Comparison of outcomes using the rituximab originator MabThera with the biosimilar Truxima in patients with ANCA-associated vasculitis
Comparison of outcomes using the rituximab originator MabThera with the biosimilar Truxima in patients with ANCA-associated vasculitis
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DOI：
10.1080/03009742.2021.1926318
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发表时间：
2021-07-24
影响因子：
2.1
通讯作者：
Salama, A. D.
中科院分区：
文献类型：
--
作者：
Antonelou, M.;Abro, A.;Salama, A. D.
利妥昔单抗（MabThera）是一种抗cd20单克隆抗体，是自1950年引入细胞毒疗法以来治疗抗中性粒细胞细胞质抗体（ANCA）相关血管炎（AAV）的最重大进展。Truxima(R)是首个获批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，改用生物类似药可显著节省成本，这可能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的反应是否与参比药物一样好是很重要的。方法回顾性分析2010年至2019年在两个三级肾脏中心连续接受MabThera或Truxima抗cd20消耗治疗的257例患者的临床结果和实验室参数，以诱导和维持缓解。结果：在诱导或维持AAV缓解时，使用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。在一个医院亚组分析中，我们发现低γ球蛋白血症、b细胞耗损和输液反应频率的水平相当，没有显著差异。结论利妥昔单抗生物类似药Truxima治疗AAV患者的疗效和安全性不逊于原研药MabThera。曲昔是一种更便宜、更安全的治疗选择，可以增加患者获得利妥昔单抗的机会。
Objectives The use of rituximab (MabThera(R)), 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(R) 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.