Eli Lilly and Incyte have announced that Olumiant (baricitinib) met the primary endpoint in BREEZE-AD7, the third pivotal Phase III trial in the BREEZE-AD program to be completed in 2019.
The investigational study was evaluating the efficacy and safety of the drug in moderate to severe atopic dermatitis (AD) in adults. Adding the treatment to standard-of-care topical corticosteroids significantly improved disease severity, measured by the validated Investigator's Global Assessment for AD (vIGA) score of "clear or almost clear" skin (vIGA 0, 1), the primary endpoint of the study at 16 weeks.
Both the 4mg and 2mg dosages met the trials’ primary endpoint in BREEZE-AD1 and BREEZE-AD2, and Lilly says that it plans to share the detailed 16-week data and analyses from BREEZE-AD7 at future scientific venues and in peer-reviewed journals later this year.
Despite recent scientific advances, moderate to severe atopic dermatitis remains a disease with “significant unmet treatment needs”, explained Lotus Mallbris, vice president of immunology development at Lilly.
She continued, “Atopic dermatitis is a chronic, relapsing condition that can vary greatly from person to person, and yet there are few medicines to address the different signs and symptoms in each patient. Today's baricitinib results in combination therapy reveal important additional clinical information in a chronic disease where patients currently have limited oral treatment options."
Olumiant is already approved for the treatment of adults with moderately to severely active RA in more than 60 countries, including the US, member states of the EU and Japan.