Gastroenterology
Volume 139, Issue 2 , Pages 418-429.e1 , August 2010

Oral Viscous Budesonide Is Effective in Children With Eosinophilic Esophagitis in a Randomized, Placebo-Controlled Trial

Received 28 December 2009 ,Accepted 5 May 2010.

  • Image Result

    Individual pre- and post-treatment peak eosinophil (Eos) counts following 3 months' treatment with OVB and PPI (n = 15) and placebo plus PPI (n = 9). HPF, high-powered field; Tx, treatment.

    Individual pre- and post-treatment peak eosinophil (Eos) counts following 3 months' treatment with OVB and PPI (n = 15) and placebo plus PPI (n = 9). HPF, high-powered field; Tx, treatment.

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    Mean symptom scores during months 1, 2, and 3 of the study for patients in the OVB and placebo groups. Comparing changes from baseline, the mean symptom score improved significantly in the OVB group d

    Mean symptom scores during months 1, 2, and 3 of the study for patients in the OVB and placebo groups. Comparing changes from baseline, the mean symptom score improved significantly in the OVB group during months 1, 2, and 3, but not in the placebo group.

  • Image Result
    (A) Pretreatment distal esophageal mucosal biopsy. Above left, showing several intraepithelial eosinophils, basal zone hyperplasia, and intercellular edema (H&E ×200). Above right, lamina propria with;

    (A) Pretreatment distal esophageal mucosal biopsy. Above left, showing several intraepithelial eosinophils, basal zone hyperplasia, and intercellular edema (H&E ×200). Above right, lamina propria with fibrosis and eosinophilic inflammation (H&E ×400). (B) Post-treatment with OVB, distal esophageal biopsy from the same patient. Above left, unremarkable epithelium (H&E ×100). Above right shows lamina propria with no evidence of fibrosis or eosinophilic inflammation (H&E ×400). (C) Esophageal mucosal biopsies (×400 light microscopy) stained for profibrotic mediators showing LP in a responder patient. Upper images show transforming growth factor–β1 (TGFβ1)-positive (brown) cells and lower images show phosphorylated Smad2/3-positive (red) cells pre- and post-treatment with OVB.

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    Flow diagram showing study patients.

    Flow diagram showing study patients.

 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

Gastroenterology
Volume 139, Issue 2 , Pages 418-429.e1 , August 2010

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