Short-Course Budesonide Clears Active Eosinophilic Esophagitis

November 30, 2010

By Megan Brooks

NEW YORK (Reuters Health) Nov 29 - In adolescents and adults with active eosinophilic esophagitis (EoE), a 15-day induction course of nebulized budesonide can induce histological remission and improve symptoms, according to a study published in the November Gastroenterology.

And while tissue remodeling is an important problem with EoE, "our study demonstrates that fibrosis can be reversed with topical corticosteroids," said co-author Dr. Alex Straumann from University Hospital Basel in Switzerland in e-mail to Reuters Health.

The prevalence of EoE is increasing; epidemiological data suggest it's now the second leading cause of chronic esophagitis, behind gastroesophageal reflux disease. EoE affects all age groups but most often individuals between 20 and 50 years old.

Standard drug therapy for EoE includes systemic or topical corticosteroids and leukotriene antagonists, but these recommendations are based on case reports and small case series. "So far no proper randomized controlled trials have been published," Dr. Straumann said.

The research team enrolled 36 patients older than 14 with clinically, endoscopically, and histologically confirmed active EoE. For 15 days, half were treated via nebulizer with 1 mg budesonide suspension formulation (Pulmicort Respules; AstraZeneca) twice daily and the other half were treated with nebulized saline placebo.

After 15 days of budesonide treatment, the average number of eosinophils in the esophageal epithelium (the primary endpoint) was significantly reduced by 91.9%, from 68.2 to 5.5 eosinophils per high power field (p < 0.001). In the placebo group, eosinophil load remained almost unchanged, going from 62.3 to 56.5 eosinophils per high power field (p = 0.48).

Thirteen of 18 patients (72.2%) in the budesonide group fulfilled criteria for complete histologic remission compared with 2 of 18 (11.1%) in the placebo group. Three patients in the budesonide group (16.7%) had histologic responses, compared with none in the placebo group.

At the outset, all patients were bothered to a similar degree by dysphagia when eating solid foods. Dysphagia symptoms improved rapidly and significantly (p < 0.0001) in 13 of 18 patients in the budesonide group, whereas the swallowing disturbances persisted in 14 of 18 in the placebo group.

Endoscopy examination showed a reversal of white exudates and red furrows in the budesonide group. Budesonide, but not placebo, also reduced epithelial cell apoptosis by 75%, as well as molecular remodeling events in the esophagus, the authors report.

A significant reduction (but not normalization) of fibrosis and fibrosis-related markers was also evident after 15 days of budesonide, they say.

Esophageal application of nebulized budesonide was well tolerated and no serious adverse events were reported.

"The study demonstrates that a short 15-day treatment is sufficient to achieve a resolution of inflammation and symptoms," Dr. Straumann said. He added that the question of the long term management of EoE is not answered by this trial, although a soon-to-be published follow up study will yield longer-term data.

The study was funded by the Swiss National Science Foundation and AstraZeneca, Switzerland.

Gastroenterology. Posted November 2010. Abstract

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