A meta-analysis and review of 9 randomized trials found high-quality evidence demonstrating the benefits of dupilumab in patients with severe atopic dermatitis.
A review of 9 randomized trials found high-quality evidence demonstrating the benefits of dupilumab (Dupixent) in patients with severe atopic dermatitis (AD), with findings of the analysis published in the Brazliian journal Revista da Associação Médica Brasileira.1
Dupilumab, an IL-4 receptor α antagonist, is FDA approved for the treatment of adults and children 6 months or older with moderate to severe AD when topical prescription therapies are not sufficiently effective or not recommended.2
The review and analysis gauged treatment efficacy based on a selection of outcomes in the studies. This included the Eczema Area and Severity Index (EASI), which is used to assess the severity and extent of AD. An EASI score of 50 indicates an improvement of 50% or greater, and an EASI score of 75 indicates an improvement of 75% or greater. The Investigator’s Global Assessment (IGA), a validated score for AD assessment, was also used. Scores of 0-1 (clear or almost clear) and/or improvement of 2 or more points was considered improvement. A reduction of 3 or more points on the numerical rating scale (NRS) for pruritus was another outcome of interest.
A total of 1344 works were identified in a search of the MEDLINE database via PubMed, and 57 were chosen based on title or abstract. Of those, 9 randomized clinical trials were included in the analysis for the review. Eligible studies included patients with severe AD refractory to conventional treatments who were treated with either dupilumab or a placebo.
Data from 2606 patients treated with dupilumab and 1441 treated with a placebo were included in the analysis, which included children, adolescents, and adults. Regimens of 300 mg administered by subcutaneous injection every 1, 2, or 4 weeks were included, and average follow-up was 6 months. In addition to the efficacy outcomes, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were examined.
The EASI 50 outcome analysis studied 1773 patients given dupilumab and 1684 given a placebo. In this analysis, dupilumab treatment improved the EASI 50 rate by 40% vs a placebo. In the EASI 75 outcome analysis, 2606 patients treated with dupilumab and 2615 given a placebo were studied. Treatment with dupilumab improved the EASI 75 rate by 37% compared with a placebo. In both the EASI 50 and EASI 75 analyses, the evidence quality was considered high.
The analysis of IGA included 2606 patients who received dupilumab and 2615 who were given a placebo, and dupilumab was shown to improve IGA outcomes by 25% compared with the placebo. The evidence quality was also high in this analysis. A total of 2126 patients treated with dupilumab and 1931 given a placebo were studied in the NRS pruritus analysis. In these patients, dupilumab reduced NRS-measured pruritus by 21% compared with the placebo, although the evidence quality was considered low in this analysis.
TEAEs were assessed in 758 patients who underwent treatment with dupilumab and 664 patients who received a placebo, and there was no difference in TEAE risk in the dupilumab cohort vs patients given a placebo. In an analysis of 1461 patients treated with dupilumab and 1349 patients given a placebo, dupilumab treatment increased the risk of SAEs by 23% vs a placebo. In these analyses, the evidence quality was considered low.
Overall, the review and analysis show that dupilumab led to improvements in patients with AD compared with a placebo, but with an increased risk of SAEs.
1. Bernardo W, Bernardo LS, Baroni JH, Santos Simōes R. Severe atopic dermatitis and dupilumab. Rev Assoc Med Bras. 2023;69(1):2-6. doi:10.1590/1806-9282.023D691
2. Dupixent. Prescribing information. Regeneron; 2017. Accessed March 9, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf