Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study

Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study
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DOI:
10.1093/rheumatology/kep346
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发表时间:
2010-01-01
期刊:
影响因子:
5.5
通讯作者:
Solomons, Neil
Solomons, Neil
中科院分区:
医学1区
文献类型:
--
作者:
Isenberg, David;Appel, Gerald B.;Solomons, Neil

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目标。比较霉酚酸酯(MMF)和静脉注射环磷酰胺(IVC)诱导治疗狼疮性肾炎(LN)的疗效和安全性,按人种、民族和地域进行比较。共有370例活动力III-V级LN患者接受MMF(目标剂量3.0 g/天)或IVC (0.5-1.0 g/m(2)/月),外加逐渐减少的强的松治疗,疗程为24周。肾功能、整体疾病活动性、免疫补体(C3和C4)和抗dsdna水平是本研究评估的结果。作为诱导治疗(主要目的),MMF并不优于IVC。治疗与种族(P = 0.047)和治疗与地区(P = 0.069)(主要终点)之间存在重要的预先规定的相互作用。亚洲人(53.2 vs 63.9%, P = 0.24)和白人(56.0 vs 54.2%, P = 0.83)的MMF和IVC缓解率相似,但在其他和黑人联合组(60.4 vs 38.5%, P = 0.03)中存在差异。黑人组(40 vs 53.9%, P = 0.39)和西班牙裔组(38.8 vs 60.9%, P = 0.011)对IVC有应答的患者较少。拉丁美洲患者对IVC的反应较低(32% vs 60.7%; P = 0.003)。基线疾病特征不能预测疗效。各组不良事件(ae)发生率相似。严重ae在亚洲人中更为普遍。MMF和IVC对LN的短期诱导治疗总体疗效相似。然而,种族、民族和地理区域可能会影响治疗反应;黑人和西班牙裔患者对MMF的反应高于IVC。由于这些因素是相互关联的,很难对它们的重要性得出确切的结论。
Objective. To compare the efficacy and safety of mycophenolate mofetil (MMF) and intravenous cyclophosphamide (IVC) as induction treatment for lupus nephritis (LN), by race, ethnicity and geographical region.Methods. A total of 370 patients with active Class III-V LN received MMF (target dose 3.0 g/day) or IVC (0.5-1.0 g/m(2)/month), plus tapered prednisone, for 24 weeks. Renal function, global disease activity, immunological complement (C3 and C4) and anti-dsDNA levels are the outcomes that were assessed in this study.Results. MMF was not superior to IVC as induction treatment (primary objective). There were important pre-specified interactions between treatment and race (P = 0.047) and treatment and region (P = 0.069) (primary endpoint). MMF and IVC response rates were similar for Asians (53.2 vs 63.9%; P = 0.24) and Whites (56.0 vs 54.2%; P = 0.83), but differed in the combined Other and Black group (60.4 vs 38.5%; P = 0.03). Fewer patients in the Black (40 vs 53.9%; P = 0.39) and Hispanic (38.8 vs 60.9%; P = 0.011) groups responded to IVC. Latin American patients had lower response to IVC (32 vs 60.7%; P = 0.003). Baseline disease characteristics were not predictive of response. The incidence of adverse events (AEs) was similar across groups. Serious AEs were slightly more prevalent among Asians.Conclusions. MMF and IVC have similar efficacy overall to short-term induction therapy for LN. However, race, ethnicity and geographical region may affect treatment response; more Black and Hispanic patients responded to MMF than IVC. As these factors are inter-related, it is difficult to draw firm conclusions about their importance.