Division of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Ubon Ratchathani University, Ubon Ratchathani, Thailand.
Division of Neurology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand; Siriraj Neuroimmunology Center, Division of Neurology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand; Bumrungrad International Hospital, Bangkok, Thailand.
Mult Scler Relat Disord. 2023 Jul;75:104729. doi: 10.1016/j.msard.2023.104729. Epub 2023 Apr 23.
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disorder of the central nervous system. The immunopathology of MS involves both T and B lymphocytes. Rituximab is one of the anti-CD20 monoclonal antibody therapies which deplete B-cells. Although some anti-CD20 therapies have been approved by the Food and Drug Administration for treatment of MS, rituximab is used off-label. Several studies have shown that rituximab has a good efficacy and safety in MS, including certain specific patient conditions such as treatment-naïve patients, treatment-switching patients, and the Asian population. However, there are still questions about the optimal dose and duration of rituximab in MS due to the different dosing regimens used in each study. Moreover, many biosimilars have become available at a lower cost with comparable physicochemical properties, pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity. Thus, rituximab may be considered as a potential therapeutic option for patients without access to standard treatment. This narrative review summarized the evidence of both original and biosimilars of rituximab in MS treatment including pharmacokinetics, pharmacodynamics, clinical efficacy, safety, and dosing regimen.
多发性硬化症(MS)是一种中枢神经系统的慢性炎症性脱髓鞘疾病。MS 的免疫病理学涉及 T 细胞和 B 细胞。利妥昔单抗是一种抗 CD20 单克隆抗体疗法,可耗竭 B 细胞。虽然一些抗 CD20 疗法已被美国食品和药物管理局批准用于治疗 MS,但利妥昔单抗是被超说明书使用的。多项研究表明,利妥昔单抗在 MS 中的疗效和安全性良好,包括某些特定患者情况,如初治患者、转换治疗患者和亚洲人群。然而,由于每个研究中使用的剂量方案不同,关于 MS 中利妥昔单抗的最佳剂量和持续时间仍存在疑问。此外,许多生物类似药以更低的成本提供,具有可比的理化特性、药代动力学、药效学、疗效、安全性和免疫原性。因此,对于无法获得标准治疗的患者,利妥昔单抗可能被视为一种潜在的治疗选择。本文综述了利妥昔单抗及其生物类似药在 MS 治疗中的证据,包括药代动力学、药效学、临床疗效、安全性和剂量方案。