Olumiant (baricitinib) is indicated for the treatment of adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Already available for the treatment of rheumatoid arthritis, baricitinib is a JAK inhibitor that modulates signalling pathways involved in inflammation and immunity. It can be used with or without topical corticosteroids to treat atopic dermatitis.
Dr Andrew Pink, consultant dermatologist and honorary clinical lecturer at St John's Institute of Dermatology, Guy's & St Thomas’ NHS Foundation Trust said: 'Mild atopic dermatitis is often successfully managed with topical therapy, but moderate-severe disease can require additional systemic therapy and we need more options for effective systemic treatment. Baricitinib, an oral therapy targeting the complex immune mechanisms underlying atopic dermatitis, is therefore an important, welcome and positive new addition'.
Rapid itch reduction
Baricitinib was approved based on results from three randomised, double-blind, placebo-controlled 16-week phase III studies which examined its efficacy and safety as either monotherapy or in combination with topical corticosteroids.
The studies BREEZE-AD1, -AD2, and AD7 included 1568 adults with moderate to severe atopic dermatitis, defined by an Investigator's Global Assessment (IGA) score >3, an Eczema Area and Severity Index (EASI) score >16, and a body surface area (BSA) involvement of >10%. Eligible patients had responded inadequately to or were intolerant of topical medication.
Participants were randomised to receive baricitinib 1mg, 2mg or 4mg, or placebo, once daily for 16 weeks. Those enrolled in BREEZE-AD7 also received topical corticosteroids.
In all three studies, the proportion of patients achieving the primary endpoint of an IGA response of 0 (clear) or 1 (almost clear) at 16 weeks was significantly greater with baricitinib 4mg than placebo: 16.8% vs 4.8% in BREEZE-AD1 (p < 0.001), 13.8% vs 4.5% in BREEZE-AD2 (p = 0.001), and 31% vs 15% in BREEZE-AD7 (p = 0.004).
In addition, a significantly greater proportion of patients randomised to baricitinib 4mg achieved a >4-point improvement in the Itch Numerical Rating Scale score compared to placebo (within the first week of treatment for BREEZE-AD1 and AD2, and as early as week 2 for BREEZE-AD7; p < 0.002).
The most commonly observed adverse reactions in patients with atopic dermatitis who received baricitinib were nasopharyngitis, headache, upper respiratory tract infections, and folliculitis.