诺华的Cosentyx率先在日本获准用于治疗银屑病和银屑病关节炎

北京2015年1月5日电 /美通社/ -- 诺华公司日前宣布，日本厚生劳动省(MHLW)正式批准Cosentyx™ (secukinumab，曾用名AIN457)用于对全身性治疗(除外生物制剂)应答不足的寻常型银屑病和银屑病关节炎(PsA)成年患者。这使得日本成为了全球第一个批准Cosentyx的国家，也使得Cosentyx成为了首个在日本获准用于上述两种适应症的白介素-17A (IL-17A)抑制剂。

Cosentyx主要通过抑制 IL-17A 发挥作用，IL-17A 蛋白在银屑病受累皮肤中浓度较高，是银屑病、PsA等炎性疾病发病的关键因素^14-19。全球大约30%的银屑病患者同时也患有PsA¹²；如今该药获批意味着日本患者有了新的治疗选择，可以同时有效治疗这两种疾病。 

诺华制药全球负责人David Epstein表示：“我们很高兴日本在全球率先批准Cosentyx用于治疗银屑病和银屑病关节炎，为日本超过400,000名银屑病和银屑病关节炎患者提供新的治疗选择。”“将近一半的银屑病和PsA患者对现有治疗不满意。如今该药获准上市，我们应该能够解决这一重要的尚未满足的治疗需求，切实提高这些患者的生活质量。”

在银屑病临床试验中，70%的患者在开始Cosentyx 300 mg治疗后16周内实现了皮损完全消除或皮损接近完全消除 (p<0.0001)，并且在大部分患者中这一效果一直持续至第52周(继续接受治疗)¹。在PsA试验中，Cosentyx与安慰剂相比在改善PsA的症状和体征方面疗效显著且持久，具体表现为美国风湿病学会应答标准评分下降20%(ACR 20)，这是评估关节炎治疗疗效的公认标准。在两项关键性试验FUTURE 1 (150 mg；p<0.0001)和FUTURE 2 (150和300 mg；p<0.0001)中，50%~54%接受了Cosentyx治疗的患者至少达到了ACR 20 ^4,5。

银屑病是一种慢性免疫介导性疾病，其特征是皮损厚而广泛，称为斑块，已知会引起瘙痒、脱屑和疼痛；银屑病可能明显影响患者生理和心理方面的生活质量^6,20,21。PsA与银屑病密切相关，可能引起关节疼痛和僵硬、皮肤和指甲银屑病、手指脚趾肿胀、持续性疼痛性肌腱炎以及不可逆转的关节损害¹³。多达40%的患者可能发生关节破坏和永久性身体畸形²²。

Cosentyx获批主要是基于相关研究的安全性和疗效结果，包括10多项总共纳入了将近4,000例中重度斑块状银屑病患者的II期和III期试验^1-3,13 以及2项纳入了1,000多例 PsA患者的关键性III期试验 FUTURE 1和FUTURE 2^4,5。在所有试验中，Cosentyx均表现出了良好的安全性特征，两个Cosentyx 治疗组(300 mg和150 mg)的不良事件 (AEs)发生率和严重程度相似 ^1-5,23。

2014年11月，Cosentyx 获得了欧洲药品管理局人用药品委员会(CHMP)的积极意见，推荐欧洲各国将Cosentyx作为中重度银屑病患者的一线治疗。并于2014年10月获得了FDA皮肤与眼科药物顾问委员会(DODAC)对该适应症的全票支持。

关于Cosentyx™ (secukinumab)和白介素-17A (IL-17A)

Cosentyx是一种选择性中和IL-17A的人单克隆抗体^14,15。IL-17A在银屑病受累皮肤中浓度较高，是试验性治疗药物的首选靶点^14,19。研究还表明，在银屑病关节炎、强直性脊柱炎等其他炎性关节疾病中，IL-17A在促进机体免疫应答方面也起着重要的作用²⁶。

针对银屑病关节炎和强直性脊柱炎的III期研发计划正在进行中；预计2015年世界各国将陆续批准Cosentyx用于治疗这些关节疾病。

关于银屑病

银屑病大约累及全球3%的人口，全球患者总人数超过1.25亿²⁵。据估计，日本大约有430,000名银屑病患者²⁷。

这种令人痛苦的常见病并非单纯的美观问题，即使患者症状很轻，其日常生活也会受到影响⁶。而且，多达50%的患者对包括生物制剂在内的现有治疗并不满意，因此急需新的银屑病治疗药物^6-9。

关于银屑病关节炎 (PsA)

银屑病关节炎(PsA)是一种使人日渐衰弱的长期炎性疾病，可能引起明显残疾、生活质量下降以及寿命缩短¹²。PsA累及大约0.3%~1%的总人口，多达四分之一的银屑病患者可能都合并有PsA，只是有的未被诊断 ^12,24。在日本，PsA累及超过3%的银屑病患者²⁸。

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