在阿伐可泮的ADVOCATE试验中，抗中性粒细胞胞浆抗体相关性血管炎和估算肾小球滤过率较低患者的肾脏恢复情况
Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan.
作者信息
Cortazar Frank B, Niles John L, Jayne David R W, Merkel Peter A, Bruchfeld Annette, Yue Huibin, Schall Thomas J, Bekker Pirow
机构信息
New York Nephrology Vasculitis and Glomerular Center, Saint Peter's Hospital-Albany, Albany, New York, USA.
Nephrology Division, Massachusetts General Hospital, Boston, Massachusetts, USA.
出版信息
Kidney Int Rep. 2023 Feb 3;8(4):860-870. doi: 10.1016/j.ekir.2023.01.039. eCollection 2023 Apr.
INTRODUCTION
In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m in the avacopan group and 4.1 ml/min per 1.73 m in the prednisone group ( = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m.
METHODS
eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups.
RESULTS
In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m. At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m in the avacopan and prednisone groups, respectively ( = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group ( = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m, respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group.
CONCLUSION
Among patients with baseline eGFR ≤20 ml/min per 1.73 m in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.
引言
在一项有330例患者参与的阿伐可泮治疗抗中性粒细胞胞浆抗体（ANCA）相关血管炎的ADVOCATE试验中，81%的患者有肾脏受累情况，在第52周时，阿伐可泮组的估算肾小球滤过率（eGFR）平均每1.73平方米增加7.3 ml/min，泼尼松组为每1.73平方米增加4.1 ml/min（P = 0.029）。这项新分析研究了试验入组时患有严重肾功能不全患者亚组的结果，即eGFR≤每1.73平方米20 ml/min。
方法
在基线和试验过程中测定eGFR。比较两个治疗组之间eGFR的变化。
结果
在ADVOCATE试验中，阿伐可泮组166例患者中有27例（16%）、泼尼松组164例患者中有23例（14%）的基线eGFR≤每1.73平方米20 ml/min。在第52周时，阿伐可泮组和泼尼松组的eGFR平均每1.73平方米分别增加16.1和7.7 ml/min（P = 0.003）。在52周治疗期内测得的最后eGFR值比基线高≥2倍的患者，阿伐可泮组为41%，泼尼松组为13%（P = 0.030）。阿伐可泮组分别比泼尼松组有更多患者的eGFR每1.73平方米增加超过20、30和45 ml/min。阿伐可泮组27例患者中有13例（48%）发生严重不良事件，泼尼松组23例患者中有16例（70%）发生严重不良事件。
结论
在ADVOCATE试验中，基线eGFR≤每1.73平方米20 ml/min的患者中，阿伐可泮组的eGFR改善情况优于泼尼松组。
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