J Am Pharm Assoc (2003). 2023 Jan-Feb;63(1):8-22.e23. doi: 10.1016/j.japh.2022.07.009. Epub 2022 Aug 1.
Currently, 19 disease-modifying therapies (DMTs) have been approved for the treatment of patients with relapsing forms of multiple sclerosis (RMS).
The objective of this study was to conduct a systematic review and network meta-analysis to evaluate the efficacy and safety of DMTs in adults with RMS.
We searched PubMed, Embase, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, the Food and Drug Administration, and European Medicines Agency websites for randomized controlled trials (RCTs) (from inception to July 2021). Eligible RCTs evaluated approved treatments for RMS as monotherapy and reported at least one of the primary outcome measures of interest. The primary outcome was efficacy (annualized relapse rate and 12-week confirmed disability progression) and safety (serious adverse events [AEs] and discontinuation due to AEs). We assessed the risk of bias (RoB) of included studies using the Cochrane RoB tool version 2.0 (https://www.bmj.com/content/343/bmj.d5928) for RCTs. Surface under the cumulative ranking (SUCRA) was used to rank therapies and to assess quality of general evidence, respectively. The Grading of Recommendations Assessment, Development and Evaluation framework was used to rank therapies and to assess quality of general evidence.
A total of 43 records represent 45 RCTs selected for network meta-analysis. In total, 30,720 participants (median of 732; interquartile range: 248-931) were included, of which 67% were female. By SUCRA analysis, alemtuzumab (94.3%) presented the highest probability of being the best alternative for annualized relapse rate, whereas ofatumumab (93.5%) presented the highest probability of being the best alternative for 12-week confirmed disability progression. Interferon beta-1b subcutaneous (87.0%) presented the highest probability of the best safety among all DMTs for serious AEs, whereas alemtuzumab (92.4%) presented the highest probability of the best safety among all DMTs for discontinuation due to AEs.
Network meta-analysis shows that alemtuzumab and ofatumumab present the highest efficacy among DMTs. Because there is little difference between these probabilities for many treatments, health professionals should use clinical shared decision making when formulating treatment plans with patients.
目前已有 19 种疾病修正疗法（DMT）获批用于治疗复发型多发性硬化症（RMS）患者。
本研究旨在进行系统评价和网络荟萃分析，以评估 DMT 在 RMS 成人患者中的疗效和安全性。
我们检索了 PubMed、Embase、Cochrane 中央对照试验注册库、ClinicalTrials.gov、美国食品药品监督管理局和欧洲药品管理局网站，以获取随机对照试验（RCT）（从建库起至 2021 年 7 月）。纳入的 RCT 评估了 RMS 的获批治疗作为单药治疗，并报告了至少一项主要疗效指标。主要结局是疗效（年化复发率和 12 周确认的残疾进展）和安全性（严重不良事件[AE]和因 AE 停药）。我们使用 Cochrane RoB 工具版本 2.0（https://www.bmj.com/content/343/bmj.d5928）评估纳入研究的偏倚风险（RoB）。表面累积排序概率（SUCRA）用于分别对治疗方法进行排序和评估一般证据质量。推荐评估、制定与评价分级框架用于对治疗方法进行排序和评估一般证据质量。
共有 43 条记录代表了 45 项纳入网络荟萃分析的 RCT。共纳入 30720 名参与者（中位数 732；四分位距：248-931），其中 67%为女性。根据 SUCRA 分析，阿仑单抗（94.3%）在年化复发率方面最有可能是最佳选择，而奥法妥木单抗（93.5%）在 12 周确认的残疾进展方面最有可能是最佳选择。皮下注射干扰素β-1b（87.0%）在所有 DMT 中最有可能具有最佳安全性，而阿仑单抗（92.4%）在所有 DMT 中最有可能因 AE 停药而具有最佳安全性。
网络荟萃分析表明，阿仑单抗和奥法妥木单抗在 DMT 中具有最高的疗效。由于许多治疗方法之间的这些概率差异很小，临床医生在制定患者治疗计划时应使用临床共享决策。
