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748 Roxadustat Lowers Risk of RBC Transfusion in Patients with Anemia of CKDClinically Relevant Abstract

Program: Oral and Poster Abstracts
Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster I
Hematology Disease Topics & Pathways:
Anemias, Adult, Diseases, Non-Biological, Therapies, Biological Processes, erythropoiesis, Study Population, Clinically relevant, pharmacology
Saturday, December 5, 2020, 7:00 AM-3:30 PM

Steven Fishbane1*, Robert Provenzano2*, Anjay Rastogi, MD, PhD3*, Daniel Coyne4*, Roberto Pecoits-Filho5*, Chaim Charytan6*, Maksym Pola7*, Lona Poole8*, Gopal Saha8*, Willis Chou8*, Tyson Lee9* and Peony Yu, MD10*

1Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
2School of Medicine, Wayne State University, Detroit, MI
3David Geffen School of Medicine at UCLA, Los Angeles, CA
4Washington University School of Medicine, Saint Louis, MO
5Arbor Research Collaborative for Health, Ann Arbor, MI
6Nephrology Associates, New Rochelle, NY
7Astra Zeneca, Warsaw, Poland
8FibroGen, Inc., San Francisco, CA
9FibroGen, Inc., san francisco, CA
10FibroGen, Inc, San Francisco, CA

Background: Anemia is a common complication of chronic kidney disease (CKD), affecting up to 50% of patients with advanced disease and > 90% of patients who require dialysis. (Coresh, et al. JAMA 2007;298(17):2038-2047. Go AS, et al. N Engl J Med. 2004;351(13):1296-1305.) Without adequate treatment, anemia of CKD is associated with increased risk of hospitalization, cardiovascular disease and death. Erythropoietin-stimulating agents are standard of care for anemia of CKD, along with IV iron. Both are associated with serious risks, leaving many patients inadequately treated. Patients with anemia of CKD often require red blood cell (RBC) transfusions, which may cause reactions, lead to allo-sensitization, or rarely transmit infections. Therefore, safer treatments that reduce transfusions are desirable. This analysis assessed whether roxadustat, an oral hypoxia–inducible factor prolyl hydroxylase inhibitor, reduced the need for RBC transfusions in patients with non-dialysis-dependent (NDD) and dialysis-dependent (DD) CKD and anemia.

Methods: Data from 6 completed randomized Phase 3 studies (up to 4y duration) in patients with Stage 3–5 CKD, comparing roxadustat with placebo in NDD-CKD, and with epoetin alfa in DD-CKD were assessed. Risk of first RBC transfusion was evaluated in individual studies and within pooled NDD and DD populations.

Results: In total, 4277 patients with NDD-CKD were evaluated (2391 roxadustat; 1886 placebo). Mean ± SD baseline hemoglobin was 9.10 ± 0.74 g/dL (roxadustat) and 9.10 ± 0.73 g/dL (placebo). The DD-CKD studies comprised 3857 patients (1929 roxadustat; 1928 epoetin alfa). Mean ± SD baseline Hb was 9.63 ± 1.30 g/dL (roxadustat) and 9.67 ± 1.30 (epoetin alfa). Roxadustat reduced the risk of RBC transfusion by 74% versus placebo in NDD patients and by 18% versus epoetin alfa in DD patients (Table 1).

Conclusion: Roxadustat markedly and significantly reduced transfusion risk versus placebo in NDD CKD, and this effect was consistent across trials. Roxadustat also significantly reduced transfusion risk versus epoetin alfa in DD CKD in the pooled analysis, although this varied within trials.

Disclosures: Fishbane: Ardelyx: Research Funding; Corvidia Therapeutics: Research Funding; MegaPro Biomedical Co Ltd: Research Funding; Akebia Inc.: Research Funding; AstraZeneca: Consultancy, Research Funding; Cara Therapeutics: Research Funding. Provenzano: Nephroceuticals: Current equity holder in private company; Vasc Alert: Current equity holder in private company; FibroGen Inc.: Consultancy; DiVita: Consultancy, Current equity holder in private company; AstraZeneca: Consultancy. Rastogi: AstraZeneca: Consultancy, Research Funding; GlaxoSmithKline: Research Funding. Coyne: FibroGen, Inc.: Consultancy. Pecoits-Filho: AstraZeneca: Consultancy; Akebia: Consultancy; Fresenius Medical Care: Research Funding. Charytan: Fibrogen: Consultancy, Research Funding; AstraZeneca: Consultancy, Research Funding; GSK: Research Funding; Akebia: Research Funding. Pola: AstraZeneca: Current Employment, Current equity holder in private company. Poole: FibroGen, Inc.: Current Employment. Saha: FibroGen, Inc.: Current Employment. Chou: FibroGen, Inc.: Current Employment. Lee: FibroGen, Inc.: Current Employment. Yu: FibroGen, Inc.: Current Employment.

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