Dataset related to article: "Full Interchangeability in Regard to Immunogenicity Between the Infliximab Reference Biologic and Biosimilars CT-P13 and SB2 in Inflammatory Bowel Disease"

This record contains raw data related to article "Full Interchangeability in Regard to Immunogenicity Between the Infliximab Reference Biologic and Biosimilars CT-P13 and SB2 in Inflammatory Bowel Disease" Infliximab (IFX) biosimilars CT-P13 and SB2 have comparable efficacy, safety, and immunogenicity to the originator Remicade (RMC). However, concerns about cross-switching patients between the 3 brands were raised in the absence of cross reactivity data between them. We aimed to determine whether antibodies to infliximab (ATI) in inflammatory bowel disease (IBD) patients cross-react with RMC, CT-P13, and SB2. Methods: Based on previous ATI status, samples from 34 patients participating in the BIOSIM01 study (13 RMC, 9 CT-P13, and 12 switchers) were selected. Patients were treated with either RMC only, or CT-P13 only, or with RMC switched to CT-P13. Additionally, 28 IFX-naïve patients were assayed as controls. In total, 180 samples were analyzed. ATI trough levels were measured in parallel with 3 different bridging Enzyme Linked Immunosorbent Assays constructed using the 3 drugs. Spearman's coefficient and percentages of agreement were used to study the correlation between each assay. Results: In total, 76 samples out of 152 IFX-treated patient samples were ATI-positive (30 RMC, 14 CT-P13, and 32 switchers). All resulted ATI-positive when either CT-P13 or SB2 bridging assays were used. The overall percentage of agreement was 100% when compared either with CT-P13 or SB2 assays. No significant differences were found among ATI levels and coefficients (Spearman's 0.98 to 1.0, P &lt; 0.0001). Conclusions: ATI of RMC-treated, CT-P13-treated or RMC to CT-P13 switched patients show full cross-reactivity with CT-P13 and SB2. Findings suggest that immunodominant epitopes in the reference and CT-P13 drugs are equally present in SB2. Data support full interchangeability between biosimilars in regard to immunogenicity.本数据集收录了与题为《英夫利昔单抗（Infliximab）原研生物制剂与生物类似药CT-P13、SB2在炎症性肠病中的免疫原性完全互换性》的学术论文相关的原始研究数据。英夫利昔单抗（Infliximab）生物类似药CT-P13与SB2的疗效、安全性及免疫原性与原研药类克（Remicade, RMC）相当。但此前因缺乏三款药物间的交叉反应数据，学界对患者在三款制剂间跨线切换治疗的安全性存在担忧。本研究旨在明确炎症性肠病（Inflammatory Bowel Disease, IBD）患者体内的英夫利昔单抗抗体（anti-infliximab antibodies, ATI）是否可与RMC、CT-P13及SB2发生交叉反应。研究方法：本研究基于既往ATI检测结果，选取了BIOSIM01研究中34例患者的样本（其中13例仅接受RMC治疗、9例仅接受CT-P13治疗、12例为跨药切换患者）。患者治疗方案分为三类：仅使用RMC、仅使用CT-P13，以及由RMC切换为CT-P13。此外纳入28例未接受过英夫利昔单抗治疗的患者作为对照。本研究共分析180份样本。采用分别以RMC、CT-P13、SB2为包被抗原的三款桥接酶联免疫吸附试验（Enzyme Linked Immunosorbent Assay, ELISA）同步检测ATI谷浓度。采用斯皮尔曼（Spearman）相关系数与一致率分析各检测方法间的相关性。研究结果：在152份接受英夫利昔单抗治疗的患者样本中，共76份ATI检测呈阳性（RMC组30份、CT-P13组14份、切换组32份）。当采用CT-P13或SB2作为包被抗原的桥接ELISA检测时，所有ATI阳性样本均呈阳性反应。以CT-P13或SB2检测方法为参照时，整体一致率均为100%。各组ATI水平与相关系数（斯皮尔曼系数0.98~1.0，P<0.0001）均无显著差异。研究结论：接受RMC治疗、CT-P13治疗，或由RMC切换为CT-P13治疗的患者体内ATI均与CT-P13、SB2完全交叉反应。本研究结果提示，原研药与CT-P13中的免疫显性表位在SB2中均完整保留。本研究数据支持各生物类似药间在免疫原性层面具备完全互换性。