Effect of Long-Term Voclosporin Treatment on Renal Histology in Patients With Active Lupus Nephritis With Repeat Renal Biopsies.

Methods

Patients were randomized to voclosporin or placebo treatment for up to 3 years; all patients received mycophenolate mofetil and low-dose glucocorticoids.

患者被随机分配接受voclosporin或安慰剂治疗，最长可达3年；所有患者均接受吗替麦考酚酯和低剂量糖皮质激素治疗。

Patients had baseline kidney biopsies within 6 months before study start and repeat biopsies after approximately 18 months of study treatment.

患者在研究开始前6个月内进行了基线肾脏活检，并在研究治疗约18个月后进行了重复活检。

The revised National Institutes of Health indices for LN activity and chronicity (CI) were calculated in addition to a semiquantitative assessment of vascular and tubular lesions.

除了对血管和小管病变进行半定量评估外，还计算了修订的国家卫生研究院狼疮性肾炎活动性和慢性指数（CI）。

Results

Sixteen patients in the voclosporin group and 10 patients in the control group had both baseline and repeat kidney biopsies.

在 voclosporin 组中有16名患者和对照组中有10名患者进行了基线和重复的肾脏活检。

Patient clinical characteristics were similar at baseline.

患者在基线时的临床特征相似。

In the voclosporin group, most (n = 13) patients had pure class IV lesions (pure class V, n = 1; mixed, n = 2).

在 voclosporin 组中，大多数（n = 13）患者有纯IV类病变（纯V类，n = 1；混合，n = 2）。

In the control group, three patients had pure class IV (pure class III, n = 3; pure class V, n = 1; mixed, n = 3).

在对照组中，三名患者有纯IV类病变（纯III类，n = 3；纯V类，n = 1；混合，n = 3）。

Most of the voclosporin-treated patients had no change in CI (n = 8) or a change no greater than 2 (n = 6); control-treated patients also had no change in CI (n = 3) or a change no greater than 2 (n = 6).

大多数接受voclosporin治疗的患者在CI上没有变化（n = 8）或变化不超过2（n = 6）；对照组患者在CI上也没有变化（n = 3）或变化不超过2（n = 6）。

No trends in vascular lesions or tubular compartment changes were observed.

未观察到血管病变或管状区室变化的趋势。

Conclusions

Outcomes from this small subgroup show that exposure to study treatment was not associated with nephrotoxicity based on histopathologic evaluation after 18 months.

这个小样本亚组的结果显示，经过18个月的组织病理学评估，研究治疗的暴露与肾毒性无关。

These data are reassuring and further contribute to the safety profile of voclosporin for the treatment of adults with active LN.

这些数据令人安心，并进一步丰富了伏立司他用于治疗活动性狼疮性肾炎成年患者的药物安全性资料。