This article is more than 5 years old. Information may no longer be current.
Budesonide tablets effective for EoE induction
Click Here to Manage Email Alerts
A recent placebo-controlled trial revealed that patients who received budesonide orodispersible tablets as induction therapy for eosinophilic esophagitis achieved better rates of clinical and histologic remission.
Alfredo J. Lucendo, MD, PhD, FEBGH, from the department of gastroenterology at Hospital General de Tomelloso in Spain, and colleagues wrote that topical-acting corticosteroids are the recommended first-line therapy for EoE, while asthma medications, although not labeled for use in EoE, are sometimes effective.
“Multiple trials have confirmed the efficacy of these compounds in improving symptoms as well as inflammation in patients with EoE,” they wrote. “Fluticasone or budesonide have shown comparable potencies but the vehicle depositing the compound on the esophageal surface seems to be critical.”
Researchers tested the effectiveness and tolerability of the budesonide orodispersible tablets (BOT), which are formulated to deliver the drug to the esophagus. They recruited 88 adult patients with active EoE and randomly assigned them to receive 1 mg of BOT twice daily (n = 59) or placebo (n = 29) for 6 weeks.
The primary endpoint of the study was complete remission defined as several clinical and histologic factors, including dysphagia and an odynophagia severity of 2 or less on a scale of 0 to 10 on each of the 7 days before the end of the double-blind phase, as well as a peak eosinophil count of less than 5 per high power field.
Patients who did not achieve remission at the end of week 6 had the opportunity to switch to 6 weeks of open-label treatment with BOT.
After 6 weeks, 58% in the BOT group were in complete remission compared with none in the placebo group (P < .0001). Additionally, 94% of patients in the BOT group achieved histologic remission compared with none in the placebo group (P < .0001).
Researchers also found that the drug was safe and well-tolerated at both 6 and 12 weeks of treatment. In patients who underwent therapy with BOT, 5% developed symptomatic, mild candida, which was easily treated.
“BOT 1 mg [twice daily] is a highly effective therapy to rapidly induce disease remission in adult patients with active EoE,” Lucendo and colleagues wrote. “An ongoing trial with the same formulation will provide evidence on its efficacy to maintain this remission in the long term.” – by Alex Young
Disclosures: Lucendo reports receiving research funding from Dr. Falk Pharma. Please see the full study for all other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts