Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial
Standard
Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial. / Lucendo, Alfredo J; Miehlke, Stephan; Schlag, Christoph; Vieth, Michael; von Arnim, Ulrike; Molina-Infante, Javier; Hartmann, Dirk; Bredenoord, Albert Jan; Ciriza de Los Rios, Constanza; Schubert, Stefan; Brückner, Stefan; Madisch, Ahmed; Hayat, Jamal; Tack, Jan; Attwood, Stephen; Mueller, Ralph; Greinwald, Roland; Schoepfer, Alain; Straumann, Alex; International EOS-1 Study Group.
In: GASTROENTEROLOGY, Vol. 157, No. 1, 07.2019, p. 74-86.e15.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial
AU - Lucendo, Alfredo J
AU - Miehlke, Stephan
AU - Schlag, Christoph
AU - Vieth, Michael
AU - von Arnim, Ulrike
AU - Molina-Infante, Javier
AU - Hartmann, Dirk
AU - Bredenoord, Albert Jan
AU - Ciriza de Los Rios, Constanza
AU - Schubert, Stefan
AU - Brückner, Stefan
AU - Madisch, Ahmed
AU - Hayat, Jamal
AU - Tack, Jan
AU - Attwood, Stephen
AU - Mueller, Ralph
AU - Greinwald, Roland
AU - Schoepfer, Alain
AU - Straumann, Alex
AU - International EOS-1 Study Group
N1 - Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.
PY - 2019/7
Y1 - 2019/7
N2 - BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE.METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-blind phase were offered 6 weeks of open-label treatment with BOT (1 mg twice daily).RESULTS: At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary end point of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent.CONCLUSIONS: In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99; ClinicalTrials.gov ID NCT02434029.
AB - BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE.METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-blind phase were offered 6 weeks of open-label treatment with BOT (1 mg twice daily).RESULTS: At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary end point of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent.CONCLUSIONS: In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99; ClinicalTrials.gov ID NCT02434029.
KW - Administration, Oral
KW - Adult
KW - Antifungal Agents/therapeutic use
KW - Budesonide/administration & dosage
KW - Candidiasis, Oral/chemically induced
KW - Double-Blind Method
KW - Eosinophilic Esophagitis/drug therapy
KW - Esophagoscopy
KW - Female
KW - Glucocorticoids/administration & dosage
KW - Humans
KW - Male
KW - Middle Aged
KW - Tablets
KW - Treatment Outcome
U2 - 10.1053/j.gastro.2019.03.025
DO - 10.1053/j.gastro.2019.03.025
M3 - SCORING: Journal article
C2 - 30922997
VL - 157
SP - 74-86.e15
JO - GASTROENTEROLOGY
JF - GASTROENTEROLOGY
SN - 0016-5085
IS - 1
ER -
