ABSTRACT

Objectives

There are few comparative data for tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).

Methods

Historical data for reference product/biosimilar intravenous infliximab, or adalimumab and etanercept, were pooled and compared with phase 3 study results for a subcutaneous (SC) formulation of the infliximab biosimilar CT-P13, in a systematic review and meta-analysis (PROSPERO: CRD42019149621).

Results

The authors identified 13 eligible controlled trials that randomized over 5400 participants to prespecified treatments of interest. Comparison with pooled historical data suggested a numerical advantage for CT-P13 SC over intravenous infliximab for almost every prespecified efficacy outcome evaluated, including Disease Activity Score in 28 joints (C-reactive protein/erythrocyte sedimentation rate), Clinical/Simplified Disease Activity Index scores, American College of Rheumatology responses, and multiple measures of disease remission and low disease activity; for the majority of outcomes, there was no overlap in 95% confidence intervals between groups. A numerical advantage for CT-P13 SC was also observed for safety outcomes (adverse events, infections, and discontinuations). Similar, but less marked, trends were observed for comparison with historical efficacy and safety data for adalimumab/etanercept.

Conclusion

CT-P13 SC offers an improved or similar benefit-to-harm ratio compared with infliximab (intravenous) and adalimumab/etanercept, for the treatment of moderate-to-severe RA.

中文翻译：

---

皮下注射英夫利昔单抗与阿达木单抗、依那西普和静脉注射英夫利昔单抗治疗类风湿性关节炎的疗效和安全性：系统文献回顾和荟萃分析

摘要

目标

类风湿性关节炎（RA）患者使用肿瘤坏死因子抑制剂的比较数据很少。

方法

在系统评价和荟萃分析中，将参考产品/生物类似药静脉注射英夫利昔单抗或阿达木单抗和依那西普的历史数据汇总并与英夫利昔单抗生物类似药 CT-P13 皮下 (SC) 制剂的 3 期研究结果进行比较 (PROSPERO: CRD42019149621）。

结果

作者确定了 13 项符合条件的对照试验，这些试验将 5400 多名参与者随机分配到预先指定的感兴趣的治疗中。与汇总的历史数据的比较表明，CT-P13 SC 与静脉注射英夫利昔单抗相比，在评估的几乎所有预先指定的疗效结果方面都具有数值优势，包括 28 个关节的疾病活动评分（C 反应蛋白/红细胞沉降率）、临床/简化疾病活动指数评分，美国风湿病学会的反应，以及疾病缓解和低疾病活动度的多种措施；对于大多数结果，组间 95% 置信区间没有重叠。还观察到 CT-P13 SC 在安全性结果（不良事件、感染和停药）方面的数值优势。相似，但标记较少，

结论

与英夫利昔单抗（静脉内）和阿达木单抗/依那西普相比，CT-P13 SC 提供了改善或相似的获益/危害比，用于治疗中度至重度 RA。