Yannis Lafazanos, DO1, Eli D. Ehrenpreis, MD, FACG2 1Advocate Lutheran General, Park Ridge, IL; 2E2Bio Consultants, Evanston, IL
Introduction: Dupilumab (Dupixent) is a monoclonal antibody against interleukin-4 and interleukin-13 and is typically used for atopic conditions including asthma, atopic dermatitis, and chronic nasal polyps. Dupilumab is also a promising treatment for eosinophilic esophagitis (EoE) and was approved for use in EoE in May, 2022. This study reviews reports of serious adverse drug reactions (ADRs) from dupilumab reported to the Federal Adverse Event Reporting System (FAERS).
Methods: The Federal Drug Administration’s (FDA) FAERS is a collection of voluntarily reported adverse reactions, used for post-marketing surveillance of medications. 5,006,103 FAERS reports from January 2022 to June 2024 were reviewed. Of these, ADRs for dupilumab accounted for 149,043 reports, with 4,557 (3%) reports related to dupilumab used for EoE. Only ADRs reported as serious are the subject of this study and were reviewed according to MedDRA terminology. Duplicate reports were removed. Significant signals for each of these serious ADRs were determined using reporter odds ratios (RORs) that were calculated for adverse events. A ROR >1 indicates an ADR frequency greater than occurring by chance alone and suggests a significant post-marketing signal.
Results: There was a total of 341 serious ADRs reported for dupilumab in patients with EoE during the investigated period. Of these, significant signals were seen for IBD (ROR 5.5) and migraine headache (ROR=1.29). Other reported serious ADRs did not appear to represent significant signals (see Table 1).
Discussion: A review of reports of serious ADRs occurring in patients receiving dupilumab for EoE suggests a significant risk for the development of IBD and migraine headaches in this patient group. Clinicians should be aware of these potential complications of dupilumab treatment in patients with EoE and these reports are ripe for further study.
Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.
Disclosures:
Yannis Lafazanos indicated no relevant financial relationships.
Eli Ehrenpreis: E2Bio Life Sciences – Intellectual Property/Patents, Owner/Ownership Interest, Stock-privately held company.
Yannis Lafazanos, DO1, Eli D. Ehrenpreis, MD, FACG2. P2192 - A Review of Serious Adverse Drug Reactions (ADRs) from Dupilumab (Dupixent) Reported to the Federal Adverse Event Reporting System (FAERS), ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.
