Department of Nephrology, RWTH University of Aachen, Aachen, Germany.
Kidney Diseases Research, Bayer Pharma AG, Wuppertal, Germany.
Nephrol Dial Transplant. 2016 Nov;31(11):1771-1774. doi: 10.1093/ndt/gfw286. Epub 2016 Aug 11.
A comprehensive supportive therapy approach constitutes the mainstay treatment of IgA nephropathy (IgAN) patients. In our recent Supportive versus immunosuppressive Therapy Of Progressive IgA Nephropathy (STOP-IgAN) trial, we systematically selected for patients at high risk of a progressive disease course and evaluated the effect of immunosuppression, combined with supportive care, on renal end points in these patients. There was a higher rate of full clinical remission and transient proteinuria reduction in immunosuppressed patients. However, deterioration of renal function (i.e. number of patients with an estimated glomerular filtration rate (eGFR) decrease of at least 15 mL/min over the 3-year trial phase) was remarkably slow in both groups, compared with previous studies, and was not slowed further by adding immunosuppression to supportive care. Here, we address several concerns raised on the design and interpretation of our trial. In our randomized patients, we confirmed a lower baseline proteinuria to be predictive of clinical remission in IgAN. However, the observed transient drop in proteinuria in the immunosuppressed patients did not translate into an improved overall renal outcome in these patients. Although longer follow-up would be desirable, there was not even a trend for the eGFR course to diverge between our two treatment arms during the trial phase. Finally, it is important to note that we excluded specific infrequent patient groups during our run-in phase. Therefore, IgAN patients with a rapidly progressing course and those with persistent proteinuria >3.5 g/day would require further evaluation regarding potential benefits of immunosuppressive therapies.
全面的支持治疗方法构成 IgA 肾病(IgAN)患者的主要治疗方法。在我们最近的支持与免疫抑制治疗进展性 IgA 肾病(STOP-IgAN)试验中,我们系统地选择了具有进展性疾病风险的患者,并评估了免疫抑制联合支持治疗对这些患者的肾脏终点的影响。免疫抑制患者的完全临床缓解率和蛋白尿短暂减少率更高。然而,与以前的研究相比,两组患者的肾功能恶化(即试验期间至少有 15ml/min 的估计肾小球滤过率(eGFR)下降的患者数量)明显缓慢,而免疫抑制联合支持治疗并未进一步减缓这一过程。在这里,我们解决了对我们试验设计和解释提出的几个关注问题。在我们的随机患者中,我们证实较低的基线蛋白尿是 IgAN 临床缓解的预测因素。然而,免疫抑制患者观察到的蛋白尿短暂下降并没有转化为这些患者整体肾脏结局的改善。尽管更长时间的随访是理想的,但在试验期间,我们的两个治疗组之间的 eGFR 病程甚至没有出现分歧的趋势。最后,需要注意的是,在我们的预试验阶段,我们排除了特定的罕见患者群体。因此,具有快速进展病程和持续性蛋白尿>3.5g/天的 IgAN 患者需要进一步评估免疫抑制治疗的潜在益处。