EoE Module 10 References-Staumann et al Gastroenterology 2020 Budesonide orodispersible tablets maintain remission in RCT EoE

Staumann et al Gastroenterology 2020 Budesonide orodispersible tablets maintain remission in RCT EoE

Pdf Summary

The study investigated the long-term efficacy and safety of budesonide orodispersible tablets (BOT) in maintaining remission in adults with eosinophilic esophagitis (EoE). EoE is a chronic inflammatory condition affecting the esophagus, commonly leading to dysphagia and food impaction. While topical corticosteroids are known to induce remission, their role in maintenance was unclear.<br /><br />The double-blind, randomized trial involved 204 adults with EoE, who were in clinical and histologic remission. These participants were administered either BOT 0.5 mg, BOT 1.0 mg, or a placebo twice daily for up to 48 weeks. The primary endpoint was maintaining remission without clinical or histologic relapse.<br /><br />Results revealed that 73.5% of patients on 0.5 mg BOT and 75% on 1.0 mg BOT remained in remission after 48 weeks, compared to just 4.4% in the placebo group. The participants in the placebo group relapsed within 87 days on average. Treatment with BOT did not significantly affect morning cortisol levels, though four BOT recipients experienced asymptomatic low cortisol levels. Candida infections occurred in 16.2% of the 0.5 mg group and 11.8% of the 1.0 mg group and resolved with treatment.<br /><br />The study concluded that both 0.5 mg and 1.0 mg BOT doses effectively maintained remission over 48 weeks compared to placebo and were well tolerated. The findings suggest BOT can be recommended as a long-term maintenance therapy for EoE. Both dosage levels proved equally effective, though the best maintenance strategy concerning dosage requires further investigation. The trial sets a standard for maintenance treatment of EoE and potentially guides future therapeutic approaches.

Keywords

budesonide orodispersible tablets

eosinophilic esophagitis

remission maintenance

chronic inflammatory condition

double-blind randomized trial

topical corticosteroids

clinical and histologic remission

cortisol levels

Candida infections

maintenance therapy