TY - JOUR
T1 - Clinical Features at Baseline Cannot Predict Symptom Response to Placebo in Patients With Eosinophilic Esophagitis
AU - Hirano, Ikuo
AU - Dellon, Evan S.
AU - Collins, Margaret H.
AU - Williams, James
AU - Lan, Lan
AU - Katzka, David A.
N1 - Funding Information:
Conflicts of interest Ikuo Hirano has received research funding from Adare Pharmaceuticals, Meritage Pharma Inc, Receptos/Celgene, Regeneron, and Shire and is a consultant for Adare Pharmaceuticals, Allakos, Meritage Pharma Inc, Receptos/Celgene, Regeneron, and Shire. Evan S. Dellon has received research funding from Adare Pharmaceuticals, Meritage Pharma Inc, Miraca Life Sciences, Nutricia, Receptos/Celgene, Regeneron, and Shire and is a consultant for Adare Pharmaceuticals, Alivio Therapeutics, Allakos, Banner Life Sciences, Calypso Biotech, Enumeral, EsoCap Biotech, GlaxoSmithKline, Receptos/Celgene, Regeneron, Robarts Clinical Trials, and Shire and has received educational grants from Banner Life Sciences and Holoclara, Inc. Margaret H. Collins has received research funding from Meritage Pharma Inc, Receptos, Regeneron, and Shire and is a consultant for Allakos, Receptos, Regeneron, and Shire. James Williams and Lan Lan are employees and stockholders of Shire. David A. Katzka has received research funding from Meritage Pharma Inc.This study was sponsored by Meritage Pharma Inc, now part of the Shire group of companies, who contributed to the design and conduct of the study and collection and management of the data. Shire provided funding for the analyses and medical writing support and reviewed the manuscript for medical accuracy. The authors thank all MPI 101-06 investigators and participants for their contribution to this study and thank Sharif Uddin of Shire for the statistical analyses reported here. They also thank Lucy Carty, PhD and Luci Witcomb, PhD of PharmaGenesis London, London, UK, for providing medical writing support funded by Shire Development GmbH.
Funding Information:
This study was sponsored by Meritage Pharma Inc, now part of the Shire group of companies, who contributed to the design and conduct of the study and collection and management of the data. Shire provided funding for the analyses and medical writing support and reviewed the manuscript for medical accuracy. The authors thank all MPI 101-06 investigators and participants for their contribution to this study and thank Sharif Uddin of Shire for the statistical analyses reported here. They also thank Lucy Carty, PhD and Luci Witcomb, PhD of PharmaGenesis London, London, UK , for providing medical writing support funded by Shire Development GmbH.
Publisher Copyright:
© 2019 AGA Institute
PY - 2019/9
Y1 - 2019/9
N2 - Eosinophilic esophagitis (EoE) is a chronic, immune-mediated disease characterized by ≥15 eosinophils per high-power field (eos/hpf) and esophageal dysfunction.1 One confounder in the assessment of drug efficacy in clinical trials for EoE2 and other gastrointestinal diseases3,4 has been the symptomatic response to placebo. In placebo-controlled, randomized trials of EoE therapies, placebo response rates as high as 78% have been reported.2 To mitigate placebo effect, a phase 2, randomized, double-blind, placebo-controlled trial of budesonide oral suspension (BOS) was designed with a single-blind, placebo run-in to attempt to screen out placebo responders before randomization.5 The aim of this post hoc analysis was to identify clinical factors associated with a symptom response during the placebo run-in.
AB - Eosinophilic esophagitis (EoE) is a chronic, immune-mediated disease characterized by ≥15 eosinophils per high-power field (eos/hpf) and esophageal dysfunction.1 One confounder in the assessment of drug efficacy in clinical trials for EoE2 and other gastrointestinal diseases3,4 has been the symptomatic response to placebo. In placebo-controlled, randomized trials of EoE therapies, placebo response rates as high as 78% have been reported.2 To mitigate placebo effect, a phase 2, randomized, double-blind, placebo-controlled trial of budesonide oral suspension (BOS) was designed with a single-blind, placebo run-in to attempt to screen out placebo responders before randomization.5 The aim of this post hoc analysis was to identify clinical factors associated with a symptom response during the placebo run-in.
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U2 - 10.1016/j.cgh.2018.11.045
DO - 10.1016/j.cgh.2018.11.045
M3 - Short survey
C2 - 30502508
AN - SCOPUS:85070863105
SN - 1542-3565
VL - 17
SP - 2126-2128.e1
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 10
ER -