title: Clinical characteristics of adverse events associated with therapeutic monoclonal antibodies in Korea.
abstract: The use of monoclonal antibodies (mAbs) is increasing in various clinical fields. Although mAb safety must be demonstrated prior to approval, targeted pharmacovigilance is essential for the recognition and assessment of adverse reactions. The purpose of this study was to identify the major clinical features of adverse reactions to mAbs in Korea.
  
  
  
  Spontaneous reports of adverse reactions attributed to 18 mAbs from January 2005 to December 2014 were extracted from the Korea Adverse Event Reporting System. We analyzed these reports for information relating to patient characteristics and the types of adverse reactions.
  
  
  
  In total, 11 492 adverse reactions were reported in 7569 patients. Almost 19% of total study population showed suspected hypersensitivity reactions. Leukocyte abnormalities were reported frequently (10.0%), as well as infections (9.5%), drug eruptions (7.5%), and pruritus (5.0%). Furthermore, 3716 of the adverse reactions in 2538 patients were classified as serious; these included severe infections (18.2%), neutropenia (12.1%), visual dysfunctions (6.6%), and anaphylaxis (4.8%). The mAbs with the highest number of adverse reaction reports were rituximab (27.6%), adalimumab (17.5%), cetuximab (11.9%), and infliximab (10.7%).
  
  
  
  Hypersensitivity reactions were observed more frequently than expected, although no previously unrecognized reactions were observed. Adverse reactions occurred more frequently in children and in elderly patients. Close monitoring of adverse reactions to therapeutic mAbs is therefore warranted because these can potentially cause serious medical conditions or death. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Division of Allergy and Immunology, Department of Internal Medicine, Institute of Allergy, Severance Hospital Regional Pharmacovigilance Center, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Da Woon
authors.identifier: 0000-0002-9723-0720
authors.initials: DW
authors.lastname: Sim
authors.affiliation: Division of Allergy and Immunology, Department of Internal Medicine, Institute of Allergy, Severance Hospital Regional Pharmacovigilance Center, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Park
authors.affiliation: Division of Allergy and Immunology, Department of Internal Medicine, Institute of Allergy, Severance Hospital Regional Pharmacovigilance Center, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Hye Jung
authors.initials: HJ
authors.lastname: Park
authors.affiliation: Division of Allergy and Immunology, Department of Internal Medicine, Institute of Allergy, Severance Hospital Regional Pharmacovigilance Center, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Young Woong
authors.initials: YW
authors.lastname: Son
authors.affiliation: Division of Allergy and Immunology, Department of Internal Medicine, Institute of Allergy, Severance Hospital Regional Pharmacovigilance Center, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Sang Chul
authors.initials: SC
authors.lastname: Lee
authors.affiliation: Division of Allergy and Immunology, Department of Internal Medicine, Institute of Allergy, Severance Hospital Regional Pharmacovigilance Center, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Jung-Won
authors.initials: JW
authors.lastname: Park
authors.affiliation: Division of Allergy and Immunology, Department of Internal Medicine, Institute of Allergy, Severance Hospital Regional Pharmacovigilance Center, Yonsei University College of Medicine, Seoul, Korea. jhleemd@yuhs.ac.
authors.forename: Jae-Hyun
authors.initials: JH
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003875:Drug Eruptions / Q000453:epidemiology* / Q000209:etiology; D004342:Drug Hypersensitivity / Q000453:epidemiology* / Q000209:etiology; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D056910:Republic of Korea / Q000453:epidemiology; D012189:Retrospective Studies; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal
keywords: adverse reaction; hypersensitivity; monoclonal antibody; neutropenia; pharmacovigilance; preferred term