Two sets of recent randomized trials have demonstrated that peginesatide, a second generation ESA, may be effective in treating anemia among patients with chronic kidney disease. Introduced in the late 1980s, ESAs have reduced dependence on transfusions among these patients.
Peginesatide is a synthetic peptide-based ESA. In March 2012, it was approved in the United States for treating anemia among patients with chronic kidney disease who were undergoing hemodialysis.
Dr. Jerry Spivak, professor of medicine and oncology at the Johns Hopkins School of Medicine had this to say about the drug:
“The advantage of this drug is that it only needs to be given once a month in contrast to the various recombinant erythropoietins which are either given once or thrice weekly or once every two weeks. Another advantage may be that the drug is less expensive than the classical recombinant erythropoietins currently on the market. But a disadvantage is that the drug does do exactly the same things as recombinant erythropoietins, namely it can cause an increase in hypertension and it has been shown to activate neutralizing antibodies though the extent of this is unknown.”
Published in The New England Journal of Medicine, two studies – the EMERALD trials – compared the efficacy and safety profiles of peginesatide, administered monthly, to epoetin, administered one to three times per week. The trials found that among patients undergoing hemodialysis who had previously received epoetin, peginesatide was equivalent to epoetin in maintaining hemoglobin levels. In addition, these trials found that both drugs had similar cardiovascular safety profiles.
Two additional trials – the PEARL studies – evaluated patients not receiving dialysis and compared peginesatide to darbepoetin, another ESA, administered biweekly. Among these patients, peginesatide was equivalent to darbepoetin in increasing and maintaining hemoglobin levels. However, peginesatide was associated with increased cardiovascular events and mortality.
Again, here is Dr. Spivak:
“These studies show conclusively that the drug is not inferior or equivalent to recombinant human erythropoietin in the correction of the anemia of end stage renal disease.”
“With respect to transfusion medicine, the drug is another agent which can reduce transfusion requirements in end-stage renal disease patients with anemia and it may be useful in patients who develop antibodies to recombinant erythropoietin and red cell aplasia although this needs to be studied further.”
We’ll be back on March 15th with another edition of Transfusion News. Thanks for joining us.
NOTE: On February 23, 2013, after the video was produced, all lots of injectable peginesatide (Brand name Omontys) were recalled by Affymax, Inc. and Takeda Pharmaceutical Company Limited, in conjunction with the US Food and Drug Administration. Post-marketing reports demonstrated that peginesatide administration had resulted in hypersensitivity reactions among 0.2% of patients, with serious reactions, including anaphylaxis, occurring in approximately one-third of these cases. Fatal reactions were reported in 0.02% of patients after intravenous administration. Please see our news brief for additional details.
1. Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S. Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis. N Engl J Med 2013;368: 320-32.
2. Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med 2013;368: 307-19.