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Ponesimod治疗复发性多发性硬化症的III期研究结果:符合其主要和次要终点

2019-07-26 Allan MedSci原创

Ponesimod是一种选择性鞘氨醇-1-磷酸受体1(S1P1)调节剂,Ponesimod被认为能够抑制S1P1活性并减少循环淋巴细胞的数量。强生公司近日公布了III期OPTIMUM研究的正面结果,该研究评估了Ponesimod治疗复发性多发性硬化症的有效性和安全性。

Ponesimod是一种选择性鞘氨醇-1-磷酸受体1S1P1)调节剂,Ponesimod被认为能够抑制S1P1活性并减少循环淋巴细胞的数量。强生公司近日公布了IIIOPTIMUM研究的正面结果,该研究评估了Ponesimod治疗复发性多发性硬化症的有效性和安全性。OPTIMUM的主要终点是直至研究结束时的年复发率(ARR),关键的次要终点是疲劳相关症状从基线到第108周的变化。结果显示,该研究符合其主要和次要终点。

多发性硬化症是一种脱髓鞘性神经病变,患者脑或脊髓中的神经细胞表面的绝缘物质(即髓鞘)受到破坏,神经系统的信号转导受损,导致一系列可能发生的症状,影响患者的活动、心智、甚至精神状态。


原始出处:

http://www.firstwordpharma.com/node/1655203#axzz5ug3cIKrI

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    2019-07-26 jml2009
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  5. 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    2020-03-05 juliusluan78
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    2019-07-28 skhzy
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    2019-07-28 docwu2019
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罗氏的抗CD20单抗ocrelizumab在英国获批上市,治疗原发性进行性多发性硬化症

罗氏选择性靶向CD20+B细胞的人源单抗Ocrevus(ocrelizumab),是欧洲第一个也是唯一一个获批用于治疗原发性进展MS的药物。但由于价格过于昂贵,最初被英国国家健康和护理卓越研究所(NICE)拒绝。

AAN:II期临床试验证实口服Bruton酪氨酸激酶(BTK)抑制剂治疗多发性硬化症的有效性

德国达姆施塔特市的Merck KGaA在2019年美国神经病学学会年会(AAN)上公布,同时在新英格兰医学杂志(NEJM)上发表了复发性多发性硬化症(RMS)患者服用evobrutinib的双盲、随机、安慰剂对照II期研究的48周结果。Evobrutinib是第一种口服、高选择性Bruton酪氨酸激酶(BTK)抑制剂。

2019年欧洲神经病学学会EAN:Ozanimod显着减少复发多发性硬化患者的脑容量损失

第5届欧洲神经病学学会(EAN)上的最新报告,与干扰素β-1a相比,Ozanimod在复发性多发性硬化症(MS)患者中更好地减少了全脑容量、皮质灰质体积和丘脑体积的损失。

显著改善认知能力,诺华公布多发性硬化症新药全新数据分析

今年3月,诺华(Novartis)公司开发的Mayzent(siponimod)获得FDA批准,治疗多发性硬化症(MS)患者。日前,诺华公司在美国神经病学学会(American Academy of Neurology, AAN)年会上,公布了对这款新药在3期临床试验中获得的试验数据的进一步分析。最新分析表明,Mayzent能够为继发进展型MS(SPMS)患者的认知处理速度(cognitive p

由于毒副作用,欧洲药品管理局建议限制Lemtrada在多发性硬化症中的使用

欧洲药品管理局的药物警戒风险评估委员会(PRAC)已开始审查赛诺菲的多发性硬化症药物Lemtrada(alemtuzumab)。这项审查是在免疫介导的疾病新报告之后进行的,这些疾病是由于身体的防御系统无法正常工作引起的,包括心脏和血管问题,还有严重的药物毒性致命事件。

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