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The efficacy of Roxadustat for the treatment of anemia in dialysis dependent chronic kidney disease patients: an updated systematic review and meta-analysis of randomized clinical trials

Department of Internal Medicine, McLaren Health Care, Flint, MI, USA. Michigan State University, Flint, MI, USA. Faculty of Medicine, Alexandria University, Alexandria, Egypt. Faculty of Medicine, Cairo University, Cairo, Egypt. Faculty of Medicine for Girls, Al-Azher University, Cairo, Egypt. Internal Medicine Department, McLaren Health Care, Flint, MI, USA. Internal Medicine Department, Louisiana State University Health Sciences Center, Monroe, LA, USA. Nephrology Department, McLaren Health Care, Flint, MI, USA.

Annals of translational medicine. 2021;9(23):1714
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PICO Summary

Population

People with dialysis-dependent chronic kidney disease who took part in randomised controlled trials (RCTs) identified by a systematic review (n= 5,768, 10 RCTs).

Intervention

Roxadustat at various doses (ROX, n= 3,031).

Comparison

Various control treatments [darbepoetin alfa; recombinant human erythropoietin or erythropoiesis-stimulating agent], (n= 2,737).

Outcome

ROX was associated with increase in haemoglobin level (standardised mean difference [SMD]: 0.2; 95% CI: 0.02, 0.39), total iron-binding capacity (SMD: 0.79; 95% CI: 0.61, 0.98), serum iron (SMD: 0.27; 95% CI: 0.18, 0.36), transferrin (SMD: 0.98; 95% CI: 0.81, 1.15) and decrease in hepcidin (SMD: -15.53; 95% CI: -28.07, -3.00) when compared with control group. There was no difference between ROX and the control group regarding ferritin level and transferrin saturation. Sensitivity analysis by removing the most recent studies, Chen et al. or Hou et al. did not show significant difference in regard to change in Hb level. There was no difference between both groups regarding the serious side effects. However, ROX showed higher treatment emergent adverse events when compared to the control group (RR: 1.03; 95% CI: 1.01, 1.05).
Abstract
BACKGROUND Anemia is a common complication in chronic kidney disease (CKD) with increased morbidity and mortality. Recently published RCTs were conducted to compare the effect of the new medication roxadustat (ROX) with erythropoiesis-stimulating agent (ESA) in dialysis-dependent CKD (DD-CKD) patients. Our article aimed to meta-analyze published RCTs to investigate the efficacy and safety of ROX for anemia in DD-CKD patients and update the effect of the new studies on overall analysis with subsequent impact on management. METHODS Electronic databases (PubMed, EMBASE, Scopus, Web of Science, Cochrane Central, and Google Scholar) were searched systematically from inception to July 2021 by using this search term (Roxadustat OR ASP1517 OR FG4592 OR "FG-4592") AND (kidney OR renal) AND (Anemia). We only included randomized control trials (RCTs) that reported the primary outcome of change in hemoglobin (Hb) level and iron utilization parameters, including ferritin, serum iron, TSAT, TIBC, transferrin, and hepcidin. RESULTS Ten RCTs were finally included with 3031 patients in the ROX group and 2737 patients in the control group. ROX was associated with increase in Hb level (SMD: 0.2; 95% CI: 0.02, 0.39; P=0.03), TIBC (SMD: 0.79; 95% CI: 0.61, 0.98; P<0.00001), serum iron (SMD: 0.27; 95% CI: 0.18, 0.36; P<0.00001), transferrin (SMD: 0.98; 95% CI: 0.81, 1.15; P<0.00001) and decrease in hepcidin (SMD: -15.53; 95% CI: -28.07, -3.00; P<0.02) when compared with control group. There was no difference between ROX and the control group regarding ferritin level and TSAT. Sensitivity analysis by removing the most recent studies, Chen et al. or Hou et al. did not show significant difference in regard to change in Hb level. There was no difference between both groups regarding the serious side effects. However, ROX showed higher TEAEs when compared to the control group (RR: 1.03; 95% CI: 1.01, 1.05; P=0.002). DISCUSSION Our updated meta-analysis concluded that ROX increased Hb level and improved iron utilization parameters in DD-CKD patients, but ROX was associated with higher TEAEs. Our results support the use of ROX for DD-CKD patients with anemia. However, higher-quality RCTs are still needed to confirm the results of our review.
Study details
Study Design : Systematic Review
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine