BACKGROUND Natalizumab has been associated with disability improvement as indicated by a confirmed Expanded Disability Status Scale (EDSS) score decrease. OBJECTIVE The aim of this study was to characterize disability improvement in patients in the Tysabri Observational Program (TOP), an ongoing observational study of relapsing-remitting multiple sclerosis patients initiating natalizumab in clinical practice. METHODS TOP data as of November 2018 were included. Confirmed disability improvement (CDI) was defined as a decrease ⩾1.0 confirmed 24 weeks later from a baseline EDSS score ⩾2.0. Confirmed functional system (FS) improvement was defined as a decrease ⩾1.0 confirmed 24 weeks later from a baseline score ⩾1.0 in that FS. RESULTS Of 5384 patients, 1287 (23.9%) had CDI; 51.8% experienced CDI in the first treatment year. Among patients with CDI, 56.6% had CDI ⩾1.5 points; 34.4% had CDI ⩾2.0 points. The cumulative probability of maintaining improvement 8 years after the CDI event was 52.6%. At treatment initiation, 5363 patients (85.2%) had impairment in ⩾1 FS. At 8 years, the cumulative probability of confirmed improvement in any FS was 88.8% and ranged from 38.3% to 58.6% in individual FS. CONCLUSION These results highlight disability improvement as a potential benefit of natalizumab treatment. Improvements across all FS demonstrate the range of functional improvement.

中文翻译：

---

在 Tysabri 观察计划中接受那他珠单抗治疗的复发缓解型多发性硬化症患者的真实残疾改善

背景 Natalizumab 与残疾改善相关，如确认的扩展残疾状态量表 (EDSS) 评分下降所示。目的 本研究的目的是表征 Tysabri 观察计划 (TOP) 中患者的残疾改善情况，这是一项针对复发缓解型多发性硬化症患者在临床实践中启动那他珠单抗的持续观察性研究。方法 包括截至 2018 年 11 月的 TOP 数据。确认的残疾改善 (CDI) 被定义为 24 周后确认的从基线 EDSS 评分⩾2.0 下降⩾1.0。确认的功能系统 (FS) 改善被定义为 24 周后确认的 FS 基线评分 ⩾1.0 的降低 ⩾1.0。结果 在 5384 名患者中，1287 名 (23.9%) 患有 CDI；51.8% 的人在第一个治疗年经历了 CDI。在 CDI 患者中，56。6% 的 CDI ⩾1.5 分；34.4% 的 CDI ⩾ 2.0 点。CDI 事件后 8 年保持改善的累积概率为 52.6%。在治疗开始时，5363 名患者 (85.2%) 有 ⩾1 FS 受损。8 年时，任何 FS 中确认改善的累积概率为 88.8%，单个 FS 的范围为 38.3% 至 58.6%。结论 这些结果强调了残疾改善是那他珠单抗治疗的潜在益处。所有 FS 的改进展示了功能改进的范围。个人 FS 6%。结论 这些结果强调了残疾改善是那他珠单抗治疗的潜在益处。所有 FS 的改进展示了功能改进的范围。个人 FS 6%。结论 这些结果强调了残疾改善是那他珠单抗治疗的潜在益处。所有 FS 的改进展示了功能改进的范围。