Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado, Denver, Colorado.
Skagg's School of Pharmacy and Pharmaceutical Sciences at Anschutz Medical Campus, University of Colorado, Denver, Colorado.
Ann Clin Transl Neurol. 2020 Sep;7(9):1466-1476. doi: 10.1002/acn3.51111. Epub 2020 Aug 6.
Limited comparative effectiveness data for rituximab (RTX) versus natalizumab (NTZ), fingolimod (FTY), and dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS) exist.
Clinician-reported data on patients prescribed RTX, NTZ, FTY, or DMF for the treatment of MS at the Rocky Mountain MS Center at the University of Colorado were retrospectively collected. Outcomes included a composite effectiveness measure consisting of clinical relapse, contrast-enhancing lesions, and/or new T2 lesions, individual effectiveness outcomes, and discontinuation. Logistic regression was used on patients matched by propensity scores and using average treatment effect on treated doubly robust weighting estimator.
A total of 182, 451, 271, and 342 patients initiated RTX, NTZ, FTY, and DMF and were followed for 2 years. Before and after adjustment, the odds of experiencing disease activity was significantly higher for FTY [adjusted OR (aOR) = 3.17 (95% CI: 1.81-5.55), P < 0.001].and DMF [aOR = 2.68 (95% CI:1.67-4.29), P < 0.001], and similar for NTZ [aOR = 1.36 (95% CI:0.83-2.23), P = 0.216] versus RTX. When examining months 6-24, NTZ demonstrated higher odds of disease activity compared to RTX [aOR = 2.21 (95% CI: 1.20-4.06), P = 0.007]. Similar odds of discontinuation were seen between NTZ and RTX [aOR = 1.39 (95% CI: 0.88-2.20), P = 0.157]; however, FTY [aOR = 2.02 (95% CI: 1.24-3.30), P = 0.005] and DMF [aOR = 3.27 (95% CI: 2.15-4.97), P < 0.001] had greater odds of discontinuation than RTX.
RTX demonstrated superior effectiveness and discontinuation outcomes compared to FTY and DMF. Although RTX demonstrated similar effectiveness and discontinuation compared to NTZ, RTX had superior effectiveness during months 6-24 and fewer discontinuations when excluding discontinuations due to insurance issues. Results suggest superiority of RTX in reducing disease activity and maintaining long-term treatment in a real-world MS cohort.
目前，关于利妥昔单抗（RTX）与那他珠单抗（NTZ）、芬戈莫德（FTY）和二甲基富马酸（DMF）治疗多发性硬化症（MS）的疗效比较，仅有有限的对照数据。
本研究回顾性收集了在科罗拉多大学洛基山 MS 中心接受 RTX、NTZ、FTY 或 DMF 治疗 MS 的患者的临床报告数据。研究结果包括一个由临床复发、增强病变和/或新的 T2 病变组成的复合疗效指标、个体疗效指标以及停药情况。采用倾向评分匹配的逻辑回归分析和基于处理的双重稳健加权估计的平均处理效果。
共有 182 例、451 例、271 例和 342 例患者分别开始接受 RTX、NTZ、FTY 和 DMF 治疗，并随访 2 年。在调整前后，FTY [校正比值比（aOR）=3.17（95%可信区间：1.81-5.55），P<0.001]和 DMF [aOR=2.68（95%可信区间：1.67-4.29），P<0.001]的疾病活动发生率明显更高，而 NTZ [aOR=1.36（95%可信区间：0.83-2.23），P=0.216]与 RTX 相比则相似。在观察 6-24 个月时，NTZ 与 RTX 相比，疾病活动的几率更高 [aOR=2.21（95%可信区间：1.20-4.06），P=0.007]。NTZ 与 RTX 的停药几率相似 [aOR=1.39（95%可信区间：0.88-2.20），P=0.157]；然而，FTY [aOR=2.02（95%可信区间：1.24-3.30），P=0.005]和 DMF [aOR=3.27（95%可信区间：2.15-4.97），P<0.001]的停药几率高于 RTX。
RTX 与 FTY 和 DMF 相比，疗效和停药结果更优。虽然 RTX 与 NTZ 的疗效和停药情况相似，但在 6-24 个月时，RTX 的疗效更好，且排除因保险问题导致的停药后，RTX 的停药率更低。结果表明，RTX 在降低疾病活动度和维持 MS 真实队列中长期治疗方面具有优越性。
