Perumal Jai, Balabanov Roumen, Su Ray, Chang Roger, Balcer Laura J, Galetta Steven L, Avila Robin L, Rutledge Danette, Fox Robert J
Weill Cornell Medical College, Cornell University, 1305 York Ave #2F, New York, NY, 10065, USA.
Northwestern University, Chicago, IL, USA.
CNS Drugs. 2023 Mar;37(3):275-289. doi: 10.1007/s40263-022-00982-6.
STRIVE was a prospective, 4-year, multicenter, observational, open-label, single-arm study of natalizumab treatment in anti-JC virus antibody-negative patients with early relapsing-remitting multiple sclerosis (RRMS).
Study objectives examined the effects of natalizumab on cognitive processing speed, confirmed disability improvement (CDI), and patient-reported outcomes (PROs).
Clinical and PRO secondary endpoints were assessed annually over 4 years in STRIVE. The Symbol Digit Modalities Test (SDMT) was used as a measure of cognitive processing speed. PROs were assessed using the Multiple Sclerosis Impact Score (MSIS-29) and the Work Productivity and Activity Impairment Questionnaire (WPAI).
At all four annual assessments, the proportion of patients in the intent-to-treat (ITT) population (N = 222) who exhibited clinically meaningful improvement in their SDMT score from baseline (i.e., change ≥ 4 points) ranged from 41.9 to 54.0%. The cumulative probability of CDI at 4 years in patients in the ITT population with a baseline Expanded Disability Status Scale score ≥ 2 (N = 133) was 43.9%. Statistically significant reductions in the mean change from screening in the MSIS-29 physical and psychological scores, indicating improved quality of life, were observed over all 4 years (P ≤ 0.0012 for all). A statistically significant decrease from screening in the impact of MS on regular activities, signifying an improvement in this WPAI measure, was also observed over all 4 years of the study.
These results further extend our knowledge of the effectiveness, specifically regarding improvements in cognitive processing speed, disability and PROs, of long-term natalizumab treatment in early RRMS patients.
GOV: NCT01485003 (5 December 2011).
STRIVE是一项前瞻性、为期4年的多中心、观察性、开放标签、单臂研究, 旨在研究那他珠单抗治疗抗JC病毒抗体阴性的早期复发缓解型多发性硬化症（RRMS）患者的效果。
研究目的是检验那他珠单抗对认知处理速度、确认的残疾改善（CDI）和患者报告结局（PRO）的影响。
在STRIVE研究中，每年对临床和PRO次要终点进行为期4年的评估。符号数字模态测试（SDMT）被用作认知处理速度的衡量指标。使用多发性硬化症影响评分（MSIS-29）和工作效率与活动障碍问卷（WPAI）评估PRO。
在所有四次年度评估中，意向性治疗（ITT）人群（N = 222）中，SDMT评分从基线水平出现具有临床意义改善（即变化≥4分）的患者比例在41.9%至54.0%之间。基线扩展残疾状态量表评分≥2的ITT人群患者（N = 133）在4年时CDI的累积概率为43.9%。在整个4年期间，观察到MSIS-29身体和心理评分相对于筛查时的平均变化有统计学意义的降低，表明生活质量有所改善（所有P≤0.0012）。在研究的所有4年中，还观察到MS对日常活动影响相对于筛查时出现统计学意义的降低，这表明该WPAI指标有所改善。
这些结果进一步扩展了我们对长期使用那他珠单抗治疗早期RRMS患者有效性的认识，特别是在认知处理速度、残疾和PRO改善方面。
政府注册号：NCT01485003（2011年12月5日）
