Abstract

Introduction: Dupilumab has shown promising results in phase III trials and has recently been approved for the treatment of moderate to severe atopic dermatitis (AD) in adults. At this moment, daily practice data on dupilumab treatment are lacking. Objective: To study the effect of 16 weeks treatment with dupilumab on clinical efficacy, serum biomarkers (and peripheral blood T-cell skewing) in adult patients with moderate-severe AD in daily practice. Methods: Data were extracted from the Bioday registry. 16-weeks clinical effectiveness of dupilumab was expressed as number of patients achieving EASI-50, EASI-75) as well as patient reported outcomes measures (POEM, DLQI, NRS-itch). 29 biomarkers representing different disease pathways were measured in 35 patients treated with dupilumab without concomitant use of oral immunosuppressive drugs at 5 different time points (baseline, 4, 8, 12 and 16 weeks). We performed a pilot study on T cell skewing within the total, but also “skin-homing” (CLA+CCR4+) CD4 T cell population. Results: In total, 105 patients treated with dupilumab in daily practice were included. At week 16, the mean percent change in EASI score was 72%. The EASI-50 and EASI-75 were achieved by 87 (85%) and 59 (58%) patients after 16 weeks of treatment. The most reported side effect were conjunctivitis in 39 (37%) and eosinophilia in 67 (65%) patients. Dupilumab significantly decreased type 2 and severity serum biomarkers including, CCL17 (TARC), CCL18 (PARC), periostin and IL-22. No change in overall T-cell skewing based on cytokine expressions was observed. However there was a decrease in the percentage of IL-13, and IL-22 expressing CLA+CCR4+ CD4 T cells and an increase in IFN-g expressing CLA+CCR4+ CD4 T cells. Conclusion: Treatment with dupilumab improved disease severity and significantly suppressed Th2 and severity related serum biomarkers in patients with very difficult-to-treat AD in a daily practice setting. In addition, dupilumab seems to affect the functional skewing of especially skin-homing T cells.

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