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罗氏称实验性多发性硬化症口服药在晚期试验中使复发率降低55%Roche says experimental MS pill cuts relapses by 55% in late-stage trials

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2020年5月27日,工人在罗特克罗伊茨清洗罗氏公司大楼的窗户。路透社/阿恩德·维格曼/资料照片Workers clean the windows of a building of Roche in Rotkreuz May 27, 2020. REUTERS/Arnd Wiegmann/File Photo

罗氏周三表示,晚期临床试验数据显示,其实验性药物非布鲁替尼(fenebrutinib)降低了慢性脑部炎症标志物,并在复发缓解型和原发进展型多发性硬化症(MS)患者中实现了比对照治疗更广泛的疾病控制。

Roche said on Wednesday late-stage trial data showed its experimental drug fenebrutinib reduced markers of chronic brain inflammation and delivered broader disease control than comparator treatments in patients with relapsing and primary progressive multiple sclerosis (MS). By Patrick Wingrove

瑞士药企在多伦多举行的多发性硬化症会议上公布的关键发现包括:合并数据显示,与对照药物特立氟胺相比,非布鲁替尼在96周内将年化复发率降低了55%在复发缓解型多发性硬化症患者中经96周、在原发进展型多发性硬化症患者中经120周,非布鲁替尼将缓慢扩大病灶体积(一种慢性炎症标志物)较活性对照药降低了多达30%与活性对照药相比,复发缓解型多发性硬化症患者的顺磁边缘病灶累积(另一种慢性炎症标志物)减少了62%罗氏表示,研究结果显示非布鲁替尼直接靶向大脑慢性神经炎症,公司将其描述为多发性硬化症残疾进展的主要驱动因素在复发缓解型多发性硬化症的合并试验中,接受非布鲁替尼治疗的患者中有75%在近两年后显示无疾病活动证据,即零复发、零MRI活动或零残疾恶化。

Key findings presented by the Swiss drugmaker at an MS conference in Toronto included: Pooled data showed fenebrutinib reduced the annualised relapse rate by 55% versus comparator drug teriflunomide, over 96 weeks Fenebrutinib reduced the volume of slowly expanding lesions, a marker of chronic inflammation, by up to 30% versus active comparators in relapsing MS patients over 96 weeks and in primary progressive MS patients over 120 weeks The accumulation of paramagnetic rim lesions, another chronic inflammation marker, was reduced by 62% in relapsing MS patients compared with active comparators Roche said the findings showed fenebrutinib directly targets chronic neuroinflammation in the brain, which it described as a primary driver of disability progression in MS In pooled trials in relapsing-MS, 75% of patients receiving fenebrutinib showed no evidence of disease activity after nearly two years, meaning zero relapses, MRI activity or disability worsening.

这代表了较对照组70%的降幅年脑容量损失减少了23%,而12周复合确诊残疾进展减少了16%,罗氏表示这凸显了该药物减缓脑组织流失和保护功能的潜力

That represented a 70% reduction versus the comparator Annual brain volume loss was reduced by 23%, while 12-week composite confirmed disability progression was reduced by 16%, which Roche said highlighted the drug's potential to slow brain tissue loss and preserve function

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