| アブストラクト | OBJECTIVE: To compare the ocular safety of intravitreal aflibercept injections and faricimab using population-based, global postmarketing data in a large pharmacovigilance study. DESIGN: Population-based, retrospective pharmacovigilance study. SUBJECTS, PARTICIPANTS, AND/OR CONTROLS: Patients for whom ocular adverse event (AE) reports were submitted to the U.S. FDA Adverse Event Reporting System (FAERS) between January 2004-June 2025, and for whom intravitreal aflibercept injections (2 mg or 8 mg, where dose was recorded) or faricimab were listed as the primary suspect drug, were included. METHODS: After deduplication, disproportionality was assessed using reporting odds ratios (RORs, 95%CI). Safety signals were considered statistically significant if they met Evans' criteria (ROR>2, chi(2)>4, n>/=3), Bonferroni-adjusted p<0.0003, and Bayesian threshold IC(025)>0. MAIN OUTCOME MEASURES: Disproportionality signals for ocular adverse events associated with intravitreal aflibercept 2 mg, aflibercept 8 mg, and faricimab, using aflibercept 2 mg as the reference comparator given its longer market availability and well-established safety profile. RESULTS: Among 13,809,873 FAERS reports, 30,761 involved intravitreal aflibercept 2 mg (n=21,058), aflibercept 8 mg (n=727), or faricimab (n=8,976). After deduplication, 8,352 reports remained for aflibercept 2 mg, 327 for aflibercept 8 mg, 4,168 for faricimab, and 13,797,026 for other drugs. Most patients were aged 65-85 years; women comprised 48.6% of the 8 mg group, 39.9% of faricimab, and 20.8% of the 2 mg group. Aflibercept 8 mg showed the highest disproportionality for intraocular inflammation and infection-related events, including anterior chamber flare (ROR=1410.5), vitritis (853.3), retinal vasculitis (352.2), and infectious (1208.3) and sterile endophthalmitis (352.0), as well as blindness (71.1) and reduced visual acuity (74.6). Faricimab had the highest RORs for injection-related inflammatory and hemorrhagic events-hypopyon (112.8), retinal pigment epithelial tear (193.9), choroidal hemorrhage (142.3), and pseudoendophthalmitis (309.9)-while aflibercept 2 mg was more often associated with structural complications, including increased intraocular pressure (187.8), posterior capsule rupture (80.1), vitreous hemorrhage (76.9), and retinal detachment (20.8). All signals met Bonferroni-adjusted significance (p<0.0001) and Bayesian criteria (IC(025)>0). CONCLUSIONS: Aflibercept 8 mg showed strong signals for intraocular inflammation, vasculitis, and endophthalmitis, aflibercept 2 mg was linked to structural complications, and faricimab had the highest disproportionality for select immuno-vascular events. These findings delineate agent- and dose-specific safety profiles within a unified comparative framework and reinforce the critical need for ongoing postmarketing surveillance. |
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| ジャーナル名 | Ophthalmology. Retina |
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| Pubmed追加日 | 2025/11/7 |
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| 投稿者 | Lakhani, Moiz; Popovic, Marko M; Al-Ani, Abdullah; Kundapur, Deeksha; Gholamian, Tara; Chaudry, Emaan; Nanji, Keean; Patil, Nikhil; Feo, Alessandro; Sadda, SriniVas; Sarraf, David; Ip, Michael S; Kertes, Peter J; Muni, Rajeev H; Adatia, Feisal; Damji, Karim F; Chaudhary, Varun; Hurley, Bernard R |
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| 組織名 | Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada; The;University of Ottawa Eye Institute, Ottawa, Ontario, Canada. Electronic address:;mlakh088@uottawa.ca.;Department of Ophthalmology, David Geffen School of Medicine at University of;California - Los Angeles (UCLA), Los Angeles, California, United States;;Department of Ophthalmology and Visual Sciences, University of Toronto, Toronto,;Ontario, Canada. Electronic address: marko.popovic@mail.utoronto.ca.;Department of Surgery, Section of Ophthalmology, University of Calgary, Alberta,;Canada. Electronic address: aalani@ucalgary.ca.;The University of Ottawa Eye Institute, Ottawa, Ontario, Canada. Electronic;address: dkund079@uottawa.ca.;address: tghol015@uottawa.ca.;address: echau100@uottawa.ca.;Department of Surgery, Division of Ophthalmology, McMaster University, Hamilton,;Ontario, Canada. Electronic address: keean.nanji@medportal.ca.;Department of Ophthalmology and Visual Sciences, University of Alberta, Edmonton,;Alberta, Canada. Electronic address: nikhil.patil@medportal.ca.;California - Los Angeles (UCLA), Los Angeles, California, United States.;Electronic address: alessandrofeo.96@gmail.com.;California - Los Angeles (UCLA), Los Angeles, California, United States; Doheny;Eye Institute, University of California - Los Angeles (UCLA), Pasadena,;California, United States. Electronic address: ssadda@doheny.org.;California - Los Angeles (UCLA), Los Angeles, California, United States; Stein;Eye Institute, University of California - Los Angeles (UCLA), Los Angeles,;California, United States. Electronic address: dsarraf@ucla.edu.;Electronic address: mip@doheny.org.;Ontario, Canada; John and Liz Tory Eye Centre, Sunnybrook Health Sciences Centre,;Toronto, Ontario, Canada. Electronic address: peter.kertes@sunnybrook.ca.;Ontario, Canada; Department of Ophthalmology, St. Michael's Hospital, Unity;Health Toronto, Toronto, Ontario, Canada; Kensington Eye Institute, Kensington;Vision and Research Centre, Toronto, Ontario, Canada. Electronic address:;rajeev.muni@gmail.com.;Canada. Electronic address: fadatia@gmail.com.;Canada; Department of Ophthalmology and Visual Sciences, Aga Khan University,;Karachi, Pakistan. Electronic address: karim.damji@aku.edu.;Ontario, Canada; Department of Health Research Methods, Evidence and Impact,;McMaster University, Hamilton, Ontario, Canada. Electronic address:;vchaudh@mcmaster.ca.;address: bhurley@toh.ca. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41197714/ |
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