Oral Viscous Budesonide Is Effective in Children With Eosinophilic Esophagitis in a Randomized, Placebo-Controlled Trial
Background & Aims
Eosinophilic esophagitis (EoE) is caused by immunologic reactions to ingested/inhaled allergens. The diagnosis is considered if ≥15 eosinophils per high-powered field (eos/hpf) are detected in mucosal biopsies. Placebo-controlled studies have not been conducted to evaluate the safety and efficacy of oral viscous budesonide (OVB).
Methods
Children with EoE were randomly assigned to groups that were given OVB (n = 15) or placebo (n = 9). Patients <5 feet and ≥5 feet tall received 1 mg and 2 mg OVB daily, respectively. All patients received lansoprazole. Duration of treatment was 3 months, followed by repeat endoscopy and biopsies. Patients were classified as responders if their peak eosinophil counts were ≤6 eos/hpf, partial responders were 7–19 eos/hpf, and nonresponders were ≥20 eos/hpf. Baseline and post-treatment symptoms and endoscopic and histologic features were scored.
Results
Thirteen (86.7%) children given OVB (P < .0001) and none who received placebo (P = .3) were classified as responders. Mean pre-/post-treatment peak eosinophil counts were 66.7 and 4.8 eos/hpf, respectively, in the group given OVB (P < .0001); they were 83.9 and 65.6 eos/hpf, respectively, in the group given placebo (P = .3). In the group given OVB, there were significant reductions from baseline values in proximal (P = .002), mid (P = .0003), and distal (P = .001) esophageal eosinophilia. After OVB therapy, compared with baseline, the mean symptom (P = .0007), endoscopy (P = .0005), and histology scores improved (P = .0035) significantly.
Conclusions
OVB is an effective treatment of pan-esophageal disease in children with EoE. OVB improves symptoms and endoscopic and histologic features. Proton pump inhibitor single therapy did not significantly improve esophageal eosinophilia or symptoms of EoE.
Keywords: Topical Corticosteroids, Lansoprazole, Lamina Propria Fibrosis, Scoring Tools
Abbreviations used in this paper: ANCOVA, analysis of covariance, EHS, epithelial histology score, EoE, eosinophilic esophagitis, GERD, gastroesophageal reflux disease, hpf, high-powered field, LP, lamina propria, LPHS, lamina propria histology score, OVB, oral viscous budesonide, PPI, proton pump inhibitor, SST, symptom scoring tool, TGFβ1, transforming growth factor–β1
This article has an accompanying continuing medical education activity on page e17. Learning Objective: Upon completion of this activity, successful participants will be able to demonstrate an increase in their level of knowledge of the histologic and clinical features of eosinophilic esophagitis and will be able to determine which patients with EoE are more likely to respond to topical steroid therapy.
Conflicts of interest The authors disclose the following: The University of California, San Diego has a financial interest in Meritage Pharma, the company sponsoring this research. Drs Dohil, Bastian, and Aceves and the University of California may financially benefit from this interest if the company is successful in developing and marketing its own product that is related to this research. The terms of this arrangement have been reviewed and approved by the University of California, San Diego in accordance with its conflict of interest policies. The remaining authors disclose no conflicts.
Funding Support was provided by a grant from Meritage Pharma, San Diego, CA.
PII: S0016-5085(10)00669-4
doi:10.1053/j.gastro.2010.05.001
© 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
