Baricitinib Demonstrates Efficacy in Treating Atopic Dermatitis in Phase 3 Studies

Data from 2 phase 3 trials showed significant improvement in disease activity in patients with moderate-to-severe atopic dermatitis treated with baricitinib (Olumiant).

Treatment with baricitinib (Olumiant) improved disease activity in patients with moderate-to-severe atopic dermatitis (AD), according to new data from the BREEZE-AD1 and BREEZE-AD2 phase 3 studies.

Baricitinib, a once-daily oral JAK inhibitor, is currently indicated for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have an inadequate response to 1 or more tumor necrosis factor antagonist therapies.

AD, a more severe form of eczema, is a chronic skin disease characterized by intense itching, dry skin, and inflammation. Individuals with moderate-to-severe AD experience intense itching that can result in visibly damaged skin and sleep loss.

In both trials, a statistically significant portion of patients treated with baricitinib monotherapy achieved the primary endpoint at week 16 defined by the Investigator’s Global Assessment for AD score of clear or almost clear. Significant improvement in disease activity was determined by the proportion of patients treated with baricitinib achieving clear or almost clear skin with a greater than or equal to 2-point improvement.

“Atopic dermatitis is a chronic inflammatory skin disease that can negatively impact the quality of life for patients, and unfortunately there are limited treatment options, particularly oral medications,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in a statement. “We are encouraged that baricitinib met the primary endpoints in these 2 studies and look forward to seeing the collective results of all 5 studies.”

Overall, the incidence of treatment-emergent adverse events (AEs) and serious AEs associated with baricitinib was similar with placebo. The most common AEs observed were nasopharyngitis and headache.

Lilly plans to share the full data from these trials as well as topline data from other phase 3 trials later this year, according to the press release.

Baricitinib is being developed by Eli Lilly and Incyte.


Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis [news release]. Eli Lilly. Accessed February 4, 2019.