Treatment with baricitinib, a selective Janus kinase (JAK) 1/JAK2 inhibitor, significantly improved symptoms of moderate to severe atopic dermatitis (AD), according to findings from the phase 3 BREEZE-AD5 trial published in the Journal of the American Academy of Dermatology.
The study included 440 patients with moderate to severe AD from 81 centers in the United States and Canada. Patients were randomly assigned to either once daily oral placebo (n=147), 1 mg baricitinib (n=147), or 2 mg baricitinib (n=146). The primary endpoint was achievement of a 75% or greater improvement in the Eczema Area and Severity Index (EASI75) from baseline to 16 weeks. The secondary endpoint was the percentage of patients who achieved a validated Investigator Global Assessment for AD (vIGA-ADTM) score of 0 (clear)/1 (almost clear) by week 16.
Approximately 65% of patients in the placebo arm required rescue medication during the 16-week treatment period vs 42% in the 1 mg baricitinib group and 33% in the 2 mg baricitinib arm.
The percentage of patients who achieved the primary endpoint (EASI75) were 8% in the placebo group, 13% in the 1 mg baricitinib arm, and 30% 2 mg baricitinib arm (P <.001). In additionally, a significantly greater percentage of patients in the 1 mg and 2 mg baricitinib arms achieved vIGA-AD 0/1 compared with placebo (13% and 24% vs 5%, respectively; P <.001).Also, more patients in the 1 mg and 2 mg baricitinib groups achieved a 4-point improvement in itch compared with the placebo group (16% vs 25% vs 6%, respectively; P <.001).
Overall, the frequencies of treatment-emergent adverse events (TEAEs) were similar across treatment groups. The most common TEAEs were upper respiratory tract infection (6% vs 6% vs 8%), nasopharyngitis (8% vs 2% vs 5%), and diarrhea (1% vs 2% vs 4%).
Limitations of this study included the relatively low doses of baricitinib administered as well as the short treatment duration, which the investigators suggest limit the generalizability of the findings across real-world settings.
Based on these results from BREEZE-AD5, the investigators suggest “baricitinib can be an oral treatment option for short-interval use in patients with more moderate, flaring disease and for chronic, long-term use, with growing long-term safety data available from AD.”
Disclosure: This clinical trial was supported by Eli Lilly and Company. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Simpson EL, Forman S, Silverberg JI, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5). J Am Acad Dermatol. Published online February 16, 2021. doi:10.1016/j.jaad.2021.02.028