Institute of Clinical Neurosciences, Hospital Regional Universitario Carlos Haya, Málaga, Spain.
Mult Scler. 2011 Feb;17(2):192-7. doi: 10.1177/1352458510385507. Epub 2010 Nov 18.
Little is known about how the level of disability at the start of treatment with natalizumab affects its efficacy.
The aim of this study was to investigate the effect of natalizumab on relapses in patients with different levels of baseline disability associated with MS.
This single-centre observational study collected demographic data for patients followed prospectively and who were scheduled to start natalizumab therapy due to the presence of disease activity. The annualized relapse rate (ARR) and Kurtzke Expanded Disability Status Scale scores were analysed for the previous year, on starting treatment (baseline) and 1 year after starting therapy.
Seventy-seven patients (mean age: 39.0 years, mean disease duration: 12.4 years) were included. The difference between ARR before and after starting treatment was 0.92 for baseline Expanded Disability Status Scale ≤ 3.5 (p < 0.0005), 0.70 for Expanded Disability Status Scale 4.0-6.0 (p < 0.007) and 0.57 for Expanded Disability Status Scale ≥ 6 (p = 0.386). Expanded Disability Status Scale did not vary during the study. One patient discontinued treatment due to an adverse event and nine patients discontinued due to positive anti-natalizumab antibodies.
The findings support the efficacy of natalizumab in reducing ARR in the year after starting treatment in patients with baseline Expanded Disability Status Scale ≤ 6.
对于在开始使用那他珠单抗治疗时的残疾程度如何影响其疗效，人们知之甚少。
本研究旨在调查那他珠单抗对基线残疾程度不同的 MS 患者的复发的影响。
这项单中心观察性研究收集了前瞻性随访患者的人口统计学数据，这些患者由于存在疾病活动而计划开始那他珠单抗治疗。分析了前一年、开始治疗时（基线）和开始治疗后 1 年的年复发率（ARR）和 Kurtzke 扩展残疾状态量表评分。
77 例患者（平均年龄：39.0 岁，平均病程：12.4 年）被纳入研究。基线扩展残疾状态量表≤3.5 时，治疗前后 ARR 的差异为 0.92（p<0.0005），扩展残疾状态量表 4.0-6.0 时为 0.70（p<0.007），扩展残疾状态量表≥6 时为 0.57（p=0.386）。在研究期间，扩展残疾状态量表没有变化。1 例患者因不良事件停止治疗，9 例患者因抗那他珠单抗抗体阳性而停止治疗。
这些发现支持那他珠单抗在基线扩展残疾状态量表≤6 的患者中降低治疗后 1 年内的 ARR 的疗效。
