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3.
Medicine (Baltimore) ; 99(2): e18723, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31914087

RESUMO

Effectiveness, efficacy and safety of biosimilar infliximab (CT-P13) in inflammatory bowel disease (IBD) patients has been shown in previous studies. Limited data exist on health-related quality of life (HRQoL) of switching originator to biosimilar infliximab (IFX) in IBD patients. The objective of this study was to evaluate impact of switching originator to biosimilar IFX on HRQoL, disease activity, and health care costs in IBD maintenance treatment.In this single-center prospective observational study, all IBD patients receiving maintenance IFX therapy were switched to biosimilar IFX. HRQoL was measured using the generic 15D health-related quality of life instrument (15D) utility measurement and the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). Crohn Disease Activity Index (CDAI) or Partial Mayo Score (pMayo), and fecal calprotectin (FC) served for evaluation of disease activity. Data were collected at time of switching and 3 and 12 months after switching. Patients' characteristics, clinical background information and costs were collected from patient records and the hospital's electronic database.Fifty-four patients were included in the analysis. No statistically significant changes were observed in 15D, CDAI, pMayo, and FC during 1-year follow-up. IBDQ scores were higher (P = .018) in Crohn disease 3 months after switching than at time of switching. Costs of biosimilar IFX were one-third of costs of originator one. Total costs related to secondary health care (excluding costs of IFX), were similar before and after the onset of biosimilar IFX.HRQoL and disease activity were after switching from originator to biosimilar IFX comparable, but the costs of biosimilar IFX were only one-third of those of the originator one.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/uso terapêutico , Qualidade de Vida , Adulto , Anticorpos Monoclonais/economia , Medicamentos Biossimilares/economia , Substituição de Medicamentos/economia , Feminino , Fármacos Gastrointestinais/economia , Recursos em Saúde/economia , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Infliximab/economia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de Remissão
5.
J Assoc Physicians India ; 67(11): 66-67, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31793272

RESUMO

Millions of people across the globe go without essential medicines resulting in many avoidable deaths each year. It's no secret that the cost of prescription drugs, including the life-saving ones has been rising far faster than inflation over the last few years. If we take the example of diabetes and as India has the largest number of patients with the condition in the world; it has been shown that patients belonging to the low income group in urban India were spending. 27% of their annual income and those in rural India 34% of their annual income on diabetes care; most of which was spent on purchase of medicines. This raises the question of whether current pricing of drugs is based on reasonable expectation of return on investment or whether it is based on what prices the market can bear. The price of pharmaceuticals has become an issue of great concern for people and governments around the world. Thus governments across the globe must make efforts to correct the present distortions around the concept of generic drugs.


Assuntos
Medicamentos Biossimilares , Medicamentos Genéricos , Humanos , Índia
7.
Clin Exp Rheumatol ; 37 Suppl 121(6): 111-115, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31856937

RESUMO

OBJECTIVES: The efficacy and safety of biosimilar infliximab (bio-IFX) was shown in randomised controlled trials and it was approved for all indications of the reference product in several countries. However, a previous case series of 3 patients with Behçet's syndrome (BS) reported disappointing results. We aimed to share our experience with bio-IFX treatment in different types of organ involvement in patients with BS. METHODS: We reviewed the charts of all BS patients who were prescribed reference infliximab (ref-IFX) or bio-IFX in our BS clinic. Among the 181 BS patients who were prescribed IFX since 2003, 6 (3%) were prescribed bio-IFX due to refractory disease despite conventional immunosuppressives. RESULTS: A total of 6 patients (mean age: 32.1±6.2, mean disease duration: 5.3±1.8 years, 5 men and 1 woman) received bio-IFX for uveitis, nervous system, vascular and joint involvement. Four of the 6 patients obtained remission and stayed in remission during the 16±6.5 months they used bio-IFX. Among the 4 patients who obtained remission, 2 were switched to ref-IFX due to unavailability of bio-IFX infusion set and did not experience adverse events or loss of efficacy. However, relapses occurred during tapering. The other 2 patients are still in remission with bio- IFX. Among the remaining 2 patients, one had to be switched to ref-IFX after the first infusion, due to a change in the reimbursement policy and the other was non-responsive. CONCLUSIONS: Our limited experience showed that bio-IFX may be a safe and effective alternative for patients with BS, refractory to conventional immunosuppressives.


Assuntos
Síndrome de Behçet , Medicamentos Biossimilares , Infliximab/uso terapêutico , Adulto , Síndrome de Behçet/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Feminino , Humanos , Masculino , Resultado do Tratamento , Uveíte/tratamento farmacológico
8.
Pharm Res ; 36(12): 177, 2019 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-31696314

RESUMO

PURPOSE: The in vitro and in vivo pharmacologic assessment of ABP 980 similarity to its reference product is intended to compare the activity of ABP 980 and trastuzumab and support the overall conclusion of similarity based on a comprehensive analytical and functional evaluation. METHODS: This work complements the primary assessment of functional similarity with additional in vitro assays, binding studies, and non-clinical studies including human epidermal growth factor receptor-2 (HER2) kinetic binding, HER2 signaling, HER2 internalization, synergy with docetaxel chemotherapy, FcγR kinetic binding, primary natural killer and monocyte cell binding, antibody-dependent cellular phagocytosis activity, in vivo xenograft studies, and toxicokinetic parameters. RESULTS: The results contribute to the totality of evidence with respect to functional similarity and support that ABP 980 is similar to trastuzumab in all primary and secondary mechanisms of action. CONCLUSIONS: These results also support the scientific justification of extrapolation to all approved indications of trastuzumab given the established functional similarity of the two products and the same mechanisms of action across all conditions of use.


Assuntos
Antineoplásicos/química , Medicamentos Biossimilares/química , Trastuzumab/química , Animais , Ligação Competitiva , Neoplasias da Mama/tratamento farmacológico , Linhagem Celular Tumoral , Feminino , Humanos , Cinética , Camundongos Nus , Estrutura Molecular , Neoplasias Experimentais , Ligação Proteica , Receptor ErbB-2/química , Transdução de Sinais , Neoplasias Gástricas/tratamento farmacológico , Relação Estrutura-Atividade
9.
Medicine (Baltimore) ; 98(48): e17750, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31770193

RESUMO

The aim of this study was to evaluate the cost-effectiveness of Anbainuo (ABN) plus methotrexate (MTX) (ABN + MTX) versus conventional disease-modifying anti-rheumatic drugs (cDMARDs) in rheumatoid arthritis (RA) patients.Forty-eight moderate to severe RA patients underwent ABN + MTX or cDMARDs treatment were consecutively enrolled and assigned to ABN + MTX group (n = 26) and control group (n = 22). Patients were followed up and their disease activity and quality of life (QoL) were evaluated at 3rd month, 6th month and 12th month after initiation of treatment. Treatment costs of 2 groups were calculated, then pharmacoeconomic analysis was performed.ABN + MTX increased drug cost and total cost while decreased indirect cost compared with cDMARDs after 12-month treatment. ABN + MTX group gained additional 0.22 quality-adjusted life years (QALY) and yielded an incremental cost-effectiveness ratio (ICER) of ¥104,293.6 per QALY after treatment. Sensitivity analysis reveals that rising ABN price by 20% produced an ICER of ¥130,403.6 per QALY, which was still lower than 3 times of the mean gross domestic product (GDP) per capita during the same period in China (¥165,960). Besides, ABN + MTX was more cost-effective in severe RA patients compared to moderate RA patients.ABN + MTX is cost-effective in treating moderate to severe RA patients compared with cDMARDs, although the total cost of ABN + MTX is relatively higher.


Assuntos
Antirreumáticos/economia , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/economia , Custos de Medicamentos/estatística & dados numéricos , Fragmentos Fc das Imunoglobulinas/economia , Metotrexato/economia , Receptores Tipo II do Fator de Necrose Tumoral/economia , Proteínas Recombinantes de Fusão/economia , Idoso , Antirreumáticos/administração & dosagem , Artrite Reumatoide/economia , Medicamentos Biossimilares/administração & dosagem , Análise Custo-Benefício , Quimioterapia Combinada/economia , Feminino , Humanos , Fragmentos Fc das Imunoglobulinas/administração & dosagem , Masculino , Metotrexato/administração & dosagem , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Receptores Tipo II do Fator de Necrose Tumoral/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Índice de Gravidade de Doença , Resultado do Tratamento
13.
Int J Mol Sci ; 20(18)2019 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-31491879

RESUMO

The effect of five approved tumour necrosis factor inhibitors (TNFi: infliximab, etanercept, adalimumab, certolizumab, and golimumab) on joint destruction in rheumatoid arthritis (RA) have been compared versus methotrexate (MTX) in randomized controlled trials (RCTs) but have not been compared directly to each other or to an otherwise untreated placebo control. The present analysis compares effects of standard doses, high doses, and low doses of TNFis on radiographic joint destruction in RA and relate these effects to MTX and placebo by means of a Bayesian network meta-analysis. We identified 31 RCTs of the effect of TNFis on joint destruction and 5 RCTs with controls, which indirectly could link otherwise untreated placebo controls to the TNFi treatments in the network. The previously untested comparison with placebo was performed to estimate not only the effect relative to another drug, but also the absolute attainable effect. Compared to placebo there was a highly significant inhibitory effect on joint destruction of infliximab, etanercept, adalimumab, certolizumab, and golimumab, which was about 0.9% per year as monotherapy and about 1.2% per year when combined with MTX. Although significantly better than MTX and placebo, golimumab seemed inferior to the remaining TNFis. There was no difference between original reference drugs (Remicade, Enbrel) and the almost identical copy drugs (biosimilars).


Assuntos
Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/patologia , Medicamentos Biossimilares/uso terapêutico , Articulações/patologia , /uso terapêutico , Artrite Reumatoide/metabolismo , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/efeitos adversos , Humanos , Articulações/metabolismo , Viés de Publicação , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , /efeitos adversos
16.
Internist (Berl) ; 60(9): 887-894, 2019 Sep.
Artigo em Alemão | MEDLINE | ID: mdl-31396651

RESUMO

A multitude of short-acting and long-acting insulin analogues are currently available for the treatment of diabetes mellitus, which mimic physiological insulin secretion better than normal insulins. By the use of ultrarapid insulin analogues postprandial glucose increases can be significantly reduced. Newer long-acting insulin analogues have a very stable action profile and reduce the rate of hypoglycemia, especially nocturnal hypoglycemia, even more than first generation long-acting insulin analogues. Future developments focus on a further acceleration of prandial insulin effects with a simultaneous shorter effect time and an even more prolonged action of long-acting insulin analogues.


Assuntos
Medicamentos Biossimilares , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glucose/metabolismo , Insulina/uso terapêutico , Diabetes Mellitus Tipo 2/metabolismo , Humanos , Hipoglicemia , Hipoglicemiantes/uso terapêutico , Insulina/análogos & derivados , Período Pós-Prandial , Qualidade de Vida
18.
J. bras. econ. saúde (Impr.) ; 11(2): 119-127, Agosto/2019.
Artigo em Português | LILACS, ECOS | ID: biblio-1021058

RESUMO

Objetivo: O Planserv oferece cobertura à terapia biológica para as patologias de artrite reumatoide (AR), espondilite anquilosante (EA) e artrite psoriática (AP). Em agosto de 2016, 78 pacientes estavam em uso do medicamento Remicade® (infliximabe). Nessa data, o valor do Remicade® foi reduzido para o mesmo valor do Remsima™ (infliximabe biossimilar). Com isso, todos pacientes que estavam usando o Remicade® trocaram por Remsima™. Conduzimos um estudo para medir a descontinuidade da terapia e a economia. Métodos: Estudo de mundo real (coorte prospectiva), não controlado, em pacientes com AR, AP e EA que estavam utilizando Remicade® e trocaram para Remsima™, entre setembro de 2016 e setembro de 2017. O desfecho primário foi o índice de descontinuidade do tratamento (por qualquer causa). O desfecho secundário foi a taxa de "aumento da atividade da doença", medida por meio dos escores SDAI, BASDAI e CASPAR. Foi considerado como "aumento da atividade da doença" qualquer medida superior à medida inicial e que estivesse acima do limite de remissão da doença. Os valores de referência para "aumento da atividade da doença" foram as medidas históricas. O impacto econômico foi medido por uma análise de custo-minimização. Resultados: Em setembro de 2017, 5 (6%) pacientes que realizaram a troca do Remicade® para o Remsima™, descontinuaram a terapia (4 por falhas e 1 perda de acompanhamento). A taxa de descontinuação de referência (Remicade®) foi de 11% (9% de falha e 2% por perda de acompanhamento). As análises de subgrupo (descontinuidade da terapia por tipo de patologia) foram equivalentes. A taxa de "aumento da atividade da doença" ocorreu em 42% dos pacientes para o Remsima™ e em 46% para o Remicade®. As análises de subgrupo (por tipo de patologia) também demonstraram que as taxas de aumento da atividade da doença foram semelhantes entre os grupos. A análise econômica mostrou que a mudança do Remicade® para o Remsima™ trouxe economia de R$ 1,75 milhão de reais (0,5 milhão de dólares), com 1.689 ampolas de infliximabe dispensadas no período. Conclusão: A troca do medicamento Remicade® pelo Remsima™ nos pacientes com AR, EA e AP, no contexto do Planserv, demonstrou ter sido uma medida segura, eficaz e econômica.


Objective: Planserv offers coverage of biological therapy for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA). In August 2016, 78 patients were on Remicade® (infliximabe). At this date the value of Remicade® was reduced to the same value as Remsima™ (infliximabe biossimilar), with this all patients who were using Remicade® exchanged for Remsima™. We conducted a study to measure therapy discontinuity, and economics. Methods: An uncontrolled real-world study (prospective cohort) these patients who were using Remicade® and switched to Remsima™ between September 2016 and September 2017. The primary outcome was the discontinuation rate of treatment (for any cause). The secondary outcome was the "increased disease activity" rate as measured by the scores SDAI, BASDAI and CASPAR. It was as "increased disease activity", any measure higher than the initial, and that was above the remission limit of the disease. The reference values for "increased disease activity" were the historical measures. The economic impact measured by a cost minimization analysis. Results: In September 2017, 5 (6%) patients who switched from Remicade® to Remsima™, discontinued therapy (4 due to failure and 1 loss of follow-up). The reference discontinuation rate (Remicade®) was 11% (9% failure and 2% loss of follow-up). Subgroup analyzes (discontinuation of therapy by type of pathology) were equivalent. The rate of "increased disease activity" occurred in 42% of patients for Remsima™, and 46% for Remicade®. Subgroup analyzes (by type of pathology) also showed that rates of increase in disease activity were similar between groups. The economic analysis showed that the change from Remicade® to Remsima™ savings of R $ 1.75 million (US $ 0.5 million), with 1,689 ampoules of infliximabe dispensed in the period. Conclusion: The switching of Remicade® by Remsima™ in patients with RA, SA and PA in the context of Planserv, has been shown to be a safe, effective and economical measure.


Assuntos
Humanos , Artrite Reumatoide , Espondilite Anquilosante , Artrite Psoriásica , Medicamentos Biossimilares , Infliximab
19.
Future Oncol ; 15(22): 2577-2584, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31339051

RESUMO

Aim: We aimed to improve oncology patients' knowledge and awareness of biosimilars. Subsequently, we conducted an assessment of this knowledge by use of an anonymous online survey. Patients & methods: Printed materials discussing major topics related to biosimilars were developed during Phase I of our educational initiative. The brochures contained a link to the online survey. Results: A total of 79 patients responded to our survey. More than 70% of survey participants selected the correct definition of biosimilars and nearly 80% did so on questions focused on regulation, adverse reactions reporting and cost issues related to biosimilars. Conclusion: Our results indicate a good level of both knowledge and awareness of major topics concerning biosimilars among our survey participants.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Conhecimentos, Atitudes e Prática em Saúde , Oncologia/tendências , Neoplasias/epidemiologia , Colorado/epidemiologia , Feminino , Humanos , Masculino , Neoplasias/tratamento farmacológico , Neoplasias/patologia , Inquéritos e Questionários
20.
J Pharm Biomed Anal ; 175: 112742, 2019 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-31344647

RESUMO

The biosimilarity assessment of the physicochemical properties of high-concentration biopharmaceuticals is usually performed with measurements on diluted solutions, at concentrations below 1 mg/mL. In this study 13 orthogonal, spectroscopy and particle size determination methods were used to characterize the structure and aggregation of undiluted, 25 mg/mL bevacizumab drug products Avastin® manufactured in the USA and in Europe, and ABX-BEV, a bevacizumab biosimilar candidate produced by Apobiologix Inc. Secondary structure, conformation and the potential occurrence of chemical degradation of the monoclonal antibodies were characterized and compared using infrared spectroscopy, intrinsic fluorescence and ANS fluorescence spectroscopy. Protein aggregation and particulate matter in the monoclonal antibody solutions were compared using UV-Vis absorbance, 90° light-scattering, nanoparticle tracking analysis, Nile red fluorescence microscopy, particle flow imaging, ultrasound resonance technology and a new scanner-based method that visualizes protein aggregates inside unopened vials. A data wheel representation was used to plot in one figure the results from the multiple analytical methods and to highlight differences between samples. The 25 mg/mL Avastin® drug product is stored at 2-8 °C during its 2-year shelf life. After a thermal stress of 4 weeks at 40 °C the ABX-BEV solution was turbid, containing particles of 20-100 µm diameter, accompanied by strong changes in antibody structural properties. Characterization of unstressed samples stored at 2-8 °C showed that the physicochemical properties of bevacizumab in ABX-BEV and the two originator drug products were similar, the observed differences between the originators being in the same range as those between ABX-BEV and the originator. To investigate the similarity of the antibodies under stress conditions, a freeze-thaw study was performed. Although freeze-thawing of bevacizumab products is prohibited by the package insert, after two freeze-thaw cycles (24 °C to -80 °C) small changes in the structural and aggregation properties of bevacizumab were observed, changes that were similar for the originator and ABX-BEV. Our study showed a good similarity of the investigated physicochemical properties of bevacizumab in originator and ABX-BEV products. It also provides an analytical approach, based on orthogonal methods, to compare high-concentration formulations of monoclonal antibodies.


Assuntos
Bevacizumab/química , Medicamentos Biossimilares/química , Soluções/química , Composição de Medicamentos/métodos , Congelamento , Tamanho da Partícula
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