Baricitinib, an oral JAK inhibitor, is effective as treatment for moderate to severe atopic dermatitis when used in combination with topical steroids, a phase 3 randomised controlled trial has shown.
Published in JAMA Dermatology, the international multicentre trial involved 329 adults with moderate to severe AD, treated at 68 centres including five clinics in Australia.
Patients were randomised to treatment with 2mg or 4mg baricitinib or placebo, in addition to use of low-to-moderate potency topical corticosteroids.
After four months, a good response was achieved by 31% of patients receiving 4mg of baricitinib, as assessed by validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear). This primary end-point was achieved in 24% of patients receiving 2 mg of baricitinib compared with 15% receiving placebo (Odds ratio vs placebo, 2.8, P = .004 for the 4mg group; OR 1.9; P = .08 for the 2mg group).
In terms of safety, treatment-emergent adverse events were reported in 58% of patients who received 4mg baricitinib (4% serious ADR) , 56% in the 2mg group (2% serious ADR), and 38% of patients in the placebo group (4% serious ADR).
The most common adverse events were nasopharyngitis, upper respiratory tract infections, and folliculitis.
The study authors noted that baricitinib provided relief from itch as early as two days after starting treatment.
Patients receiving baricitinib also showed early benefits on sleep disturbance and skin pain, with associated improvements in symptoms of anxiety, depression, quality of life, and work productivity.
The study investigators said the side effect profile with baricitinib was similar to that seen in monotherapy trials and the low doses used did not lead to clinically meaningful JAK2 inhibition that would result in potential increases in anemia, neutropenia, and thrombocytopenia.
They said the findings suggested that baricitinib may offer a novel alternative option to current treatment of AD with topical steroids, which is limited by poor efficacy and lack of sustainability.
“Data in this study suggest that patients with atopic dermatitis treated with baricitinib may be able to reduce the frequency and total quantity of concomitant topical corticosteroids used, thus mitigating concerns associated with continual or sustained application of topical treatments,” they wrote.
“Because atopic dermatitis is a chronic disease with recurrent flares, the addition of TCSs to baricitinib could allow patients and physicians to escalate and reduce topical corticosteroid therapy based on symptoms.”
The European Medicines Agency has recently recommended an extension to baricitinib’s indications to include the treatment of moderate to severe atopic dermatitis, making it the first JAK inhibitor for the treatment of AD, according to manufacturer Lilly.
The Australian centres included in the baricitinib trial were Woden Dermatology, ACT, the Skin Health Institute, Melbourne, Skin & Cancer Foundation Australia, Westmead, Fremantle Dermatology, Perth and The Skin Centre, Benowa, Queensland.