Division of Neuroimmunology Department of Neurology Rocky Mountain Multiple Sclerosis Center at the University of Colorado Aurora Colorado.
Skaggs School of Pharmacy and Pharmaceutical Sciences University of Colorado Aurora Colorado.
Ann Clin Transl Neurol. 2018 Dec 9;6(2):252-262. doi: 10.1002/acn3.700. eCollection 2019 Feb.
To compare 2-year effectiveness and discontinuation of natalizumab (NTZ) versus fingolimod (FTY) and dimethyl fumarate (DMF) in the treatment of multiple sclerosis (MS).
Patients prescribed NTZ, FTY, or DMF at the Rocky Mountain MS Center at University of Colorado were identified. Clinician-reported data were retrospectively collected. Outcomes include a composite effectiveness measure consisting of new T2 lesion, gadolinium-enhancing lesion, and/or clinical relapse, individual effectiveness outcomes and discontinuation over 2 years. Logistic regression was used for data analysis on patients matched by propensity scores and using ATT doubly robust weighting estimator.
A total of 451, 271, and 342 patients were evaluated on NTZ, FTY, and DMF over 2 years, respectively. Patients had a mean age of 39.8 (NTZ), 42.5(FTY), and 45.8 (DMF) years; were predominantly female (76.7% NTZ; 72.0% FTY; 69.6% DMF); and had a mean MS disease duration of 11-12 years for all groups. At ≤24 months, 22.2%, 34.7%, and 33.6% experienced a new T2 lesion, gadolinium-enhancing lesion, and/or clinical relapse on NTZ, FTY, and DMF, respectively. Using ATT doubly robust weighting estimator, FTY versus NTZ and DMF versus NTZ had an odds ratio of 2.00 (95%CI:[1.41-2.85], < 0.001) and 2.38 [95% CI: 1.68-3.37], < 0.001) respectively, for experiencing a new T2 lesion, gadolinium enhancing lesion, and/or clinical relapse. At ≤24 months, 32.6%, 34.3%, and 47.1% discontinued NTZ, FTY, and DMF, respectively. The majority of discontinuations were due to becoming JCV positive(12.6%) for NTZ and due to adverse events for both FTY(17%) and DMF(24.0%).
NTZ appears to be more effective and tolerable than FTY and DMF.
比较纳武利尤单抗（NTZ）、芬戈莫德（FTY）和二甲基富马酸（DMF）治疗多发性硬化症（MS）的 2 年疗效和停药率。
在科罗拉多大学洛基山 MS 中心，确定了接受 NTZ、FTY 或 DMF 治疗的患者。回顾性收集临床医生报告的数据。结果包括新 T2 病变、钆增强病变和/或临床复发的综合有效措施、个体有效结果和 2 年内停药率。采用倾向评分匹配的逻辑回归分析和 ATT 双重稳健加权估计进行数据分析。
在 2 年内，分别有 451、271 和 342 例患者接受了 NTZ、FTY 和 DMF 治疗。患者的平均年龄分别为 39.8（NTZ）、42.5（FTY）和 45.8（DMF）岁；均为女性（76.7% NTZ；72.0% FTY；69.6% DMF）；MS 病程平均为 11-12 年。在≤24 个月时，NTZ、FTY 和 DMF 组分别有 22.2%、34.7%和 33.6%的患者出现新 T2 病变、钆增强病变和/或临床复发。使用 ATT 双重稳健加权估计，FTY 与 NTZ 和 DMF 与 NTZ 相比，新 T2 病变、钆增强病变和/或临床复发的比值比分别为 2.00（95%CI：[1.41-2.85]，<0.001）和 2.38[95%CI：1.68-3.37]，<0.001）。在≤24 个月时，NTZ、FTY 和 DMF 组分别有 32.6%、34.3%和 47.1%的患者停药。大多数停药是由于 JCV 阳性（NTZ 组 12.6%）和不良反应（FTY 组 17%和 DMF 组 24.0%）。
NTZ 似乎比 FTY 和 DMF 更有效和耐受。
