Dupilumab: A New Treatment Option for Patients With Eosinophilic Esophagitis
Prateek Sharma, MD, FASGE, reviewing Hirano I, et al. Gastroenterology 2020 Jan.
Medical treatment options for patients with eosinophilic esophagitis (EoE) include proton pump inhibitors, oral corticosteroids, and various food elimination diets. Dupilumab, a monoclonal antibody against the interleukin-4 receptor, has been shown to be effective in the treatment of atopic dermatitis, asthma, and chronic sinusitis. This trial assessed the safety and efficacy of dupilumab in the management of EoE.
In this multicenter phase-2 study, adult patients with EoE (2 episodes of dysphagia per week; peak eosinophils >15 per high-power field) were randomized to receive weekly subcutaneous dupilumab (300 mg; n=23) or placebo (n=24) for 12 weeks with a 16-week follow-up period. The primary endpoint was a change from baseline to week 10 in the dysphagia score using patient-reported outcomes (PROs); additional outcomes, including histologic features (eosinophil count and EoE histologic scores), the endoscopic reference score, esophageal distensibility, and safety, were also assessed. There was a significant decrease in the dysphagia PRO scores at week 10 in patients receiving dupilumab compared to placebo (3.0 vs 1.3; P=.0304). Similarly, compared to placebo, dupilumab treatment was associated with a significant decrease in the esophageal eosinophil count (reduction of 107.1%; P<.0001), the EoE-histologic severity score (decreased by 68.3%; P<.0001), and the endoscopic reference score (decreased by 1.6; P=.0006). Esophageal distensibility was increased by dupilumab by 18% compared to placebo (P<.0001). Injection-site erythema (35% vs 8%) and nasopharyngitis (17% vs 4%) were higher in the dupilumab group compared to placebo.
COMMENT
In the short term (12 weeks), dupilumab, a targeted biologic agent, can improve dysphagia and histologic and endoscopic features in adult patients with EoE, with reasonably few side effects. Currently, long-term impact of this drug on the disease is unknown. However, given the few medical treatment options available at this time, this offers promise for patients with EoE.
Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
Prateek Sharma, MD, FASGE
CITATION(S)
Hirano I, Dellon ES, Hamilton JD, et al. Efficacy of dupilumab in a phase 2 randomized trial of adults with active eosinophilic esophagitis. Gastroenterology 2020;158:111-122.e10. (https://doi.org/10.1053/j.gastro.2019.09.042)
