Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis(EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT) that allows the drug to be delivered to the esophagus in adults with active EoE.

METHODS:

We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily ; n=59) or placebo (n=29) for 6 weeks. The primary endpoint was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-bind phase were offered 6 weeks of open-label treatment with BOT (1 mg twice daily).

RESULTS:

At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary endpoint of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six- and 12-weeks administration of BOT were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent.

CONCLUSIONS:

In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT no: 2014-001485-99; ClinicalTrials.gov no: NCT02434029.

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