ABSTRACT

Background

Switching from IFX originator to CT-P13 is safe; however, little data on immunogenicity exists.

Research design and methods

Consecutive IBD patients on IFX originator were switched to CT-P13 and followed-up for 12 months. Clinical activity, infliximab trough levels (ITLs), anti-drug antibodies (ATIs), and adverse events were recorded at predefined timepoints (baseline, second CT-P13 infusion, 6 and 12 months). The outcomes investigated were immunogenicity, pharmacokinetics, effectiveness and safety.

Results

119 patients were switched to CT-P13 after a median time with IFX of 5.8 years. No changes in mean ITLs were observed. ATIs were detected in 30 patients (25.2%): 14 before and 16 after switch. Mean persistent ATIs were significantly higher compared to mean transient ones (109.74 ng/mL ±84.70 vs 18.22 ng/mL ±11.37, p < 0.001), with significantly lower ITLs associated (mean 0.32 µg/mL ±0.6 vs 3.08 µg/mL ±3.22, p < 0.001). A significant decrease of patients in steroid-fee clinical remission was observed after the switch (p = 0.004), with subsequent improvement at 6 months (p = 0.005). Eighteen patients (15.1%) discontinued IFX, only 6 (5%) for loss of response.

Conclusions

Switching from infliximab originator to CT-P13 seems safe and effective, without differences in immunogenicity. A temporary reduction of clinical benefit after switching could be potentially explained by a ‘nocebo-effect response’.

中文翻译：

---

从 IFX 原研药转换为生物仿制药 CT-P13 不会影响大量 IBD 患者的有效性、安全性和免疫原性

摘要

背景

从 IFX 创始者切换到 CT-P13 是安全的；然而，关于免疫原性的数据很少。

研究设计和方法

连续使用 IFX 原研药的 IBD 患者改用 CT-P13 并随访 12 个月。在预定时间点（基线、第二次 CT-P13 输注、6 个月和 12 个月）记录临床活性、英夫利昔单抗谷浓度 (ITL)、抗药抗体 (ATI) 和不良事件。研究的结果是免疫原性、药代动力学、有效性和安全性。

结果

119 名患者在中位时间为 5.8 年的 IFX 后转为 CT-P13。没有观察到平均 ITL 的变化。在 30 名患者 (25.2%) 中检测到 ATI：转换前 14 名和转换后 16 名。与平均瞬态 ATI 相比，平均持续性 ATI 显着更高（109.74 ng/mL ±84.70 对 18.22 ng/mL ±11.37，p < 0.001），相关的 ITL 显着降低（平均 0.32 µg/mL ±0.6 对 3.08 µg/mL ± 3.22，p < 0.001）。转换后观察到类固醇费用临床缓解患者显着减少 (p = 0.004)，随后在 6 个月时有所改善 (p = 0.005)。18 名患者 (15.1%) 停用 IFX，仅有 6 名 (5%) 患者因反应丧失而停止治疗。

结论

从英夫利昔单抗原研药转换为 CT-P13 似乎安全有效，免疫原性没有差异。转换后临床益处的暂时减少可能可以用“反安慰剂效应反应”来解释。