The JAK inhibitor previously approved for rheumatoid arthritis has reported early primary endpoint outcomes in its ongoing phase 3 trial.
Baricitinib (OLUMIANT) has met primary endpoint marks in its most recent pivotal phase 3 trial designed to assess the Janus kinase (JAK) inhibitor for the treatment of moderate to severe adult atopic dermatitis (eczema).
Recent findings from the third phase 3 trial in the BREEZE-AD program, to be fully completed later this year, show baricitnib plus standard-of-care topical corticosteroids significantly improved patient disease severity per validated Investigator’s Global Assessment for atopic dermatitis (vIGA) score of “clear” or “almost clear” skin (vIGA 0, 1) at 16 weeks.
The trial is currently being conducted outside of the US, and marks the midway point of the planned 5 placebo-controlled phase 3 studies from Eli Lilly and Company that will assess barictinib.
A total of 329 patients were randomized 1:1 to either baricitnib 2 mg (n = 109), 4 mg (n = 111), or placebo (n = 109), plus corticosteroids. At week 16, 23.9% and 30.6% of patients administered baracitnib 2 mg and 4 mg achieved vIGA 0 or 1, respectively (P≤ .01). Just 14.7% of patients administered placebo achieved either mark.
A significantly greater rate of patients on baricitnib 2 mg (43.1%; P≤ .01) and 4 mg (47.7%; P≤ .001) also achieved Eczema Area and Severity Index improvement of at least 75% (EASI75) at week 16, compared to just 22.9% of placebo patients.
The safety data for baricitnib were consistent with the therapy’s known profile, and the most common treatment-emergent adverse events included nasopharyngitis, upper respiratory tract infection and folliculitis. No patients reported major adverse cardiovascular events, malignancies, or deaths during the trial.
The findings follow the successful BREEZE-AD1 and BREEZE-AD2 clinical trials from earlier this year, and precede the remaining 2 phase 3 trials to be announced in late 2019 or 2020.
Baricitinib is currently approved for adults with moderately to severely active rheumatoid arthritis in 60-plus countries, including the US.
Lotus Mallbris, MD, PhD, vice president of Immunology Development for Lilly, said in a statement that moderate to severe atopic dermatitis persists as a significantly unmet disease clinically, despite recent advances in the field.
“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," Mallbris said. "Today's baricitinib results in combination therapy reveal important additional clinical information in a chronic disease where patients currently have limited oral treatment options."