Boyko A N, Bakhtiyarova K Z, Boyko O V, Dudin V A, Zaslavskii L G, Malkova N A, Parshina E V, Poverennova I Ye, Sivertseva S A, Totolyan N A, Shchur S G, Khabirov F A, Goncharova Z A, Zakharova M N, Bolsun D D, Zinkina-Orikhan A V, Lin'kova Yu N, Chernovskaya T V, Porozova A A
Pirogov National Medical Research University, Moscow, Russia.
Federal Center for Brain Research and Neurotechnologies, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(2):52-59. doi: 10.17116/jnevro202312302152.
To assess the efficacy and safety of sampeginterferon-β1a (samPEG-IFN-β1a) 180 μg and 240 μg administered once every 2 weeks compared to placebo and low dose interferon beta-1a (LIB) 30 μg administered once weekly.
Patients with relapsing-remitting multiple sclerosis aged 18-60 years, with Expanded Disability Status Scale score ≤5.5 were randomized at a ratio of 2:2:2:1 to the following groups: samPEG-IFN-β1a 180 µg, samPEG-IFN-β1a 240 µg, LIB, placebo. After 20 weeks, the placebo group completed the study. After week 52, the final analysis was performed, which included the primary endpoint analysis, the LIB group patients completed their participation in the study. The patients in samPEG-IFN-β1a groups continued to receive therapy with samPEG-IFN-β1a 240 µg until week 100 inclusive. The results of the final analysis after 52 weeks have been previously published. The current article presents a long-term efficacy and safety of samPEG-IFN-β1a after 104 weeks of the trial.
The annualized relapse rate over the second year was 0.16 in the samPEG-IFN-β1a 180 μg group and 0.09 in the samPEG-IFN-β1a 240 μg group. By week 104, the proportion of relapse-free patients was 77.0% (87/113) and 83.3% (95/114) in the samPEG-IFN-β1a 180 μg and 240 μg groups, respectively. There were no negative dynamics of MRI markers, neurological deficit parameters and cognitive functions by scales and tests. The safety profile of samPEG-IFN-β1a was consistent with the known safety profile of IFN-β therapy.
Treatment with samPEG-IFN-β1a is an effective and safe first-line therapy for relapsing-remitting multiple sclerosis patients.
评估每2周一次皮下注射180μg和240μg聚乙二醇化干扰素β-1a（samPEG-IFN-β1a）与安慰剂及每周一次皮下注射30μg低剂量干扰素β-1a（LIB）相比的疗效和安全性。
将年龄在18 - 60岁、扩展残疾状态量表（EDSS）评分≤5.5的复发缓解型多发性硬化患者按2:2:2:1随机分为以下几组：samPEG-IFN-β1a 180μg组、samPEG-IFN-β1a 240μg组、LIB组、安慰剂组。20周后，安慰剂组完成研究。52周后进行最终分析，包括主要终点分析，此时LIB组患者完成研究。samPEG-IFN-β1a组患者继续接受240μg samPEG-IFN-β1a治疗至第100周（含第100周）。52周后最终分析结果已发表。本文展示了试验104周后samPEG-IFN-β1a的长期疗效和安全性。
samPEG-IFN-β1a 180μg组第二年的年化复发率为0.16，samPEG-IFN-β1a 240μg组为0.09。至第104周时，samPEG-IFN-β1a 180μg组和240μg组无复发患者的比例分别为77.0%（87/113）和83.3%（95/114）。通过量表和测试评估，MRI指标、神经功能缺损参数和认知功能均无不良变化。samPEG-IFN-β1a的安全性与已知的IFN-β治疗安全性一致。
对于复发缓解型多发性硬化患者，samPEG-IFN-β1a治疗是一种有效且安全的一线治疗方法。
