Department of Neurology and Neuroscience, Weill Cornell Medical College, Cornell University, 1300 York Avenue, New York, NY, 10065, USA.
Department of Neurology, Northwestern University, Chicago, IL, USA.
Adv Ther. 2021 Jul;38(7):3724-3742. doi: 10.1007/s12325-021-01722-w. Epub 2021 May 20.
STRIVE was a 4-year, multicenter, observational, open-label, single-arm study of natalizumab treatment in anti-JC virus antibody-negative (JCV-negative) relapsing-remitting multiple sclerosis (RRMS) patients with disease duration ≤ 3 years. The objective of STRIVE was to examine no evidence of disease activity (NEDA) status and predictors of NEDA in natalizumab-treated patients with early RRMS.
Proportions of patients with NEDA were evaluated along with baseline predictors of NEDA, annualized relapse rate, 24-week confirmed disability worsening (CDW), magnetic resonance imaging assessments (T2 and gadolinium-enhancing lesions), and serious adverse events.
In years 1 and 2, 56.1% (95% confidence interval [CI] 48.7-63.4%) and 73.6% (95% CI 66.2-80.2%) of patients (intent-to-treat population [N = 222]), respectively, achieved NEDA. In years 3 and 4, 84.6% (95% CI 78.0-89.9%) and 91.9% (95% CI 86.4-95.8%) of patients, respectively, achieved Clinical NEDA (no relapses or 24-week CDW). Baseline predictors of NEDA in year 4 were Expanded Disability Status Scale score ≤ 2.0 (odds ratio [OR] = 3.85 [95% CI 1.54-9.63]; p = 0.004) and T2 lesion volume > 4 cc (OR = 0.39 [95% CI 0.15-0.98]; p = 0.046), with the latter also predicting Clinical NEDA in year 4 (OR = 0.21 [95% CI 0.05-0.92]; p = 0.038). The cumulative probability of CDW at year 4 was 19.3%. Serious adverse events were reported in 11.3% of patients.
These results support the long-term safety and effectiveness of natalizumab. Baseline predictors of NEDA help to inform benefit-risk assessments of natalizumab treatment in JCV-negative patients with early RRMS.
ClinicalTrials.gov identifier NCT01485003.
STRIVE 是一项为期 4 年、多中心、观察性、开放性、单臂研究，旨在评估纳武利尤单抗治疗抗 JC 病毒抗体阴性（JCV 阴性）、病程≤3 年的复发缓解型多发性硬化（RRMS）患者的疗效。该研究的目的是评估纳武利尤单抗治疗早期 RRMS 患者的无疾病活动（NEDA）状态和 NEDA 预测因素。
评估患者的 NEDA 比例，以及 NEDA 的基线预测因素、年化复发率、24 周确认的残疾恶化（CDW）、磁共振成像评估（T2 和钆增强病变）和严重不良事件。
在第 1 年和第 2 年，分别有 56.1%（95%置信区间 [CI] 48.7-63.4%）和 73.6%（95% CI 66.2-80.2%）的患者（意向治疗人群 [N=222]）达到 NEDA。在第 3 年和第 4 年，分别有 84.6%（95% CI 78.0-89.9%）和 91.9%（95% CI 86.4-95.8%）的患者达到临床 NEDA（无复发或 24 周 CDW）。第 4 年 NEDA 的基线预测因素包括扩展残疾状态量表评分≤2.0（比值比 [OR] = 3.85 [95% CI 1.54-9.63]；p = 0.004）和 T2 病变体积>4cc（OR = 0.39 [95% CI 0.15-0.98]；p = 0.046），后者也预测第 4 年的临床 NEDA（OR = 0.21 [95% CI 0.05-0.92]；p = 0.038）。第 4 年 CDW 的累积概率为 19.3%。11.3%的患者报告了严重不良事件。
这些结果支持纳武利尤单抗的长期安全性和有效性。NEDA 的基线预测因素有助于为 JCV 阴性、早期 RRMS 患者使用纳武利尤单抗治疗的获益风险评估提供信息。
ClinicalTrials.gov 标识符 NCT01485003。
