Secukinumab是一種完全人源化的IgG1單克隆抗體,可以選擇性地中和促炎性細(xì)胞因子白細(xì)胞介素17A(IL-17A),而IL-17和IL-23/T17軸在銀屑病的發(fā)病機(jī)制中具有核心作用,因此,IL-17是銀屑病治療中的一個關(guān)鍵靶標(biāo)。II期臨床和III期臨床試驗(yàn)研究表明secukinumab作為皮下注射的IL-17抑制劑,在中度至重度斑塊型銀屑病和銀屑病關(guān)節(jié)炎(PsA)治療中具有明顯的優(yōu)勢,且安全性及耐受性良好。美國FDA于2015年1月已批準(zhǔn)其作為治療成人中度至重度斑塊型銀屑病的新藥申請,是治療該類疾病的第一個靶向IL-17的上市藥物,預(yù)計(jì)到2020年其銷售額將突破10億美元。

IL-23 and its downstream TH17 cytokines are likely pathogenic in human psoriatic skin, because mRNA for IL-17A, IL-17F, and IL-22 accumulates in cutaneous lesions. Therefore, IL-17 may be a therapeutic target in T cell-driven inflammatory disorders. Novartis is developing secukinumab, a fully human anti-IL-17A monoclonal antibody, for the potential treatment of several indications. Data from several phase II and phase III clinical trials were reported that targeted inhibition of the proinflammatory cytokine IL-17A with secukinumab through sc injection is a valid therapeutic approach and useful in the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis (PsA) with good safety and tolerability. It has been approved by the FDA on January 2015 as the first IL-17 blocking agent for the treatment of moderate-to-severe plaque psoriasis in adult patients. The market is projected to reach about US$1.0 billion in 2020.

天津市應(yīng)用基礎(chǔ)與前沿技術(shù)研究計(jì)劃重點(diǎn)項(xiàng)目(14JCZDJC33500)