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

2019; Elsevier BV; Volume: 157; Issue: 1 Linguagem: Inglês

10.1053/j.gastro.2019.03.025

1528-0012

Alfredo J. Lucendo, Stephan Miehlke, Christoph Schlag, Michael Vieth, Ulrike von Arnim, Javier Molina‐Infante, Dirk Hartmann, Albert J. Bredenoord, Constanza Ciriza de los Ríos, Stefan Schubert, Stefan Brückner, Ahmed Madisch, Jamal Hayat, Jan Tack, Stephen Attwood, Ralph Müeller, Roland Greinwald, Alain Schoepfer, Alex Straumann, Jan Tack, Tim Vanuytsel, Hubert Louis, Carmen Musala, Stephan Miehlke, Dorothea Frederking, Monther Bajbouj, Christoph Schlag, Simon Nennstiel, Stefan Brückner, Renate Schmelz, Schmelz Heimerl, Anna-Magdalena Stephan, Christiane Fibbe, Niels Liedtke, Jutta Keller, Ulrich Rosien, Sebastian Haag, A Schneider, Dirk Hartmann, Christoph Schmöcker, Hendrik Buchholz, Frank Lammert, Markus Casper, Matthias Reichert, Ahmed Madisch, D. Sommer, Hubert Mönnikes, Miriam Stengel, M. Schmidtmann, Michaela Müller, Alexander J. Eckardt, Till Wehrmann, Stefan Schubert, Peter Armerding, Wolf Peter Hofmann, Thomas Liceni, Ulrike von Arnim, Arne Kandulski, Jochen Weigt, Norbert Börner, A. Lutz-Vorderbrügge, Jörg Albert, Stefan Zeuzem, Irina Blumenstein, Kathrin Sprinzl, Johannes Hausmann, Arjan Bredenoord, Arjan Bredenoord, Marijn J. Warners, Alfredo Lucendo Villarin, Ángel Arias, Maria Ángeles Tejero Bustos, María Jesús Carrillo Ramos, J.M. Gallardo, Rocío Juárez Tosina, Javier Molina‐Infante, José Luis Zamorano, Cecílio Santander, Sergio Casabona, Maria T. Perez, Teresa Rodríguez, Constanza Ciriza de los Ríos, Fernando Canga Rodríguez‐Valcárcel, Isabel Castel de Lucas, Antonia Perelló Juan, Mercè Barenys, Carlos Casasnovas, Isabel Pérez‐Martínez, M. Eugenia Lauret, Andrés Castaño García, Esmeralda Rubio, Alex Straumann, Petr Hrúz, Simon Brunner, Jamal Hayat, Andrew Poullis,

Eosinophilic Disorders and Syndromes

Background & AimsSwallowed 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.MethodsWe 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).ResultsAt 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.ConclusionsIn 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. 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. 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). 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. 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.