Eosinophilic esophagitis (EoE) is an inflammation of the esophagus, or stomach, caused by an abnormal amount of bacteria in the stomach. It is a common condition in children and adults and can lead to irritation, pain, and other symptoms.
Every 1 in 2000 people has EoE. However, the numbers are rising rapidly worldwide. It is so because EoE is a recently discovered condition. EoE can affect people of any age. Yet, studies have shown people in their 30s are the most prevalent.
Eosinophilic Esophagitis may not be life-threatening but is very concerning if left untreated.
This shows why the approval of for EoE is very significant! On 20th May 2022, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE). It is the first EoE treatment that the FDA has approved.
We have discussed the Dupixen for EoE treatment in detail. Continue reading to learn more!
What is the Dupixent Treatment for Eosinophilic Esophagitis?
Dupixent is an artificial protein. This protein hinders the growth of the inflammatory pathways in the esophagus. It takes 16 weeks of regular Dupixent treatment to stabilize EoE. Dupixent is also preferred for treating pediatric patients at least 12 years of age. It can also be used for patients weighing over 40 kg.
Dupixent is the only therapy for eosinophilic esophagitis approved by the FDA. It is used for EoE treatment in adults.
How is the Study Worked?
The FDA has approved this new medicine for EoE based on a randomized study in a parallel-group trial. This trial was conducted independently in separate groups of patients, including two 24-week treatment courses (Part A and Part B).
Between the two treatment courses (Part A and Part B), patients received either a placebo or 300 milligrams of Dupixent weekly.
Part A Experiment | Part B Experiment |
In this study, 60% of the 42 patients who got Dupixent met the target level of esophageal eosinophil reduction. In contrast to 5% of the 39 patients who got a placebo. | In the Part B experiment, 59% of the 80 patients who received Dupixent achieved the predefined level of decreased eosinophils in the esophagus. Compared to 6% of the 79 patients who received a placebo, |
“Today’s approval will fulfil an important unmet need for the increasing number of patients with eosinophilic esophagitis,” said Jessica Lee, MD, director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research.
In 2017, Dupilumab was also approved to treat atopic dermatitis in adults and children aged up to 6, patients with moderate to severe asthma, or chronic rhinosinusitis with nasal polyposis.
Does Dupixent have any side effects?
Like every other drug, Dupixent also has adverse effects. Even though they are not severe, one must learn them before consuming them.
So pay attention! We have mentioned the adverse effects of Dupixent for EoE below; read them carefully!
There are several other factors that one should consider before taking Dupixent.
We have compiled them below for you!
So make sure you read them attentively!
What Should Patients Know Before Treatment?
- Dupixent may cause severe allergic reactions in patients. If so, immediate medical attention is needed. Dupixent should be discontinued in such cases.
- Patients with acute asthma should not take Dupixent for treatment. If taken, consult your doctor as soon as possible.
- Immediately discontinuing Corticosteroids upon starting Dupixent for Eosinophilic Esophagitis treatment is not advised.
- Patients should take the needed vaccinations before starting Dupixent treatment. It is not suggested to take any vaccination during Dupixent treatment.
References:
https://www.sanofi.com/en/media-room/press-releases/2022/2022-07-14-05-00-00-2479427
https://www.uptodate.com/contents/whats-new-in-gastroenterology-and-hepatology