Center of Clinical Neuroscience, University Clinic Carl Gustav Carus, University of Technology Dresden, Fetscherstrasse 74, 01307, Dresden, Germany.
Division of Molecular and Cognitive Neuroscience, University of Basel, Basel, Switzerland.
J Neurol. 2016 Apr;263(4):784-91. doi: 10.1007/s00415-016-8058-7. Epub 2016 Feb 25.
Treatment of symptoms and signs beyond the expanded disability status scale remains a major target in multiple sclerosis. QualiCOP was an observational, non-interventional, open-label study conducted at 170 sites in Germany. Of the 754 enrolled patients, 96 % had relapsing-remitting multiple sclerosis (MS) and were either disease-modifying therapy naïve (de novo, n = 481) or previously treated (n = 237) with once-daily, subcutaneous 20-mg/mL glatiramer acetate (GA). Assessments of relapse rate, disease progression, overall functioning, quality of life (QoL), cognition, fatigue, and depression were performed over 24 months. GA treatment over 24 months was associated with reduced annual relapse rate for previously treated (from 0.98 to 0.54 relapses) and de novo (from 0.81 to 0.48 relapses) patients. Multiple Sclerosis Functional Composite scores showed slight improvement in both cohorts (all p < 0.01). Paced Auditory Serial Addition Test and Multiple Sclerosis Inventory Cognition scale scores showed robust improvement in cognition among previously treated and de novo cohorts (all p < 0.001). General Depression Scale scores showed significantly reduced depressive symptoms (p < 0.001). Disease severity, fatigue, and QoL were stable over the observational period. These real-world findings suggest that patients with MS show benefit from GA treatment in important QoL parameters beyond standard measures of relapse and disease severity.
治疗扩展残疾状态量表之外的症状和体征仍然是多发性硬化症的主要目标。QualiCOP 是一项在德国 170 个地点进行的观察性、非干预性、开放性标签研究。在纳入的 754 名患者中，96%患有复发缓解型多发性硬化症（MS），要么是初治（新诊断，n=481），要么是之前接受过每日一次、皮下 20mg/ml 聚甘酯治疗（n=237）。在 24 个月内评估复发率、疾病进展、整体功能、生活质量（QoL）、认知、疲劳和抑郁。在 24 个月内，GA 治疗与既往治疗（从 0.98 次降至 0.54 次）和初治（从 0.81 次降至 0.48 次）患者的年复发率降低相关。两个队列的多发性硬化功能综合评分均略有改善（均 p<0.01）。在既往治疗和初治队列中，Paced Auditory Serial Addition Test 和多发性硬化症认知量表评分显示认知能力有明显改善（均 p<0.001）。一般抑郁量表评分显示抑郁症状显著减轻（p<0.001）。疾病严重程度、疲劳和 QoL 在观察期间保持稳定。这些真实世界的发现表明，多发性硬化症患者在重要的生活质量参数方面从 GA 治疗中获益，超出了复发和疾病严重程度的标准衡量标准。
