Neurology Department, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
Neurology Department, Hospital Universitario Santa Lucía, Cartagena, Spain.
Ann Clin Transl Neurol. 2021 Feb;8(2):385-394. doi: 10.1002/acn3.51282. Epub 2020 Dec 25.
Pivotal trial have shown that patients with multiple sclerosis (MS) receiving ocrelizumab had better outcomes. However, data on ocrelizumab in clinical practice are limited. The aim of this study was to evaluate the preliminary safety profile and effectiveness of ocrelizumab treatment for multiple sclerosis (MS) in a real-world clinical setting.
We conducted a retrospective study including consecutive patients from nine public hospitals in south-eastern Spain who received ocrelizumab after it was approved.
A total of 228 MS patients were included (144 with relapsing-remitting MS [RRMS], 25 secondary progressive MS [SPMS], and 59 primary progressive MS [PPMS]). Median follow-up period was 12 months (range, 1-32). No evidence of disease activity (NEDA) status at year 1 was achieved in 91.2% of the relapsing MS (RMS) population, while disability progression was detected in 37.5% of the PPMS patients (median follow-up period, 19 months). The most common adverse events reported were infusion-related reactions and infections, with the most common infections being urinary tract infections followed by upper respiratory infections and COVID-19.
The preliminary results in our real-world setting show that ocrelizumab presented excellent results in suppressing disease activity with a favorable and consistent safety profile.
关键性试验表明,接受奥瑞珠单抗治疗的多发性硬化症(MS)患者有更好的结局。然而,临床实践中关于奥瑞珠单抗的数据有限。本研究旨在评估奥瑞珠单抗治疗多发性硬化症(MS)在真实临床环境中的初步安全性和有效性。
我们进行了一项回顾性研究,纳入了西班牙东南部 9 家公立医院接受奥瑞珠单抗治疗的连续患者,该药物在这些医院获批后开始使用。
共纳入 228 例 MS 患者(144 例复发缓解型 MS [RRMS],25 例继发进展型 MS [SPMS],59 例原发进展型 MS [PPMS])。中位随访期为 12 个月(范围,1-32 个月)。在复发型 MS(RMS)人群中,有 91.2%的患者在第 1 年达到无疾病活动(NEDA)状态,而有 37.5%的 PPMS 患者出现残疾进展(中位随访期为 19 个月)。报告的最常见不良事件是输注相关反应和感染,最常见的感染是尿路感染,其次是上呼吸道感染和 COVID-19。
我们的真实世界研究初步结果显示,奥瑞珠单抗在抑制疾病活动方面表现出了出色的效果,且安全性良好且一致。