Background\nSince 2007 biosimilars of erythropoiesis-stimulating agents (ESAs) are available on the Italian\nmarket. Very limited post-marketing data exist on the comparative effectiveness of biosimilar\nand originator ESAs.\nAim\nThis population-based study was aimed to compare the effects of biosimilars, reference\nproduct and other ESAs still covered by patent on hemoglobinemia in chronic kidney disease\n(CKD) and cancer patients in a Local Health Unit (LHU) from Northern Italy.\nMethods\nA retrospective cohort study was conducted during the years 2009ââ?¬â??2014 using data from\nTreviso LHU administrative database. Incident ESA users (no ESA dispensing within 6\nmonths prior to treatment start, i.e. index date (ID)) with at least one hemoglobin measurement\nwithin one month prior to ID (baseline Hb value) and another measurement between\n2nd and 3rd month after ID (follow-up Hb value) were identified. The strength of the consumption\n(as total number of defined daily dose (DDD) dispensed during the follow-up divided by days of follow-up) and the difference between follow-up and baseline Hb values\n[delta Hb (Ã?â?Hb)] were evaluated. Based on Hb changes, ESA users were classified as nonresponders\n(Ã?â?Hb0 g/dl), responders (0<Ã?â?Hb2 g/dl), and highly responders (Ã?â?Hb>2 g/\ndl). A multivariate ordinal logistic regression model to identify predictors for responsiveness\nto treatment was performed. All analyses were stratified by indication for use and type of\ndispensed ESA at ID.\nResults\nOverall, 1,003 incident ESA users (reference product: 252, 25.1%; other ESAs covered by\npatent: 303, 30.2%; biosimilars: 448, 44.7%) with CKD or cancer were eligible for the study.\nNo statistically significant difference in the amount of dose dispensed during the follow-up\namong biosimilars, reference product and other ESAs covered by patent was found in both\nCKD and cancer. After three months from treatment start, all ESAs increased Hb values\non average by 2g/dl. No differences in Ã?â?Hb as well as in frequency of non-responders,\nresponders and highly responders among different types of ESAs were observed in both\nindications of use. Overall, around 15ââ?¬â??20% of ESA users were non-responders. Strength of\ntreatment, but no type of dispensed ESAs was found to be predictor of responsiveness to\ntreatment.\nConclusions\nNo difference on the effects on hemoglobinemia among users of either biosimilars or reference\nproduct or ESAs covered by patent was observed in a general population from Northern\nItaly, despite a comparable dispensed dose of the different ESAs during the first three\nmonths of treatment.
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