Department of Medicine and Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne Melbourne, Australia.
Biogen Idec Inc. Cambridge, Massachusetts.
Ann Clin Transl Neurol. 2015 Apr;2(4):373-87. doi: 10.1002/acn3.180. Epub 2015 Feb 27.
To compare treatment efficacy and persistence in patients who switched to natalizumab versus those who switched between glatiramer acetate (GA) and interferon-beta (IFNβ) after an on-treatment relapse on IFNβ or GA using propensity score matched real-world datasets.
Patients included were registered in MSBase or the TYSABRI Observational Program (TOP), had relapsed on IFNβ or GA within 12 months prior to switching to another therapy, and had initiated natalizumab or IFNβ/GA treatment ≤6 months after discontinuing prior therapy. Covariates were balanced across post switch treatment groups by propensity score matching at treatment initiation. Relapse, persistence, and disability measures were compared between matched treatment arms in the total population (n = 869/group) and in subgroups defined by prior treatment history (IFNβ only [n = 578/group], GA only [n = 165/group], or both IFNβ and GA [n = 176/group]).
Compared to switching between IFNβ and GA, switching to natalizumab reduced annualized relapse rate in year one by 65-75%, the risk of first relapse by 53-82% (mean follow-up 1.7-2.2 years) and treatment discontinuation events by 48-65% (all P ≤ 0.001). In the total population, switching to natalizumab reduced the risk of confirmed disability progression by 26% (P = 0.036) and decreased the total disability burden by 1.54 EDSS-years (P < 0.0001) over the first 24 months post switch.
Using large, real-world, propensity-matched datasets we demonstrate that after a relapse on IFNβ or GA, switching to natalizumab (rather than between IFNβ and GA) led to superior outcomes for patients in all measures assessed. Results were consistent regardless of the prior treatment identity.
通过使用倾向评分匹配的真实世界数据集，比较在接受 IFNβ 或 GA 治疗后发生治疗中复发的患者，由转换为那他珠单抗与转换为 GA 或 IFNβ 之间的治疗效果和持续性。
纳入的患者登记在 MSBase 或 TYSABRI 观察性计划（TOP）中，在转换为另一种治疗方法之前的 12 个月内，因复发而停止 IFNβ 或 GA 治疗，且在停止先前治疗后≤6 个月开始使用那他珠单抗或 IFNβ/GA 治疗。在治疗开始时通过倾向评分匹配平衡转换后治疗组的协变量。在总人群（每组 n=869）和根据先前治疗史定义的亚组（仅 IFNβ[每组 n=578]、仅 GA[每组 n=165]或 IFNβ 和 GA 两者[每组 n=176]）中比较匹配治疗组之间的复发、持续性和残疾指标。
与在 IFNβ 和 GA 之间转换相比，转换为那他珠单抗可使第一年的年化复发率降低 65-75%，首次复发的风险降低 53-82%（平均随访 1.7-2.2 年），并降低治疗停药事件的风险 48-65%（均 P≤0.001）。在总人群中，转换为那他珠单抗可使确认残疾进展的风险降低 26%（P=0.036），并在转换后 24 个月内减少 1.54 个 EDSS 年的总残疾负担（P<0.0001）。
使用大型、真实世界、倾向评分匹配的数据集，我们证明在 IFNβ 或 GA 治疗后发生复发后，转换为那他珠单抗（而非在 IFNβ 和 GA 之间转换）可使所有评估指标的患者获得更好的结果。结果在无论先前的治疗身份如何，结果都是一致的。
