Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden.
Department of Clinical Sciences Neurology, Lund University, Lund, Sweden.
Acta Neurol Scand. 2018 Jan;137(1):117-124. doi: 10.1111/ane.12833. Epub 2017 Sep 13.
Cognitive impairment is common in multiple sclerosis (MS) and can have serious impact on social and occupational functioning. Natalizumab reduces relapse rates, magnetic resonance imaging (MRI) lesions, and progression of disability. Previous studies on cognitive functioning have not based inclusion on cognitive performance criteria. The aim of the present study was to determine any potential natalizumab-related cognitive effects on MS patients performing below normal limits on neuropsychological testing.
Patients starting natalizumab (n = 21) and a quasi-control group of stable MS patients (n = 13) on first line disease modifying treatment were included following neuropsychological assessment demonstrating subnormal cognitive performance. Assessment, using ten cognitive variables, was repeated after 12 months. Symptoms of fatigue, anxiety and depression were also examined. Raw scores on the cognitive tests were transformed into Z-scores based on published age-corrected normative data.
Between-group analyses on difference Z-scores (baseline - follow-up) yielded significant results on Paced Auditory Serial Addition Test-2 (PASAT-2) (P = .008), with the natalizumab group showing larger improvement than quasi control patients. On PASAT-2, 28,5% from the natalizumab group demonstrated >1 SD improvement, indicative of clinically meaningful change, compared with none in the quasi control group. Patients receiving natalizumab showed within-group improvements on six of the ten cognitive variables. There were no group differences in symptoms of fatigue, anxiety or depression.
The results demonstrate improvement in information processing speed following 12-months of natalizumab treatment. The results are interpreted as reflection of anti-inflammatory properties of natalizumab rather than retest- or long-term restorative effects.
认知障碍在多发性硬化症（MS）中很常见，会对社交和职业功能产生严重影响。那他珠单抗可降低复发率、磁共振成像（MRI）病变和残疾进展。以前关于认知功能的研究并未基于认知表现标准纳入患者。本研究旨在确定认知表现低于神经心理学测试正常范围的 MS 患者接受那他珠单抗治疗是否存在潜在的认知相关影响。
对神经心理学评估后认知表现低于正常范围的开始使用那他珠单抗（n=21）和接受一线疾病修正治疗的稳定 MS 患者（n=13）准对照组患者进行入组。使用 10 个认知变量进行评估，12 个月后重复评估。还检查了疲劳、焦虑和抑郁的症状。根据已发表的年龄校正的正常数据，将认知测试的原始分数转换为 Z 分数。
基于差异 Z 分数（基线-随访）的组间分析在 paced auditory serial addition test-2（PASAT-2）上产生显著结果（P=0.008），那他珠单抗组的改善程度大于准对照组。在 PASAT-2 上，那他珠单抗组有 28.5%的患者改善超过 1 个标准差，表明有临床意义的变化，而准对照组无一例患者。接受那他珠单抗治疗的患者在 10 个认知变量中的 6 个方面显示出组内改善。疲劳、焦虑或抑郁的症状在两组之间没有差异。
结果表明，接受那他珠单抗治疗 12 个月后，信息处理速度有所提高。结果解释为那他珠单抗的抗炎特性的反映，而不是重测或长期恢复效应。
