Eli Lilly and Incyte announced Friday that adding the oral JAK inhibitor Olumiant (baricitinib) to standard-of-care topical corticosteroids significantly improved disease severity in adults with moderate-to-severe atopic dermatitis, compared with placebo. "Despite recent scientific advances, moderate-to-severe atopic dermatitis remains a disease with significant unmet treatment needs," noted Lotus Mallbris, vice president of immunology development at Eli Lilly, adding that data from the BREEZE-AD7 trial "reveal important additional clinical information in a chronic disease where patients currently have limited oral treatment options."
The study involved 329 patients with moderate-to-severe atopic dermatitis who were randomly assigned to treatment with Olumiant, at a dose of 2 mg or 4 mg, or placebo, in combination with topical corticosteroids. The primary endpoint evaluated improvements in disease activity as determined by the proportion of patients achieving "clear" or "almost clear" skin, denoted by scores of 0 or 1, respectively, with at least a two-point improvement as measured by a validated Investigator's Global Assessment for atopic dermatitis (vIGA) scale at 16 weeks.
Top-line results showed that 23.9% and 30.6% of patients in the low-dose and high-dose Olumiant groups, respectively, had vIGA scores of 0 or 1 at 16 weeks, compared with 14.7% for placebo. The companies also reported that 43.1% of patients in the low-dose group and 47.7% of those given the high dose achieved an improvement of at least 75% in the Eczema Area and Severity Index (EASI75) score at week 16, versus 22.9% of placebo-treated patients. In addition, 38.1% and 44% of patients in the low-dose and high-dose Olumiant arms, respectively, experienced a four-point improvement in the itch Numeric Rating Scale, compared with 20.2% for placebo.
Eli Lilly and Incyte noted that safety data for the therapy were consistent with the known safety profile of the treatment, with no malignancies, major adverse cardiovascular events or deaths reported in the study.
The results follow similar positive findings from the Phase III BREEZE-AD1 and BREEZE-AD2 trials disclosed in February. Eli Lilly will present detailed findings from the BREEZE-AD7 study at upcoming medical meetings and in peer-reviewed journals later this year. Meanwhile, top-line data from the two other trials will be unveiled later this year or early in 2020.
Olumiant has been approved in more than 60 markets, including the US and EU, for the treatment of rheumatoid arthritis. Eli Lilly reported sales of $102.4 million for the therapy in the second quarter, up from $44.7 million in the year-ago period.
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