Roxadustat Versus ESA Therapy for Sustained Hemoglobin Response in ESA-Hyporesponsive Hemodialysis Patients

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.

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.

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.

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.