Roxadustat versus ESA therapy for sustained hemoglobin response in ESA-hyporesponsive hemodialysis patients

Abstract

Background: In Erythropoiesis-Stimulating Agent (ESA)-hyporesponsive hemodialysis patients, hemoglobin (Hb) change from baseline may not fully capture durable treatment response. This secondary analysis evaluated sustained Hb ≥ 10 g/dL achievement and month-to-month Hb variability with roxadustat versus continued ESA therapy. Methods: This multicenter retrospective secondary analysis included adult maintenance hemodialysis patients with ESA-hyporesponsive anemia and complete monthly Hb data from Months 1–6. Sustained target achievement was defined as Hb ≥ 10 g/dL in at least 3 of 6 months. Hb variability was assessed using within-patient Hb SD, coefficient of variation, range, mean absolute monthly change, and maximum absolute change. Predictors were evaluated using logistic and linear regression. Results: Among 108 patients, 78 received roxadustat and 30 continued ESA therapy. Sustained Hb ≥ 10 g/dL achievement occurred in 52 patients. Roxadustat was associated with higher adjusted odds of sustained target achievement versus ESA therapy (adjusted OR: 4.44, 95% CI: 1.24–15.84; p = 0.022). Higher baseline Hb was also independently associated with sustained response (adjusted OR: 2.95 per 1 g/dL, 95% CI: 1.57–5.55; p < 0.001). By Month 6, Hb ≥ 10 g/dL was achieved by 50.0% of roxadustat-treated patients versus 33.3% of ESA-treated patients. Hb variability metrics were numerically lower with roxadustat but were not significantly different between groups. Conclusions: In ESA-hyporesponsive hemodialysis patients, roxadustat was associated with higher adjusted odds of sustained Hb ≥ 10 g/dL achievement but did not clearly reduce month-to-month Hb variability over 6 months. These retrospective findings support sustained target achievement as a clinically relevant response metric and warrant prospective validation.