Ocrelizumab和安慰剂主要进展型多发性硬化症。

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Ocrelizumab和安慰剂主要进展型多发性硬化症。

郑传经地中海J。2017年1月19日,376 (3):209 - 220。doi: 10.1056 / NEJMoa1606468。Epub 2016年12月21日。

PubMed ID

28002688 (在PubMed

]

文摘

背景:一个不断发展的了解多发性硬化症的免疫发病机理表明,耗尽B细胞可能是有用的治疗。我们研究ocrelizumab人源化单克隆抗体,选择性耗尽CD20-expressing B细胞,主要进行式的疾病。方法:在这3期临床试验中,我们随机选取了732名原发性进行性多发性硬化症患者接受静脉注射ocrelizumab是2:1(600毫克)或安慰剂每24周至少120周,直到指定数量的确认残疾发展事件发生。主要终点是残疾患者的比例确认在12周进展比较分析。结果:12周证实患者残疾的比例发展与ocrelizumab 32.9%和39.3%和安慰剂(风险比,0.76;95%可信区间(CI), 0.59 - 0.98;P = 0.03)。24周证实患者残疾的比例发展与ocrelizumab 29.6%和35.7%和安慰剂(风险比,0.75;95%可信区间,0.58 - 0.98;P = 0.04)。 By week 120, performance on the timed 25-foot walk worsened by 38.9% with ocrelizumab versus 55.1% with placebo (P=0.04); the total volume of brain lesions on T2-weighted magnetic resonance imaging (MRI) decreased by 3.4% with ocrelizumab and increased by 7.4% with placebo (P<0.001); and the percentage of brain-volume loss was 0.90% with ocrelizumab versus 1.09% with placebo (P=0.02). There was no significant difference in the change in the Physical Component Summary score of the 36-Item Short-Form Health Survey. Infusion-related reactions, upper respiratory tract infections, and oral herpes infections were more frequent with ocrelizumab than with placebo. Neoplasms occurred in 2.3% of patients who received ocrelizumab and in 0.8% of patients who received placebo; there was no clinically significant difference between groups in the rates of serious adverse events and serious infections. CONCLUSIONS: Among patients with primary progressive multiple sclerosis, ocrelizumab was associated with lower rates of clinical and MRI progression than placebo. Extended observation is required to determine the long-term safety and efficacy of ocrelizumab. (Funded by F. Hoffmann-La Roche; ORATORIO ClinicalTrials.gov number, NCT01194570 .).

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Ocrelizumab