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Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology.
Eur J Clin Pharmacol. 2018 Jun; 74(6):805-810.EJ

Abstract

PURPOSE

The aim of this multicenter prospective study was to evaluate efficacy and safety of biosimilar erythropoiesis-stimulating agents (ESAs) vs originator, based on data from clinical practice in patients with chronic kidney disease (CKD).

METHODS

We collected data of the patients with diagnosis of CKD on conservative treatment from nine Italian structures. Patients were enrolled applying different exclusion criteria, and various individual parameters were registered at the beginning for descriptive analysis. Patients were treated with epoetin alfa, beta, and darbepoetin as originator and epoetin zeta as biosimilar. Hemoglobin levels have been analyzed at baseline and after 3, 6, and 12 months. Descriptive statistics were used to analyze the results.

RESULTS

At baseline, 47 patients were in the biosimilar group and 57 in the originator; the basal level of hemoglobin was similar between the groups (mean Hb 9.4 and 9.3 g/dL, respectively). Median age, weight, and comorbidities were almost comparable. After 3 months, 44 patients remained in the biosimilar group and 48 in the originator; hemoglobin increase was significantly greater in patients treated with biosimilar [absolute increase 1.6 vs 1.0 g/dL, p < 0.001]. After 6 and 12 months, number of patients fall furthermore. Hemoglobin levels increased more in the biosimilar group after 6 months (2.1 vs 1.1 g/dL, p < 0.001) and 12 months (2.0 vs 1.0 g/dL, p < 0.001).

CONCLUSIONS

Biosimilar ESAs have similar risk/benefit profile compared to originators. Our data are in agreement with relevant scientific literature and, on the other hand, they are in contrast with common thought that considers biosimilar less efficacious and less safe than originators.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Motola D
Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, via Irnerio 48, 40126, Bologna, Italy. domenico.motola@unibo.it.
Vaccheri A
Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, via Irnerio 48, 40126, Bologna, Italy.
Roncadori A
CINECA - Interuniversity Consortium - Health Department, via Magnanelli 6/3, 40033, Casalecchio di Reno, BO, Italy.
Donati M
Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, via Irnerio 48, 40126, Bologna, Italy.
Bonaldo G
Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, via Irnerio 48, 40126, Bologna, Italy.
Covezzoli A
CINECA - Interuniversity Consortium - Health Department, via Magnanelli 6/3, 40033, Casalecchio di Reno, BO, Italy.
Polidori P
Department of Clinical Pharmacy, Mediterranean Institute for Transplantation and Advanced Specialised Therapies (ISMETT), Palermo, Italy.
Bianchi S
Department of Pharmacy, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.

MeSH

AdultAgedAged, 80 and overAnemiaBiosimilar PharmaceuticalsDarbepoetin alfaEpoetin AlfaErythropoietinFemaleHematinicsHumansMaleMiddle AgedRecombinant ProteinsRenal Insufficiency, ChronicRisk AssessmentTreatment Outcome

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Observational Study

Language

eng

PubMed ID

29429032

Citation

Motola, Domenico, et al. "Comparative Risk/benefit Profile of Biosimilar and Originator Erythropoiesis-stimulating Agents (ESAs): Data From an Italian Observational Study in Nephrology." European Journal of Clinical Pharmacology, vol. 74, no. 6, 2018, pp. 805-810.
Motola D, Vaccheri A, Roncadori A, et al. Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology. Eur J Clin Pharmacol. 2018;74(6):805-810.
Motola, D., Vaccheri, A., Roncadori, A., Donati, M., Bonaldo, G., Covezzoli, A., Polidori, P., & Bianchi, S. (2018). Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology. European Journal of Clinical Pharmacology, 74(6), 805-810. https://doi.org/10.1007/s00228-018-2428-2
Motola D, et al. Comparative Risk/benefit Profile of Biosimilar and Originator Erythropoiesis-stimulating Agents (ESAs): Data From an Italian Observational Study in Nephrology. Eur J Clin Pharmacol. 2018;74(6):805-810. PubMed PMID: 29429032.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology. AU - Motola,Domenico, AU - Vaccheri,Alberto, AU - Roncadori,Andrea, AU - Donati,Monia, AU - Bonaldo,Giulia, AU - Covezzoli,Anna, AU - Polidori,Piera, AU - Bianchi,Stefano, Y1 - 2018/02/10/ PY - 2017/09/25/received PY - 2018/02/01/accepted PY - 2018/2/13/pubmed PY - 2018/10/12/medline PY - 2018/2/12/entrez KW - Biosimilar KW - Erythropoiesis-stimulating agents KW - Observational study KW - Risk/benefit profile SP - 805 EP - 810 JF - European journal of clinical pharmacology JO - Eur J Clin Pharmacol VL - 74 IS - 6 N2 - PURPOSE: The aim of this multicenter prospective study was to evaluate efficacy and safety of biosimilar erythropoiesis-stimulating agents (ESAs) vs originator, based on data from clinical practice in patients with chronic kidney disease (CKD). METHODS: We collected data of the patients with diagnosis of CKD on conservative treatment from nine Italian structures. Patients were enrolled applying different exclusion criteria, and various individual parameters were registered at the beginning for descriptive analysis. Patients were treated with epoetin alfa, beta, and darbepoetin as originator and epoetin zeta as biosimilar. Hemoglobin levels have been analyzed at baseline and after 3, 6, and 12 months. Descriptive statistics were used to analyze the results. RESULTS: At baseline, 47 patients were in the biosimilar group and 57 in the originator; the basal level of hemoglobin was similar between the groups (mean Hb 9.4 and 9.3 g/dL, respectively). Median age, weight, and comorbidities were almost comparable. After 3 months, 44 patients remained in the biosimilar group and 48 in the originator; hemoglobin increase was significantly greater in patients treated with biosimilar [absolute increase 1.6 vs 1.0 g/dL, p < 0.001]. After 6 and 12 months, number of patients fall furthermore. Hemoglobin levels increased more in the biosimilar group after 6 months (2.1 vs 1.1 g/dL, p < 0.001) and 12 months (2.0 vs 1.0 g/dL, p < 0.001). CONCLUSIONS: Biosimilar ESAs have similar risk/benefit profile compared to originators. Our data are in agreement with relevant scientific literature and, on the other hand, they are in contrast with common thought that considers biosimilar less efficacious and less safe than originators. SN - 1432-1041 UR - https://www.unboundmedicine.com/medline/citation/29429032/Comparative_risk/benefit_profile_of_biosimilar_and_originator_erythropoiesis_stimulating_agents__ESAs_:_data_from_an_Italian_observational_study_in_nephrology_ DB - PRIME DP - Unbound Medicine ER -