Neurology Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel, University of Basel, Basel, Switzerland.
Department of Neurology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.
Mult Scler. 2017 Nov;23(13):1736-1747. doi: 10.1177/1352458516683266. Epub 2016 Dec 22.
No evidence of disease activity (NEDA) is a composite endpoint being increasingly applied as an outcome measure in clinical trials as well as proposed for individual therapeutic decisions in multiple sclerosis (MS).
Assess the proportion of patients with relapsing-remitting MS achieving NEDA in the DECIDE study of daclizumab 150 mg subcutaneous versus intramuscular interferon beta-1a 30 µg for 96-144 weeks.
NEDA was defined as no relapses, no onset of 12-week confirmed disability progression (CDP), no new/newly enlarging T2 hyperintense lesions (NET2), and no gadolinium-enhancing (Gd) lesions. Logistic regression models adjusted for baseline covariates compared treatment groups for baseline to week 96, weeks 0-24, and weeks 24-96.
From baseline to week 96, more daclizumab versus intramuscular interferon beta-1a patients achieved NEDA (24.6% vs 14.2%; odds ratio (OR; 95% confidence interval): 2.059 (1.592-2.661); p < 0.0001). ORs for clinical NEDA (no relapses, no CDP) and magnetic resonance imaging (MRI) NEDA (no NET2, no Gd lesions) were 1.651 (1.357-2.007; p < 0.0001) and 2.051 (1.628-2.582; p < 0.0001), respectively. ORs in favor of daclizumab for weeks 24-96 were consistently higher than for weeks 0-24.
More daclizumab versus intramuscular interferon beta-1a patients achieved NEDA early in DECIDE, with effects increasing over time.
无疾病活动（NEDA）是一种复合终点，在临床试验中越来越多地被用作疗效指标，也被提议用于多发性硬化症（MS）的个体化治疗决策。
评估在 DECIDE 研究中，皮下注射达利珠单抗 150mg 与肌内注射干扰素β-1a 30μg 治疗 96-144 周后，复发缓解型多发性硬化症患者达到 NEDA 的比例。
NEDA 定义为无复发、无 12 周确认的残疾进展（CDP）、无新/扩大的 T2 高信号病变（NET2）和无钆增强（Gd）病变。采用基于基线协变量的逻辑回归模型，比较两组从基线到第 96 周、0-24 周和 24-96 周的治疗情况。
从基线到第 96 周，与肌内注射干扰素β-1a 相比，更多的达利珠单抗患者达到 NEDA（24.6% vs 14.2%；比值比[OR]；95%置信区间）：2.059（1.592-2.661）；p<0.0001）。临床 NEDA（无复发、无 CDP）和磁共振成像（MRI）NEDA（无 NET2、无 Gd 病变）的 OR 分别为 1.651（1.357-2.007；p<0.0001）和 2.051（1.628-2.582；p<0.0001）。达利珠单抗在第 24-96 周的 OR 始终高于第 0-24 周。
与肌内注射干扰素β-1a 相比，达利珠单抗在 DECIDE 研究中早期达到 NEDA 的患者更多，且疗效随时间增加。
