Multiple Sclerosis Centre, S. Andrea Hospital, Sapienza University, Rome, Italy.
Mult Scler. 2011 Mar;17(3):372-5. doi: 10.1177/1352458510392098. Epub 2010 Dec 9.
In this prospective post-marketing study, 21 patients with multiple sclerosis treated with natalizumab for 24 consecutive months elected a trial of treatment interruption (90-180 days). During a mean duration of treatment interruption of 111.5 days 4 patients (19.0%) experienced a relapse and 9 out of 19 (47.4%) had MRI activity. Number of contrast-enhancing lesions at baseline was lower than during treatment interruption, but the difference was not significant. These findings suggest that disease activity may return after the last infusion of natalizumab. Patients should have regular MRI assessment during treatment interruption to rapidly identify any return of disease activity. The aim of this study was to determine the optimal duration for temporary interruption of natalizumab therapy in patients who have received continuous therapy with natalizumab for 24 months.
在这项前瞻性上市后研究中，21 例接受那他珠单抗连续治疗 24 个月的多发性硬化症患者选择了中断治疗试验（90-180 天）。在平均 111.5 天的治疗中断期间，4 例患者（19.0%）出现复发，19 例中有 9 例（47.4%）出现 MRI 活动。基线时的增强病变数量低于治疗中断时，但差异无统计学意义。这些发现表明，在那他珠单抗的最后一次输注后，疾病活动可能会恢复。在治疗中断期间，患者应进行定期 MRI 评估，以快速识别任何疾病活动的恢复。本研究的目的是确定在接受那他珠单抗连续治疗 24 个月的患者中，临时中断那他珠单抗治疗的最佳持续时间。
