Dupilumab in Adults and Adolescents With Eosinophilic Esophagitis.

PURPOSE OF THE STUDY: To determine if dupilumab (a fully human monoclonal antibody, blocks interleukin-4 and interleukin-13 signaling) plays any key roles in eosino-philic esophagitis. STUDY POPULATION: Patients 12 years and older with eosinophilic esophagitis and a histologic diagnosis of >15 eosi-nophils per high-power field despite 8 weeks of high dose protein pump inhibitor (PPI) were enrolled. A Dysphagia Symptom Questionnaire (DSQ) of >10 (range 0-84) was required at baseline. Patients could not initiate PPI or change their elimination diet. Patients could not use swallowed topical corticosteroid for the 8 weeks before or during the trial. Rescue medications or systemic glucocorticoids and esopha-geal dilation were permitted if medically necessary. METHODS: In this 3-part study, endpoints were analyzed at 24 and 52 weeks. Dosing was 300 mg every 1 or 2 weeks subcutaneous or placebo every 1 week subcutaneous. The primary endpoints were histologic response of #6 eosinophils per high-power field and the absolute change in DSQ. RESULTS: The histologic remission rate of 60% occurred with both dosing regimen at 24 weeks. Inflammation persisted in 93% of placebo patients. Relevant reduction in DSQ occurred in the 1 weekly patient (--12.3) compared with every 2 weeks (--0.51) compared with placebo. The side effect profile was good for all dosing regiments. CONCLUSIONS: The histologic remission with swallowed corticosteroids is up to 90% of patients. The histologic response in this study of 60% is puzzling. Note that less effectiveness of dupilumab has been shown in this study.