Safety and Efficacy of Reslizumab for Children and Adolescents With Eosinophilic Esophagitis Treated Over Nine Years

ABSTRACT Background: Eosinophilic esophagitis (EoE) is a chronic disease characterized by infiltration of eosinophils in the esophageal epithelium. There are limited treatment options for EoE. Rationale: To evaluate the long term safety and efficacy of reslizumab (RSZ) in pediatric patients who received RSZ in a randomized controlled trial (RCT) and expanded access program. Methods: Records of patients who received RSZ in our center were reviewed. Patients received RSZ 2 mg/kg (or placebo) every 4 weeks as part of the RCT, open label extension (OLE), and compassionate use (CU). Data were analyzed as of their most recent evaluation in August 2017. Labwork, history, and examinations were conducted every 12 weeks. Biopsy results were compared from baseline (prior to RCT) and at the most recent evaluation. Adverse events (AE) were recorded. Results: 12 patients entered the RCT at our center. 6 patients completed the OLE. 4 received RSZ through CU. Between the RCT, OLE, and CU periods, patients received 549 doses of RSZ (median 37, range 2–116). No serious AE were attributed to RSZ. Symptoms improved on treatment: dysphagia (42% vs 0%); abdominal pain (58% vs 0%); heartburn (18% vs. 0%); vomiting (67% vs. 17%); reflux (58% vs. 0%). Median esophageal eosinophil count improved (35 eos/hpf vs 3, p value 

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