Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis

ABSTRACT BACKGROUND & AIMS Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear if these drugs are effective for long-term maintenance of remission. METHODS We performed a double-blind trial to compare the efficacy and safety of 2 doses of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histological relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n=68), BOT 1.0 mg twice daily (n=68), or placebo twice daily (n=68) for up to 48 weeks. RESULTS At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission, compared with 4.4% of patients in the placebo group (P CONCLUSIONS In a phase 3 trial, up to 48 weeks of treatment with BOT (.5 mg or 1.0 mg, twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. (Funded by Dr. Falk Pharma GmbH; EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.)