Objectives

The use of rituximab (MabThera®), an anti-CD20 monoclonal antibody, is the most significant development in the management of anti-neutrophil cytoplasm antibody (ANCA)-associated vasculitis (AAV) since the introduction of cytotoxic therapy in 1950. Truxima® is the first anti-CD20 biosimilar approved for the same indications, and has been available in the UK since 2017. Significant cost savings have been reported when switching to biosimilars, which could lead to greater patient access to such treatment. Therefore, it is important to know whether patients’ clinical and laboratory parameters respond equally well to biosimilars as to reference medicines, tested in clinical trials.

Method

We retrospectively reviewed the clinical outcomes and laboratory parameters in 257 consecutive patients treated with anti-CD20 depletion therapy using MabThera or Truxima, for induction and maintenance of remission, in two tertiary renal centres between 2010 and 2019.

Results

We demonstrated no difference between patients treated with MabThera or Truxima in rates of remission, relapse, and hospitalization with infection when used for either induction or maintenance of remission of AAV. In one hospital subgroup analysis, we showed comparable levels of hypogammaglobulinaemia, B-cell depletion, and frequency of infusion reactions, with no significant differences.

Conclusion

The efficacy and safety of the rituximab biosimilar Truxima are not inferior to the originator MabThera in patients with AAV. Truxima represents a cheaper and safe therapeutic alternative that could increase patient access to rituximab.

中文翻译：

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使用利妥昔单抗原药 MabThera 与生物仿制药 Truxima 在 ANCA 相关性血管炎患者中的疗效比较

 目标

利妥昔单抗 (MabThera®) 是一种抗 CD20 单克隆抗体，它的使用是自 1950 年引入细胞毒性疗法以来抗中性粒细胞胞质抗体 (ANCA) 相关性血管炎 (AAV) 治疗方面最重要的进展。是第一个被批准用于相同适应症的抗 CD20 生物仿制药，自 2017 年起在英国上市。 据报道，改用生物仿制药可节省大量成本，这可能会导致更多患者获得此类治疗。因此，了解患者的临床和实验室参数对临床试验中测试的生物仿制药和参考药物的反应是否同样良好非常重要。

 方法

我们回顾性审查了 2010 年至 2019 年间在两个三级肾脏中心使用 MabThera 或 Truxima 接受抗 CD20 耗竭治疗以诱导和​​维持缓解的 257 名连续患者的临床结果和实验室参数。

 结果

我们证明，当用于诱导或维持 AAV 缓解时，接受 MabThera 或 Truxima 治疗的患者在缓解率、复发率和感染住院率方面没有差异。在一项医院亚组分析中，我们显示低丙种球蛋白血症、B 细胞耗竭和输注反应频率的水平相当，但没有显着差异。

 结论

利妥昔单抗生物仿制药 Truxima 在 AAV 患者中的疗效和安全性并不逊色于原研药美罗华 (MabThera)。 Truxima 代表了一种更便宜且安全的治疗替代方案，可以增加患者获得利妥昔单抗的机会。