P42 | Efficacy and safety of roxadustat in patients with non-dialysis-dependent chronic kidney disease with or without inflammation: pooled analysis of four phase 3 studies
G. Choukroun1, A. Harkavyi2, V. Santos3, A. Jiletcovici3, L. Del Vecchio4 | 1CHU Amiens Picardie and Jules Verne University, Amiens, France, 2Astellas Pharma Europe, Addlestone, UK, 3Astellas Pharma, Inc., Northbrook, USA, 4Sant’Anna Hospital, Como, Italy
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Premises and Purpose of the Study: Inflammation may cause erythropoiesis-stimulating agent (ESA) hyporesponsiveness for patients with anemia of chronic kidney disease (CKD). This pooled analysis examined the efficacy and safety of roxadustat in correcting hemoglobin (Hb) levels in patients with non‒dialysis-dependent (NDD) CKD by baseline inflammation levels.
Materials and Methods: Four phase 3, randomized, placebo-controlled (OLYMPUS [NCT02174627], ALPS [NCT01887600], ANDES [NCT01750190]) or ESA-controlled (DOLOMITES [NCT02021318]) studies were pooled. Mean Hb change from baseline (CFB) to Weeks 28‒52 and mean weekly total roxadustat dose (mg/kg body weight) at Week 24 by baseline inflammation levels (high-sensitivity C-reactive protein [hsCRP] levels divided into quintiles) were evaluated. Safety data were summarized descriptively.
Results: In total, 3573 patients with NDD CKD (roxadustat N=2068; placebo N=1212; ESA N=293) were evaluated. The mean Hb CFB to Weeks 28‒52 was greater with roxadustat vs. placebo, and comparable with ESA, regardless of baseline inflammation. Patients with moderate-to-high baseline hsCRP levels did not require higher roxadustat doses at Week 24 compared with doses in patients with low baseline hsCRP levels. The overall percentages of patients with at least one treatment-emergent adverse event were similar for the roxadustat, placebo, and ESA groups.
Conclusions: Roxadustat increased Hb levels, without requiring increased doses, greater than placebo and comparable to ESA with a similar safety profile in patients with anemia of NDD CKD regardless of inflammation status.
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