Use of Dupilumab for 543 Adult Patients with Moderate-To-Severe Atopic Dermatitis: A Multicenter, Retrospective Study.

BACKGROUND Dupilumab has been demonstrated to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, evidence of real-world experience with dupilumab in a broader population is limited to date. METHODS Adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at ten Italian academic centers, were included in the study. Physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index, DLQI) and serological markers [immunoglobulin (Ig) E and eosinophil count] after 16 weeks were analyzed. RESULTS We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median ± interquartile percentage change from baseline to 16 weeks of treatment in the EASI score was -87.5±22.0 (p<0.001). EASI-50, EASI-75 and EASI-90 response rates were 98.1%, 81.5%, and 50.8% after 16 weeks. At 16 weeks, 93.0% of the patients had achieved a 4- point or higher improvement in DLQI from baseline. During dupilumab treatment, 12.2% of the patients developed conjunctivitis, and total IgE significantly decreased (p<0.001). Interestingly, in the multivariate logistic regression model, the risk of developing dupilumab-related conjunctivitis was associated with early AD onset [OR, 2.25; 95%CI, 1.07-4.70; p=0.03] and presence of eosinophilia [OR, 1.91; 95%CI, 1.05-3.39; p=0.03]. CONCLUSION To date, this is the broadest real-life study in AD patients treated with dupilumab. We observed significant improvements induced by dupilumab in adult patients with moderate-to-severe AD, to a greater extent than those reported in clinical trials.