Roxadustat for Anemia in CKD in Patients Treated for ≥3 Years

Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that is in development in the United States for chronic treatment of anemia with chronic kidney disease (CKD). During a virtual poster session at ASN Kidney Week 2021, Chuan-Ming Hao, MD, PhD, and colleagues reported the results of pooled post hoc analysis of outcomes in patients with dialysis-dependent CKD (DD-CKD) who were treated with roxadustat for ≥3 years. The poster was titled Efficacy and Safety of Roxadustat in Patients with Anemia of Dialysis-Dependent CKD (DD-CKD) Treated Continuously for ≥3 Years.

There were three phase 3 DD-CKD trials comparing roxadustat with epoetin alfa: ROCKIES, SIERRAS, HIMALAYAS.  A total of 3980 patients were randomized to open-label roxadustat (n=1943) or epoetin alfa (n=1947). Per local care protocols, intravenous iron was given for epoetin alfa and limited to need for roxadustat. Regardless of rescue therapy use, data were analyzed in patients treated continuously for ≥3 years. The researchers also assessed adverse events.

Overall, 288 patients in the roxadustat group and 360 in the epoetin alfa group were treated for ≥3 years. Of those, 95% and 94%, respectively, completed treatment. Baseline values in the two groups were generally balanced between the roxadustat and epoetin alfa groups: mean age 55 years versus 57 years, mean hemoglobin (Hb) 9.8 g/dL versus 9.7 g/dL, dialysis modality (hemodialysis, 94% vs 93%), and median dialysis vintage 21.9 months versus 17.4 months.

During the period of weeks 28 to 52, the change in Hg from baseline was greater in the roxadustat group than in the epoetin alfa group (+1.3 g/dL vs +1.0 g/dL; P<.001) and the proportion of patients with Hb 19 g/dL was higher (95% vs 85%). To week 156, higher Hb was maintained in the roxadustat group versus epoetin alfa, with 11% increase in mean roxadustat weekly dose from week 25 to 28 versus 20% increase in mean epoetin alfa weekly dose. The need for red blood cell transfusion appeared less with roxadustat versus epoetin alfa (11% vs 16% of patients, respectively).

Rates of serious adverse events were 18.0 per 100 patient-exposure years for roxadustat versus 16.9 per 100 patient-exposure years for epoetin alfa.

In conclusion, the researchers said, “In DD-CKD patients who remained on treatment for ≥3 years, Hb stability with roxadustat was achieved with minimal dose change and less need for red blood cell transfusion versus epoetin alfa. Safety was comparable with roxadustat versus epoetin alfa.”

Funding for the analysis was provided by AstraZeneca, Astellas Pharma, and FibroGen, Inc.

Source: Hao C-M, Dahl NK, Tham S, Orias M, Pecoits-Filho R. Efficacy and safety of roxadustat in patients with anemia of dialysis-dependent CKD (DD-CKD) treated continuously for ≥3 years. Abstract of a poster presented at the American Society of Nephrology virtual Kidney Week 2021 (Abstract PO0450), November 2021.