{"doi":"10.1159/000534545","title":"Characterizing Adverse Events of Biologic Treatment of T2 Disease: A Disproportionality Analysis of the FDA Adverse Event Reporting System","abstract":"INTRODUCTION: Over the last 3 years, the FDA has approved dupilumab, omalizumab, and mepolizumab for the treatment of CRSwNP; however, adverse events of these biologics have not been described in post-marketing surveillance trials. By utilizing the FDA Adverse Event Reporting System (FAERS), this study describes and compares biologic-associated adverse events in T2 disease. METHODS: This case-non-case study assessed disproportionate reporting rates using reporting odds ratios (RORs). RORs and p values for biologic-associated AEs were categorized and compared among dupilumab, omalizumab, and mepolizumab. This analysis included AEs associated with all treatment indications. Relative AE rates and outcomes were calculated. RESULTS: There were a total of 112,560, 24,428, and 18,741 unique AE reports associated with dupilumab, omalizumab, and mepolizumab, respectively. Omalizumab had the strongest association with anaphylaxis (ROR = 20.80, 95% confidence interval [CI]: 18.58, 23.29). Dupilumab had large relative proportions and positive signals in the ophthalmologic category (7.76%, ROR = 6.20, 95% CI: 6.06, 6.35), such as with blurry vision (ROR = 3.80, CI: 3.52, 4.12) and visual impairment (ROR = 1.98, CI: 1.80, 2.19). Dupilumab was the only biologic associated with injection-site reactions (7.98%, ROR = 8.17, 95% CI: 7.98, 8.37). DISCUSSION/CONCLUSION: This is the first large-scale comparative analysis of the AE profiles of dupilumab, omalizumab, and mepolizumab. Our data suggest possible relations between dupilumab and ophthalmologic and injection-site AEs. Omalizumab was the only biologic with a positive anaphylaxis signal. This FAERS investigation suggests important AE differences among these biologics.","journal":"ORL","year":2023,"id":353269,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9539,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1099360,"name":"Sulgi Kim","orcid":"0000-0002-2465-1305","position":1,"is_corresponding":false},{"id":1100009,"name":"Meredith Lamb","orcid":null,"position":2,"is_corresponding":false},{"id":1099487,"name":"Ibtisam Mohammad","orcid":"0000-0003-1765-8098","position":3,"is_corresponding":false},{"id":913540,"name":"Abdullah Zeatoun","orcid":"0000-0002-1083-8646","position":4,"is_corresponding":false},{"id":1099488,"name":"Erin M. Lopez","orcid":"0000-0002-4636-055X","position":5,"is_corresponding":false},{"id":390570,"name":"Cristine Klatt‐Cromwell","orcid":"0000-0002-5110-6118","position":6,"is_corresponding":false},{"id":286872,"name":"Brian D. Thorp","orcid":null,"position":7,"is_corresponding":false},{"id":284289,"name":"Charles S. Ebert","orcid":"0000-0002-8254-302X","position":8,"is_corresponding":false},{"id":284288,"name":"Brent A. Senior","orcid":"0000-0002-1503-3150","position":9,"is_corresponding":false},{"id":105527,"name":"Adam J. Kimple","orcid":"0000-0003-1670-8401","position":10,"is_corresponding":false},{"id":1100010,"name":"Daniel Alicea","orcid":null,"position":11,"is_corresponding":false},{"id":913539,"name":"Taylor Stack","orcid":"0000-0002-6014-3308","position":0,"is_corresponding":true}],"reference_count":24,"raw_metadata":null,"created_at":"2026-07-19T01:12:58.542950Z","pmid":"37963438","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}