Tu Yan, Li Zuo-Lin, Liu Hong, Tang Ri-Ning, Wang Gui-Hua, Lv Lin-Li, Wang Bin, Liu Bi-Cheng
Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine, Nanjing, China.
Kidney Dis (Basel). 2024 Mar 18;10(3):193-199. doi: 10.1159/000538372. eCollection 2024 Jun.
Roxadustat, the first-in-class drug for the treatment of renal anemia, has demonstrated efficacy in renal anemia with microinflammation. Additional data are needed regarding the efficacy of roxadustat on renal anemia with systemic macroinflammation.
Three cohorts of renal anemia based on the basic level of high-sensitivity CRP were included. Patients with hsCRP ≤2 mg/L were selected as non-inflammation (NI) group; 2< hsCRP ≤10 mg/L as microinflammation (MI) group; hsCRP≥10 mg/L as macroinflammation (MA) group. Patients received oral roxadustat three times per week for 52 weeks. The primary end point was the hemoglobin level over weeks 12-52. The second end point was the cumulative proportion of patients achieving hemoglobin response by the end of week 12.
A total of 107 patients with chronic kidney diseases (CKDs) were enrolled. Overall, the baseline hemoglobin level of patients was 79.99 ± 11.20 g/L. Roxadustat could significantly increase the hemoglobin level in all of the three groups and did not show any significant difference ( > 0.05, respectively). Meanwhile, compared with that of the NI group, there was no significant difference in hemoglobin response rate in the MA group both at week 12 ( = 0.06; 95% confidence interval [CI], 0.9531-13.75) and week 52 ( = 0.37; 95% CI, 0.5080-7.937). Moreover, the hemoglobin response was independent of baseline hsCRP level ( = 0.72, 95% CI, -0.1139 to 0.0794). More importantly, roxadustat significantly reduced ferritin and serum iron levels and increased total iron-binding capacity in the three groups, which showed no significant differences among the three groups ( > 0.05, respectively).
Roxadustat significantly improves anemia in CKD patients with systemic macroinflammation.
罗沙司他是治疗肾性贫血的同类首创药物，已在伴有微炎症的肾性贫血中显示出疗效。关于罗沙司他对伴有全身性大炎症的肾性贫血的疗效，还需要更多数据。
根据高敏C反应蛋白的基线水平纳入三组肾性贫血患者。将高敏C反应蛋白≤2mg/L的患者选为非炎症（NI）组；2＜高敏C反应蛋白≤10mg/L为微炎症（MI）组；高敏C反应蛋白≥10mg/L为大炎症（MA）组。患者每周口服罗沙司他三次，共52周。主要终点是第12 - 52周的血红蛋白水平。次要终点是到第12周结束时达到血红蛋白反应的患者累积比例。
共纳入107例慢性肾脏病（CKD）患者。总体而言，患者的基线血红蛋白水平为79.99±11.20g/L。罗沙司他可显著提高三组患者的血红蛋白水平，且未显示出任何显著差异（分别为P＞0.05）。同时，与NI组相比，MA组在第12周（P = 0.06；95%置信区间[CI]，0.9531 - 13.75）和第52周（P = 0.37；95%CI，0.5080 - 7.937）的血红蛋白反应率均无显著差异。此外，血红蛋白反应与基线高敏C反应蛋白水平无关（P = 0.72，95%CI， - 0.1139至0.0794）。更重要的是，罗沙司他显著降低了三组患者的铁蛋白和血清铁水平，并提高了总铁结合力，三组之间无显著差异（分别为P＞0.05）。
罗沙司他可显著改善伴有全身性大炎症的CKD患者的贫血状况。
