CERA Outcomes Promising
Efficacy and safety comparable to that of epoetin and darbepoetin
In an analysis of pooled data from six phase III trials of about 2,400 dialysis and predialysis patients, CERA's efficacy was com-parable to that of epoetin and darbepoetin, but required less frequent administration, according to investigators led by Steven Fishbane, MD, of Winthrop University Hospital in Mineola, N.Y. He presented findings here at the National Kidney Foundation 2007 Spring Clinical Meetings.
Additionally, extended dosing in-tervals (every two weeks and every four weeks), with CERA administered IV or subcutaneously, were effective. Two of the pooled trials were correction studies to demonstrate efficacy of CERA in patients not previously treated with epoetin or darbepoetin. Mean Hb levels increased over time with CERA, as they did with comparator medications. In both studies, however, peak Hb level was greater with CERA than with epoetin or darbepoetin.
The other four trials were to show that CERA maintains Hb levels in patients previously on epoetin or darbepoetin. These trials demonstrated that CERA achieved steady Hb levels within the target range as well as epoetin. CERA generally was well tolerated, with an adverse-event profile comparable to that of epoetin and darbepoetin.
In a separate analysis of two phase III studies by Dr. Fishbane and his colleagues, CERA administered every two weeks or once monthly was found to maintain stable Hb levels in dialysis patients with and without congestive heart failure (CHF).
The two 52-week, randomized controlled trials en-rolled a total of 1,245 patients, all of whom had been taking epoetin alfa or beta with the same dosing interval for at least eight weeks. A total of 413 patients were randomized to receive CERA every two weeks, 415 to receive CERA every four weeks, and 417 to continue on epoetin. In one study, patients received subcutaneous doses of the study drugs; in the other, patients received the drugs intravenously.
For patients with and without CHF, the two CERA groups were clinically comparable to the epoetin groups in terms of Hb response. The overall adverse-effect profile for the three groups was similar, regardless of CHF status.
“Taken together, the phase III data related to CERA indicate excellent efficacy even when administered at extended dose intervals,” Dr. Fishbane said. “This should provide the opportunity to improve the convenience of anemia treatment for both patients and staff.”