英国NICE否定了Zeposia治疗多发性硬化症的作用

2021-01-24 Allan MedSci原创

英国国家健康与护理卓越研究所(NICE)拒绝了百时美施贵宝(BMS)的Zeposia(ozanimod)用于治疗复发难治多发性硬化症(RRMS)的申请。

英国国家健康与护理卓越研究所(NICE)拒绝了百时美施贵宝(BMS)的Zeposia(ozanimod)用于治疗复发难治多发性硬化症(RRMS)的申请。

NICE在一份评估咨询文件中说,尽管有证据表明Zeposia与干扰素beta-1a相比可以减少多发性硬化症患者的复发次数和脑部病变,但尚不清楚该药物对残疾进展的影响。NICE还表示,由于临床有效性证据中存在“局限性”,因此不确定Zeposia的成本效益估算。

去年5月,Zeposia被欧洲药品管理局批准用于RRMS的治疗,并且去年还获得了美国食品和药品监督管理局(FDA)的批准。

MS协会研究和对外事务总监Sarah Rawlings说:“令人沮丧的是,NICE决定不建议使用Zeposia治疗MS。虽然针对这种情况有多种治疗方法,但口服型药物仍然很少,人们可以从一种新的,更方便的替代方案中受益匪浅。NICE的决定并非最终决定,我们敦促他们和制造商审查证据,并考虑哪种方法最适合MS患者”。

 

原始出处:

http://www.pharmatimes.com/news/nice_no_for_bms_multiple_sclerosis_drug_zeposia_1361753

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    2021-01-24 ms1000001433472600

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进展性多发性硬化缺乏有效治疗的原因是多方面的。进展性多发性硬化症的病理生理学尚不清楚,目前还没有一种动物模型能准确地模拟该病的整个过程。因此,新的靶点和药物的发现是具有挑战性的。药物再利用是更快捷的方

Lancet Neurol:金刚烷胺、莫达非尼和哌醋甲酯对多发性硬化性疲劳效果不显著

金刚烷胺、莫达非尼和哌醋甲酯在改善多发性硬化性疲劳方面并不优于安慰剂,且导致更频繁的不良事件。研究的结果不支持金刚烷胺、莫达非尼或哌醋甲酯治疗多发性硬化症导致的疲劳

Lancet Neurol:高剂量生物素对进行性多发性硬化症患者残疾进展的影响

高剂量、药物级生物素不能显著改善进行性多发性硬化症患者的残疾进展或步行速度,不推荐其用于进行性多发性硬化症的治疗

拓展阅读

NNN:多发性硬化病灶的细胞特异性机制驱动单细胞图谱绘制

在进行性多发性硬化症(MS)中,不同分区炎症在组织损伤的复杂病理过程中起着关键作用。

《新英格兰杂志》:CD40L抗体Frexalimab对多发性硬化症的作用

在此项使用Frexalimab治疗MS患者第2阶段试验中,CD40L抗体在治疗第12周,更有利于减少钆增强T1加权病变的新损伤数量。

JNNP: 复发缓解型多发性硬化症的造血干细胞移植——一项观察性队列研究

使用aHSCT治疗RRMS可使大多数患者摆脱疾病活动,且不良反应可接受。

Neurology:脊髓萎缩和脑顺磁环病变与多发性硬化症患者病情进展或复发活动的相关性

PIRA 与脊髓萎缩和 PRL 负担的增加有关,这种关联在 RRMS 患者中也很明显。

JNNP:多发性硬化症患者的心肺功能和磁共振成像神经炎症测量对海马体积的影响

较好的 CRF 可对多发性硬化症患者的海马完整性起到特殊的神经保护作用,但仅限于疾病的复发缓解阶段。

Annals of neurology:高水平的血管周围炎症和活动性脱髓鞘病变与快速进展性多发性硬化症病程有关

ALs 是疾病早期阶段的一个特征,在 PVI 水平较高的MS亚组换着中持续存在直到死亡。