1. Cosentyx 是首个也是仅有一个在欧洲被同意用于医治这两种最常见炎症性关节疾病的 IL-17A 抑制剂类新药 1
2. Cosentyx 在强直性脊柱炎(AS)和银屑病性关节炎(PsA)患者中显现出快速且继续的临床获益, X 线查看显现,在 2 年期间,约 80% 的 AS 患者的脊柱损害和 84% 的 PsA 患者的关节损害未呈现发展 2-5
3. 鉴于许多患者对现有药物医治的反响欠安,亟需新的药物 6
欧洲委员会(EC)日前已同意 Cosentyx®(secukinumab)用于医治强直性脊柱炎(AS)和银屑病性关节炎(PsA)。关于强直性脊柱炎而言,这是自抗肿瘤坏死因子(抗 TNF)呈现之后 16 年来首个获批的新药 7。
Cosentyx 是首个被欧洲同意用于医治 AS 和 PsA 的白细胞介素-17A(IL-17A)抑制剂新药。此前 EC 还同意 Cosentyx 用于中至重度斑块型银屑病患者的一线医治。
在欧洲,AS 和 PsA 是常见的炎症性关节疾病,影响约 5 百万人,且现在这两种疾病仍存在明显的确诊缺乏和医治缺乏的状况 1,8-12。假如不进行有用医治,这两种疾病可导致脊柱和关节呈现不可逆的损害,形成毕生痛苦和残疾 13。鉴于许多患者对现有药物医治的反响欠安,有多达 40% 的患者经抗 TNF 药物医治后未取得充沛缓解,现在亟需医治这两种疾病的新药 6。
诺华制药全球负责人 David Epstein 标明,「咱们研讨中观察到的明显医治获益标明,Cosentyx 可阻挠疾病发展,防备毕生痛苦和残疾。这种新一代的生物制剂有或许成为这些常见但医治缺乏的炎症性疾病的规范医治药物,此次同意意味着欧洲的强直性脊柱炎和银屑病性关节炎患者自此可从这种生物制剂中获益。」
最新研讨标明,Cosentyx 可明显削减 AS 或 PsA 体征和症状,这种获益最早在第 1~3 周开端呈现并在 2 年期间继续存在 2,3。X 线查看发现,在 2 年期间,多达 80% 的承受 Cosentyx 医治的 AS 患者的脊柱损害 4 和 84% 的 PsA 患者的关节损害 5 未呈现发展。
已有 9600 余例患者在触及多种适应症的临床试验中承受了 Cosentyx 医治,上市以来已经有超越 12500 余例患者承受了 Cosentyx 医治 14。Cosentyx 的安全性与既往临床试验在多种适应症中观察到的安全性共同 2-5,14。
Cosentyx 现在被同意用于医治既往经惯例药物(如非甾体抗炎药)医治后反响欠安的成人患者的活动性 AS 和用于独自或联合甲胺喋呤医治既往经缓解疾病抗风湿药物(DMARDS)医治后反响欠安的成人患者的活动性 PsA。
Cosentyx 尚未在我国取得同意。
参考资料
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14. Novartis data on file, November 2015.