Evaluation of the Cross-reactivity of Antidrug Antibodies to CT-P13 and Infliximab Reference Product (Remicade): An Analysis Using Immunoassays Tagged with Both Agents
DC Field | Value | Language |
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dc.contributor.author | Reinisch, Walter | - |
dc.contributor.author | Jahnsen, Jorgen | - |
dc.contributor.author | Schreiber, Stefan | - |
dc.contributor.author | Danese, Silvio | - |
dc.contributor.author | Panes, Julian | - |
dc.contributor.author | Balsa, Alejandro | - |
dc.contributor.author | Park, Won | - |
dc.contributor.author | Kim, JiSoo | - |
dc.contributor.author | Lee, Jee Un | - |
dc.contributor.author | Yoo, Dae Hyun | - |
dc.date.accessioned | 2021-07-30T05:12:13Z | - |
dc.date.available | 2021-07-30T05:12:13Z | - |
dc.date.created | 2021-05-12 | - |
dc.date.issued | 2017-06 | - |
dc.identifier.issn | 1173-8804 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/3535 | - |
dc.description.abstract | Background During two pivotal clinical trials of the infliximab biosimilar CT-P13 (PLANETAS and PLANETRA), antidrug antibodies (ADAs) and neutralising antibodies (NAbs) were detected in the sera of patients treated with CT-P13 and the reference product (RP; Remicade). Objective The aim was to assess the comparability of Remicade- and CT-P13-tagged immunoassays for the detection of ADAs and NAbs using data from these trials, in order to determine the cross-reactivity of CT-P13 and RP ADAs. Methods Sera from patients with rheumatoid arthritis and ankylosing spondylitis were analysed using an electrochemiluminescence (ECL) bridging assay or Gyros immunoassay, tagged with Remicade or CT-P13 at screening, weeks 14, 30 and 54, and the end of study visit. NAb titre was compared at screening and weeks 14 and 30. The proportion of cross-reactive samples was determined and an inter-rater agreement analysis performed to assess the concordance of results between assays. Results In PLANETAS, 93.1% (94/101) of RP ADA-positive samples and 93.0% (93/100) of RP NAb-positive samples cross-reacted with CT-P13; 99.0% (103/104) of CT-P13 ADA-positive and 98.0% (98/100) of CT-P13 NAb-positive samples cross-reacted with the RP. In PLANETRA, 94.7% (426/450) of RP ADA-positive samples and 94.3% (415/440) of RP NAb-positive samples cross-reacted with CT-P13, and 96.6% (458/474) of CT-P13 ADA-positive and 96.4% (452/469) of CT-P13 NAb-positive samples cross-reacted with the RP. In both studies, there was strong agreement in outcome between assays at all post-screening time points (PLANETAS: Cohen’s κ 0.89–0.98 for ADA, 0.86–0.98 for NAb; PLANETRA: 0.92–0.94 for both ADA and NAb, all p < 0.001). Significant concordance between assays was observed for NAb titre at weeks 14 and 30 (PLANETAS: Spearman’s ρ 0.73 and 0.74, respectively; PLANETRA: 0.61 and 0.72, respectively; all p < 0.001). Conclusions This study has demonstrated that ADAs and NAbs against CT-P13 and RP are cross-reactive, indicating that CT-P13 and RP share immunodominant epitopes. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ADIS INT LTD | - |
dc.title | Evaluation of the Cross-reactivity of Antidrug Antibodies to CT-P13 and Infliximab Reference Product (Remicade): An Analysis Using Immunoassays Tagged with Both Agents | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Yoo, Dae Hyun | - |
dc.identifier.doi | 10.1007/s40259-017-0219-4 | - |
dc.identifier.scopusid | 2-s2.0-85019144709 | - |
dc.identifier.wosid | 000402070900007 | - |
dc.identifier.bibliographicCitation | BIODRUGS, v.31, no.3, pp.223 - 237 | - |
dc.relation.isPartOf | BIODRUGS | - |
dc.citation.title | BIODRUGS | - |
dc.citation.volume | 31 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 223 | - |
dc.citation.endPage | 237 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | ACTIVE RHEUMATOID-ARTHRITIS | - |
dc.subject.keywordPlus | ANKYLOSING-SPONDYLITIS | - |
dc.subject.keywordPlus | PARALLEL-GROUP | - |
dc.subject.keywordPlus | INFLAMMATORY DISEASES | - |
dc.subject.keywordPlus | INNOVATOR INFLIXIMAB | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | IMMUNOGENICITY | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | PHARMACOKINETICS | - |
dc.identifier.url | https://link.springer.com/article/10.1007/s40259-017-0219-4 | - |
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