Voclosporin 為cyclosporine 之類似物， 為一種新的口服的鈣調磷酸酶抑制劑 (calcineurin inhibitor)。美國藥政單位 (U.S. Food and Drug Administration) 於2021年1月22日批准伏環孢素 (voclosporin, LupkynisTM) 作為紅斑性狼瘡腎炎 (lupus nephritis) 患者之免疫抑制劑。AURORA1 試驗中顯示口服voclosporin 一年後可有效降低蛋白尿肌酸酐比值 (urine protein and creatinine ratio, UPCR)。建議使用劑量為每日兩次，每次23.7 mg。其嚴重之藥物不良反應為腎損傷，故治療時需監控腎功能並審視併用藥物是否也同樣具腎毒性；並且注意由於voclosporin 為一免疫抑制劑，因此病患更易感染。回顧相關文獻後結論為，病患使用mycophenolate mofetil 及volclosporin 治療紅斑性狼瘡腎炎可降低類固醇之劑量，且UPCR 亦有顯著改善。

 

In January 2021, the U.S. Food and Drug Administration (FDA) approved voclosporin (LupkynisTM), a calcineurin inhibitor, to be used in combination with background immunosuppressive therapy to treat adults with active lupus nephritis. The Aurinia Renal Response in Active Lupus with Voclosporin(AURORA 1) trial showed the complete renal response at week 52,namely the reduction of the urine protein creatinine ratio (UPCR), was significantly achieved in the patients receiving oral voclosporin therapies (23.7 mg twice daily). The most frequently reported adverse reaction was the decrease of glomerular filtration rate, indicating that kidney problems might be noticed. For safety, patients should be monitored for kidney function during treatment and examined if the concomitant drugs possess nephrotoxic effects. Patients on voclosporin treatment were found to be more susceptible to infections as well. Volclosporinin combination with mycophenolate mofetil for the treatment of lupus nephritis led to clinical and significant reduction of steroid doses and UPCR improvement.

 

Submitted for publication: 2021.10.27; Accepted for publication: 2022.8.1