Kotov S V, Yakushina T I, Novikova E S, Lizhdvoy V Yu, Belova Yu A
Moscow Regional Research and Clinical Institute («MONIKI»), Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(7. Vyp. 2):77-83. doi: 10.17116/jnevro202312307277.
To study the efficacy of ocrelizumab (OCR) and natalizumab (NAT) using indicators of activity and progression in patients with highly active multiple sclerosis (HAMS) during the first year of therapy in real clinical practice.
The study included 110 patients with HAMS and 13 patients with rapidly progressive MS (RPMS), aged 19 to 60 years, who received monoclonal antibody (MAT) therapy for 12 months. Group 1 consisted of 77 patients receiving NAT therapy, group 2 of 46 patients receiving OCR therapy. To assess the efficacy of therapy, we used indicators of the average frequency of exacerbations per year, EDSS estimates, and MRI data.
EDSS score at the time of initiation of MAT therapy was 2.4±1.0 in group 1 and 2.8±1.2 in group 2 (=0.047); 12 months after the start of MAT therapy, EDSS score in group 1 decreased slightly (=0.001), in group 2 it has not changed. The frequency of exacerbations per year after the start of MAT therapy was 0.04±0.2 in group 1 and 0.07±0.2 in group 2 (<0.0001 in both groups). The number of foci accumulating gadolinium detected during the year was 3 in group 1, one in group 2 (=0.629 between groups). Subgroups of patients who received line 1 DMT (=22) or NAT (=21) before the start of OCR therapy were considered separately. In both subgroups, a stable assessment of EDSS was noted, the average annual number of exacerbations did not differ (=0.117). In patients with RPMS after a year of MAT therapy, EDSS scores were stable, the average annual frequency of exacerbations was 0.08±0.3 per year.
The administration of MAT therapy led to a statistically significant decrease in the number of exacerbations and stabilization of neurological deficits during the first year of follow-up. After 12 months of therapy, both groups experienced a dramatic decrease in the average annual number of exacerbations, no increase in disability, and positive dynamics according to MRI results. A similar level of OCR efficacy was found in patients who switched from DMT 1 line therapy and NAT.
在实际临床实践中，使用活动和进展指标研究奥瑞珠单抗（OCR）和那他珠单抗（NAT）对高度活动性多发性硬化症（HAMS）患者治疗第一年的疗效。
该研究纳入了110例HAMS患者和13例快速进展型多发性硬化症（RPMS）患者，年龄在19至60岁之间，接受单克隆抗体（MAT）治疗12个月。第1组由77例接受NAT治疗的患者组成，第2组由46例接受OCR治疗的患者组成。为评估治疗效果，我们使用了每年发作的平均频率指标、扩展残疾状态量表（EDSS）评估以及磁共振成像（MRI）数据。
MAT治疗开始时，第1组的EDSS评分为2.4±1.0，第2组为2.8±1.2（P = 0.047）；MAT治疗开始12个月后，第1组的EDSS评分略有下降（P = 0.001），第2组未变化。MAT治疗开始后每年的发作频率，第1组为0.04±0.2，第2组为0.07±0.2（两组均P<0.0001）。一年内检测到的钆沉积病灶数量，第1组为3个，第2组为1个（两组间P = 0.629）。分别考虑在OCR治疗开始前接受一线疾病修饰治疗（DMT）（n = 22）或NAT（n = 21）的患者亚组。在两个亚组中，均观察到EDSS评估稳定，每年发作的平均次数无差异（P = 0.117）。MAT治疗一年后，RPMS患者的EDSS评分稳定，每年发作的平均频率为0.08±0.3次。
在随访的第一年，MAT治疗导致发作次数在统计学上显著减少，神经功能缺损稳定。治疗12个月后，两组每年发作的平均次数均显著减少，残疾无增加，且MRI结果显示有积极变化。从一线DMT治疗和NAT转换而来的患者中发现了相似水平的OCR疗效。
