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 Methods A 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.
Results The 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.
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