Orodispersible budesonide tablets for the treatment of eosinophilic esophagitis: a review of the latest evidence

Abstract

Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder of the esophagus characterized by symptoms of esophageal dysfunction and eosinophil-predominant inflammation. The incidence of EoE has increased substantially over the past two decades in Europe and North America. The natural course of EoE appears to be progressive with a high risk of stricture formation. The current European guideline recommend swallowed topical corticosteroids, proton-pump inhibitors or dietary intervention for initial and long-term treatment of EoE. Swallowed topical corticosteroids can be considered to be the best studied drug class in EoE, with more than 1000 patients enrolled in randomized clinical trials worldwide. In most of them, fluticasone or budesonide formulations have been used that were originally designed for asthma therapy, thus presumably suboptimal for EoE treatment. The new orodispersible budesonide tablet with effervescent properties is the first approved esophageal-targeted formulation specifically developed for the treatment of EoE, which has become available in many European countries. This article gives an overview of the evolution of topical corticosteroids in EoE and provides an update on recent data from large-scale multicenter trials exploring the efficacy and safety of the orodispersible budesonide tablet with effervescent properties in adult EoE patients.

Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension

“…21 Heterogeneity between study designs, response criteria, and results has led to challenges comparing efficacy end points and reproducing outcomes between maintenance studies. 22 Budesonide orodispersible tablet (BOT; 1.0 mg twice daily) has been evaluated vs placebo for maintaining remission in adults with EoE (48 weeks). 18 In the BOT trial, 75% of patients reported persistent remission vs 4% of placebo-treated patients.…”

A Study on the Correlation Between Endoscopic Findings and Symptoms of Gastro-Esophageal Reflux Disease

“…Another study was conducted on 159 morbidly obese patients on vertical gastroplasty before and after the endoscopy. About 31% of patients had visible EE on endoscopy 22 . Another study found 53 and 35 patients with gastritis and reflux respectively while carrying their study on a total of 104 gastro esophageal patients.…”

Therapie der eosinophilen Ösophagitis – Fortschritte und Perspektiven

“…Bei insgesamt sehr guter Verträglichkeit wurde in den Kontrollendoskopien bei weniger als 10 % der Patienten eine geringgradige lokale Candidiasis beobachtet, die lokal behandelt wurde und in keinem Fall zu einem Abbruch der lokalen Steroidtherapie führte [22,25]. Die konsistent hohe Wirksamkeit der orodispersiblen Budesonid-Tablette erklärt sich möglicherweise durch die ösophagus-spezifische Darreichungsform, bei der das im Speichel aufgelöste Budesonid schrittweise geschluckt in das Zielorgan gelangt, und aufgrund der mukoadhäsiven Eigenschaften des Speichels mutmaßlich eine verlängerte Exposition des Wirkstoffs auf der Ösophagusschleimhaut erreicht wird [29]. Schließlich wurde in zwei aktuellen Metaanalysen die hohe Effektivität der orodispersiblen Budesonid-Tablette in der Remissionsinduktion der EoE unterstrichen [18,30].…”