Eli Lilly and Incyte announced that their baricitinib, an oral JAK inhibitor developed to treat moderate to severe atopic dermatitis (AD) in adults, has reached the primary endpoint in BREEZE-AD7, the third pivotal Phase 3 trial in the BREEZE-AD programme.

Eli Lilly said that the BREEZE-AD7 study was conducted outside of the US, recruiting Asian, European, South American and Australian patients.

Lilly immunology development vice president Lotus Mallbris said: “Despite recent scientific advances, moderate to severe atopic dermatitis remains a disease with significant unmet treatment needs. 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.”

BREEZE-AD7 is the third pivotal Phase 3 trial in the BREEZE-AD programme

In the study, baricitinib is added to the standard of care topical corticosteroids, which showed significant improvement in disease severity, measured using validated Investigator’s Global Assessment for AD (vIGA) score of ‘clear or almost clear’ skin, which is the primary endpoint of the study at 16 weeks.

Both Baricitinib 4mg and 2mg have reached the primary endpoint on previously announced BREEZE-AD1 and BREEZE-AD2 clinical trials.

Baricitinib is permitted in 60 countries, including the US, member states of the EU and Japan, marketed as OLUMIANT, to treat adults with moderately to severely active rheumatoid arthritis (RA).

OLUMIANT (baricitinib) 2mg is advised for the treatment of adult patients with moderately to severely active rheumatoid arthritis and with inadequate response to one or more tumour necrosis factor (TNF) antagonist therapies.

In addition, OLUMIANT is not recommended to use in combination with other JAK inhibitors, biologic disease modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants including azathioprine and cyclosporine.