Once-monthly injections of peginesatide are as effective as one to three injections per week of epoetin in maintaining hemoglobin levels in anemic hemodialysis patients, but peginesatide treatment is associated with significantly decreased use of intravenous iron, according to post-hoc analyses of data from two large trials comparing the erythropoiesis-stimulating agents.
The analyses, by Robert Provenzano, MD, of St. John Hospital & Medical Center in Detroit, and collaborators, examined pooled data from U.S. patients enrolled in the EMERALD 1 and 2 studies and included two analysis populations: a full analysis group (randomized patients who received at least one study dose); and completers (those who had at least 60 weeks of drug exposure and serum ferritin and transferrin saturation [TSAT] measured at the same visit). Serum ferritin and TSAT were measured every 12 weeks for up to 60 weeks. The full analysis group included 853 peginesatide recipients and 436 epoetin recipients. The completers included 604 peginesatide recipients and 336 epoetin recipients.
In the full analysis group, the peginesatide- and epoetin-treated patients had mean Hb levels of 11.3 and 11.3 g/dL, respectively, at baseline. In addition 52% of the peginesatide arm and 55% of the epoetin group were receiving IV iron; median IV iron use was 33.7 and 36.2 mg/month respectively.
Among the completers, the peginesatide and epoetin groups had mean Hb levels of 11.3 and 11.3 g/dL, respectively, at baseline; 51% and 56% of these groups, respectively, were receiving IV iron, and their median IV iron use was 18.1 and 40.7 mg/month.
In both the full analysis group and completers, Hb levels at four-week intervals were similar among peginesatide and epoetin recipients. Study results showed that median IV iron use was significantly less in the peginesatide than epoetin recipients (148.8 vs. 168.5 mg/month for the full analysis group and 152.9 vs. 171.8 mg/month for completers, respectively). In both study populations, the peginesatide and epoetin arms had similar serum ferritin levels, but peginesatide recipients had higher TSAT levels.
The FDA last March approved peginesatide, which is marketed under the name Omontys, for the treatment of anemia in adult dialysis patients. It is not indicated for patients with chronic kidney disease not on dialysis or for patients with cancer-related anemia.
The approval was based on the results of two randomized, active-controlled clinical trials involving a total of 1,608 patients showing that once monthly administration of peginesatide was as safe and effective as epoetin in maintaining hemoglobin levels with the studies’ pre-specified range of 10-12 g/dL.