PEG 化干扰素治疗成人复发性多发性硬化症的疗效和安全性:匹配调整间接比较的结果

T. Simaniv, M. Zakharova, K. V. Sapozhnikov, D. Tolkacheva, Valeriia D. Sokolova, N. Sableva, O. Mironenko, Taras V. Khimich
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引用次数: 0

摘要

导言。β干扰素是治疗复发缓解型多发性硬化症(RRMS)的有效而安全的药物。为了提高患者的依从性,已开发出 PEG 化干扰素。目前尚未对 PEG 化干扰素的疗效和安全性进行直接比较。我们的目标是评估 SamPEG-IFN-β1a 与 PEG-IFN-β1a 在 RRMS 成年患者中的疗效和安全性。材料与方法。我们使用 PubMed、Embase 和 eLIBRARY.RU 数据库对随机临床试验 (RCT) 进行了系统检索。疗效根据治疗第一年和第二年复发患者的比例和年复发率(ARR)进行评估。安全性根据出现不良事件(AEs)、严重不良事件(SAEs)和任何导致治疗中止的不良事件的患者人数进行评估。我们进行了配对调整间接比较 (MAIC),以评估 PEG 化 IFNs 的疗效比较。为了评估疗效,我们检验了 SamPEG-IFN-β1a 对 PEG-IFN-β1a 的非劣效性假设和 SamPEG-IFN-β1a 对 PEG-IFN-β1a 的优效性假设。结果。根据系统综述的结果,选取了四篇文章,分别介绍了 PEG-IFN-β1a 3 期临床试验和 SamPEG-IFN-β1a 2-3 期临床试验的结果。PEG-IFN-β1a 组(n = 512)每两周给药一次,SamPEGIFN-β1a 组(n = 114)给药剂量为 240 μg。分析结果证实了 SamPEG-IFN-β1a 疗效不劣于 PEG-IFN-β1a 的假设,而 SamPEG-IFN-β1a 疗效优于 PEG-IFN-β1a 的假设未得到证实。在安全性方面,SamPEG-IFN-β1a优于PEG-IFN-β1a的假设也得到了证实,因为SAEs和导致治疗中断的AEs的发生率显著降低。结论治疗 1 年和 2 年的复发患者比例和 ARR 表明,SamPEG-IFN-β1a 的疗效不劣于 PEG-IFN-β1a。与 PEG-IFN-B1a 相比,SamPEG-IFN-B1a 的安全性更佳,因为出现 SAE 和导致治疗中断的 AE 的几率更低。
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Efficacy and Safety of PEGylated Interferons for Relapsing-Remitting Multiple Sclerosis in Adult Patients: Results of Matching-Adjusted Indirect Comparison
Introduction. Beta interferons are effective and safe agents for the treatment of relapsing-remitting multiple sclerosis (RRMS). PEGylated interferons have been developed in order to increase patient adherence. Direct comparisons of the efficacy and safety of PEGylated interferons have not yet been conducted. Our objective was to evaluate the efficacy and safety of SamPEG-IFN-β1a versus PEG-IFN-β1a in adult patients with RRMS. Materials and methods. We conducted a systematic search of randomized clinical trials (RCTs) using the PubMed, Embase and eLIBRARY.RU databases. Efficacy was assessed based on the proportion of patients with disease relapses and the annualized relapse rate (ARR) during the 1st and the 2nd years of treatment. Safety was assessed by the number of patients with adverse events (AEs), serious AEs (SAEs), and any AEs that led to the treatment discontinuation. We conducted pairwise matching-adjusted indirect comparison (MAIC) to assess comparative efficacy of PEGylated IFNs. To evaluate the efficacy, hypotheses of non-inferiority of SamPEG-IFN-β1a to PEG-IFN-β1a and superiority of SamPEG-IFN-β1a over PEG-IFN-β1a were tested. Results. Based on results of the systematic review, four articles were selected wherein the results of phase 3 clinical trial of PEG-IFN-β1a and phase 2–3 clinical trial of SamPEG-IFN-β1a were described. In PEG-IFN-β1a group (n = 512) the agent was administered once every 2 weeks, in SamPEGIFN-β1a group (n = 114) the agent was administered at a dose of 240 μg. The analysis results confirmed the hypothesis of SamPEG-IFN-β1a non-inferiority to PEG-IFN-β1a in efficacy, while SamPEG-IFN-β1a superiority over PEG-IFN-β1a in efficacy was not confirmed. The hypothesis of SamPEG-IFN-β1a superiority over PEG-IFN-β1a in safety was also confirmed based on a significantly lower incidence of SAEs and any AEs that led to treatment discontinuation. Conclusions. The proportion of patients with relapses and the ARR in 1 year and in 2 years of therapy indicates that SamPEG-IFN-β1a is non-inferior to PEG-IFN-β1a in efficacy. SamPEG-IFN-B1a demonstrated a more favourable safety profile than PEG-IFN-B1a as showing less odds of SAEs and AEs leading to treatment discontinuation.
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来源期刊
Annals of Clinical and Experimental Neurology
Annals of Clinical and Experimental Neurology Medicine-Neurology (clinical)
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0.80
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0.00%
发文量
32
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