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

Abstract

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 < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. CONCLUSIONS: In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.

Letter: PPIs in EoE—More questions than answers

“…Neither is it consistent with Table 1 where the symptom scores after PPI maintenance were 0‐4 in 8.3% and 5‐15 in 92%. The latter would be even lower than the placebo response rates observed in recent randomised controlled trials of budesonide for induction and maintenance 7,8 …”

Eosinophilic esophagitis—established facts and new horizons

“…Since EoE is a chronic disease and relapses occur rapidly after cessation of an induction treatment, a maintenance therapy is required. Subsequently, two controlled long-term studies using budesonide have demonstrated that this compound is able to maintain a clinico-histological remission in up to 75% of the patients, whereas less than 5% of the participants under placebo were still in remission after one year of treatment [ 67 ]. Of note, as four of the total 136 patients (≈3 % ) exposed to budesonide had decreased morning cortisol levels, further studies evaluating the safety of the long-term use of STCs are needed.…”

Immune system and microbiome in the esophagus: implications for understanding inflammatory diseases

“…However, the six-food elimination diet significantly impacts life quality, limiting the compliance for this treatment for EoE [130][131][132]. Topical corticosteroids improve clinical symptoms and are highly efficacious for induction and maintenance therapy of EoE [133,134]. Small molecules and biologicals that specifically target checkpoints are of significant interest to further improve the treatment of EoE.…”