Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial

Lucendo AJ, Miehlke S, Schlag C, Vieth M, von Arnim U, Molina-Infante J, Hartmann D, Bredenoord AJ, Ciriza de los Rios C, Schubert S, Brückner S, Madisch A, Hayat J, Tack J, Attwood S, Mueller R, Greinwald R, Schoepfer A, Straumann A, Vanuytsel T, Louis H, Musala C, Frederking D, Bajbouj M, Nennstiel S, Schmelz R, Heimerl S, Stephan AM, Fibbe C, Liedtke (née Laschinsky) N, Keller J, Rosien U, Haag S, Schneider A, Schmöcker C, Buchholz H, Lammert F, Casper M, Reichert M, Sommer D, Mönnikes H, Stengel M, Schmidtmann M, Müller M, Eckardt A, Wehrmann T, Armerding P, Hofmann WP, Liceni T, Kandulski A, Weigt J, Börner N, Lutz-Vorderbrügge A, Albert J, Zeuzem S, Blumenstein I, Sprinzl K, Hausmann J, Bredenoord A, Warners M, Villarin AL, Arias ÁA, Tejero Bustos MÁ, Carrillo Ramos MJ, Olalla Gallardo JM, Tosina RJ, Zamorano J, Vaquero CS, Francés SC, Pérez T, Rodriguez T, Ciriza de los Ríos C, Rodríguez-Valcárcel FC, Castel de Lucas I, Juan AP, Barenys M, Pons C, Martinez IP, Lauret ME, García AC, Rubio E, Hruz P, Brunner S, Poullis A (2019)

Publication Type: Journal article

Publication year: 2019

Journal

Book Volume: 157

Pages Range: 74-86.e15

Journal Issue: 1

DOI: 10.1053/j.gastro.2019.03.025

Abstract

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.

Involved external institutions

Amsterdam University Medical Centers (Amsterdam UMC) / Amsterdam Universitair Medische Centra Netherlands (NL) Otto-von-Guericke-Universität Magdeburg Germany (DE) Centro de Investigación Biomédica en Red - Enfermedades Hepáticas y Digestivas (CIBERHD) Spain (ES) Hospital Universitario 12 de Octubre Spain (ES) Public General Hospital Tomelloso / Hospital General de Tomelloso Spain (ES) Universitätsklinikum Carl Gustav Carus Dresden Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) Germany (DE) KRH Hospital Siloah / KRH Klinikum Siloah Germany (DE) Klinikum rechts der Isar Germany (DE) Klinikum Bayreuth Germany (DE) St George’s University Hospitals NHS Foundation Trust United Kingdom (GB) Sana Kliniken AG Germany (DE) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven Belgium (BE) Durham University United Kingdom (GB) Lausanne University Hospital / Centre hospitalier universitaire vaudois (CHUV) Switzerland (CH)

How to cite

APA:

Lucendo, A.J., Miehlke, S., Schlag, C., Vieth, M., von Arnim, U., Molina-Infante, J.,... Poullis, A. (2019). Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial. Gastroenterology, 157(1), 74-86.e15. https://doi.org/10.1053/j.gastro.2019.03.025

MLA:

Lucendo, Alfredo J., et al. "Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial." Gastroenterology 157.1 (2019): 74-86.e15.

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