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              開創銀屑病長效、便捷治療新模式
              2019-07-24 10:11:40 來源:丁香園 瀏覽:1782

              (2019 年 6 月 5 日,北京)強生公司在華制藥子公司西安楊森制藥有限公司今日宣布,全球首個全人源「雙靶向」白細胞介素 12(IL-12)和白細胞介素 23(IL-23)抑制劑喜達諾?(STELARA ?),即烏司奴單抗注射液,已在中國上市。

              烏司奴單抗注射液是一款具有創新給藥模式——維持期每三個月皮下注射一次的生物制劑,用于治療對環孢素、甲氨蝶呤(MTX)或 PUVA(補骨脂素和紫外線 A)等其他系統治療不應答、有禁忌或無法耐受的成年中重度斑塊狀銀屑病患者 [1]

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              「始于喜,達于諾」喜達諾?中國上市啟動儀式?

              004288bf3b4437a34792fdea9b8bf10.jpg
              中華醫學會皮膚性病學分會前主任委員、北京大學人民醫院皮膚科主任張建中教授發言

              中華醫學會皮膚性病學分會前主任委員、北京大學人民醫院皮膚科主任張建中教授指出,「銀屑病是一種以紅斑、鱗屑為主要表現的慢性、復發性、炎癥性疾病。流行病學調查顯示我國有超過 650 萬的銀屑病患者 [2],[3],其中 80%-90% 患者是斑塊狀銀屑病,約 30% 的患者是中重度斑塊狀銀屑病,對患者生活質量有很大影響,需要積極治療。」

              0f9b202f5d55a8836a994db10793146.jpg
              銀屑病病友互助網創始人史星翔先生發言

              銀屑病病友互助網創始人史星翔先生強調,「中重度銀屑病患者亟需長效、安全、便捷的醫療解決方案,幫助他們改善生存現狀、盡可能減少疾病對身體、工作、生活的負面影響。」

              烏司奴單抗注射液是靶向針對 IL-12 和 IL-23 的全人源化單克隆抗體,通過與 IL-12 和 IL-23 所共有的 p40 蛋白亞單位以高親和力特異性結合,從而抑制這兩種在銀屑病的發生和發展中起著關鍵作用的胞因子。

              868b4273d4ae2fcc4d8879eee2b5fe3.jpg
              中國人民解放軍總醫院皮膚科主任李承新教授發言

              中國人民解放軍總醫院皮膚科主任李承新教授表示,「生物制劑的應用給銀屑病的治療帶來了重大變革。與傳統系統性療法不同,它針對性地阻斷引起銀屑病患者皮膚細胞過度增生的特定免疫環節。作為生物療法中的佼佼者,烏司奴單抗注射液在全球擁有逾十年的臨床使用數據,其有效性、安全性和依從性也已被大量真實世界研究驗證。」

              涉及 1,996 例患者的兩項隨機、雙盲、安慰劑對照的 III 期臨床試驗 PHOENIX 1 和 PHOENIX 2 的研究結果表明烏司奴單抗注射液長期療效持久,維持皮損清除及生活質量改善可達 5 年。[4]另一項針對中國人群的 III 期臨床試驗 LOTUS 顯示, 82.5%(132/60)使用烏司奴單抗注射液 的患者在 12 周達到試驗主要終點 PASI75,安慰劑組的數據為 11.1%。所有關鍵次要終點也得到了顯著改善,包括超過 80% 使用烏司奴單抗注射液 的患者在 28 周達到了 PASI90[5]

              另外,PHOENIX 延長擴展研究 [4],[6] 顯示,烏司奴單抗注射液可長期維持銀屑病臨床治療反應,隨著烏司奴單抗注射液治療時間的延長,未觀察到劑量相關或累積的毒性。真實世界 PSOLAR 研究 8 年間共納入了超過 12,000 名使用烏司奴單抗注射液和其他治療方案的患者數據,該研究結果與烏司奴單抗注射液總體安全性相一致。[7] 此外, 多個真實世界注冊研究顯示,與納入研究中的其它生物制劑相比,烏司奴單抗注射液的總體藥物留存率更高,停藥風險更低。[8],[9],[10]

              6c868ea830c0b7f2d676300cc06b457.jpg
              西安楊森醫學事務部副總裁李濱發言

              西安楊森醫學事務部副總裁李濱介紹:「作為國內首個獲批維持期每三個月用藥一次的生物制劑,烏司奴單抗注射液的上市為國內中重度斑塊狀銀屑病患者提供了一種全新、長效、便捷的治療選擇。」

              e46f6e9315000ae6a00bb17b32d134b.jpg
              西安楊森總裁 Asgar Rangoonwala 先生致辭

              「楊森始終致力于為自身免疫疾病患者提供創新的生物制劑和醫療解決方案,包括銀屑病患者,我們會繼續關注患者亟待解決的治療需求,幫助他們切實改善治療效果,回歸正常生活。」西安楊森總裁 Asgar Rangoonwala 強調,「西安楊森將堅守對中國患者的承諾,繼續與相關機構通力合作,為提升藥品可及性、造福中國患者而不懈努力。」

              目前,烏司奴單抗注射液(喜達諾?)已進入中國,覆蓋北京、上海和廣州等城市。并已在 89 個國家獲批。


              參考文獻

              [1] 烏司奴單抗注射液說明書

              [2] Ding?X,?et al. Eur J Dermatol?2012;?22(5):?663-667

              [3] http://data.stats.gov.cn/easyquery.htm?cn = C01&zb = A030605&sj = 2018

              [4] Kimball et al. JEADV 2013;27:1535-45.

              [5] Xuejun Zhu et al. J Drugs Dermatol. 2013; 12 (2): 166-174

              [6] Papp, et al. BJD 2013;168:844-54

              [7] Papp, et al. JDD 2015;14:706-14.

              [8] Menter, et al. JEADV 2016;30:1148-58

              [9] Egeberg et al. BJD 2018;178:509-19

              [10] Warren et al. JID 2015;135:2632-40

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