Efficacy and safety of dupilumab plus topical tacrolimus for atopic dermatitis in 6- to 12-year-old patients.

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of combining dupilumab with topical tacrolimus for the treatment of atopic dermatitis (AD) in children aged 6 to 12 years. PATIENTS AND METHODS: A total of 168 pediatric (aged 6 to 12 years) patients with severe AD admitted to our hospital between April 2022 and April 2023 were included in this retrospective study. These patients are grouped according to different medication methods, assigned them to receive either tacrolimus plus topical corticosteroids (control group) or dupilumab combined with tacrolimus and topical corticosteroids (study group), with 84 patients in each group. Clinical efficacy and adverse reactions were primary clinical endpoints. RESULTS: The use of dupilumab significantly increased the total effective rate for the patients by 14.29%, from 77.38% (65/84) in the control group to 91.67% (77/84) in the study group. Following treatment, patients given dupilumab showed a more significantly decreased peripheral blood eosinophils (EOS) and immunoglobulin E (IgE) levels than those without dupilumab treatment. Patients administered with dupilumab exhibited markedly lower scores on the Patient-oriented Eczema Measure (POEM) at weeks 12 and 16 and lower Eczema Area and Severity Index (EASI) scores at weeks 8, 12, and 16 when compared to those patients who did not receive dupilumab therapy. At the 16-week, 37 patients in the study group obtained a score of 1/0 on the Verified Investigator's Global Assessment (v-IGA) scale, whereas the control group had 24 such cases, indicating a significantly higher response rate provided by the protocol incorporating dupilumab. After 16 weeks of treatment, both groups demonstrated a marked decrease in itch numeric rating scale (NRS) scores and Dermatology Life Quality Index (DLQI) scores, with lower scores observed in the study group than in the control group. The absence of a significant difference in the incidence of adverse reactions between the two groups suggested a high safety profile of dupilumab. CONCLUSIONS: The combination of dupilumab with topical tacrolimus demonstrated favorable efficacy in the management of AD in children aged 6 to 12 years. This treatment protocol effectively alleviates symptoms, enhances the quality of life of patients, and shows no increased risk of adverse reactions.