- 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. D3T01.2A, EADV Congress 2021, 29 Sept–2 Oct.
“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 because we need to start patient profiling,” said Prof. Kristian Reich (University Medical Center Hamburg-Eppendorf, Germany)1. In AD, more and more targeted therapies are emerging. 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 AD. The co-primary endpoints were an early effect on itch, assessed as change in peak pruritus numerical rating scale (PP-NRS4) with response based on achieving at least a 4-point improvement in the severity of PP-NRS4 at week 2, and an improvement of 90% in the Eczema Area and Severity Index (EASI 90) at week 4. “This study was done on a topical therapy background,” Prof. Reich explained. From day 1, low or medium potency topical steroids (TCS) was allowed to be applied once daily to areas with active lesions.
Baseline characteristics were similar between both groups. At week 2, 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 than 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 a EASI 90 response (P<0.001 in favour of abrocitinib). 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 adverse events reported by patients taking abrocitinib, and conjunctivitis was more frequent in the dupilumab group.