Queen Mary University of London, London, UK.
Research Center for Clinical Neuroimmunology and Neuroscience and MS Center, University Hospital Basel and University of Basel, Basel, Switzerland.
Eur J Neurol. 2022 Apr;29(4):1238-1242. doi: 10.1111/ene.14823. Epub 2021 May 5.
Requiring a walking aid is a fundamental milestone in multiple sclerosis (MS), represented by an Expanded Disability Status Scale (EDSS) score ≥6.0. In the present study, we assess the effect of ocrelizumab (OCR) on time to EDSS score ≥6.0 in relapsing MS.
Time to EDSS score ≥6.0 confirmed for ≥24 and ≥48 weeks was assessed over the course of 6.5 years (336 weeks) in the double-blind period (DBP) and open-label extension (OLE) period of the OPERA I (NCT01247324) and OPERA II (NCT01412333) studies.
Time to reach EDSS score ≥6.0 was significantly delayed in those initially randomized to OCR versus interferon. Over 6.5 years, the risk of requiring a walking aid confirmed for ≥24 weeks was 34% lower among those who initiated OCR earlier versus delayed treatment (average hazard ratio [HR] DBP + OLE 0.66, 95% confidence interval [CI] 0.45-0.95; p = 0.024); the risk of requiring a walking aid confirmed for ≥48 weeks was 46% lower (average HR DBP+OLE 0.54, 95% CI 0.35-0.83; p = 0.004).
The reduced risk of requiring a walking aid in earlier initiators of OCR demonstrates the long-term implications of earlier highly effective treatment.
需要使用助行器是多发性硬化症（MS）的一个重要里程碑，表现为扩展残疾状况量表（EDSS）评分≥6.0。在本研究中，我们评估奥瑞珠单抗（OCR）对复发型 MS 患者达到 EDSS 评分≥6.0 的时间的影响。
在 OPERA I（NCT01247324）和 OPERA II（NCT01412333）研究的双盲期（DBP）和开放标签扩展期（OLE）中，评估 6.5 年内（336 周） EDSS 评分≥6.0 经≥24 和≥48 周确认的时间。
与干扰素相比，最初随机分配到 OCR 的患者达到 EDSS 评分≥6.0 的时间明显延迟。在 6.5 年内，与延迟治疗相比，更早开始 OCR 治疗的患者需要助行器的风险降低了 34%（DBP+OLE 平均危险比 [HR] 0.66，95%置信区间 [CI] 0.45-0.95；p=0.024）；需要助行器的风险降低了 46%（DBP+OLE 平均 HR 0.54，95%CI 0.35-0.83；p=0.004）。
OCR 更早开始治疗的患者需要助行器的风险降低，表明早期高效治疗具有长期影响。
