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February 3, 2020

Top-line results announced for phase three study of baricitinib in atopic dermatitis

By GlobalData Healthcare

Eli Lilly and Incyte have announced that baricitinib in combination with topical corticosteroids has met its primary endpoint in an outside-the-US investigational phase three study of atopic dermatitis sufferers named BREEZE-AD4.

This was a randomised, placebo-controlled study of adult patients with moderate to severe atopic dermatitis who were poor responders, intolerant to or contraindicated for treatment with cyclosporine. The primary endpoint achieved was at least a 75% improvement in skin inflammation as assayed by a change from baseline in their Eczema Area and Severity Index (EASI) at week 16. The safety profile was consistent with the known safety findings of baricitinib for atopic dermatitis.

Baricitinib is a selective and reversible inhibitor of Janus-associated kinase (JAK) activity, which is involved in intracellular signal transduction for inflammatory diseases. It is currently licensed for the treatment of moderate to severe rheumatoid arthritis in adult patients who are poor responders to other therapies.

Baricitinib has been submitted by Eli Lilly for regulatory review in Europe as a treatment for patients with moderate to severe atopic dermatitis. The company plans to submit baricitinib for approval in the US and Japan in 2020.

There is a need for additional treatment options for atopic dermatitis outside the current conventional ones and GlobalData believes new drugs like baricitinib can provide hope for patients that are not controlled by the conventional treatment.

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