莫須瘤使用於國人狼瘡腎炎之效果評估

Rituximab therapy in Chinese patients with lupus nephritis

目的：研究B細胞導向治療在國人狼瘡腎炎的療效。方法：收案對象為狼瘡腎炎的患者在使用類固醇和免疫抑制劑治療後蛋白尿仍持續超過每日1克。實驗室檢查包括血球計數、肌酐酸、白蛋白、補體蛋白、抗雙股螺旋去核醣核酸抗體和尿蛋白，於rituximab注射前、注射後第三個月和第六個月進行檢測。實驗終點為第二十四週病人的腎臟反應（renal response）。結果：於2009年至2011年期間共收案14人，年齡分佈為18到24歲（中位數31）。在rituximab治療前的尿蛋白量為1.27到24.7克。在24週時，有8個病人（57.1%）達到完全或部份的腎臟緩解。有8人抗雙股螺旋去核醣核酸抗體於治療後顯著下降。分別有6人和3人的C3和C4蛋白於治療後顯著改善。結論：Rituximab在我們的狼瘡腎炎病人治療上有一定的療效，但其長期的效果仍有待進一步的研究證實。

Background: Systemic lupus erythematosus (SLE) is a common autoimmune disease in Chinese, and there is high morbidity and mortality in patients with initial renal involvement or severe nephritis. We investigated the efficacy of B cell depletion therapy with rituximab as treatment of Chinese patients with lupus nephritis (LN). Methods: We enrolled 14 patients with lupus nephritis (LN) from Taipei Veterans General Hospital beginning in 2009. LN was confirmed by clinical and laboratory evaluation. Rituximab was indicated when a patient had proteinuria ( >1 g/day urinary protein) that was poorly responsive to treatment with corticosteroids or immunosuppressants. Laboratory examination, including measurements of CBC, creatinine, albumin, C3, C4, anti-dsDNA antibodies, and urinary protein, were performed before rituximab infusion and at 3-month and 6-month follow-ups. Intravenous rituximab was given twice over 2 weeks at a total dosage of 1 or 2 g. The primary endpoint was renal response status at week 24. Results: A total of 14 patients were enrolled from 2009 to 2011. There were 11 females and 3 males and the age range was 18 to 41 years (median: 31 years, IQR 10.5 years). The median urinary protein was 3.38 g/day (IQR: 1.76 to 6.47) before rituximab infusion, and was 1.25 g/day (IQR: 0.49-3.13) at the 6 month follow-up. At week 24, the overall renal response rate (complete + partial response) was 57% (8 of 14 patients). There were improvements in C3 levels (>20 mg/dL) in 6 patients (43%), improvements in C4 levels (>10 mg/dL) in 3 patients (21%), and reductions in anti-dsDNA antibody levels (>50%) in 8 patients (57%). Conclusion: Rituximab appeared to have acceptable efficacy in our group of 14 LN patients. Future controlled studies should examine the long-term safety and efficacy of rituximab and determine the optimal rituximab regimen for Chinese patients with LN.