Toxicological Research

  • 제40권4호
  • /
  • Pages.673-682
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  • 2024
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  • 1976-8257(pISSN)
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  • 2234-2753(eISSN)
한국독성학회 (Korean Society of Toxicology & Korea Environmental Mutagen Society)
권호 표지
DOI QR코드

DOI QR Code

Adverse events associated with SARS-CoV-2 neutralizing monoclonal antibodies using the FDA adverse event reporting system database

  • Min Joung Choi (Research Institute of Pharmaceutical Sciences, College of Pharmacy, Chosun University) ;
  • Se‑Hun Oh (College of Pharmacy, The Catholic University of Korea) ;
  • Yun‑Kyoung Song (College of Pharmacy, The Catholic University of Korea) ;
  • Sung Hwan Ki (Research Institute of Pharmaceutical Sciences, College of Pharmacy, Chosun University)
  • 투고 : 2024.03.28
  • 심사 : 2024.07.10
  • 발행 : 2024.10.15
⟨ 이전 논문 다음 논문 ⟩

초록

The purpose of this study was to analyze the important medical events (IMEs) of anti-severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) monoclonal antibodies using the reports from the United States Food and Drug Administration (US FDA) adverse event reporting system (FAERS) and to detect safety signals. In this study, data from the FAERS from January 2020 to December 2022 were used to investigate signals associated with fve monoclonal antibody products (bamlanivimab, bamlanivimab/etesevimab, bebtelovimab, casirivimab/imdevimab, sotrovimab) in coronavirus disease 2019 (COVID-19) patients and one monoclonal antibody product (tixagevimab/cilgavimab) in patients wherein COVID-19 vaccination was not recommended. Disproportionality analyses were conducted using the reporting odds ratio, and an information component to identify safety signals. There were 17,937,860 drug AE reports associated with all drugs in the FAERS documented during research period. Among them, 42,642 were AE reports associated with anti-SARS-CoV-2 monoclonal antibodies. The SOCs including respiratory, thoracic and mediastinal, and vascular disorders were frequently reported for all the six products. The three most commonly detected IMEs were hypoxia, COVID-19 pneumonia, and anaphylactic reaction due to SARS-CoV-2 neutralizing antibodies. Even though the purposes of use were different, the types of signals between drugs were similar. Careful monitoring of these AEs should be considered for certain COVID-19 patients, at risk, when they are treated with monoclonal antibody products.

키워드

과제정보

This study was supported by Chosun University (2022).

참고문헌

  1. FDA. Information about the covid 19 treatments. http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs. Accessed 31 Dec 2023 
  2. Jiang S, Hillyer C, Du L (2020) Neutralizing antibodies against SARS-CoV-2 and other human coronaviruses. Trends Immunol 41:355-359. https://doi.org/10.1016/j.it.2020.03.007 
  3. Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ (2022) Intramuscular AZD7442 (tixagevimab-cilgavimab) for prevention of COVID-19. N Engl J Med 386:2188-2200. https://doi.org/10.1056/NEJMoa2116620 
  4. FDA. Administration US FDA Adverse event reporting system. http://open.fda.gov/data/fares. Accessed 31 Dec 2023 
  5. de Abajo FJ (2005) Improving pharmacovigilance beyond spontaneous reporting. Intern J Pharma Med 19:209-218. https://doi.org/10.2165/00124363-200519040-00002 
  6. Woo EJ (2014) Postmarketing safety of biologics and biological devices. Spine J 14:560-565. https://doi.org/10.1016/j.spinee.2013.09.056 
  7. Fukazawa C, Hinomura Y, Kaneko M, Narukawa M (2018) Significance of data mining in routine signal detection: analysis based on the safety signals identified by the FDA. Pharmacoepidemiol Drug Saf 27:1402-1408. https://doi.org/10.1002/pds.4672 
  8. Brown EG, Wood L, Wood S (1999) The medical dictionary for regulatory activities (MedDRA). Drug Saf 20:109-117. https://doi.org/10.2165/00002018-199920020-00002 
  9. Gatti M, Fusaroli M, Raschi E, Moretti U, Poluzzi E, De Ponti F (2021) Serious adverse events with tedizolid and linezolid: pharmacovigilance insights through the FDA adverse event reporting system. Expert Opin Drug Saf 20:1421-1431. https://doi.org/10.1080/14740338.2021.1956461 
  10. Fusaroli M, Raschi E, Giunchi V, Menchetti M, Rimondini Giorgini R, De Ponti F, Poluzzi E (2022) Impulse control disorders by dopamine partial agonists: a pharmacovigilance-pharmacodynamic assessment through the FDA adverse event reporting system. Int J Neuropsychopharmacol 25:727-736. https://doi.org/10.1093/ijnp/pyac031 
  11. EMA. Agency EMA important medicinal event terms list version 25. http://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eurdavigilance/eudravigilance-system-overview. Accessed 31 Dec 2023 
  12. Baek J-W, Yang BR, Choi S, Shin K-H (2021) Signal Detection for adverse events of finasteride using Korea Adverse Event Reporting System (KAERS) database. Korean J Clin Pharm 31:324-331. https://doi.org/10.24304/kjcp.2021.31.4.324 
  13. Sakaeda T, Tamon A, Kadoyama K, Okuno Y (2013) Data mining of the public version of the FDA adverse event reporting system. Int J Med Sci 10:796.https://doi.org/10.7150/ijms.6048 
  14. Hazell L, Shakir SA (2006) Under-reporting of adverse drug reactions. Drug Saf 29:385-396. https://doi.org/10.2165/00002018-200629050-00003 
  15. Ramirez E, Gonzalez-Munoz M, Kulkarni C, de Abajo FJ (2022) Reducing the harm of medication-recent trends in pharmacovigilance. Front Pharmacol 13:964125. https://doi.org/10.3389/fphar.2023.1175039 
  16. Sarker A, Ginn R, Nikfarjam A, O'Connor K, Smith K, Jayaraman S, Upadhaya T, Gonzalez G (2015) Utilizing social media data for pharmacovigilance: a review. J Biomed Inform 54:202-212. https://doi.org/10.1016/j.jbi.2015.02.004 
  17. Yin Y, Shu Y, Zhu J, Li F, Li J (2022) A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for osimertinib. Sci Rep 12:19555. https://doi.org/10.1038/s41598-022-23834-1 
  18. FDA (2022) Fact sheet for healthcare providers: emergency use authorization for bamlanivimab. https://www.fda.gov/media/143603/download 
  19. FDA (2021) Fact sheet for healthcare providers: emergency use authorization of REGEN-COV (casirivimab and imdevimab). https://www.fda.gov/media/145611/download 
  20. FDA (2022) Fact sheet for healthcare providers: Emergency use authorization of bamlanivimab and etesevimab. https://www.fda.gov/media/145802/download 
  21. FDA (2022) Fact sheet for healthcare providers: emergency use authorization (EUA) of sotrovimab. https://www.fda.gov/media/149534/download 
  22. FDA (2022) Fact sheet for healthcare providers: emergency use authorization for bebtelovimab. https://www.fda.gov/media/156152/download 
  23. FDA (2023) Fact sheet for healthcare providers: emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab). https://www.fda.gov/media/154701/download 
  24. EMA (2021) Regkirona. https://www.ema.europa.eu/en/medicines/human/EPAR/regkirona 
  25. Abani O, Abbas A, Abbas F, Abbas J, Abbas K, Abbas M, Abbasi S, Abbass H, Abbott A, Abbott A (2022) Baricitinib in patients admitted to hospital with COVID-19 (recovery): a randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet 400:359-368. https://doi.org/10.1016/S0140-6736(22)01109-6 
  26. Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A (2022) Oral nirmatrelvir for high-risk, nonhospitalized adults with Covid-19. N Engl J Med 386:1397-1408. https://doi.org/10.1056/NEJMoa2118542 
  27. Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martin-Quiros A, Caraco Y, Williams-Diaz A, Brown ML (2022) Molnupiravir for oral treatment of Covid-19 in nonhospitalized patients. N Engl J Med 386:509-520. https://doi.org/10.1056/NEJMoa2116044 
  28. Chung C, Kudchodkar SB, Chung CN, Park YK, Xu Z, Pardi N, Abdel-Mohsen M, Muthumani K (2023) Expanding the reach of monoclonal antibodies: a review of synthetic nucleic acid delivery in immunotherapy. Antibodies 12:46. https://doi.org/10.3390/antib12030046 
  29. Renn A, Fu Y, Hu X, Hall MD, Simeonov A (2020) Fruitful neutralizing antibody pipeline brings hope to defeat SARS-Cov-2. Trends Pharmacol Sci 41:815-829. https://doi.org/10.1016/j.tips.2020.07.004 
  30. Corti D, Purcell LA, Snell G, Veesler D (2021) Tackling COVID19 with neutralizing monoclonal antibodies. Cell 184:3086-3108. https://doi.org/10.1016/j.cell.2021.05.005 
  31. Rao SS, Parthasarathy K, Sounderrajan V, Neelagandan K, Anbazhagan P, Chandramouli V (2023) Susceptibility of SARS Coronavirus-2 infection in domestic and wild animals: a systematic review. 3 Biotech 13:5. https://doi.org/10.1007/s13205-022-03416-8 
  32. Planas D, Saunders N, Maes P, Guivel-Benhassine F, Planchais C, Buchrieser J, Bolland W-H, Porrot F, Staropoli I, Lemoine F (2022) Considerable escape of SARS-CoV-2 Omicron to antibody neutralization. Nature 602:671-675. https://doi.org/10.1038/s41586-021-04389-z 
  33. Molina KC, Kennerley V, Beaty LE, Bennett TD, Carlson NE, Mayer DA, Peers JL, Russell S, Wynia MK, Aggarwal NR (2023) Real-world evaluation of bebtelovimab effectiveness during the period of COVID-19 Omicron variants, including BA. 4/BA. 5. Int J Infect Dis 132:34-39. https://doi.org/10.1016/j.ijid.2023.04.396 
  34. Phillips SP, Carver LF (2023) Greatest risk factor for death from covid-19: older age, chronic disease burden, or place of residence? descriptive analysis of population-level canadian data. Int J Environ Res Public Health 20:7181. https://doi.org/10.3390/ijerph20247181 
  35. de Leeuw AJ, Oude Luttikhuis MA, Wellen AC, Muller C, Calkhoven CF (2021) Obesity and its impact on COVID-19. J Mol Med 99:899-915. https://doi.org/10.1007/s00109-021-02072-4 
  36. Dessie ZG, Zewotir T (2021) Mortality-related risk factors of COVID-19: a systematic review and meta-analysis of 42 studies and 423,117 patients. BMC Infect Dis 21:855. https://doi.org/10.1186/s12879-021-06536-3 
  37. Klaassen Z, Wallis CJ (2021) Assessing patient risk from cancer and COVID-19: managing patient distress. Urol Oncol 39:243-246. https://doi.org/10.1016/j.urolonc.2021.01.023 
  38. Purohit D, Ahirwar AK, Sakarde A, Asia P, Gopal N (2021) COVID-19 and lung pathologies. Horm Mol Biol Clin Invest 42:435-443. https://doi.org/10.1515/hmbci-2020-0096 
  39. Zhou Y, Chi J, Lv W, Wang Y (2021) Obesity and diabetes as high-risk factors for severe coronavirus disease 2019 (Covid-19). Diabetes Metab Res Rev 37:e3377. https://doi.org/10.1002/dmrr.3377 
  40. Saxena P, Muthu J (2023) COVID-19 and sickle cell disease: two independent risk factors for venous thromboembolism. Cureus 15:e37226. https://doi.org/10.7759/cureus.37226 
  41. Li P, Liu Y, Cheng Z, Yu X, Li Y (2022) COVID-19-associated liver injury: clinical characteristics, pathophysiological mechanisms and treatment management. Biomed Pharmacotherap 154:113568. https://doi.org/10.1016/j.biopha.2022.113568 
  42. Gandhi RT, Lynch JB, Del Rio C (2020) Mild or moderate Covid19. N Engl J Med 383:1757-1766. https://doi.org/10.1056/NEJMcp2009249 
  43. Lee SJ, Kim J, Lee KH, Lee JA, Kim CH, Lee SH, Park BJ, Kim JH, Ahn JY, Jeong SJ (2023) Risk factors of pneumothorax and pneumomediastinum in COVID-19: a matched case-control study. BMC Infect Dis 23:137. https://doi.org/10.1186/s12879-023-08104-3 
  44. Berenguer J (2022) Neutralizing antibodies for SARS-CoV-2 infection. Rev Esp Quimioter 35:16. https://doi.org/10.37201/req/s03.04.2022 
  45. Yu B, Xiaonan T (2021) Comparison of COVID-19 and influenza characteristics. J Zhejiang Univ Sci B 22:87. https://doi.org/10.1631/jzus.B2000479 
  46. Wolf J, Abzug MJ, Anosike BI, Vora SB, Waghmare A, Sue PK, Olivero RM, Oliveira CR, James SH, Morton TH (2022) Updated guidance on use and prioritization of monoclonal antibody therapy for treatment of COVID-19 in adolescents. J Pediatric Infect Dis Soc 11:177-185. https://doi.org/10.1093/jpids/piab124 
  47. Ntanasis-Stathopoulos I, Filippatos C, Gavriatopoulou M, Malandrakis P, Eleutherakis-Papaiakovou E, Spiliopoulou V, Syrigou R-E, Theodorakakou F, Fotiou D, Migkou M (2023) Tixagevimab/Cilgavimab as pre-exposure prophylaxis against covid-19 for multiple myeloma patients: a prospective study in the omicron era. Diseases 11:123. https://doi.org/10.3390/diseases11030123 
  48. Harrison SL, Buckley BJ, Rivera-Caravaca JM, Zhang J, Lip GY (2021) Cardiovascular risk factors, cardiovascular disease, and COVID-19: an umbrella review of systematic reviews. Eur Heart J Qual Care Clin Outcomes 7:330-339. https://doi.org/10.1093/ehjqcco/qcab029 
  49. Patone M, Mei XW, Handunnetthi L, Dixon S, Zaccardi F, Shankar-Hari M, Watkinson P, Khunti K, Harnden A, Coupland CA (2022) Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat Med 28:410-422. https://doi.org/10.1038/s41591-021-01630-0 
  50. Haidar MA, Shakkour Z, Reslan MA, Al-Haj N, Chamoun P, Habashy K, Kaafarani H, Shahjouei S, Farran SH, Shaito A (2022) SARS-CoV-2 involvement in central nervous system tissue damage. Neural Regen Res 17:1228. https://doi.org/10.4103/1673-5374.327323 
  51. Yu S-Y, Choi M, Cheong C, Ryoo S, Huh K, Yoon YK, Choi J, Kim SB (2023) Clinical efficacy and safety of SARS-CoV-2-neutralizing monoclonal antibody in patients with COVID-19: a living systematic review and meta-analysis. J Microbiol Immunol Infect 56:909-920. https://doi.org/10.1016/j.jmii.2023.07.009 
  52. Carnovale C, Mazhar F, Pozzi M, Gentili M, Clementi E, Radice S (2018) A characterization and disproportionality analysis of medication error related adverse events reported to the FAERS database. Expert Opin Drug Saf 17:1161-1169. https://doi.org/10.1080/14740338.2018.1550069