Dupilumab Use in Eosinophilic Esophagitis: Analysis of the FDA Adverse Event Reporting System Database

O’Shea KM Aceves SS Dellon ES , et al Pathophysiology of eosinophilic esophagitis. Gastroenterology. 2018;154(2):333-345. doi:10.1053/j.gastro.2017.06.065.

Lee CJ Dellon ES. Real-world efficacy of dupilumab in severe, treatment-refractory, and fibrostenotic patients with eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2024;22(2):252-258. doi:10.1016/j.cgh.2023.08.015.

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(1):111-122. doi:10.1053/j.gastro.2019.09.042.

Hirano I Collins MH Assouline-Dayan Y , et al RPC4046, a monoclonal antibody against IL13, reduces histologic and endoscopic activity in patients with eosinophilic esophagitis [published correction appears in Gastroenterology. 2024 Jul;167(2):421-422. doi: 10.1053/j.gastro.2024.04.013.]. Gastroenterology. 2019;156(3):592-603.e10. doi:10.1053/j.gastro.2018.10.051.

Questions and answers on FDA’s adverse event reporting system (FAERS). FDA; 2018. Accessed February 6, 2024. https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers.

Dellon ES Rothenberg ME Collins MH , et al Dupilumab in adults and adolescents with eosinophilic esophagitis. N Engl J Med. 2022;387(25):2317-2330. doi:10.1056/NEJMoa2205982.

Ou Z Chen C Chen A Yang Y Zhou W. Adverse events of dupilumab in adults with moderate-to-severe atopic dermatitis: a meta-analysis. Int Immunopharmacol. 2018;54:303-310. doi:10.1016/j.intimp.2017.11.031.

Bachert C Mannent L Naclerio RM , et al Effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyposis: a randomized clinical trial. JAMA. 2016;315(5):469-479. doi:10.1001/jama.2015.19330.

Blauvelt A de Bruin-Weller M Gooderham M , et al Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303. doi:10.1016/S0140-6736(17)31191-1.

Maudinet A Law-Koune S Duretz C Lasek A Modiano P Tran THC . Ocular Surface Diseases Induced by Dupilumab in Severe Atopic Dermatitis. Ophthalmol Ther. 2019;8(3):485-490. doi:10.1007/s40123-019-0191-9.