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Gascon P.,University of Barcelona | Aapro M.,Institute Multidisciplinaire dOncologie | Ludwig H.,Medizinische Abteilung I Onkologie und Haematologie | Bokemeyer C.,Universitaetsklinikum Hamburg Eppendorf | And 5 more authors.
Supportive Care in Cancer | Year: 2016

Purpose: The purpose of this study is to examine the real-world treatment patterns and outcomes of chemotherapy-induced (febrile) neutropenia (chemotherapy-induced (CIN)/febrile neutropenia (FN)) prophylaxis with biosimilar filgrastim (Zarzio®). Methods: MONITOR-GCSF is an international (12 countries), multi-center (140), prospective (max. six cycles), observational, open-label, pharmaco-epidemiologic study of cancer patients (n = 1447) treated with myelosuppressive chemotherapy across a total of 6,213 cycles and receiving prophylaxis with Zarzio®. Data were analyzed using both the patient and cycle as unit of analysis. Results: Most (72.3 %) received primary prophylaxis; dosed mainly (53.2 %) at 30 MIU but differentiated by weight, chemotoxicity, and tumor type; and mainly (53.2 %) initiated in the 24–72h post-chemotherapy window but differentiated by prophylaxis type, tumor type, and chemotoxicity and for modal/median duration of 5 days. Relative to European Organisation for Research and Treatment of Cancer (EORTC) guidelines, 56.6 % were correctly prophylacted, 17.4 % under-prophylacted, and 26.0 % over-prophylacted. The following incidence rates were recorded: CIN grade 4 13.2 % of patients and 3.9 % of cycles, FN 5.9 % of patients and 1.4 % of cycles, CIN/FN-related hospitalizations 6.1 % of patients and 1.5 % of cycles, CIN/FN-related chemotherapy disturbances 9.5 % of patients and 2.8 % of cycles, and composite outcomes index 22.3 % of patients and 6.7 % of cycles. Rates varied by type of prophylaxis and tumor, chemotoxicity, initiation day, and prophylaxis duration. There were 1834 musculoskeletal events with 24.7 % of patients reporting bone pain of any grade (mostly mild to moderate), and 148 adverse drug reactions, including 4 serious, were recorded in 76 patients. Conclusions: The clinical and safety outcomes are well within the range of historically reported data for originator filgrastim underscoring the clinical effectiveness and safety of biosimilar filgrastim in daily clinical practice. © 2015, Springer-Verlag Berlin Heidelberg. Source


Abraham I.,University of Arizona | MacDonald K.,Matrix45 | Hermans C.,Novartis | Aerts A.,Novartis | And 4 more authors.
Vascular Health and Risk Management | Year: 2011

The pharmacological efficacy of various monotherapy, single pill, and combination therapies of the angiotensin II receptor blocker valsartan have been established, mainly through randomized controlled trials that used similar methodological and statistical platforms and thus enabled synthesis of evidence. The real world effectiveness of valsartan has been studied extensively, but the relative lack of scientific and technical congruence of these studies render synthesis virtually impossible. To date, all have focused on blood pressure outcomes, despite evidence-based calls to grade antihypertensive treatment to patients' total cardiovascular risk. We review a T3 translational research program of seven studies involving valsartan monotherapy as well as single and separate pill combinations, and the determinants and effect on blood pressure and total cardiovascular risk outcomes. All seven studies examined not only the impact of valsartan-based regimens on blood pressure values and control, but also, within a statistical hierarchical approach, the physician- and patient-related determinants of these blood pressure outcomes. Two studies also investigated the determinants and outcomes of valsartan-based treatment on total cardiovascular risk - among the first studies to use this risk coefficient as an outcome rather than only a determinant. These seven studies included a total of 19,533 patients, contributed by 3434 physician-investigators in Belgium - a country particularly well-suited for observational effectiveness studies because of demographics and epidemiology. Each study used the same methodological and statistical platform. We summarize the impact of various valsartan regimens on such outcomes as blood pressure values and control, change in total cardiovascular risk, and reduction in risk by at least one category. We also review the results of statistical multilevel and logistic modeling of physician- and patient-related determinants on these outcomes, including the proportion of variance attributable to a physician class effect before patients enter the equation. In its different formulations, valsartan has major real-world benefits in lowering blood pressure and total cardiovascular risk within a 90-day period. It is essential to understand the physician- and patient-related determinants of blood pressure and total cardiovascular risk outcomes associated with valsartan treatment. Antihypertensive research should expand its historical focus on lowering blood pressure with an emphasis on lowering total cardiovascular research. © 2011 Abraham et al, publisher and licensee Dove Medical Press Ltd. Source


Rakic J.-M.,University of Liege | Leys A.,Leuven University Eye Hospital | Brie H.,Novartis | Denhaerynck K.,Matrix45 | And 6 more authors.
Clinical Ophthalmology | Year: 2013

Introduction: The aim of this study was to examine ranibizumab treatment patterns in "real-world" practice and clinical settings, as well as to assess quality of life outcomes over a 24-month period. Materials and methods: This was a prospective, observational, multicenter, open-label study of 0.5 mg of ranibizumab administered intravitreally. Patients were followed over 24 ± 3 months with intermediate data points at 6 ± 2 months and 12 ± 2 months, and a limited data point at 2.5 ± 1 month that coincided with the end of the loading phase. Outcomes included visual acuity (Early Treatment Diabetic Retinopathy Study), visual function (National Eye Institute Visual Function Questionnaire-25 [NEI VFQ-25]), quality of life (Health Utilities Index Mark III [HUI3]), and safety. Results: A total of 267 patients with wet age-related macular degeneration (mean ± standard deviation [SD] age = 78.5 ± 7.3 years; 62.4% were female; 34.5% with dual eye involvement; 74.9% were treatment-naïve) were treated (309 eyes were treated). The mean ± SD Early Treatment Diabetic Retinopathy Study score at baseline was 56.3 ± 14.3 letters. The mean ± SD number of injections over 24 months was 7.6 ± 4.1, including 2.5 ± 0.7 and 5.9 ± 3.6 during the loading and maintenance phases, respectively, with corresponding treatment intervals of 4.8 ± 1.4 weeks and 11.5 ± 9.5 weeks, respectively. Improvements in visual acuity over baseline were reached at 2.5 months and maintained at 6 months (both P < 0.0001). The mean visual acuity increase over baseline at 12 months was not significant (P = 0.08); the decline over baseline at 24 months statistically significant (P = 0.02). Overall, 94.3% of patients showed stable or improved disease at 6 months and 81.5% of patients showed stable or improved disease at 24 months. At 6 months, improvements over baseline were significant for VFQ-25 (P = 0.03) and HUI3 (P = 0.02), but not at 12 months and 24 months. Improvements in VFQ-25 and HUI3 were maintained at 24 months in 38% and 34% of patients, respectively. In total 78 serious adverse events were reported in 40 patients and 77 nonserious adverse events in 34 patients. Nine serious adverse events and nine nonserious adverse events in 14 patients were suspected to be related to ranibizumab treatment. Conclusion: The "real-world" clinical effectiveness of ranibizumab was evidenced by the initial improvements over baseline in visual acuity and quality of life, as well as the maintenance of these outcomes at baseline levels at 24 months, and this was observed under variable treatment conditions. The findings underscore the need for individualized treatment with regular monitoring to achieve optimal vision and quality of life outcomes. © 2013 Rakic et al. Source


Abraham I.,University of Arizona | Tharmarajah S.,University of Arizona | Macdonald K.,Matrix45
Expert Opinion on Drug Safety | Year: 2013

Introduction: A 'biosimilar', or 'similar biological medicinal product', is a biologic agent that is similar in terms of quality, safety and efficacy to an authorized reference biological medicine. Since the expiration of the filgrastim patent in Europe, three agents have received marketing authorization from the EMA: Tevagrastim, Zarzio and Nivestim. Tevagrastim has also been approved as a biologic by the FDA as tbo-filgrastim. Areas covered: Using the EMA dossiers (all three agents), the FDA dossier (Tevagrastim), and journal publications, this article reviews clinical safety data for these products with emphasis on serious/severe adverse events and special consideration of immunogenicity, bone pain, splenomegaly, allergic reactions, acute respiratory distress syndrome and mortality. Expert opinion: All three agents have similar safety profiles. None were statistically higher on safety parameters to what is known about originator filgrastim (Neupogen). What is known about filgrastim in general regarding safety can be extended to biosimilar filgrastim. Safety profiles may become more differentiated once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific safety profiles. Current evidence indicates that statistically no one product is less and no one product is more safe. © 2013 Informa UK, Ltd. Source


Olvey E.L.,University of Arizona | MacDonald K.,Matrix45 | Abraham I.,University of Arizona
Pharmaceuticals Policy and Law | Year: 2012

Recent health care legislation in the United States has turned considerable focus to comparative effectiveness research (CER) domestically, though it has been a topic of discussion internationally for many years. Without a fully comprehensive and consistent definition of CER developed, much uncertainty and confusion surrounds its utilization. In addition, contention exists regarding the incorporation of cost and economic considerations as a component of CER. This discussion includes various suggested definitions of CER, methodological considerations, legislation and utilization, and the role of cost-effectiveness evaluations in CER. © 2012 - Network of Centres for Study of Pharmaceutical Law. All rights reserved. Source

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