Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis.

Autor: Lucendo AJ; Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain.; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.; Instituto de Investigación Sanitaria de Castilla-La Mancha (IDISCAM), Toledo, Spain.; Instituto de Investigación Sanitaria Princesa, Madrid, Spain., Nantes-Castillejo Ó; Department of Gastroenterology, Complejo Hospitalario de Navarra, Pamplona, Spain.; IdiSNA. Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain., Straumann A; Department of Gastroenterology & Hepatology, Universitäty Hospital Zurich, Zurich, Switzerland., Biedermann L; Department of Gastroenterology & Hepatology, Universitäty Hospital Zurich, Zurich, Switzerland., Bredenoord AJ; Department of Gastroenterology, Amsterdam University Medical Center, Amsterdam, The Netherlands., Guagnozzi D; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.; Department of Gastroenterology, Hospital Universitario Vall d'Hebrón, Barcelona, Spain., Blas-Jhon L; Department of Gastroenterology, Fundación Jiménez Díaz, Madrid, Spain., Wiechowska-Kozlowska A; Endoscopy Unit, Sonomed Medical Centre, Szczecin, Poland., Weidlich S; Department of Internal Medicine II, School of Medicine and Health, University Hospital Rechts der Isar, Technical University of Munich, Munich, Germany., von Arnim U; Department of Gastroenterology, Hepatology and Infectious Diseases, Universitätsklinikum Magdeburg AöR, Magdeburg, Germany., Santander-Vaquero C; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.; Instituto de Investigación Sanitaria Princesa, Madrid, Spain.; Department of Gastroenterology, Hospital Universitario de La Princesa, Madrid, Spain., Perelló A; Department of Gastroenterology, Hospital de Viladecans, Viladecans, Spain., Pérez-Martínez I; Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain.; Diet, Microbiota and Health Group, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain., Barrio J; Department of Gastroenterology, Hospital Universitario Río Hortega. Gerencia Regional de Salud de Castilla y León (SACYL), Valladolid, Spain., Vieth M; Institut für Pathologie, Friedrich-Alexander-Universität Erlangen-Nürnberg, Klinikum Bayreuth, Bayreuth, Germany., Gouya G; Gouya Insights, Vienna, Austria., Dellon ES; Department of Medicine, Division of Gastroenterology and Hepatology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Jazyk: angličtina
Zdroj: Alimentary pharmacology & therapeutics [Aliment Pharmacol Ther] 2024 Dec 16. Date of Electronic Publication: 2024 Dec 16.
DOI: 10.1111/apt.18443
Abstrakt: Background: EsoCap is a thin mucoadhesive film designed to target the oesophageal mucosa. The device loaded with mometasone furoate (ESO-101) is under investigation for the treatment of eosinophilic oesophagitis (EoE).
Aims: To evaluate the efficacy, safety and tolerability of ESO-101 in patients with active EoE.
Methods: We conducted a randomised, placebo-controlled, phase 2, proof-of-concept trial at 14 European sites in adults with EoE. Participants received placebo, uncoated EsoCap (n = 15), or EsoCap loaded with 800 μg of mometasone furoate (n = 28) once daily during 28 days. The primary outcome was the absolute change in the peak eosinophil count; secondary outcomes were histologic, clinical and endoscopic measures.
Results: Treatment with ESO-101 resulted in reduction (mean ± SD) of 49.1 ± 88.4 eosinophils/high-power field from baseline, compared with 6.6 ± 65.1 with placebo (p = 0.03). With ESO-101, 48% and 44% of patients achieved < 15 and < 6 eosinophils/high-power field, respectively; these were 0% with placebo. EoE Endoscopic Reference Score reduced significantly in patients treated with ESO-101. In contrast, dysphagia and odynophagia severity decreased similarly in both groups. There were no serious treatment-emergent adverse events. Mean serum cortisol did not change significantly throughout the trial. Notably, no oropharyngeal or oesophageal candidiasis was documented. The device was well tolerated.
Conclusions: ESO-101 was superior to placebo in reducing oesophageal eosinophilia. The device was safe and well tolerated in adults with EoE, supporting the continued development of ESO-101 for the treatment of EoE (Trials.gov No.: NCT04849390; Eu-CT No.: 2020-000082-16).
(© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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