Department of Neurology, University of Thessaly School of Medicine, Larissa, Greece.
J Clin Pharm Ther. 2013 Dec;38(6):433-9. doi: 10.1111/jcpt.12090. Epub 2013 Aug 20.
The relative effectiveness and safety profile of the treatments with marketing authorization for relapsing multiple sclerosis (MS) are not well known because randomized controlled trials with head-to-head comparisons between these treatments do not exist. Thus, a network of multiple-treatments meta-analysis was performed using four clinical outcomes: 'patients free of relapse', 'patients without disease progression', 'patients without MRI progression' and 'patients with adverse events'.
Randomized controlled trials (RCTs) on MS were systematically searched in PubMed and Cochrane Central Register of Controlled Trial. The network analysis performed pairwise comparisons between the marketed treatments (Betaferon 250mcg, Avonex 30mcg, Rebif 44mcg, Rebif 22mcg, Aubagio 7 mg, Aubagio 14 mg, Copaxone 20 mg, Tysabri 300 mg, Gilenya 0·5 mg and Novantrone 12 mg/m(2)) using direct and indirect analyses.
The analysis included 48 articles, involving 20 455 patients with MS. The direct analysis showed better response for more than one outcome for Gilenya compared with Avonex ('patients free of relapse' and 'patients without MRI progression') and for Betaferon compared with Avonex ('patients without disease progression' and 'patients without MRI progression'). The indirect analysis indicated that Tysabri may have better relative effectiveness compared with the other treatments for two outcomes: 'patients free of relapse' and 'patients without MRI progression'. Regarding 'patients with adverse events', no data were available for all comparisons to make fair inferences.
This was an attempt, for the first time, to compare the efficacy and safety profile of existing approved treatments for relapsing MS. Although some treatments have shown better response, the results of the network analysis should be interpreted with caution because of the lack of RCTs with head-to-head comparisons between treatments.
由于不存在这些治疗方法之间的头对头随机对照试验，因此对于获得上市许可用于治疗复发型多发性硬化症（MS）的治疗方法，其相对有效性和安全性概况尚不清楚。因此，进行了一项多治疗方法网络荟萃分析，使用了 4 个临床结局：“无复发的患者”、“无疾病进展的患者”、“无 MRI 进展的患者”和“发生不良事件的患者”。
在 PubMed 和 Cochrane 对照试验中心注册库中系统地搜索了关于 MS 的随机对照试验（RCT）。网络分析对市场上销售的治疗方法（Betaferon 250mcg、Avonex 30mcg、Rebif 44mcg、Rebif 22mcg、Aubagio 7mg、Aubagio 14mg、Copaxone 20mg、Tysabri 300mg、Gilenya 0·5mg 和 Novantrone 12mg/m2）进行了直接和间接比较。
分析共纳入 48 篇文章，涉及 20455 例 MS 患者。直接分析显示，与 Avonex 相比，Gilenya 在多个结局上的反应更好（“无复发的患者”和“无 MRI 进展的患者”），与 Avonex 相比，Betaferon 在两个结局上的反应更好（“无疾病进展的患者”和“无 MRI 进展的患者”）。间接分析表明，与其他治疗方法相比，Tysabri 可能在两个结局上具有更好的相对有效性：“无复发的患者”和“无 MRI 进展的患者”。关于“发生不良事件的患者”，由于没有比较所有治疗方法的数据，因此无法做出公平推断。
这是首次尝试比较现有获批用于治疗复发型 MS 的治疗方法的疗效和安全性概况。虽然某些治疗方法显示出更好的疗效，但由于缺乏治疗方法之间的头对头 RCT，因此应谨慎解释网络分析的结果。
