TY - JOUR
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
N1 - Publisher Copyright:
© 2021 The Authors
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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UR - http://www.scopus.com/inward/citedby.url?scp=85101228149&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2020.03.060
DO - 10.1016/j.cgh.2020.03.060
M3 - Article
C2 - 32272243
AN - SCOPUS:85101228149
SN - 1542-3565
VL - 19
SP - 699-706.e4
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 4
ER -