Sehrawat Mukul, Madhusudhan Santhosh K, Bakkappa Shubha D, Devendrappa Srinivas L
Department of Pharmacology, JJM Medical College, Davangere, Karnataka, India.
JJM Medical College, Davangere, Karnataka, India.
Ann Indian Acad Neurol. 2023 Nov-Dec;26(6):895-901. doi: 10.4103/aian.aian_467_23. Epub 2023 Sep 27.
Real-world data on the efficacy and cost-effectiveness of multiple sclerosis (MS) disease-modifying drugs (DMTs) is lacking in the Indian setting. The primary objective of this study was to evaluate the efficacy of DMTs, and the secondary objective was to evaluate cost-effectiveness and the quality of life (QoL) in these patients.
Seventy-four patients fulfilling study criteria were recruited in the retrospective observational study, of which 69 completed the study. Primary outcome was measured by annualized relapse rate (ARR), and secondary outcome was measured by WHOQOL-BREF scale, modified Kuppuswamy scale, and rating of DMT scale through a subjective questionnaire.
Patients on natalizumab, rituximab, and glatiramer acetate showed the highest reduction in ARR. The highest reduction of ARR (2.5) was produced by natalizumab and least by Peg-IFNβ1a (0.5). In QoL analysis, teriflunomide group had the highest average score for both physical health (22.7, SD 4.7) and psychological (21.3, SD 4.0) domains, whereas natalizumab group had the lowest average score. Socio-economic status analysis showed DMF, IFNβ 1a, peg-IFNβ 1a, rituximab, and glatiramer acetate are affordable to the upper middle class and above, whereas natalizumab could be afforded only by high-class strata. Teriflunomide was most affordable annually. Study of adverse drug reactions showed natalizumab was very well tolerated by the study participants.
Natalizumab, an infusion DMT, was highly effective in terms of reducing the ARR. Rituximab, an off-label DMT, was found to be very effective. Teriflunomide was overall an effective DMT in terms of affordability, QoL balance, and an acceptable ARR reduction.
在印度环境中,缺乏关于多发性硬化症(MS)疾病修饰药物(DMTs)疗效和成本效益的真实世界数据。本研究的主要目的是评估DMTs的疗效,次要目的是评估这些患者的成本效益和生活质量(QoL)。
在回顾性观察研究中招募了74名符合研究标准的患者,其中69名完成了研究。主要结局通过年化复发率(ARR)衡量,次要结局通过WHOQOL-BREF量表、改良的库普苏瓦米量表以及通过主观问卷对DMT量表进行评分来衡量。
使用那他珠单抗、利妥昔单抗和醋酸格拉替雷的患者ARR降低最多。那他珠单抗使ARR降低最多(2.5),聚乙二醇干扰素β-1a使ARR降低最少(0.5)。在生活质量分析中,特立氟胺组在身体健康(22.7,标准差4.7)和心理(21.3,标准差4.0)领域的平均得分最高,而那他珠单抗组的平均得分最低。社会经济地位分析表明,二甲基富马酸盐、干扰素β-1a、聚乙二醇干扰素β-1a、利妥昔单抗和醋酸格拉替雷对于中上层及以上阶层来说是可承受的,而那他珠单抗只有高阶层能够承受。特立氟胺每年的费用最为低廉。药物不良反应研究表明,研究参与者对那他珠单抗的耐受性非常好。
那他珠单抗,一种静脉输注的DMT,在降低ARR方面非常有效。利妥昔单抗,一种非标签DMT,被发现非常有效。就可承受性、生活质量平衡和可接受的ARR降低而言,特立氟胺总体上是一种有效的DMT。