Eli Lilly and Incyte have reported positive data from the Phase III BREEZE-AD4 clinical trial performed to assess a combination of baricitinib and topical corticosteroids (TCS) for moderate to severe atopic dermatitis (AD).
The trial involved adult patients who did not experience adequate response with, were intolerant to or had contraindication to cyclosporine treatment.
The long-term, multi-centre, double-blind, randomised, placebo-controlled BREEZE-AD4 trial investigated the safety and efficacy of 1mg, 2mg and 4mg doses of the drug plus TCS.
The primary endpoint of the Phase III study was the proportion of patients with a minimum of 75% or higher change in their Eczema Area and Severity Index (EASI) from baseline to week 16.
The 4mg dose of the baricitinib and TCS combination met the primary goal. Data also showed a safety profile consistent with the known findings of the drug in atopic dermatitis.
During the Phase III trial, the most common treatment-emergent adverse events (TEAEs) were nasopharyngitis, headache and influenza. Investigators did not report any venous thromboembolic events (VTEs) or deaths.
Eli Lilly immunology development vice-president Lotus Mallbris said: “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.
“As we look to progress our treatment portfolio for chronic skin conditions, the continued insights from the development programme in AD further the potential of baricitinib to pursue this indication and to reach patients.”
The company filed a regulatory submission of baricitinib in Europe, seeking approval to treat moderate to severe atopic dermatitis patients. Lilly also intends to seek US and Japanese approval this year.