Zeng Li, Chen Huihui, Xiang Heng, Zeng Mengru, Zhou Mi, Tan Chongqing, Liu Hong, Chen Guochun
Department of Nephrology, The Second Xiangya Hospital of Central South University, Changsha, China.
Hunan Key Laboratory of Kidney Disease and Blood Purification, The Second Xiangya Hospital of Central South University, Changsha, China.
Front Pharmacol. 2024 Jan 8;14:1309930. doi: 10.3389/fphar.2023.1309930. eCollection 2023.
Rituximab (RTX) is a monoclonal antibody that selectively targets CD20 and is frequently used in the treatment of membranous nephropathy (MN). Analysis of the therapeutic efficacy and safety of RTX in treating MN in practice and a comparative pharmacoeconomic analysis of the RTX and traditional tacrolimus (TAC) regimens can provide valuable insights to aid decision-making by the government and relevant medical insurance departments. We conducted a statistical analysis of medical records from patients diagnosed with MN who underwent RTX treatment between 1 January 2019 and 1 January 2023. The TAC data were obtained from the clinical literature. The efficacy rates and incidence of adverse effects (AEs) were calculated to compare the efficacy and safety of RTX and TAC. Based on the patient's disease status, we developed a Markov model to compare the total cost, remission rate, and incremental cost-effectiveness ratio (ICER) of the two regimens. Both univariate and probability sensitivity analyses were performed to validate the stability of the developed model. The RTX group enrolled 53 patients with MN, and the 12-month overall efficacy rate was not significantly different from that of the TAC group with 35 patients (86.79% vs. 71.4%, = 0.0131); however, the relapse rate was significantly lower in the RTX group (3.77% vs. 22.8%, = 0.016). The RTX group demonstrated no severe AEs (SAEs), while the TAC group demonstrated six cases of SAEs, including 4 cases of severe pneumonia, 1 case of lung abscess and 1 case of interstitial lung disease, accounting for 7.89% of traditional tacrolimus-treated patients. The baseline analysis results revealed that over a 5-year post-treatment period, RTX increased quality-adjusted life years (QALYs) by 0.058 and costs by ¥7,341. Assuming three times the 2022 domestic gross domestic product as the willingness-to-pay (WTP) threshold per QALY, the ICER of RTX compared to TAC was ¥124,631.14/QALY, which is less than the WTP threshold of ¥257,094/QALY, indicating that RTX treatment is approximately two times more cost-effective compared to TAC. The current analysis indicates that despite the expensive unit price of RTX, it remains a cost-effective treatment option for MN compared to TAC.
利妥昔单抗（RTX）是一种选择性靶向CD20的单克隆抗体，常用于治疗膜性肾病（MN）。分析RTX在治疗MN中的实际疗效和安全性，并对RTX与传统他克莫司（TAC）治疗方案进行药物经济学对比分析，可为政府和相关医疗保险部门的决策提供有价值的见解。我们对2019年1月1日至2023年1月1日期间接受RTX治疗的MN患者的病历进行了统计分析。TAC数据来自临床文献。计算有效率和不良反应（AE）发生率，以比较RTX和TAC的疗效和安全性。根据患者的疾病状况，我们建立了一个马尔可夫模型，以比较两种治疗方案的总成本、缓解率和增量成本效益比（ICER）。进行了单因素分析和概率敏感性分析，以验证所建立模型的稳定性。RTX组纳入了53例MN患者，其12个月的总有效率与35例患者的TAC组无显著差异（86.79%对71.4%，P = 0.0131）；然而，RTX组的复发率显著更低（3.77%对22.8%，P = 0.016）。RTX组未出现严重AE（SAE），而TAC组出现了6例SAE，包括4例严重肺炎、1例肺脓肿和1例间质性肺病，占接受传统他克莫司治疗患者的7.89%。基线分析结果显示，在治疗后的5年期间，RTX使质量调整生命年（QALY）增加了0.058，成本增加了7341元。假设以2022年国内生产总值的三倍作为每QALY的支付意愿（WTP）阈值，RTX与TAC相比的ICER为124631.14元/QALY，低于257094元/QALY的WTP阈值，这表明与TAC相比，RTX治疗的成本效益约高两倍。目前的分析表明，尽管RTX单价昂贵，但与TAC相比，它仍然是MN一种具有成本效益的治疗选择。
