Improvements in Dysphagia and Pain With Swallowing in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension

Evan S. Dellon; Margaret H. Collins; David A. Katzka; Stacie Hudgens; Lan Lan; James Williams; Montserrat Vera-Llonch; Ikuo Hirano

doi:10.1016/j.cgh.2020.03.060

Improvements in Dysphagia and Pain With Swallowing in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension

Evan S. Dellon^*, Margaret H. Collins, David A. Katzka, Stacie Hudgens, Lan Lan, James Williams, Montserrat Vera-Llonch, Ikuo Hirano

^*Corresponding author for this work

Medicine, Gastroenterology Division

Research output: Contribution to journal › Article › peer-review

18 Scopus citations

Abstract

Background & Aims: Quantification of eosinophilic esophagitis (EoE) symptoms is crucial for assessing treatment outcomes. We aimed to explore the effect of budesonide oral suspension (BOS) on dysphagia and pain with swallowing. Methods: We performed a secondary analysis of data from a phase 2 multicenter, double-blind, trial (conducted from July 2012 through October 2014) of patients with EoE, 11–40 y old, who were randomly assigned to groups given placebo or BOS (2.0 mg twice daily) for 12 weeks. Symptoms were quantified using the Dysphagia Symptom Questionnaire (DSQ) from baseline to week 12 of therapy. Results: Overall, 93 patients were randomly assigned to groups; the prespecified modified intention-to-treat analysis set comprised 87 patients (38 from the placebo group and 49 from the BOS group). Improvements from baseline in least-squares mean (standard error) DSQ (Q2+Q3) scores were observed. The difference between groups was statistically significant only at week 12 (placebo vs BOS: week 4, −4.9 [1.7] vs −7.4 [1.5]; P = .265; week 8, −7.4 [2.1] vs −10.3 [1.8]; P = .288; week 12, −7.5 [1.9] vs −14.3 [1.7]; P = .01). Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, −2.5 [0.8] vs −3.3 [0.7]; P = .484; week 8, −3.0 [0.8] vs −4.9 [0.7]; P = .066; week 12, −3.1 [0.8] vs −4.9 [0.7]; P = .109). More severe DSQ and DSQ+pain scores were associated with presence of other symptoms (such as regurgitation) and physician-rated severity. Improvements in DSQ and DSQ+pain scores were greater in patients with either a histologic or endoscopic response than in patients without a response. Conclusions: In a secondary analysis of data from a phase 2 trial of patients with EoE, we found evidence for improvements in dysphagia and pain scores in patients who received BOS (2.0 mg twice daily) vs placebo. Pain with swallowing should be considered in the clinical assessment of patients with EoE. ClinicalTrials.gov no: NCT01642212.

Original language	English (US)
Pages (from-to)	699-706.e4
Journal	Clinical Gastroenterology and Hepatology
Volume	19
Issue number	4
DOIs	https://doi.org/10.1016/j.cgh.2020.03.060
State	Published - Apr 2021

Funding

Conflicts of interest Evan S. Dellon has received research funding from Adare Pharmaceuticals, Allakos, GlaxoSmithKline, Meritage Pharma, Inc, Miraca Life Sciences, Nutricia, Receptos/Celgene, Regeneron, and Shire, a Takeda company; is a consultant for Adare Pharmaceuticals, Aimmune Therapeutics, Alivio Therapeutics, Allakos, AstraZeneca, Banner Life Sciences, Biorasi, Calypso, Enumeral, EsoCap, GlaxoSmithKline, Gossamer Bio, Receptos/Celgene, Regeneron, Robarts Clinical Trials, Salix Pharmaceuticals, and Shire, a Takeda company; has received educational grants from Allakos, Banner Life Sciences, and Holoclara; and is an associate editor of Clinical Gastroenterology and Hepatology. Margaret H. Collins has received research funding from Meritage Pharma, Inc, Receptos/Celgene, Regeneron, and Shire, a Takeda company; and is a consultant for Allakos, AstraZeneca, Esocap, GlaxoSmithKline, Receptos/Celgene, Regeneron, and Shire, a Takeda company. David A. Katzka has received research funding from Shire, a Takeda company. Stacie Hudgens was funded by Endpoint Outcomes to conduct analyses relating to the psychometric validation of the DSQ and is an employee of Clinical Outcome Solutions. Lan Lan and James Williams are employees of Shire, a Takeda company, and stockholders of Takeda. Montserrat Vera-Llonch was an employee of Shire, a member of the Takeda group of companies, at the time this research was carried out. Ikuo Hirano has received research funding from Adare Pharmaceuticals, Allakos, Meritage Pharma, Inc, Receptos/Celgene, Regeneron, and Shire, a Takeda company; and is a consultant for Meritage Pharma, Inc, Receptos/Celgene, Regeneron, and Shire, a Takeda company. The authors thank all the MPI 101-06 investigators (listed in the Supplementary Materials ) and participants for their contribution to this study. Medical writing support was provided by Luci Witcomb, PhD, of PharmaGenesis London, funded by Shire International GmbH, a member of the Takeda group of companies.

Keywords

Clinical Trial
Esophageal Eosinophilia
Esophagus
Odynophagia

ASJC Scopus subject areas

Gastroenterology
Hepatology

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10.1016/j.cgh.2020.03.060

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@article{1644e71f1d5c47638a63b49491dc0382,

title = "Improvements in Dysphagia and Pain With Swallowing in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension",

abstract = "Background & Aims: Quantification of eosinophilic esophagitis (EoE) symptoms is crucial for assessing treatment outcomes. We aimed to explore the effect of budesonide oral suspension (BOS) on dysphagia and pain with swallowing. Methods: We performed a secondary analysis of data from a phase 2 multicenter, double-blind, trial (conducted from July 2012 through October 2014) of patients with EoE, 11–40 y old, who were randomly assigned to groups given placebo or BOS (2.0 mg twice daily) for 12 weeks. Symptoms were quantified using the Dysphagia Symptom Questionnaire (DSQ) from baseline to week 12 of therapy. Results: Overall, 93 patients were randomly assigned to groups; the prespecified modified intention-to-treat analysis set comprised 87 patients (38 from the placebo group and 49 from the BOS group). Improvements from baseline in least-squares mean (standard error) DSQ (Q2+Q3) scores were observed. The difference between groups was statistically significant only at week 12 (placebo vs BOS: week 4, −4.9 [1.7] vs −7.4 [1.5]; P = .265; week 8, −7.4 [2.1] vs −10.3 [1.8]; P = .288; week 12, −7.5 [1.9] vs −14.3 [1.7]; P = .01). Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, −2.5 [0.8] vs −3.3 [0.7]; P = .484; week 8, −3.0 [0.8] vs −4.9 [0.7]; P = .066; week 12, −3.1 [0.8] vs −4.9 [0.7]; P = .109). More severe DSQ and DSQ+pain scores were associated with presence of other symptoms (such as regurgitation) and physician-rated severity. Improvements in DSQ and DSQ+pain scores were greater in patients with either a histologic or endoscopic response than in patients without a response. Conclusions: In a secondary analysis of data from a phase 2 trial of patients with EoE, we found evidence for improvements in dysphagia and pain scores in patients who received BOS (2.0 mg twice daily) vs placebo. Pain with swallowing should be considered in the clinical assessment of patients with EoE. ClinicalTrials.gov no: NCT01642212.",

keywords = "Clinical Trial, Esophageal Eosinophilia, Esophagus, Odynophagia",

author = "Dellon, {Evan S.} and Collins, {Margaret H.} and Katzka, {David A.} and Stacie Hudgens and Lan Lan and James Williams and Montserrat Vera-Llonch and Ikuo Hirano",

note = "Publisher Copyright: {\textcopyright} 2021 The Authors",

year = "2021",

month = apr,

doi = "10.1016/j.cgh.2020.03.060",

language = "English (US)",

volume = "19",

pages = "699--706.e4",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

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T1 - Improvements in Dysphagia and Pain With Swallowing in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension

AU - Dellon, Evan S.

AU - Collins, Margaret H.

AU - Katzka, David A.

AU - Hudgens, Stacie

AU - Lan, Lan

AU - Williams, James

AU - Vera-Llonch, Montserrat

AU - Hirano, Ikuo

PY - 2021/4

Y1 - 2021/4

N2 - Background & Aims: Quantification of eosinophilic esophagitis (EoE) symptoms is crucial for assessing treatment outcomes. We aimed to explore the effect of budesonide oral suspension (BOS) on dysphagia and pain with swallowing. Methods: We performed a secondary analysis of data from a phase 2 multicenter, double-blind, trial (conducted from July 2012 through October 2014) of patients with EoE, 11–40 y old, who were randomly assigned to groups given placebo or BOS (2.0 mg twice daily) for 12 weeks. Symptoms were quantified using the Dysphagia Symptom Questionnaire (DSQ) from baseline to week 12 of therapy. Results: Overall, 93 patients were randomly assigned to groups; the prespecified modified intention-to-treat analysis set comprised 87 patients (38 from the placebo group and 49 from the BOS group). Improvements from baseline in least-squares mean (standard error) DSQ (Q2+Q3) scores were observed. The difference between groups was statistically significant only at week 12 (placebo vs BOS: week 4, −4.9 [1.7] vs −7.4 [1.5]; P = .265; week 8, −7.4 [2.1] vs −10.3 [1.8]; P = .288; week 12, −7.5 [1.9] vs −14.3 [1.7]; P = .01). Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, −2.5 [0.8] vs −3.3 [0.7]; P = .484; week 8, −3.0 [0.8] vs −4.9 [0.7]; P = .066; week 12, −3.1 [0.8] vs −4.9 [0.7]; P = .109). More severe DSQ and DSQ+pain scores were associated with presence of other symptoms (such as regurgitation) and physician-rated severity. Improvements in DSQ and DSQ+pain scores were greater in patients with either a histologic or endoscopic response than in patients without a response. Conclusions: In a secondary analysis of data from a phase 2 trial of patients with EoE, we found evidence for improvements in dysphagia and pain scores in patients who received BOS (2.0 mg twice daily) vs placebo. Pain with swallowing should be considered in the clinical assessment of patients with EoE. ClinicalTrials.gov no: NCT01642212.

AB - Background & Aims: Quantification of eosinophilic esophagitis (EoE) symptoms is crucial for assessing treatment outcomes. We aimed to explore the effect of budesonide oral suspension (BOS) on dysphagia and pain with swallowing. Methods: We performed a secondary analysis of data from a phase 2 multicenter, double-blind, trial (conducted from July 2012 through October 2014) of patients with EoE, 11–40 y old, who were randomly assigned to groups given placebo or BOS (2.0 mg twice daily) for 12 weeks. Symptoms were quantified using the Dysphagia Symptom Questionnaire (DSQ) from baseline to week 12 of therapy. Results: Overall, 93 patients were randomly assigned to groups; the prespecified modified intention-to-treat analysis set comprised 87 patients (38 from the placebo group and 49 from the BOS group). Improvements from baseline in least-squares mean (standard error) DSQ (Q2+Q3) scores were observed. The difference between groups was statistically significant only at week 12 (placebo vs BOS: week 4, −4.9 [1.7] vs −7.4 [1.5]; P = .265; week 8, −7.4 [2.1] vs −10.3 [1.8]; P = .288; week 12, −7.5 [1.9] vs −14.3 [1.7]; P = .01). Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, −2.5 [0.8] vs −3.3 [0.7]; P = .484; week 8, −3.0 [0.8] vs −4.9 [0.7]; P = .066; week 12, −3.1 [0.8] vs −4.9 [0.7]; P = .109). More severe DSQ and DSQ+pain scores were associated with presence of other symptoms (such as regurgitation) and physician-rated severity. Improvements in DSQ and DSQ+pain scores were greater in patients with either a histologic or endoscopic response than in patients without a response. Conclusions: In a secondary analysis of data from a phase 2 trial of patients with EoE, we found evidence for improvements in dysphagia and pain scores in patients who received BOS (2.0 mg twice daily) vs placebo. Pain with swallowing should be considered in the clinical assessment of patients with EoE. ClinicalTrials.gov no: NCT01642212.

KW - Clinical Trial

KW - Esophageal Eosinophilia

KW - Esophagus

KW - Odynophagia

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Improvements in Dysphagia and Pain With Swallowing in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension

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