Dupilumab Now Approved for Eosinophilic Esophagitis

Dupilumab Now Approved for Eosinophilic Esophagitis Posted By:

Eosinophilic esophagitis (EoE) is a gastrointestinal disorder characterized by eosinophilic inflammation of the esophagus. Symptoms of EoE present broadly; they range from nausea to dysphagia to failure to thrive and poor weight gain. In EoE, there is infiltration of eosinophils by ≥15 eosinophils per high-power field on histologic analysis or biopsy. Without treatment, EoE can progress to stricture formation, food impactions, and esophageal remodeling. The goals of management in EoE are to prevent remodeling, control inflammation, and control symptoms. The prevalence of EoE is increasing and, until recently, treatment consisted of a combination of dietary avoidance, proton-pump inhibitor use, and corticosteroids.

In May 2022, the FDA approved dupilumab for use in management of EoE in patients ≥12 years of age. This agent is a monoclonal antibody that blocks interleukin (IL)-4 alpha chain, which also shares a common receptor site to IL-13, thereby effectively blocking both IL-4 and IL-13. These cytokines are significantly involved in type 2 inflammation, which is involved in the recruitment and activation of eosinophils.

The approval of dupilumab was based on a randomized, double-blind, placebo-controlled phase III trial in which patients with EoE were randomized to receive dupilumab 300 mg or placebo once weekly over 2 separate 24-week treatment periods (Parts A and B). Primary endpoints included histologic remission and change in Dysphagia Symptom Questionnaire (DSQ) score. In the first part (Part A), 59.5% of patients receiving dupilumab achieved histologic remission compared with 5.1% receiving placebo, with a treatment difference of 57%; DSQ scores improved in the treatment arm by almost 22 points vs 9.6 points in the placebo group. In Part B, 58.8% of patients receiving dupilumab achieved histologic remission vs 6.3% in the placebo group—a treatment difference of more than 53%. In the dupilumab group, DSQ scores improved by 23.8 points vs 13.9 in the placebo group. Overall, this study found dupilumab for EoE is well tolerated; the most common adverse events included injection site reaction, upper respiratory infection, joint pain, and herpes viral skin infections. It is important to note that dupilumab is not an immune suppressant.

Dupilumab is also approved and used for moderate to severe atopic conditions, moderate to severe or steroid-dependent asthma, and chronic sinusitis with nasal polyposis. Many patients with EoE have other atopic comorbidities such as the ones mentioned above and will benefit from dupilumab for those conditions as well.

  • Rank MA, et al. Technical review on the management of eosinophilic esophagitis: a report from the AGA institute and the joint task force on allergy-immunology practice parameters. Ann Allergy Asthma Immunol. 2020 May; 124:424.
  • FDA approves Dupixent® (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis. News release. Regeneron Pharmaceuticals, Inc. Accessed June 14, 2022.
  • Dupilumab [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2022.
  • Study to determine the efficacy and safety of dupilumab in adult and adolescent patients with eosinophilic esophagitis (EoE). Phase 3, randomized, double-blind, placebo-controlled trial. Regeneron. NCT03633617.


Filed under: Gastroenterology , Preventive Medicine

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