"The EMERALD results are important because they not only evaluated the efficacy of OMONTYS and epoetin; they also represent data from the first studies to prospectively compare the cardiovascular safety of different erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in dialysis patients with CKD,” said Steven Fishbane, M.D., Professor of Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, lead author of the NEJM publication, and principal investigator for the EMERALD studies. “The EMERALD data demonstrated that OMONTYS administered once a month has a similar efficacy and cardiovascular safety profile when compared to epoetin administered one-to-three times weekly.”
About the EMERALD Studies and Cardiovascular Safety Assessment
Approximately 1,600 adult CKD hemodialysis patients across 178 sites in the U.S. and Europe were evaluated in the EMERALD 1 and 2 trials (1,066 patients received OMONTYS; 542 received epoetin). The primary efficacy endpoint of these studies was the mean change in Hb from the baseline Hb level to the mean level during the evaluation period (between weeks 29 through 36). In these trials, CKD patients on hemodialysis who were stable on epoetin, were randomized to receive OMONTYS either once every four weeks or to continue treatment with epoetin (according to epoetin labeling), with the dose adjusted as necessary to maintain Hb levels within the study-specified range (10.0-12.0 g/dL) for 52 weeks or more. Current Prescribing Information recommends reducing or interrupting the dose as Hb levels approach or exceed 11 g/dL.
The EMERALD studies were part of the first Phase 3 program to prospectively evaluate the CV safety of different ESAs based on a composite cardiovascular safety endpoint (CSE). The CSE was adjudicated by a blinded and independent committee. Events included in the CSE pre-specified analysis were death from any cause, stroke, myocardial infarction, serious adverse events associated with congestive heart failure, unstable angina, or arrhythmia.