Petrie John L, Smith Charlie A, Fountain Donna, Machnicki Gerardo
Putnam, Portland House, New Bridge Street West, Newcastle Upon Tyne, NE1 8AP, UK.
F. Hoffmann-La Roche Ltd, Grenzacherstrasse, Basel, Switzerland.
Neurol Ther. 2024 Dec;13(6):1597-1605. doi: 10.1007/s40120-024-00667-w. Epub 2024 Oct 19.
In clinical trials, the percentage of patients discontinuing treatment with ocrelizumab due to adverse events was low. However, real-world populations are often more diverse than randomized controlled trials (RCTs), therefore it is important to assess discontinuation rates in real-world studies. This systematic literature review (SLR) was conducted to identify real-world discontinuation and persistence data for ocrelizumab in studies of patients with relapsing remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). Searches were conducted in MEDLINE and Embase to identify relevant real-world studies that met pre-determined Population, Intervention, Comparison, Outcomes, and Study (PICOS) criteria. Only articles published in English were included, but the study country was not restricted. A total of 30 studies were included, with the majority reporting real-world persistence data that appear to be similar to or better than in the pivotal clinical trials, with only 1 study reporting higher discontinuation rates due to adverse events compared with the clinical trials. Other studies identified reported that the risk of discontinuation was higher for other disease-modifying therapies (DMTs) compared with ocrelizumab, and adherence was also higher for ocrelizumab versus other DMTs. These findings have clinical relevance, as other studies have reported improved clinical outcomes and lower care costs for patients that are persistent or adherent to other DMTs.
在临床试验中,因不良事件而停止使用奥瑞珠单抗治疗的患者比例较低。然而,真实世界人群往往比随机对照试验(RCT)中的人群更加多样化,因此在真实世界研究中评估停药率很重要。进行这项系统文献综述(SLR)的目的是,在复发缓解型多发性硬化症(RRMS)和原发性进展型多发性硬化症(PPMS)患者的研究中,确定奥瑞珠单抗的真实世界停药和持续用药数据。在MEDLINE和Embase中进行检索,以确定符合预先确定的人群、干预措施、对照、结局和研究(PICOS)标准的相关真实世界研究。仅纳入以英文发表的文章,但对研究国家没有限制。总共纳入了30项研究,大多数研究报告的真实世界持续用药数据似乎与关键临床试验中的数据相似或更好,只有1项研究报告因不良事件导致的停药率高于临床试验。其他已确定的研究报告称,与奥瑞珠单抗相比,其他疾病修饰疗法(DMT)的停药风险更高,而且与其他DMT相比,奥瑞珠单抗的依从性也更高。这些发现具有临床相关性,因为其他研究报告称,持续使用或依从其他DMT的患者临床结局得到改善,护理成本降低。