EoE Science Minutes: Dupixent as a potential effective treatment of EoE

EoE Science Minutes: Dupixent as a potential effective treatment of EoE

Dupixent is a monoclonal antibody (dupilumab) blocking type 2 inflammation, specifically inhibiting interleukin 4 and interleukin 13. Dupixent is currently approved for use in several type 2 chronic inflammatory diseases such as moderate-to-severe atopic dermatitis, asthma, and nasal polyps. It is well known that EoE is also considered a type 2 chronic inflammatory disease with strong involvement of interleukin 4 and 13. The type 2 inflammation in EoE has a negative effect on esophageal scarring with subsequent narrowing of the esophagus and food impaction. There are currently no FDA-approved medications for EoE treatment and therefore there is an intensive search for effective therapy. Since Dupixent proved effective in type 2 chronic inflammatory diseases, there is a big potential in the use of Dupixent in EoE disease.

Dupixent passed successfully part A of a pivotal phase 3 clinical trial. The results from the study show that Dupixent improved the ability to swallow and also the structural abnormalities in the esophagus in EoE patients. During this A phase study, EoE patients were treated with Dupixent 300 mg or with placebo weekly over a 24-week period (80 subjects treated with Dupixent, 79 subjects with placebo). The results of the study were the following: (1) rapid improvement in ability and comfort of swallowing, (2) reduction of esophageal eosinophil counts, (3) improvement of the health of esophageal tissue at the microscopic level, (4) elimination of type 2 inflammation pattern in esophageal tissue.

The reported adverse effects were mainly connected to the injection site reaction and so did not vary much between Dupixent and placebo treatment. One subject treated by Dupixent was removed from the study because of joint pain. Additionally, some cases of upper respiratory tract infection were reported during the study, but with a similar frequency between Dupixent treated group and the placebo-treated group and so were not specific to the Dupixent treatment.

In September 2020, the FDA granted the Breakthrough Therapy designation to Dupixent for treatment of patients 12 years and older with EoE, which allowed expediting the development and review of drugs targeting serious conditions.

In late 2021, the results of the second phase 3 trial were summarized and are planned to be presented this year. The second phase 3 study focused on extending the active treatment period up to 52 weeks (compared to the first part A Phase 3 study which was 24 weeks).

We are hoping to soon see updates and possible FDA approval of Dupixent as the first and only biology treatment for EoE. My husband is excited to try it out. We feel safe about him using it since many people have been using it for a few years for other inflammatory diseases.

Source:
https://newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-late-breaking-pivotal-data-showing
https://www.sanofi.com/en/media-room/press-releases/2021/2021-10-25-07-00-00-2319486



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