Therapeutic efficacy of a biosimilar epoetin alfa in hemodialysis patients

الملخص EN

Anemia is a frequent complication in patients with chronic kidney disease.

However, human recombinant erythropoietin (rHu-EPO) has revolutionized the management of anemia in chronically dialyzed patients.

Epomax® is a new rHu-EPO alfa manufactured in Tunisia (Medis Laboratories).

The aim of this study was to evaluate the efficacy and tolerance of Epomax® in chronic hemodialysis (HD) patients in a phase-III, multicenter, clinical trial.

Fiftythree HD patients (mean age 47.7 ± 13 years) who received a stable dose of rHu-EPO (Hemax®, a rHu-EPO alfa manufactured by Biosidus Laboratories) subcutaneously were switched to Epomax® via the same route of administration.

At baseline, the mean systolic pressure was 132 ± 18 mm Hg and the mean diastolic pressure was 79 ± 8 mm Hg.

The mean blood hemoglobin was 10.2 g / dL and the median ferritin level was 667 ng/mL.

After a follow-up of 43 days, the mean blood hemoglobin was 10.5 g/dL under the effect of Epomax®.

There was no significant difference in the mean hemoglobin levels between the treatments with both drugs.

Few adverse events were reported during the study.

We conclude that Epomax® was effective at maintaining the hemoglobin levels at target concentrations and was well tolerated in HD patients.