UBMD Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA.
Providence Multiple Sclerosis Center, Providence Brain and Spine Institute, Portland, OR, USA.
Mult Scler. 2018 May;24(6):795-804. doi: 10.1177/1352458517707345. Epub 2017 May 9.
Cognitive impairment is common in multiple sclerosis (MS), with cognitive processing speed being the most frequently affected domain.
Examine the effects of daclizumab beta versus intramuscular (IM) interferon (IFN) beta-1a on cognitive processing speed as assessed by Symbol Digit Modalities Test (SDMT).
In DECIDE, patients with relapsing-remitting multiple sclerosis (RRMS) (age: 18-55 years; Expanded Disability Status Scale (EDSS) score 0-5.0) were randomized to daclizumab beta ( n = 919) or IM IFN beta-1a ( n = 922) for 96-144 weeks. SDMT was administered at baseline and at 24-week intervals.
At week 96, significantly greater mean improvement from baseline in SDMT was observed with daclizumab beta versus IM IFN beta-1a ( p = 0.0274). Significantly more patients treated with daclizumab beta showed clinically meaningful improvement in SDMT (increase from baseline of ⩾3 points ( p = 0.0153) or ⩾4 points ( p = 0.0366)), and significantly fewer patients showed clinically meaningful worsening (decrease from baseline of ⩾3 points ( p = 0.0103)). Odds representing risk of worsening versus stability or improvement on SDMT were significantly smaller for daclizumab beta ( p = 0.0088 (3-point threshold); p = 0.0267 (4-point threshold)). In patients completing 144 weeks of treatment, the effects of daclizumab beta were generally sustained.
These results provide evidence for a benefit of daclizumab beta versus IM IFN beta-1a on cognitive processing speed in RRMS.
ClinicalTrials.gov identifier NCT01064401 (Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis (DECIDE)): https://clinicaltrials.gov/ct2/show/NCT01064401 .
认知障碍在多发性硬化症（MS）中很常见，认知处理速度是受影响最频繁的领域。
检查达利珠单抗β与肌肉内（IM）干扰素（IFN）β-1a 对符号数字模态测试（SDMT）评估的认知处理速度的影响。
在 DECIDE 中，将复发缓解型多发性硬化症（RRMS）患者（年龄：18-55 岁；扩展残疾状况量表（EDSS）评分 0-5.0）随机分配至达利珠单抗β（n=919）或 IM IFNβ-1a（n=922）治疗 96-144 周。在基线和 24 周间隔时进行 SDMT 测试。
在第 96 周，与 IM IFNβ-1a 相比，达利珠单抗β治疗组的 SDMT 从基线的平均改善显著更大（p=0.0274）。接受达利珠单抗β治疗的患者中，有更多的患者在 SDMT 上表现出有临床意义的改善（与基线相比增加了 ⩾3 分（p=0.0153）或 ⩾4 分（p=0.0366）），而表现出有临床意义的恶化的患者则显著减少（与基线相比下降了 ⩾3 分（p=0.0103））。SDMT 恶化与稳定或改善相比，达利珠单抗β的风险比（OR）显著较小（p=0.0088（3 分阈值）；p=0.0267（4 分阈值））。在完成 144 周治疗的患者中，达利珠单抗β的疗效基本保持稳定。
这些结果为达利珠单抗β与 IM IFNβ-1a 相比在 RRMS 患者的认知处理速度上的获益提供了证据。
ClinicalTrials.gov 标识符 NCT01064401（BIIB019（达利珠单抗高产工艺）与干扰素β1a 在复发性缓解型多发性硬化症患者中的疗效和安全性比较（DECIDE））：https://clinicaltrials.gov/ct2/show/NCT01064401。
