White Paper AGA: Drug Development for Eosinophilic Esophagitis.
Since first characterized in 2 small case series in the early 1990s, eosinophilic esophagitis (EoE) has emerged as a commonly identified cause of esophageal symptoms in children and adults.1,2Although several highly effectively dietary, pharmacologic, and endoscopic therapies have been reported, none is currently approved by either the US Food and Drug Administration (FDA) or European regulatory authorities. Evolving diagnostic criteria have challenged drug development, in particular the recognition of complex interactions with the most prevalent esophageal disorder, gastroesophageal reflux disease (GERD). Heterogeneity in the clinical presentations of affected children and adults has created difficulties with uniform inclusion criteria and the development of disease-specific, patient-reported outcome (PRO) instruments. Furthermore, controversies regarding the appropriate therapeutic endpoints of EoE have impeded the design of clinical trials. Despite these obstacles, collaborative efforts by investigators, industry, the FDA, and patient advocacy groups have resulted in substantial progress in drug development in EoE over the past 2 decades.3The purpose of this article is to summarize discussions on EoE based on the 2016 Drug Development Conference sponsored by the Center for Diagnostics and Therapeutics of the American Gastroenterological Association.
Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Electronic address: i-hirano@northwestern.edu.
Ikuo
I
Hirano
Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Stuart
S
Spechler
Division of Gastroenterology, Center for Esophageal Diseases, Baylor University Medical Center at Dallas and Center for Esophageal Research, Baylor Scott & White Research Institute, Dallas, Texas.
Glenn
G
Furuta
Division of Gastroenterology, University of Colorado School of Medicine, Denver, Colorado.
Evan S
ES
Dellon
D002986:Clinical Trials as Topic; D055808:Drug Discovery / Q000639:trends*; D057765:Eosinophilic Esophagitis / Q000188:drug therapy*; D006801:Humans
Dysphagia; Eosinophilic Esophagitis; Esophageal Stricture; Esophagitis; Food Allergy; Gastroesophageal Reflux Disease