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Drug Saf. 2019 Jun 21. doi: 10.1007/s40264-019-00845-y. [Epub ahead of print]

Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study.

Author information

1
Department of Epidemiology, Lazio Regional Health Service, Via Cristoforo Colombo, 112, 00147, Rome, Italy. v.belleudi@deplazio.it.
2
Italian Medicines Agency, Rome, Italy.
3
Department of Epidemiology, Lazio Regional Health Service, Via Cristoforo Colombo, 112, 00147, Rome, Italy.
4
Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
5
Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
6
Caserta-1 Local Health Service, Caserta, Italy.
7
Toscana Regional Healthcare Agency, Florence, Italy.
8
Department of Pharmacy, Palermo Local Health Unit, Palermo, Italy.
9
Department of Epidemiologic Observatory, Health Department of Sicily, Palermo, Italy.
10
Sicilian Regional Centre of Pharmacovigilance, Servizio 7-Farmaceutica, Health Department of Sicily, Palermo, Italy.
11
Pharmacoepidemiology Unit, National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy.

Abstract

INTRODUCTION:

Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence on the clinical effects of switching between originator and biosimilar epoetins in chronic kidney disease (CKD) patients.

OBJECTIVE:

The objective of this study was to evaluate the effectiveness and safety of switching versus non-switching and of switching from originator/biosimilar epoetin alpha (ESA α) to any other epoetin in CKD patients.

METHODS:

An observational, record-linkage, multi-database, retrospective cohort study was carried out in four Italian geographical areas. All subjects with at least one ESA α dispensing between 1 January 2009 and 31 December 2015 were retrieved. Switching was defined as any transition between originator/biosimilar ESA α to any other epoetin in a series of two consecutive prescriptions up to 2 years. Switchers were matched 1:1 with non-switchers by baseline propensity score and by duration of ESA α treatment. Switchers and non-switchers were followed up from switching date to a maximum of 1 year. Lack of effectiveness and safety of switching versus non-switching were evaluated through Cox regression models (hazard ratio [HR], 95% confidence interval [CI]). A direct comparison between the two switcher categories (switchers from originator/biosimilar ESA α to any other epoetin) was also performed.

RESULTS:

Overall, 14,400 incident users of ESA α for anaemia due to CKD (61.4% originator, 38.6% biosimilar) were available for analysis. During the follow-up, we found no differences on effectiveness (HR 1.02, 95% CI 0.79-1.31 originators; HR 1.16, 95% CI 0.75-1.79 biosimilars) and safety outcomes (HR 1.08, 95% CI 0.77-1.50 originators; HR 1.20, 95% CI 0.66-2.21 biosimilars) between switchers and non-switchers of ESA α. Cumulative probabilities of recording an adverse event, either in terms of lack of effectiveness or safety issue, were the same for two switching categories CONCLUSIONS: In this large-scale Italian observational multi-database study, switching versus non-switching as well as switching from biosimilar/originator ESA α to any other epoetin in CKD patients is not associated with any effectiveness and safety outcomes.

PMID:
31228010
DOI:
10.1007/s40264-019-00845-y

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