A recent study led by Cincinnati Children’s physician-scientist Marc Rothenberg, MD, PhD, from Cincinnati Children’s, was published online on Aug. 31, 2023, in The Lancet: Gastroenterology and Hepatology.

Background

Dupilumab is a biologic that blocks the shared receptor component for interleukin 4 and interleukin 13, two cytokines known to be involved in the pathogenesis of eosinophilic oesophagitis (EoE). The FDA recently approved this treatment, and it was recommended for EU approval by the Committee for Medicinal Products for Human Use (CHMP) for EoE.

Dupilumab is the first biologic drug in the EU and the USA indicated for EoE for sufferers aged 12+.

This study was to assess Dupilumab for the long-term management of eosinophilic oesophagitis.

Methods

The LIBERTY EoE TREET is a comprehensive, international phase 3 study involving 65 medical facilities in Australia, Canada, Europe, and the USA. 

It was 52 week period study and involved 240 patients initially, with 227 continuing into the subsequent analysis.

It focused on adults and adolescents aged 12 and above diagnosed with eosinophilic oesophagitis via biopsy. Patients were randomly (1:1:1) assigned to receive subcutaneous dupilumab 300 mg weekly or every two weeks or weekly placebo until week 24.

At week 24, those taking a placebo were reassigned to Dupilumab weekly or fortnightly for 28 weeks.

The study was designed to maintain anonymity among all parties involved. Its primary findings have been reported, specifically detailing the outcomes up to week 52 of treatment. This study is registered under ClinicalTrials.gov with the number NCT03633617.

Findings

The study supports earlier findings that weekly dupilumab treatment for eosinophilic oesophagitis (EoE) produces stronger histologic, symptomatic, endoscopic, and molecular improvements than treatment every two weeks. 

In terms of safety, very few patients needed rescue medications or procedures. The most common side effect was injection-site reactions, which were generally mild.

These findings suggest that dupilumab is an effective and relatively safe treatment option for those with EoE and reinforces the importance of weekly treatment. 

What Do These Findings Mean To The Eosinophilic Community?

As people who navigate the challenges of finding a proper treatment, we appreciate new findings. The news that weekly treatments offer stronger improvements over bi-weekly doses provides insight and understanding of what to expect, which we all need.

Accessing the right treatment means more than medication frequency; it’s about enhanced quality of life. 

However, a more frequent dosing schedule might be more burdensome, not just physically or logistically, but also financially.  An open and honest conversation with your healthcare provider is essential to weigh the pros and cons.

EoE is a complex area with varying treatment pathways depending on individual needs, and we must remember that this treatment is not currently available worldwide.

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