Long-Term Budesonide Shows Sustained Efficacy in EoE

TOPLINE:

Budesonide orodispersible tablets (BOTs) maintain remission and improve quality of life (QOL) in a majority of adults with eosinophilic esophagitis (EoE) for up to 144 weeks.

METHODOLOGY:

• There is an urgent need for long-term data on medical therapeutics in EoE, given that patients with this chronic condition often experience relapse after treatment discontinuation.
• Researchers evaluated the long-term benefits of BOT as maintenance therapy for EoE in the open-label extension (OLE) phase of a randomized, double-blind, 48-week phase 3 maintenance study.
• Adult patients choosing to participate in the OLE received either 0.5 mg or 1.0 mg of BOT twice daily, at the investigator’s discretion, for up to 96 weeks.
• Clinical and histologic remission were defined as Eosinophilic Esophagitis Activity Index Patient-Reported Outcome scores ≤ 20 and a peak eosinophil count ² per high-power field, respectively.
• Endoscopic findings were evaluated using modified EoE Endoscopic Reference scores (EREFS).
• QOL was evaluated using the EoE Quality of Life in Adults (QOL-A) Scale score.

TAKEAWAY:

• Among 204 patients in the 48-week maintenance study, 186 (mean age, 36.7 years; 82.8% men) elected to participate in the OLE.
• Clinical remission rates remained consistently above 84.0% at 96 weeks compared with 80.6% at OLE baseline.
• At 96 weeks, 80.1% and 78.8% of patients showed histologic remission and deep histologic remission, respectively.
• EREFS scores remained stable through 48 and 96 weeks, with mean total EREFS scores of 0 noted at all assessments.
• QOL improved substantially over 96 weeks, with the 4-point EoE QOL-A scores improving by 0.4 points from the 48-week baseline to OLE 96 weeks.
• No new safety concerns were identified with BOT therapy during the OLE.

IN PRACTICE:

“We observed clear durability and even improvement of disease control based on clinical, endoscopic, histologic, and QOL parameters,” the authors wrote. “BOT therapy also halted and may even sustainably reverse fibrostenotic remodeling of the esophagus, raising hope of disease modification in EoE.”

SOURCE:

The study, led by Luc Biedermann, MD, and Christoph Schlag, MD, Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS: 

Although a placebo effect on EoE symptoms has been documented, this open-label trial did not include a placebo comparator. Because response to BOT induction therapy was an inclusion criterion for the 48-week double-blind study conducted previously, primary nonresponders to BOT were excluded. Due to the pragmatic nature of the BOT dosage, treatment adherence was not assessed.

DISCLOSURES:

The study was funded by Dr. Falk Pharma GmbH, for which some authors work as employees. Several authors declared receiving consulting fees or speaking fees, research grants, or honoraria from various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.