Limitations of the current study included the small sample size, short treatment period, and that pediatric patients were not eligible for enrollment.
The investigators concluded that studies with longer follow-up are warranted to confirm the efficacy and safety of baricitinib in patients with AD.
Guttman-Yassky E, Silverberg JI, Nemoto O, et al. Baricitinib in adult patients with moderate-to-severe atopic dermatitis: a phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study [published online February 1, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.01.018