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在沙特阿拉伯,对那他珠单抗、利妥昔单抗和奥瑞珠单抗治疗复发缓解型多发性硬化症的临床和经济评价。

Clinical and economic evaluations of natalizumab, rituximab, and ocrelizumab for the management of relapsing-remitting multiple sclerosis in Saudi Arabia.

机构信息

Department of Pharmacy, King Saud Medical City, Riyadh, 12746, Saudi Arabia.

Department of Neurology, King Saud Medical City, Riyadh, 12746, Saudi Arabia.

出版信息

BMC Health Serv Res. 2023 May 26;23(1):552. doi: 10.1186/s12913-023-09462-z.

Abstract

INTRODUCTION

The advent of new disease-modifying therapies (DMTs), such as monoclonal antibodies (mAbs), resulted in significant changes in the treatment guidelines for Multiple sclerosis (MS) and improvement in the clinical outcomes. However, mAbs, such as rituximab, natalizumab, and ocrelizumab, are expensive with variable effectiveness rates. Thus, the present study aimed to compare the direct medical cost and consequences (e.g., clinical relapse, disability progression, and new MRI lesions) between rituximab and natalizumab in managing relapsing-remitting multiple sclerosis (RRMS) in Saudi Arabia. Also, the study aimed to explore the cost and consequence of ocrelizumab in managing RRMS as a second-choice treatment.

METHODS

The electronic medical records (EMRs) of patients with RRMS were retrospectively reviewed to retrieve the patients' baseline characteristics and disease progression from two tertiary care centers in Riyadh, Saudi Arabia. Biologic-naïve patients treated with rituximab or natalizumab or those switched to ocrelizumab and treated for at least six months were included in the study. The effectiveness rate was defined as no evidence of disease activity (NEDA-3) (i.e., absence of new T2 or T1 gadolinium (Gd) lesions as demonstrated by the Magnetic Resonance Imaging (MRI), disability progression, and clinical relapses), while the direct medical costs were estimated based on the utilization of healthcare resources. In addition, bootstrapping with 10,000 replications and inverse probability weighting based on propensity score were conducted.

RESULTS

Ninety-three patients met the inclusion criteria and were included in the analysis (natalizumab (n = 50), rituximab (n = 26), ocrelizumab (n = 17)). Most of the patients were otherwise healthy (81.72%), under 35 years of age (76.34%), females (61.29%), and on the same mAb for more than one year (83.87%). The mean effectiveness rates for natalizumab, rituximab, and ocrelizumab were 72.00%, 76.92%, and 58.83%, respectively. Natalizumab mean incremental cost compared to rituximab was $35,383 (95% CI: $25,401.09- $49,717.92), and its mean effectiveness rate was 4.92% lower than rituximab (95% CI: -30-27.5) with 59.41% confidence level that rituximab will be dominant.

CONCLUSIONS

Rituximab seems to be more effective and is less costly than natalizumab in the management of RRMS. Ocrelizumab does not seem to slow the rates of disease progression among patients previously treated with natalizumab.

摘要

简介

随着新型疾病修正疗法(DMT)的出现,如单克隆抗体(mAbs),多发性硬化症(MS)的治疗指南发生了重大变化,临床疗效也得到了改善。然而,利妥昔单抗、那他珠单抗和奥瑞珠单抗等 mAbs 价格昂贵,且有效率存在差异。因此,本研究旨在比较利妥昔单抗和那他珠单抗治疗沙特阿拉伯复发性多发性硬化症(RRMS)的直接医疗成本和结果(如临床复发、残疾进展和新的 MRI 病变)。此外,本研究还旨在探讨奥瑞珠单抗作为二线治疗 RRMS 的成本和结果。

方法

回顾性检索沙特利雅得两家三级护理中心的电子病历(EMR),以获取 RRMS 患者的基线特征和疾病进展情况。纳入接受利妥昔单抗或那他珠单抗治疗或转为奥瑞珠单抗且至少治疗 6 个月的生物初治患者。有效率定义为无疾病活动证据(NEDA-3)(即磁共振成像(MRI)显示无新的 T2 或 T1 钆增强(Gd)病变、残疾进展和临床复发),而直接医疗成本则根据医疗资源的利用情况进行估算。此外,还进行了 10000 次重复的自举和基于倾向评分的逆概率加权。

结果

93 名患者符合纳入标准并纳入分析(那他珠单抗(n=50)、利妥昔单抗(n=26)、奥瑞珠单抗(n=17))。大多数患者身体健康(81.72%)、年龄在 35 岁以下(76.34%)、女性(61.29%)、使用同一种 mAb 超过一年(83.87%)。那他珠单抗、利妥昔单抗和奥瑞珠单抗的平均有效率分别为 72.00%、76.92%和 58.83%。那他珠单抗与利妥昔单抗相比,增量成本为 35383 美元(95%CI:25401.09-49717.92),其有效率比利妥昔单抗低 4.92%(95%CI:-30-27.5),置信度为 59.41%,认为利妥昔单抗更具优势。

结论

利妥昔单抗在 RRMS 治疗中的有效性优于那他珠单抗,且成本更低。奥瑞珠单抗似乎不能降低先前接受那他珠单抗治疗的患者的疾病进展速度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59b7/10223862/a50eae84bfa2/12913_2023_9462_Fig1_HTML.jpg

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