Abstract：
Rituximab is a monoclonal antibody that targets CD20 antigen in B cells. For pemphigus, rituximab has been highly effective in steroid-sparing therapy for moderate to severe cases. Originator rituximab has demonstrated favorable treatment effects in patients with pemphigus, but its high cost remains a challenge. Biosimilar rituximab is expected to offer a potential solution. However, it is required for the comparative study of efficacy and safety between biosimilar and originator because all biosimilars may not be identical to the originator. In this study, we compared the treatment effects and safety of biosimilar (Truxima) and originator (MabThera) rituximab in patients with pemphigus. A final cohort of 52 patients in the MabThera group and 72 patients in the Truxima group was enrolled. Except for the intravenous immunoglobulin administration rate, there were no differences in baseline characteristics between the two groups, and for the purpose of comparing efficacy, investigations into time to complete remission, total steroid intake to complete remission, and total steroid intake for 6 months following rituximab treatment revealed no significant differences between the two groups. Truxima can be considered a relatively affordable alternative treatment option for pemphigus, offering cost-effectiveness to patients who are indicated for the treatment with MabThera.
摘要：
利妥昔单抗是一种靶向B细胞中CD20抗原的单克隆抗体。天疱疮,利妥昔单抗在中度至重度患者的类固醇保留治疗中非常有效。起源利妥昔单抗已证明天疱疮患者具有良好的治疗效果，但是它的高成本仍然是一个挑战。生物类似药利妥昔单抗有望提供一个潜在的解决方案。然而,在生物仿制药和鼻祖之间的疗效和安全性的比较研究中，这是有必要的，因为所有生物仿制药可能与鼻祖不相同。在这项研究中,我们比较了生物仿制药(Truxima)和鼻源利妥昔单抗(MabThera)在天疱疮患者中的治疗效果和安全性.纳入MabThera组52例患者和Truxima组72例患者的最终队列。除静脉注射免疫球蛋白给药率外，两组之间的基线特征没有差异，为了比较疗效，对完全缓解时间的调查，总类固醇摄入量完全缓解，利妥昔单抗治疗后6个月的类固醇总摄入量显示两组间无显著差异.Truxima可以被认为是天疱疮相对负担得起的替代治疗选择，为接受MabThera治疗的患者提供成本效益。
