Cohen B A, Coyle P K, Leist T, Oleen-Burkey M A, Schwartz M, Zwibel H
Department of Neurology, Northwestern University, 710 North Lake Shore Drive, Abbott Hall 1121, Chicago, IL 60611, USA.
Department of Neurology, Stony Brook University, Health Sciences Center, T12-020, Stony Brook, NY 11794, USA.
Mult Scler Relat Disord. 2015 Jan;4(1):75-82. doi: 10.1016/j.msard.2014.09.214. Epub 2014 Oct 7.
The objective of the Therapy Optimization in MS (TOP MS) Study was to prospectively assess the relationship between MS disease-modifying therapy (DMT) adherence and MS relapse risk over 2 years.
Potential participants were recruited for TOP MS by specialty pharmacies who dispensed glatiramer acetate and beta interferons for MS nationwide. Signed IRB-approved informed consents were returned to the pharmacies. TOP MS used electronic data capture with monthly patient entries. Adherence, measured by medication possession ratio (MPR), was derived from pharmacy shipment records. Logistic regression examined the association between protocol-defined relapses and DMT MPR (<0.5; >0.5-<0.9; >0.9).
TOP MS enrolled 3151 persons with MS, and 2410 completed the full 2 years. Across all therapies, the mean MPR for the 2-year completer cohort of 2049 who maintained the same DMT was 0.9+0.2 (range: 0.1-1.0), with 63.8% reaching a 2-year MPR >0.9. Evaluated by categories of MPR, the proportion of participants remaining relapse-free for 24 months increased with increasing MPR, and the proportion with >1 relapses declined with increasing levels of MPR (p<0.0008). Regression analysis revealed the odds of relapse for a patient in the MPR >0.9 MPR group was 64% that of a patient in the MPR <0.5 category (p=0.02). Use of >1 DMT prior to the current one was an independent predictor of relapse.
The study provides class III evidence that improvement in adherence to DMT for MS is associated with improved clinical outcomes as measured by relapse reduction.
“多发性硬化症治疗优化（TOP MS）研究”的目的是前瞻性评估2年内多发性硬化症疾病修饰治疗（DMT）依从性与多发性硬化症复发风险之间的关系。
专业药房招募TOP MS的潜在参与者，这些药房在全国范围内为多发性硬化症患者配发醋酸格拉替雷和β干扰素。已签署的经机构审查委员会（IRB）批准的知情同意书被返还给药房。TOP MS使用电子数据采集，患者每月录入信息。通过药物持有率（MPR）衡量的依从性来自药房发货记录。逻辑回归分析了方案定义的复发与DMT MPR（<0.5；>0.5至<0.9；>0.9）之间的关联。
TOP MS招募了3151例多发性硬化症患者，其中2410例完成了完整的2年研究。在所有治疗中，2049例维持相同DMT的2年完成者队列的平均MPR为0.9±0.2（范围：0.1至1.0），63.8%的患者2年MPR>0.9。按MPR类别评估，24个月无复发的参与者比例随MPR升高而增加，复发>1次的比例随MPR水平升高而下降（p<0.0008）。回归分析显示，MPR>0.9组患者复发几率是MPR<0.5组患者的64%（p=0.02）。在当前使用的DMT之前使用过>1种DMT是复发的独立预测因素。
该研究提供了III类证据，表明多发性硬化症DMT依从性的改善与通过减少复发衡量的临床结果改善相关。
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