Budesonide tablets effectively increase esophageal distensibility in EoE
Click Here to Manage Email Alerts
During induction, budesonide tablets were effective in increasing esophageal distensibility in eosinophilic esophagitis and was further improved during maintenance therapy, according to a presenter at UEG Week.
“A 6-week treatment with budesonide orodispersible tablets 1mg was highly effective to increase the esophageal distensibility compared to placebo in adult patients with active eosinophilic esophagitis,” Alfredo J. Lucendo, MD, PhD, from the department of gastroenterology, General Hospital of Tomelloso, Spain, said during his presentation. “The esophageal distensibility further improved during the maintenance of therapy under both budesonide 0.5 and 1 mg tablets even twice daily. In contrast, it reduced significantly among patients who receive placebo and presented recurrence of activity in EoE.”
In the EOS-1 trial, Lucendo and colleagues randomly assigned 88 adults with active EoE to 6 weeks of treatment with a budesonide orodispersible tablet formulation (BOT; n = 59) or to placebo twice daily (n = 29). In the EOS-2 trial, 204 adult EoE patients with clinic-histological remission were randomly assigned to 48 weeks of treatment with BOT 1 mg twice daily (n = 68), BOT 0.5 mg twice daily (n = 68) or placebo twice daily (n = 68).
At six specialized centers, the Endoluminal Functional Lumen Imaging Probe technology was used to measure esophageal distensibility in 22 EOS-1 patients and 38 EOS-2 patients at baseline and end-of-treatment endoscopy.
Results showed distensibility increased from baseline in patients who underwent a 6-week induction of remission treatment with BOT 1 mg twice daily vs. placebo (P = .004). Lucendo noted during the 48-week maintenance of remission treatment, the esophageal distensibility further increased with BOT 1 mg twice daily and BOT 0.5 mg twice daily compared with changes noted with placebo (P = .021).
“Budesonide tablets are an effective therapy to stop and also revert the fibrostenotic remodeling process in adult patients with eosinophilic esophagitis,” Lucendo said.
Perspective
Back to Top
Claire Beveridge, MD
In this study, patients with active EoE who underwent 6 weeks of treatment with BOT 1 mg twice daily had significantly improved distensibility on the functional lumen imaging probe compared with those receiving placebo. This study brings up two interesting topics in EoE.
The first topic would be novel and tailored formulations for patients with EoE. Currently, there are no medications that are FDA approved for EoE. For topical corticosteroids, patients swallow from an inhaler or create their own slurry. There are a few medications on the horizon that will hopefully be FDA approved soon. BOT is an example of an excellent and specific formulation for EoE which disintegrates in the mouth and is then swallowed to coat the esophagus.
The second topic is the importance of assessing distensibility and fibrostenosis in EoE. EoE is considered a progressive disease from an inflammatory to a fibrostenotic phenotype. It is important to try to prevent this progression as it is characterized by rings and strictures leading to dysphagia, food impactions and repeated dilations. A study done by Manish B. Singla, MD, and colleagues published in Clinical and Translational Gastroenterology suggested that early treatment can prevent progression to fibrostenosis and potentially even help reverse it. This study shows that treatment with BOT compared with placebo can improve distensibility, which, while not always, can be a marker of fibrostenosis.
Singla MB, et al. Clin Transl Gastroenterol. 2015;doi:10.1038/ctg.2015.62.
Collapse
Lucendo AJ, et al. Abstract OP179. Presented at: UEG Week; Oct. 3-5, 2021 (virtual meeting).
Read more about
Click Here to Manage Email Alerts