DUPILUMAB SHOWS PROMISE FOR EOSINOPHILIC GASTRITIS IN FIRST-OF-ITS-KIND STUDY​​

Featuring: Nirmala Gonsalves, MD
A new multisite study is the first to demonstrate that dupilumab improves clinical and histologic outcomes in patients with eosinophilic gastritis (EoG), which currently has no FDA-approved treatments. The clinical trial was conducted by the Consortium of Eosinophilic Gastrointestinal Disease Researchers within NIH’s Rare Diseases Clinical Research Network, in collaboration with Northwestern Medicine.

How the study evaluated efficacy
Building on the success of dupilumab in eosinophilic esophagitis, investigators explored its efficacy in EoG. To do so, the team leveraged outcome measures developed through CEGIR’s OMEGA study, which advanced clinical trial readiness in rare GI diseases.

In the randomized, placebo-controlled study, 41 patients with EoG received dupilumab or placebo over 12 weeks. Dupilumab met the primary endpoint and significantly improved secondary measures, including gastric eosinophil counts, endoscopic findings, histologic features and molecular biomarkers. Dr. Nirmala Gonsalves was co-lead of this study and a CEGIR site principal investigator.

Takeaways
The findings:
  • Reinforce that EoG, a rare gastrointestinal disorder is driven by type 2 inflammation.
  • Suggest that targeting this pathway can meaningfully alter disease activity.
  • Support consideration of off-label use.
  • Lay the groundwork for larger trials aimed at regulatory approval.

“This represents a major unmet need for patients,” says Nirmala Gonsalves, MD, a co-first author and co-lead of this study. “Treatment approaches to date have relied on limited evidence and expert opinion. This study provided insights into disease mechanisms and is a first step in improving the lives of patients with these debilitating diseases.”

Read the full study in The Lancet Gastroenterology & Hepatology.
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The study was published in collaboration with The Consortium of Eosinophilic Gastrointestinal Researcher.

See more from the NIH: ​How Repurposing a Drug May Help Treat More Rare Gastrointestinal Diseases | National Center for Advancing Translational Sciences
Nirmala Gonsalves, MD, is a study co-first author and professor of Gastroenterology and Hepatology at Northwestern Medicine.

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