Department of Neurology with the Stroke Treatment Unit, Clinical Hospital No. 2, Rzeszow, Poland.
Department of Neurology, Institute of Medical Sciences, College of Medical Sciences of the University of Rzeszow, Rzeszow, Poland.
Neurol Neurochir Pol. 2024;58(1):84-93. doi: 10.5603/pjnns.97040. Epub 2023 Dec 19.
To evaluate the clinical and radiological consequences of delayed escalation of therapy in patients with relapsing-remitting multiple sclerosis (RRMS), in whom, despite finding platform therapy ineffective, high-efficacy drugs were introduced with a delay.
We performed a single-centre, observational study evaluating patients with RRMS for ineffectiveness of disease-modifying therapies (DMTs). Depending on the time of therapy escalation to high-efficacy drugs, the patients were divided into an early escalation or a late escalation group, both of which were then observed for 48 months. All patients underwent a neurological examination every six months and a brain magnetic resonance imaging (MRI) every 12 months. The primary endpoint was a change in the Expanded Disability Status Scale (EDSS) score during the observation period. The secondary endpoint was the time to 6-month confirmed disability progression (6mCDP). In addition, we analysed the annualised relapse rate and the cumulative number of new Gd+ and T2 lesions on brain MRI.
165 patients were qualified for the analysis. On treatment initiation, mean age was 38 years (± 10.9), and mean EDSS was 1.41 ± 0.38. After 48 months, there was a statistically insignificant decrease in the EDSS score in the early escalation group (-0.17 ± 0.35; p > 0.05), while in the late escalation group there was an increase in the EDSS score. The highest increase was noted in the group in which the escalation was performed with a delay of more than two years (1.2 ± 0.63; p < 0.001), and moreover 80% of patients in this group met the 6mCDP criteria. The median time to 6mCDP was 4.6 years (LESC1) and 4.5 years (LESC2) in the late escalation groups. In the early escalation group, zero subjects met the 6mCDP criteria after 48 months of observation.
In everyday practice, the long-term outcomes in patients with RRMS and disease activity, despite DMT being used, are more favourable after early implementation of high-efficacy drugs. Delaying therapy escalation results in the accumulation of permanent disability in patients with RRMS.
评估复发缓解型多发性硬化症（RRMS）患者中延迟强化治疗的临床和影像学后果，这些患者尽管发现基础治疗无效，但仍延迟使用高效药物。
我们进行了一项单中心观察性研究，评估了 RRMS 患者基础治疗无效的情况。根据疾病修饰治疗（DMT）升级为高效药物的时间，患者分为早期升级组或晚期升级组，两组均观察 48 个月。所有患者每 6 个月接受一次神经系统检查，每 12 个月接受一次脑部磁共振成像（MRI）检查。主要终点是观察期间扩展残疾状况量表（EDSS）评分的变化。次要终点是 6 个月确认残疾进展（6mCDP）的时间。此外，我们分析了年度复发率和脑 MRI 上新 Gd+和 T2 病变的累积数量。
165 名患者符合分析条件。治疗开始时，平均年龄为 38 岁（±10.9），平均 EDSS 为 1.41 ± 0.38。48 个月后，早期升级组 EDSS 评分有统计学意义的下降（-0.17 ± 0.35；p>0.05），而晚期升级组 EDSS 评分则有所上升。在延迟超过两年的组中，EDSS 评分增加最多（1.2 ± 0.63；p<0.001），此外该组中有 80%的患者符合 6mCDP 标准。晚期升级组中位至 6mCDP 的时间为 4.6 年（LESC1）和 4.5 年（LESC2）。在早期升级组中，经过 48 个月的观察，零名患者符合 6mCDP 标准。
在日常实践中，RRMS 患者在疾病活动的情况下，早期使用高效药物，其长期结局更为有利。延迟强化治疗会导致 RRMS 患者永久性残疾的积累。
