New analyses of BREEZE-AD5 Phase 3 clinical trial data have demonstrated the efficacy and long-term safety of baricitinib (Olumiant®; Eli Lilly and Company/Incyte) in the treatment of patients with moderate to severe atopic dermatitis, according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.

Analyses of BREEZE-AD5 (NCT03435081) demonstrated improvement in key treatment outcomes vs placebo associated with baricitinib.

Baricitinib “showed early improvement across multiple symptoms among patients with moderate to severe atopic dermatitis,” said Lotus Mallbris, MD, PhD, vice president of immunology development at Eli Lilly, in a press release.1 “We are pleased the extended safety analysis helps further define the long-term safety profile of [baricitinib] in atopic dermatitis.”

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In one post-hoc BREEZE-AD5 (NCT03435081) analysis,2 patients treated with baricitinib 2 mg demonstrated “statistically significant and concurrent improvements” in atopic dermatitis severity, in addition to improvements in key symptoms like itch, nighttime awakening due to itch, skin discomfort and pain, and quality of life; many changes were measured as early as 1 week after treatment initiation.

In another post-hoc analysis,3 researchers evaluated the efficacy of baricitinib 2 mg on baseline Body Surface Area (BSA). After 2 weeks of treatment, 2 of 10 patients with BSA 10% to 50% experienced significant improvements in both severity and extent of atopic dermatitis vs placebo. By week 16, 4 of 10 patients saw significant  improvements in severity and extent vs placebo (37.5% vs 9.9%), and 3 of 10 patients saw significant improvement based on the achievement of clear or almost clear skin, measured by the validated Investigator Global Assessment for Atopic Dermatitis.

In addition, investigators conducted a long-term safety analysis of baricitinib 2 mg,4 the results of which demonstrated “no observed increase in rates of serious adverse events or serious infections” compared with placebo.

Olumiant is currently under review by the US Food and Drug Administration as an investigational medication for moderate to severe atopic dermatitis in adults and has been approved outside of the U.S as the first JAK inhibitor for atopic dermatitis in more than 40 countries.


  1. Olumiant® showed significant improvements in the severity and extent of atopic dermatitis and other patient-reported outcomes in phase 3 study analyses. News release. Eli Lilly and Company. Presented at: AAD VMX 2021; April 23-25, 2021.
  2. Lio P, Soung J, Cather J, et al. Rapid and concurrent improvements in the signs and symptoms of atopic dermatitis with baricitinib in the phase 3 study, BREEZE-AD5. Presented at: AAD VMX 2021; April 23-24, 2021. Abstract/Poster 26691.
  3. Silverberg JI, Boguniewicz M, Waibel J, et al. Efficacy of baricitinib 2-mg stratified by baseline body surface area in adults with moderate-to-severe atopic dermatitis. Presented at: AAD VMX 2021; April 23-24, 2021. Abstract/Poster 27050.
  4. King B, Maari C, Lain E, et al. Extended safety analysis of baricitinib 2-mg in adult patients with atopic dermatitis: an integrated analysis from 8 randomized clinical trials. Presented at: AAD VMX 2021; April 23-24, 2021. Abstract/Poster 27030.