TY - JOUR
T1 - White Paper AGA
T2 - Drug Development for Eosinophilic Esophagitis
AU - Hirano, Ikuo
AU - Spechler, Stuart
AU - Furuta, Glenn
AU - Dellon, Evan S.
N1 - Publisher Copyright:
© 2017 AGA Institute
PY - 2017/8
Y1 - 2017/8
N2 - 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.1,2 Although 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.3 The 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.
AB - 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.1,2 Although 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.3 The 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.
KW - Dysphagia
KW - Eosinophilic Esophagitis
KW - Esophageal Stricture
KW - Esophagitis
KW - Food Allergy
KW - Gastroesophageal Reflux Disease
UR - http://www.scopus.com/inward/record.url?scp=85028875179&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85028875179&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2017.03.016
DO - 10.1016/j.cgh.2017.03.016
M3 - Article
C2 - 28342955
AN - SCOPUS:85028875179
SN - 1542-3565
VL - 15
SP - 1173
EP - 1183
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 8
ER -