Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 (IL-4) and interleukin-13 (IL-13), was evaluated in clinical trials for the treatment of moderate-to-severe atopic dermatitis. The trials included randomized, double-blind, placebo-controlled studies involving adults with atopic dermatitis not adequately controlled by topical glucocorticoids and calcineurin inhibitors. Dupilumab was tested as monotherapy in 4-week and 12-week trials, and in combination with topical glucocorticoids in a 4-week study. Key endpoints included the Eczema Area and Severity Index (EASI) score, investigator's global assessment, pruritus, and safety assessments. In the 4-week monotherapy studies, dupilumab showed rapid and dose-dependent improvements in clinical indices, biomarker levels, and the transcriptome. The 12-week study confirmed and extended these findings, with 85% of dupilumab-treated patients achieving a 50% reduction in EASI score (EASI-50) compared to 35% in the placebo group. Additionally, 40% of dupilumab-treated patients had a score of 0 to 1 on the investigator's global assessment, compared to 7% in the placebo group. Pruritus scores decreased by 55.7% in the dupilumab group versus 15.1% in the placebo group. In the combination study, 100% of dupilumab-treated patients met the EASI-50 criterion, compared to 50% in the placebo plus glucocorticoid group. Dupilumab was associated with significant improvements in all evaluated measures of atopic dermatitis disease activity. Adverse events, such as skin infections, occurred more frequently with placebo, while nasopharyngitis and headache were more common with dupilumab. The side-effect profiles were not dose-limiting. Dupilumab treatment resulted in marked and rapid improvement in all evaluated measures of atopic dermatitis disease activity. The study was funded by Regeneron Pharmaceuticals and Sanofi.Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 (IL-4) and interleukin-13 (IL-13), was evaluated in clinical trials for the treatment of moderate-to-severe atopic dermatitis. The trials included randomized, double-blind, placebo-controlled studies involving adults with atopic dermatitis not adequately controlled by topical glucocorticoids and calcineurin inhibitors. Dupilumab was tested as monotherapy in 4-week and 12-week trials, and in combination with topical glucocorticoids in a 4-week study. Key endpoints included the Eczema Area and Severity Index (EASI) score, investigator's global assessment, pruritus, and safety assessments. In the 4-week monotherapy studies, dupilumab showed rapid and dose-dependent improvements in clinical indices, biomarker levels, and the transcriptome. The 12-week study confirmed and extended these findings, with 85% of dupilumab-treated patients achieving a 50% reduction in EASI score (EASI-50) compared to 35% in the placebo group. Additionally, 40% of dupilumab-treated patients had a score of 0 to 1 on the investigator's global assessment, compared to 7% in the placebo group. Pruritus scores decreased by 55.7% in the dupilumab group versus 15.1% in the placebo group. In the combination study, 100% of dupilumab-treated patients met the EASI-50 criterion, compared to 50% in the placebo plus glucocorticoid group. Dupilumab was associated with significant improvements in all evaluated measures of atopic dermatitis disease activity. Adverse events, such as skin infections, occurred more frequently with placebo, while nasopharyngitis and headache were more common with dupilumab. The side-effect profiles were not dose-limiting. Dupilumab treatment resulted in marked and rapid improvement in all evaluated measures of atopic dermatitis disease activity. The study was funded by Regeneron Pharmaceuticals and Sanofi.