GRP-179 Switch from CERA to EPO Zeta in Patients with Anaemia and Chronic Kidney Disease

Abstract

Background As the result of a possible shortage of methoxy polyethylene glycol epoetin beta (CERA) within Italy, with the agreement of the EMA, AIFA (the Italian Medicines Agency) prepared a document inviting prescribers to switch patients who were undergoing treatment with different doses of CERA to any Erythropoiesis Stimulating Agent (ESA), for the treatment of anaemia associated with chronic kidney disease (CKD). This recommendation emphasised the need to monitor haemoglobin levels (Hb) and safety and efficacy parameters. Purpose To evaluate variations of efficacy (Hb levels) and safety (immunological reaction) of a new treatment, in patients with CKD after switching from CERA to epoetin zeta (EPO zeta), as per international and national guidelines. To keep the same Hb level obtained before the shift. To compare the cost differences of the two ESAs. Materials and MethodsA preliminary observational study (April–September 2012) was carried on CKD patients in haemodialysis care at the Department of Nephrology. The patients enrolled were treated with some of the doses of CERA indicated in the Recommendation for at least ten months. We evaluated ESA dosage, Hb level and dosage/kg. ResultsThe study included 12 patients (7 men and 5 women) with mean age 56.64 years (range 40–75). All patients were treated with EPO zeta (average initial dose 6500 IU/Kg/week); after monthly monitoring of Hb levels, the initial dose of EPO zeta was increased by 7.69% (average dose 7000 IU/Kg/week) and three months later, the median Hb level observed was 11.28 g/dl. Statistical analysis showed no significant difference between CERA and EPO zeta in terms of Hb level (P = 0.408). No adverse events due to treatment were recorded; no variation in iron supplementation The use of EPO zeta resulted in savings of 250 euro per month/patient versus CERA treatment. Conclusions After switching from CERA therapy, the use of EPO zeta appears effective and safe for CKD patient treatment. Data showed the need to increase the dose of EPO zeta to maintain a steady Hb level. Despite the increased consumption, the use of this biosimilar could contribute to containing pharmaceutical costs. No conflict of interest.

Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility

“…However, ESAs are very expensive and access to them is likely to be restricted. With the advent of biosimilars, drug access and treatment options improved adding potential health economic benefits over the reference biopharmaceutical ESA therapy 87,88,93,94,96. In one survey in Spain, the epoetin zeta cost analysis reported a total cost saving of nearly 45% with respect to epoetin alfa 97.…”

“…Eight studies reported the safety of epoetin zeta in patients with renal anemia. Of those, there are four clinical trials, 24 , 28 , 41 , 79 three observational studies, 76 , 81 , 87 and one post hoc analysis based on two clinical trials. 88 Table 4 summarizes the common adverse events observed in more than 5% of the patients in the four clinical trials.…”

“…Bajraktar et al 81 evaluated the safety of epoetin zeta in 33 dialysis patients and reported that 3% of the patients develop hypotension, in-dialyzers clotting, or thrombosis of the arteriovenous fistula. Perani et al 87 examined the immunological reaction of epoetin zeta in 12 patients with CKD. This study showed no adverse events after switching from methoxy polyethylene glycol epoetin beta to epoetin zeta.…”

“…With the advent of biosimilars, drug access and treatment options improved adding potential health economic benefits over the reference biopharmaceutical ESA therapy. 87 , 88 , 93 , 94 , 96 In one survey in Spain, the epoetin zeta cost analysis reported a total cost saving of nearly 45% with respect to epoetin alfa. 97 Costs per patient per month declined from €298 for epoetin alfa therapy to €177 per patient per month for epoetin zeta.…”

Clinical efficacy and safety of biosimilar epoetin: focus on epoetin zeta

“…Eight studies reported the safety of epoetin zeta in patients with renal anemia. Of those, there are four clinical trials, 9,10,16,18 three observational studies, 14,30,31 and one post-hoc analysis based on two clinical trials. 26 Again there was no reported cases of anti-epoetin antibodies or PRCA associated with the administration of epoetin zeta in these trials.…”