诺华制药:抗VEGF药物疗效比较,头对头数据来验证

2017-09-14 佚名 MedSci原创

西班牙巴塞罗那2017年9月14日电 /美通社/ -- 2017 EURETINA在巴塞罗那召开,诺华制药直击现场。在AMD环节中,抗VEGF仍然是被讨论的一个热门话题。虽然目前抗VEGF药物有了大量的询证医学证据,但是头对头的前瞻性研究非常罕见,因此很难通过一个单臂研究来比较两种药物的优劣。

RIVAL研究是第一个比较雷珠单抗和阿柏西普使用T&E方案RCT研究,将278例患者随机分为两组,一组接受雷珠单抗0.5mg治疗,一组接受阿柏西普2mg治疗,都使用相同的T&E方案,主要根据视力和OCT来决定是否再治疗。该研究的主要观察终点是2种药物2年后地图样萎缩的发生情况,此次会议中对于1年后的视力和治疗次数做了分析和讨论。

该研究两组基线情况无显著差异,基线视力两组约为65个字母,12个月后,雷珠单抗组视力提高6.9个字母,阿柏西普提高4.7个字母(P=0.06)。即使在65个字母基线较好的情况下,接受雷珠单抗治疗,仍能有约7个字母的视力提高,这一结果令人感到欣喜。

分析造成视力提高差异的原因,使用4周的结果进行waterfall plot分析,发现阿柏西普组视力丢失>10个字母的患者,要多于雷珠单抗。推测造成这一结果的原因,可能与基线情况、治疗时间、疾病史等因素都相关。但是通过这一研究我们仍能发现,在使用相同治疗方案、相同注射次数的情况下,雷珠单抗视力提高字母数比阿柏西普多2.2个字母。

期待2年结果的出现,为临床用药提供更多参考。

注:阿柏西普未在中国大陆地区上市

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    2017-09-16 d830379