On May 20, 2022, the US Food and Drug Administration (FDA) approved dupilumab (Dupixent) to treat eosinophilic esophagitis (EoE) in patients aged 12 years and older weighing at least 40 kilograms (around 88 pounds). This is the first-ever medication, which has been approved by the FDA for Eosinophilic Esophagitis.
Eosinophilic Esophagitis is a chronic, allergic inflammatory disease developed due to the formation of eosinophils in the lining of the esophagus. Signs and symptoms may vary but Eosinophilic Esophagitis patients often experience difficulty swallowing, difficulty eating, and food getting stuck in the esophagus
Dupilumab (Dupixent) typically is a monoclonal antibody, designed to inhibit part of the inflammatory pathway.
The approval of dupilumab (Dupixent) was largely based on outcomes from a phase-III trial that included two 24-week treatment periods (Part A and Part B) that were carried out independently in separate groups of patients. In Part A and B, patients received either placebo or dupilumab 300 mg every week. The primary endpoint(s) were the proportion of patients who achieved the peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field (eos/hpf) at week 24, and the change in the patient-reported Dysphagia Symptom Questionnaire (DSQ) score from baseline to week 24.
The Dysphagia Symptom Questionnaire is a questionnaire designed in order to measure the difficulty swallowing associated with eosinophilic esophagitis, with total scores ranging from 0-84; higher Dysphagia Symptom Questionnaire scores represents worse symptoms.
In Part-A of the trial, 60% of the 42 patients who received dupilumab achieved the pre-established level of reduced eosinophils in the esophagus compared to 5% of the 39 patients with placebo. Patients in Part-A with dupilumab experienced an average improvement of 22 points in their Dysphagia Symptom Questionnaire score compared to 10 points in patients with placebo.
In Part-B, 59% of the 80 patients with dupilumab achieved the pre-established level of reduced eosinophils in the esophagus compared to 6% of the 79 patients with placebo. Patients in Part-B with dupilumab experienced an average improvement of 24 points in their Dysphagia Symptom Questionnaire score compared to 14 points in patients with placebo.
The most commonly reported adverse events with dupilumab treatment were joint pain, upper respiratory tract infections, injection site reactions, and herpes viral infections.
Dupilumab (Dupixent) is contraindicated in patients with previous or known hypersensitivity to it’s active ingredient or any of its inactive ingredients.
Dupixent (Dupilumab) was originally approved in the year of 2017. It is approved for moderate-to-severe atopic dermatitis in adults and pediatric patients aged six years and older whose disease is not adequately managed by topical prescription therapies or when those therapies are not advisable.
As an add-on maintenance therapy, dupixent (Dupilumab) is also approved for adults and pediatric patients aged six years and older with certain kinds of moderately to severely asthma, as well as an add-on maintenance therapy in adult patients with not adequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).