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Long-Term Safety and Efficacy of Reslizumab in Children and Adolescents with Eosinophilic Esophagitis: A Review of 477 Doses in 12 Children over 7 Years
Monday, March 7, 2016
South Exhibit Hall H (Convention Center)
Jonathan E. Markowitz, Laura Jobe, Michelle Miller, Carrie Frost, Ransome Eke
Rationale: To evaluate the long term safety and efficacy of resilizumab (RSZ), a monoclonal humanized antibody to interleukin-5, in pediatric patients who have received the drug through participation in a randomized controlled trial (RCT), followed by an open-label extension (OLE), and ongoing treatment on a compassionate use (CU) basis.

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 from March 2008 to October 2009, OLE from July 2008 to January 2012, and CU from January 2012 until July 2015. 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 477 doses of RSZ (mean 40, range 2-89). No serious AE were attributed to RSZ in any phase of administration. No clinically significant laboratory abnormalities were identified.  Symptoms improved on treatment: dysphagia (42% vs 9%); abdominal pain (58% vs 0%); heartburn (18% vs. 0%); vomiting (67% vs. 33%); reflux (58% vs. 0%). Mean esophageal eosinophil count improved on treatment (33 eos/hpf vs. 3).

Conclusions: RSZ appears to be safe in children with eosinophilic esophagitis over 7 years of experience.  Symptoms and eosinophil count improved in our patients treated with RSZ.