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              輝瑞擬降低 RA 藥物托法替布劑量以減少肺栓塞風險
              2019-02-26 09:47:53 來源:丁香園 瀏覽:2547

              日前,輝瑞宣布擬將托法替布劑量從每天兩次 10 mg 降至每天兩次 5 mg,此舉是因為之前發現接受高劑量治療的患者有較高的肺栓塞風險。

              在托法替布上市之后,按照 FDA 的要求,輝瑞開展該藥物的上市后研究,即 A3921133 研究。這是一項開放標簽的研究,旨在評估兩種劑量的托法替布與對照組腫瘤壞死因子抑制劑(TNFi)的安全性以及心血管事件的風險。

              研究結果顯示,與接受 TNFi 治療的患者相比,接受 10 mg 劑量托法替布治療的患者在肺栓塞發生率方面具有顯著的統計學和臨床差異,而 5 mg 劑量組的風險收益比相對較為平衡。

              托法替布是由輝瑞研發的針對 JAK3 及 JAK1 的口服抑制劑,于 2012 年獲得 FDA 批準用于治療中度至重度活動性類風濕關節炎(RA)的患者,是首個可口服的 JAK 類藥物。

              該公司已表示將「繼續評估托法替布的風險收益情況,隨著更多數據的披露,我們將繼續與監管機構合作,并在 A3921133 研究結束后審查完整結果。」

              托法替布在美國也被批準用于治療患有活動性銀屑病關節炎和中度至重度潰瘍性結腸炎的成人,其中藥物以 10 mg 的劑量每天兩次給藥至少 8 周,然后給予 5 mg 的劑量或每日兩次 10 毫克。

              ?


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