Long-term budesonide maintenance treatment is partially effective for patients with eosinophilic esophagitis.

Abstract

BACKGROUND & AIMS:

Topical corticosteroids are effective in inducing clinical and histologic remission in patients with eosinophilic esophagitis (EoE). However, the best long-term management strategy for this chronic inflammatory disease has not been determined.

METHODS:

In a randomized, double-blind, placebo-controlled, 50-week trial, we evaluated in 28 patients the efficacy of twice-daily swallowed budesonide (0.25 mg each) to maintain quiescent EoE in remission. Pretreatment and posttreatment activity was assessed clinically, endoscopically, histologically, immunohistologically, and by endosonography. The primary end point was the therapy's ability to maintain EoE in histologic remission. Secondary end points were efficacy in symptom control, prevention of tissue remodeling, and safety.

RESULTS:

In patients given low-dose budesonide, the load of esophageal eosinophils increased from 0.4 to 31.8 eosinophils/high-power field (P = .017). In patients given placebo, the load increased from 0.7 to 65.0 eosinophils/high-power field (P = .0001); this increase was significantly greater than in patients given budesonide (P = .024). The symptom scores developed in a similar manner in the 2 groups. Budesonide, but not placebo, reduced noneosinophilic markers of inflammation, epithelial cell apoptosis, and remodeling events. Compared with control individuals, patients had significantly thickened esophageal walls, based on endosonography (3.05 vs 2.18 mm; P < .0001). Budesonide therapy was associated with a significant reduction in mucosal thickness (0.75-0.45 mm; P = .025), but epithelial thickness remained stable (261.22 vs 277.23 μm; P = .576). No serious adverse events occurred.

CONCLUSIONS:

Low-dose budesonide is more effective than placebo in maintaining EoE in histologic and clinical remission. Signs of esophageal remodeling showed a trend toward normalization. Long-term administration of topical corticosteroids was well tolerated without induction of epithelial atrophy.

• Authors: Alex Straumann, Sebastien Conus, Lukas Degen, Cornelia Frei, Christian Bussmann, Christoph Beglinger, Alain Schoepfer, Hans-Uwe Simon
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 9 Issue 5 Pg. 400-9.e1 (May 2011) ISSN: 1542-7714 [Electronic] United States
• PMID: 21277394 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Anti-Inflammatory Agents
• Placebos
• Budesonide

Topics

• Administration, Oral
• Adult
• Anti-Inflammatory Agents (administration & dosage)
• Budesonide (administration & dosage)
• Chronic Disease
• Double-Blind Method
• Eosinophilic Esophagitis (drug therapy, pathology)
• Esophagus (pathology)
• Female
• Histocytochemistry
• Humans
• Immunohistochemistry
• Male
• Middle Aged
• Placebos (administration & dosage)
• Secondary Prevention
• Treatment Outcome