Baricitinib (Olumiant, Eli Lilly and Incyte), an oral Janus Kinase (JAK) inhibitor, demonstrated positive results in a phase 3 clinical trial of patients with atopic dermatitis (AD), according to new data.
The BREEZE-AD5 study evaluated the safety and efficacy of the 1-mg and 2-mg doses of baricitinib monotherapy for the treatment of adults with moderate-to-severe AD. The primary endpoint was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at week 16.
Baricitinib is currently approved for the treatment of adults with moderately-to-severely active rheumatoid arthritis.
According to the study results, the 2-mg dose of baricitinib met the primary endpoint, as well as key secondary endpoints including another measure of skin inflammation defined by clear or almost clear skin and at least 2 points improvement on the validated Investigator’s Global Assessment for AD (vIGA 0 or 1 at week 16), and reduced itch severity.
At week 16, 12.9% of patients treated with 1-mg baricitinib and 29.5% of patients treated with 2-mg baricitinib achieved EASI75 compared with 8.2% of patients in the placebo group, according to the data.
For the secondary endpoints, 12.9% treated with 1-mg baricitinib and 24% treated with 2-mg baricitinib achieved vIGA of 0 or 1 at week 16, compared with 5.4% in the placebo group. Additionally, 15.9% of those treated with the 1-mg dose and 25.2% treated with the 2-mg dose achieved a 4-point improvement in itch at week 16, compared with 5.7% in the placebo group.
The safety profile of baricitinib in the study was similar with its known safety findings in AD. The most common treatment-emergent adverse events included upper respiratory tract infections, nasopharyngitis, and diarrhea. No venous thromboembolic events or deaths repored in the trial.
“The results show the potential that baricitinib could offer as an additional treatment option to patients where there are otherwise limited choices,” principal trial investigator Eric Simpson, MD, MCR, professor of dermatology and director of clinical research at Oregon Health & Science University, said in a statement.
1. Lilly and Incyte Announce Positive Top-Line Results from the North American (BREEZE-AD5) Phase 3 Study of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate to Severe Atopic Dermatitis [news release]. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/lilly-and-incyte-announce-positive-top-line-results-north. Accessed January 31, 2020.