Abrocitinib demonstrates fast itch control and skin clearance in atopic dermatitis

A head-to-head trial compared the efficacy of the Janus kinase (JAK) inhibitor abrocitinib with dupilumab in adult patients with moderate-to-severe atopic dermatitis (AD). Abrocitinib showed a faster treatment effect and might be the right treatment option for patients with severe pruritus.

In AD, in previous years more and more targeted therapies were emerging. “Once we have more treatment options for a disease, it is really important to start doing head-to-head trials to know the characteristics of a drug,” said Prof. Kristian Reich (University Medical Center Hamburg-Eppendorf, Germany) [1]. The JADE DARE trial was a 26-week, randomised, double-blind, phase 3b trial (NCT04345367) that compared the JAK inhibitor abrocitinib in a high dose to the IL-4/IL-13 blocker dupilumab in the approved dose. Participants were adult patients with moderate-to-severe AD with an inadequate response to topical medication or requirement for systemic therapy to control the disease. The co-primary endpoints were proportion of patients achieving a clinically relevant improvement of peak pruritus of at least 4-points on the 10-point numerical rating scale (PP-NRS4)at week 4?, and proportion of patients achieving an improvement of at least 90% in the Eczema Area and Severity Index (EASI 90) at week 4. Low-potency or medium-potency topical steroids (TCS) applied once daily to areas with active lesions were allowed from day 1.

Baseline characteristics were similar between both groups. At week 2, the PP-NRS4 response rate was significantly higher in the abrocitinib group compared with the dupilumab group (48.2% vs 25.5%; P<0.001). “The longer you wait, the more the 2 curves are overlapping, but the early effect is different,” Prof. Reich explained. After 16 weeks, both dupilumab and abrocitinib showed a similar PP-NRS4 response rate. “If you have a patient that is desperate because of itch and who cannot sleep at night, then a JAK inhibitor appears to be a very meaningful choice,” Prof. Reich commented.

At week 4, the EASI 90 response rate was 28.5% of patients treated with abrocitinib compared with 14.6% with dupilumab (P<0.001). “At week 16, you still see a clinically relevant difference between the 2 treatment modalities,” Prof. Reich said. At week 16, 54.3% of patients treated with abrocitinib and 41.9% of patients treated with dupilumab achieved an EASI 90 response (P<0.001). Later, patients treated with the biologic catch up, and there is no meaningful difference with regard to EASI 90 response and itch.

A few patients had serious treatment-emergent adverse event or events that led to study discontinuation. Nausea, headache, and acne were the most common adverse events reported by patients taking abrocitinib, and conjunctivitis was more frequent in the dupilumab group.

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   1. Reich K. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis who received background topical therapy in a 26-week, randomized, head-to-head trial. D3T01.2B, EADV Congress 2021, 29 Sept–2 Oct.

 

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Posted on 18 November 202118 November 2021