Department of Medicine, Division of Neurology and the Djavad Mowafaghian Centre for Brain Health, University of British Columbia , Vancouver, BC, Canada.
School of Population and Public Health, University of British Columbia , Vancouver, BC, Canada.
Expert Opin Drug Saf. 2020 Sep;19(9):1069-1094. doi: 10.1080/14740338.2020.1807002. Epub 2020 Aug 31.
We systematically reviewed adverse events (AEs) for ocrelizumab for multiple sclerosis (MS).
We searched Medline, Embase, Web of Science, and Toxicology Data Network-TOXLINE (inception to 8-July-2020), clinical trial registries, and product monographs for any clinical trials, observational studies or case reports examining AEs to ocrelizumab. Studies with/without a comparator drug or placebo were eligible.
Seventy-eight records were included (4 randomized controlled trials (RCTs), 4 open-label trials, 29 observational studies, and 27 case reports). AEs affected 2756/4498 (61.3%) of ocrelizumab-exposed patients. The most common AEs were infections (n=1342, 39.2% of ocrelizumab-exposed patients) and infusion-related reactions (n=1391, 26.2%). Compared to beta-interferon, infections were more likely in ocrelizumab-exposed patients (Risk Ratio (RR)=1.10; 95% confidence interval (CI):1.01-1.19), including: herpes-related (RR=1.75; 95%CI:1.11-2.76), respiratory tract-related (RR=1.42; 95%CI:1.10-1.84 and RR=1.61; 95%CI:1.10-2.35), nasopharyngitis (RR=1.47; 95%CI:1.13-1.90), and rhinitis (RR=4.00; 95%CI:1.13-14.14). Infusion-related reactions (RR range: 1.57-4.42) were more common for ocrelizumab versus placebo or beta-interferon. From pooled analyses (three RCTs), the risk of 'any' serious AE did not differ significantly between the ocrelizumab and comparator groups. However, insufficient data were available to assess longer-term AEs, e.g., malignancy.
我们系统地回顾了奥瑞珠单抗治疗多发性硬化症的不良事件（AE）。
我们检索了 Medline、Embase、Web of Science 和毒理学数据网络-TOXLINE（从建库到 2020 年 7 月 8 日）、临床试验注册库和产品说明书，以寻找评估奥瑞珠单抗 AE 的任何临床试验、观察性研究或病例报告。有/无对照药物或安慰剂的研究符合入选标准。
纳入了 78 篇记录（4 项随机对照试验（RCT）、4 项开放标签试验、29 项观察性研究和 27 项病例报告）。AE 影响了 4498 名奥瑞珠单抗暴露患者中的 2756 名（61.3%）。最常见的 AE 是感染（n=1342，奥瑞珠单抗暴露患者的 39.2%）和输注相关反应（n=1391，奥瑞珠单抗暴露患者的 26.2%）。与β干扰素相比，奥瑞珠单抗暴露患者发生感染的可能性更高（风险比（RR）=1.10；95%置信区间（CI）：1.01-1.19），包括：疱疹相关（RR=1.75；95%CI：1.11-2.76）、呼吸道相关（RR=1.42；95%CI：1.10-1.84 和 RR=1.61；95%CI：1.10-2.35）、鼻咽炎（RR=1.47；95%CI：1.13-1.90）和鼻炎（RR=4.00；95%CI：1.13-14.14）。与奥瑞珠单抗相比，输注相关反应（RR 范围：1.57-4.42）在奥瑞珠单抗与安慰剂或β干扰素之间更为常见。来自汇总分析（3 项 RCT）的数据显示，奥瑞珠单抗与对照组之间“任何”严重 AE 的风险无显著差异。然而，尚无足够的数据评估长期 AE，例如恶性肿瘤。
