Skin infections during dupilumab monotherapy in moderate-to-severe atopic dermatitis - a meta-analysis of randomized clinical trials.

Objective: Atopic dermatitis (AD) increases the risk of bacterial and viral cutaneous infections. This study assesses the risk of skin infections related to dupilumab monotherapy in moderate-to-severe AD.

Methods: We searched PubMed/Medline, Embase, Web of Science, ClinicalTrials.gov, and Cochrane Library. For gray literature, Google Scholar was searched. A meta-analysis of randomized clinical trials (RCTs) for overall skin infections, eczema herpeticum, nonherpetic skin infections and subgroup meta-analysis based on overall herpetic infection type was performed.

Results: We observed a statistically significant ( < 0.005) lower incidence rate in the dupilumab group compared to placebo for overall skin infections (Risk Ratio [RR] = 0.59, 95% confidence interval [CI]: [0.47, 0.75],  < 0.0001) and nonherpetic skin infections (RR = 0.42, 95% CI: [0.27, 0.66],  = 0.0001). For herpetic infections in 2b phase studies a meta-analysis demonstrated significantly higher events in dupilumab group compared to placebo (RR = 3.38, 95% CI: [1.98, 5.76],  < 0.00001, test for subgroup differences:  = 0.02, I = 65.6%).

Conclusions: In moderate-to-severe AD, dupilumab in monotherapy may be an effective and safe therapeutic approach, not associated with an increased risk of overall skin infections and nonherpetic skin infections. Due to the lack of statistical significance in heterogeneity associated with potential confounders in some cases, results should be interpreted cautiously.

Registration: The meta-analysis was registered in PROSPERO, ID: CRD42023441346.