On May 20, 2022, the Food and Drug Administration (FDA) approved Dupixent® (dupilumab) for people 12 and older with eosinophilic [EE-oh-sin-oh-FILL-ick] esophagitis [uh-sof-uh-JIE-tis], also known as EoE. In the clinical trial, Dupixent greatly improved EoE symptoms. This is the first FDA-approved medicine available in the U.S. to treat EoE.
What Is Eosinophilic Esophagitis (EoE)?
EoE is an allergic, progressive condition that causes swelling in your esophagus (swallowing tube). The esophagus is in an upper part of the gastrointestinal (GI) tract (gut). It is the tube that moves food from your mouth to your stomach when you swallow. EoE happens when certain white blood cells called eosinophils [EE-oh-sin-oh-FILLS] migrate to and build up in the lining of the esophagus. This buildup can damage the esophagus and make it harder to swallow. For people with EoE, swallowing even the smallest amount of food can be painful and lead to choking. This can lead to significant anxiety, frustration, and poor quality of life. In addition, this disease can cause narrowing of the esophagus, which may need to be dilated by a gastroenterologist.
There are about 160,000 people in the U.S. living with EoE who are being treated medically. Of these, treatments have failed for around 48,000. Many children and adults with EoE respond well to changes in their diet, such as specific food elimination diets (e.g., milk, egg, wheat, and soy). Certain medicines, such as proton pump inhibitors (PPIs) typically used to treat gastroesophageal reflux and swallowed corticosteroids, may also help manage and reduce symptoms. But these treatments may not give full relief because they don’t adequately combat or reverse the buildup of eosinophils in the esophagus – the underlying cause of the disease.
What Is Dupixent?
Dupixent is a type of treatment called a biologic, or monoclonal antibody therapy. In general, biologics target specific cells (pathways that are part of your immune system) to block inflammation and swelling. They are typically prescribed when conditions do not respond to other treatments. Biologics are not steroids. Several specific biologic therapies have been developed to use in the management of difficult-to-control conditions such as atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP).
Dupixent is currently approved by the FDA for the treatment of moderate-to-severe asthma and atopic dermatitis (eczema) for people ages 6 and older. It is also approved for CRSwNP for people ages 18 and older. It is an injection you can give yourself at home every few weeks (children will need help or supervision). It comes in two options – a prefilled syringe or prefilled auto-injector.
What Should People With EoE Know About Dupixent ?
Clinical trials looked at how safe and effective the treatment (Dupixent) is compared to other treatments already available. The first study of the trial showed positive results for EoE when participants took 300mg of Dupixent once a week for 24 weeks compared to a similar group of patients not taking Dupixent (i.e., placebo group).
The second part of the Phase 3 trial enrolled 159 people. Eighty people in the trial were in the treatment group that received Dupixent. Researchers reviewed their symptoms, such as swelling in the esophagus and trouble swallowing. After 24 weeks, the people who got Dupixent showed the following improvements compared to the placebo group not receiving Dupixent:
- Reduced eosinophils in the esophagus
- Reduced swelling in the esophagus
- Reduced EoE symptoms, such as trouble swallowing
Overall, the people who took Dupixent saw significantly larger improvements than the people who did not take Dupixent (placebo group). Dupixent is the first biologic to show such positive results in EoE patients.
What Happens Next?
The FDA approved this treatment for adults or children ages 12 years or older who weigh at least 88 pounds. Talk with your doctor (allergist or gastroenterologist) to find out if this new treatment may be an option for your child (or you, if you have EoE).
Read more about the study and the FDA announcement.
Medical Review: May 2022 by John M. James, MD
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