Budesonide effervescent tablets induce remission of eosinophilic esophagitis

Last Updated: 2015-04-09

By Will Boggs MD

NEW YORK (Reuters Health) - Budesonide effervescent tablets are at least as effective as budesonide viscous suspension for inducing remission in adults with eosinophilic esophagitis (EoE), according to results from a small randomized trial.

Topical budesonide has been shown in several trials to be effective for treating EoE in pediatric and adult patients, but no approved formulations exist of any topical corticosteroid for esophageal indications.

Dr. Stephan Miehlke, from the Center for Digestive Diseases Eppendorf, Hamburg, Germany, and colleagues from 21 centers in Germany, Switzerland, and Belgium compared the efficacy and safety of budesonide effervescent tablets (1 mg twice daily, BET1) or 2 mg twice daily (BET2) and budesonide viscous suspension (BVS; 2 mg daily) for short-term induction treatment of active EoE in a randomized trial of 76 adults.

They terminated the study after an interim analysis of 61 patients demonstrated significant benefits of all three budesonide formulations compared with placebo.

In the final analysis, nearly all patients in the budesonide groups achieved histological remission, compared with no histological remission among the 19 patients assigned to placebo.

Reductions in esophageal eosinophilic load were also significantly greater for the budesonide groups than for the placebo group.

Significantly more patients in the budesonide groups (73.7% of BET1, 57.9% of BET2, and 57.9% of BVS patients) than in the placebo group (26.3%) showed improvements in esophageal endoscopic abnormalities, according to the March 19 Gut online report.

Dysphagia scores decreased to a similar extent in the budesonide and placebo groups, but sustained improvement two weeks after the end of treatment occurred only among patients taking budesonide.

Four out of five patients preferred budesonide effervescent tablets, compared with only 17% who preferred budesonide viscous suspension.

"Interestingly, all patients in this trial who received budesonide effervescent tablet 1 mg twice daily achieved histological remission, and therefore no additional benefit could be shown for the higher dose of 2 mg twice daily," the researchers note.

"Based on the promising results of the present study, further prospective studies are warranted in order to define the optimal schedules for long-term treatment in pediatric and adult patients with EoE," they conclude.

Dr. Miehlke did not respond to a request for comments.

Dr. Falk Pharma GmbH sponsored the trial, employed three of the authors, and had various relationships with nine of the other 18 authors.

These data were presented in abstract form during Digestive Disease Week in Chicago, Illinois in November 2014. (here: http://bit.ly/1DMLfY1)

SOURCE: http://bmj.co/1aqhxKU

Gut 2015.