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Nationwide pharmacovigilance data for cetuximab-induced anaphylaxis and predictive model validation using prospective specific IgE detection

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dc.contributor.author김성렬-
dc.contributor.author박경희-
dc.contributor.author박중원-
dc.contributor.author범승훈-
dc.contributor.author신상준-
dc.contributor.author안중배-
dc.contributor.author이재현-
dc.date.accessioned2021-09-29T01:51:25Z-
dc.date.available2021-09-29T01:51:25Z-
dc.date.issued2021-07-
dc.identifier.issn*-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/184584-
dc.description.abstractBackground: Cetuximab (chimeric monoclonal antibody to human epidermal growth factor receptor) is used to treat colorectal and head and neck cancers. Due to cross-reactivity with galactose-α-1,3-galactose (alpha-gal), it can induce hypersensitivity even at first administration. We aimed to determine the incidence and clinical manifestation of cetuximab-induced anaphylaxis, and to establish a means of predicting its incidence in patients ahead of treatment. Methods: Nationwide and single-center pharmacovigilance data from 2010 to 2017 were collected from the Korea Institute of Drug Safety-Korea Adverse Event Reporting System and Severance Regional Pharmacovigilance Center. Patients scheduled for cetuximab administration were enrolled prospectively. A skin prick test was carried out and serum IgE specific to cetuximab and cross-reactive allergens were measured. Reactions were monitored after cetuximab infusion. Results: Over 8 years, there were 23 reports of anaphylaxis nationwide. In a single-center study, incidence of cetuximab-induced anaphylaxis was 1.1%. Most anaphylaxis occurred at first injection (93.3%), even under pretreatment with anti-allergic drugs. Four of 64 patients (6.3%) experienced severe anaphylaxis. The median cetuximab-specific IgE titer was 6.9 kUA/L in patients experiencing anaphylaxis and 0 kUA/L in those who did not (P < 0.001). The results of alpha-gal, beef sIgE, and cetuximab skin prick testing were similar to those of cetuximab sIgE. Patients who did not experience hypersensitivity were negative in all 4 allergy tests. Its positive and negative predictive values were 100%. Conclusions: Specific IgE detection of cetuximab or alpha-gal can accurately predict cetuximab-induced anaphylaxis prior to first administration.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherElsevier Inc.-
dc.relation.isPartOfWORLD ALLERGY ORGANIZATION JOURNAL-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleNationwide pharmacovigilance data for cetuximab-induced anaphylaxis and predictive model validation using prospective specific IgE detection-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorKyung Hee Park-
dc.contributor.googleauthorJongsun Lee-
dc.contributor.googleauthorSeung Hoon Beom-
dc.contributor.googleauthorSang Joon Shin-
dc.contributor.googleauthorJoong Bae Ahn-
dc.contributor.googleauthorSung-Ryeol Kim-
dc.contributor.googleauthorJae-Hyun Lee-
dc.contributor.googleauthorJung-Won Park-
dc.identifier.doi10.1016/j.waojou.2021.100553-
dc.contributor.localIdA00566-
dc.contributor.localIdA01427-
dc.contributor.localIdA01681-
dc.contributor.localIdA04581-
dc.contributor.localIdA02105-
dc.contributor.localIdA02262-
dc.contributor.localIdA03086-
dc.relation.journalcodeJ03985-
dc.identifier.eissn1939-4551-
dc.identifier.pmid34257795-
dc.subject.keywordAnaphylaxis-
dc.subject.keywordCetuximab-
dc.subject.keywordSpecific IgE-
dc.contributor.alternativeNameKim, Sung Ryeol-
dc.contributor.affiliatedAuthor김성렬-
dc.contributor.affiliatedAuthor박경희-
dc.contributor.affiliatedAuthor박중원-
dc.contributor.affiliatedAuthor범승훈-
dc.contributor.affiliatedAuthor신상준-
dc.contributor.affiliatedAuthor안중배-
dc.contributor.affiliatedAuthor이재현-
dc.citation.volume14-
dc.citation.number7-
dc.citation.startPage100553-
dc.identifier.bibliographicCitationWORLD ALLERGY ORGANIZATION JOURNAL, Vol.14(7) : 100553, 2021-07-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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