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Evaluation of the Cross-reactivity of Antidrug Antibodies to CT-P13 and Infliximab Reference Product (Remicade): An Analysis Using Immunoassays Tagged with Both Agents

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
Author
유대현
Keywords
ACTIVE RHEUMATOID-ARTHRITIS; ANKYLOSING-SPONDYLITIS; PARALLEL-GROUP; INFLAMMATORY DISEASES; INNOVATOR INFLIXIMAB; DOUBLE-BLIND; EFFICACY; IMMUNOGENICITY; SAFETY; PHARMACOKINETICS
Issue Date
2017-06
Publisher
ADIS INT LTD
Citation
BIODRUGS, v. 31, no. 3, page. 223-237
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 electro-chemiluminescence (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 kappa 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 rho 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.
URI
https://link.springer.com/article/10.1007%2Fs40259-017-0219-4http://repository.hanyang.ac.kr/handle/20.500.11754/114457
ISSN
1173-8804; 1179-190X
DOI
10.1007/s40259-017-0219-4
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COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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