Eli Lilly and Incyte reported top-line data on Monday showing that the Phase III BREEZE-AD4 trial evaluating Olumiant (baricitinib) in patients with moderate-to-severe atopic dermatitis (AD) met the primary endpoint of at least 75% improvement from baseline on the Eczema Area and Severity Index (EASI75) at week 16. Lotus Mallbris, vice president of immunology development at Eli Lilly, noted that "there is a high need for additional treatment options for patients living with moderate-to-severe AD, particularly those who failed conventional systemic treatments like cyclosporine."
The trial enrolled 463 adults with moderate-to-severe AD who have experienced failure to cyclosporine, or are intolerant to or have a contraindication to cyclosporine. Participants were randomised to receive Olumiant at doses of 1 mg, 2 mg and 4 mg, or placebo, in combination with topical corticosteroids.
Eli Lilly reported that the primary endpoint was met in the 4-mg dose group, where the proportion of patients achieving EASI75 was 31.5%. For patients in the 2-mg and 1-mg Olumiant dose groups, the rates were 27.6% and 22.6%, respectively, while the rate for the placebo arm was 17.2%. The treatment also improved disease severity, as measured by validated Investigator's Global Assessment (vIGA) scores of 0 or 1, denoting "clear" or "almost clear" skin, in 21.7% of patients in the 4-mg group, 15.1% in the 2-mg group and 12.9% in the 1-mg group, compared with 9.7% for placebo. Meanwhile, the proportion of patients achieving a four-point improvement in the itch Numeric Rating Scale (NRS) at week 16 was 38.2%, 22.9% and 23.1%, for the respective 4-mg, 2-mg and 1-mg Olumiant groups, versus 8.2% for placebo.
The company said the safety of Olumiant in the study was consistent with the oral JAK inhibitor's known profile in AD, with the most common treatment-emergent adverse events including nasopharyngitis, headache and influenza. Further, no venous thromboembolic events or deaths were reported in BREEZE-AD4. Full study results will be presented at future scientific meetings and in peer-reviewed journals.
The study follows recent positive findings from the Phase III BREEZE-AD7 trial, which showed that adding Olumiant to standard-of-care topical corticosteroids significantly improved disease severity in adults with moderate-to-severe AD. Eli Lilly said it recently submitted Olumiant for regulatory review in Europe for patients with moderate-to-severe AD and plans to file applications for approval in the US and Japan this year.
Olumiant is already approved for the treatment of adults with moderate-to-severe rheumatoid arthritis in more than 60 countries, including the US at the 2-mg dose, and in the EU at doses of 2 mg and 4 mg.
Meanwhile, Pfizer recently presented detailed results showing that its JAK inhibitor abrocitinib in moderate-to-severe AD met all the co-primary and secondary endpoints of the Phase III JADE MONO-1 trial. For related analysis, see ViewPoints: Pfizer's abrocitinib raises bar for JAKs in atopic dermatitis.
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