1. The co-primary endpoints at weeks 2 and 4 were significantly higher with abrocitinib than with dupilumab.
2. The overall incidence of adverse events, such as nausea and acne, was more frequent with abrocitinib, but was mostly mild in severity.
Evidence Rating Level: 1 (Excellent)
Study overview: Topical therapy is often considered a first-line option for the treatment of moderate to severe atopic dermatitis. However, when topical therapies are not sufficient, systemic therapies are often recommended. Dupilumab, an anti-interleukin [IL]-4 receptor antibody and abrocitinib, a Janus kinase [JAK] 1 inhibitor, are two systemic therapies that may play a role in the treatment of atopic dermatitis. To date, however, few studies have compared the relative efficacy of these therapies. This randomized controlled trial aimed to compare the safety and efficacy of abrocitinib versus dupilumab for the treatment of moderate to severe dermatitis. The primary outcome was an improvement in severity, defined by an improvement of 4 or more points on the Peak Pruritus Numerical Rating Scale (PP-NRS4) at week 2 and a 90% or greater improvement in the eczema area and severity index (EASI -90) at week 4. According to study results, a higher proportion of patients in the abrocitinib group achieved the primary endpoint compared to dupilumab. Although general adverse reactions were more frequent in the abrocitinib group, most adverse reactions were considered mild in severity. There were no differences in the number of serious adverse events between groups. A major advantage of this study was that it included participants from different countries, including individuals of different races. This contributes to the external validity of the results.
Click to read the study in The Lancet
Relevant literature: Abrocitinib versus placebo or dupilumab for atopic dermatitis
in-depth [randomized-controlled trial]: As of June 11, 2020 and December 16, 2020, 940 patients were screened for eligibility at 151 locations in 15 different countries. Included were patients ≥ 18 years of age with atopic dermatitis for ≥ 6 months and either 1) use of systemic oral therapy within the past 12 months or 2) inadequate response to topical therapy within the past 6 months. A total of 727 patients (362 in the abrocitinib group and 365 in the dupilumab group) were included. Patients received abrocitinib (200 mg daily) or subcutaneous dupilumab (300 mg every 2 weeks) for a total of 26 weeks with matching placebos in both groups. The primary outcome of PP-NRS4 at week 2 (48%, 95% confidence interval [CI] 43.0-53.4 vs. 26%, 95% CI 15.8-29.5, p<0.0001) and EASI-90 at week 4 (29%, 95% CI 23.8-33.2 vs. 15%, 95% CI 10 .9-18.2), p < 0.0001) was significantly greater in the abrocitinib group than in the dupilumab group, respectively. Abrocitinib was associated with more adverse events (268 of 362 patients, 74%) compared to dupilumab (239 of 365, 65%). Notably, mild nausea (19% vs 2%) and acne or folliculitis (13% vs 3%) were more common with abrocitinib than with dupilumab, respectively. Findings from this study suggest that abrocitinib is more effective than dupilumab in adults with moderate to severe atopic dermatitis.
Image: PD
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