Roxadustat shows greater hemoglobin gains compared to epoetin alfa for ESKD
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WASHINGTON — Data presented here from the ROCKIES phase 3 trial showed use of the investigational hypoxia-inducible factor prolyl hydroxylase inhibitor drug roxadustat led to greater increases in hemoglobin levels compared to use of epoetin alfa in patients with ESKD and anemia.
Steven Fishbane, MD, of the Zucker School of Medicine at Hofstra/Northwell in Great Neck, New York, and a primary investigator in the ROCKIES trial, said in a press release, “These data demonstrated that roxadustat effectively increased hemoglobin levels for patients with anemia from chronic kidney disease, including those who show signs of inflammation. Patients who experience chronic inflammation are often more difficult to treat than the overall chronic kidney disease patient population, emphasizing the need for new treatment options.”
Patients in the phase 3, randomized, open-label, active-controlled trial who were given roxadustat orally three times a week demonstrated a statistically significant improvement in hemoglobin levels from baseline, with a mean increase of 0.77g/dL averaged during an evaluation period of weeks 28 to 52 of the trial compared to an increase of 0.68g/dL with epoetin alfa, the primary efficacy endpoint. Roxadustat also improved hemoglobin levels from baseline in a subgroup of patients with elevated high-sensitivity C-reactive protein (greater than 5 mg/L). The mean increase of 0.80g/dL compared to 0.59g/dL with epoetin alfa demonstrated a statistically significant improvement.
A lower use of IV iron was also noted in patients treated with roxadustat (mean=59 mg) compared to those treated with epoetin alfa (mean=91 mg) from week 36 to the end of the study. Fishbane said the dose of roxadustat needed to maintain hemoglobin went down during the trial, while the dose of epoetin alfa had to be maintained or increased slightly.
The ROCKIES trial involved 2,133 patients either hemodialysis or peritoneal dialysis who were randomized to either roxadustat (1,068 patients), or epoetin alfa (1,065 patients). The mean age of the patients was 54 years old; 59% were men and 57% were white. The mean duration of dialysis was 37.5 months; 19.5% were relatively new to dialysis (2 weeks to 4 months). Fishbane said 20% of patients in the study had been on dialysis for fewer than 4 months.
The number of patients who received red blood cell transfusions was comparable between the roxadustat and epoetin alfa arms, but patients receiving roxadustat used less monthly IV iron from week 36 to the end of study. – by Mark E. Neumann
References:
Fishbane S, et al. TH-OR022. Presented at: ASN Kidney Week; Nov. 7-10, 2019; Washington, D.C.
www.astrazeneca-us.com/content/az-us/media/press-releases/2019/roxadustat-significantly-increased-hemoglobin-levels-for-chronic-kidney-disease-patients-with-anemia-in-phase-iii-olympus-and-rockies-trials-11072019.html
Disclosure: Fishbane reports grants from Cara Therapeutics Inc.