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1.
Arq. gastroenterol ; 57(3): 232-243, July-Sept. 2020. tab, graf
Article in English | LILACS | ID: biblio-1131668

ABSTRACT

ABSTRACT BACKGROUND: Biologics have revolutionized the treatment of inflammatory bowel disease (IBD). However, these drugs had a significant influence on treatment-related costs, which resulted in the development of biosimilars. OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the drug discontinuation rate in the IBD population who switched from originator to biosimilars in real-world switching studies and address potential nocebo effects as reasons for drug discontinuation. METHODS: Medline (via PubMed), EMBASE, Cochrane Library, and abstract databases of selected congresses were screened for reports of monoclonal antibody (mAb) switching with a minimum post-switch follow-up of >6 months or three infusions. All available information on discontinuation rates was assessed. RESULTS: A total of 30 observational studies were included, involving 3,594 patients with IBD. Twenty-six studies reported a switch from infliximab to CT-P13, two studies involved a switch to SB2, and switching information was not available in two studies. The discontinuation rates were 8%, 14%, and 21% at 6, 12, and 24 months, respectively. The main reasons for drug discontinuation and their respective risks were: disease worsening (2%), remission (4%), loss of adherence (4%), adverse events (5%), and loss of response (7%). The quality of the evidence ranged from low to very low depending on the outcome analyzed. Subjective symptoms leading to drug discontinuation were infrequently reported, and the nocebo effect was clearly assessed in just one of the included papers. CONCLUSION: Discontinuation rates following a switch to a biosimilar in patients with IBD increase over time. However, it was not possible to confirm the nocebo effect as a reason for discontinuation. Therefore, long-term studies evaluating the use of biosimilars to monitor adverse events and potential nocebo effects in post-marketing surveillance are still needed.


RESUMO CONTEXTO: Os biológicos revolucionaram o tratamento da doença inflamatória intestinal (DII). Ademais, esses medicamentos influenciaram os custos relacionados ao tratamento. Tal aumento significativo nos gastos com o tratamento motivou desenvolvimento dos biossimilares. OBJETIVO: Esta revisão sistemática e metanálise objetivou avaliar a taxa de descontinuação de medicamentos na população com DII que foi submetida à troca do biológico originador para um biossimilar, em estudos observacionais que abordaram possíveis razões para a descontinuação do tratamento. MÉTODOS: Tendo como base de dados Medline (via PubMed), EMBASE, Cochrane Library e resumos de congressos médicos, foram rastreados artigos com relatos de troca de um biológico originador por um biossimilar, com acompanhamento pós-troca de no mínimo 6 meses ou três infusões. Todas as informações disponíveis sobre as taxas de descontinuação foram avaliadas. RESULTADOS: Foram incluídos no total 30 estudos observacionais, envolvendo 3.594 pacientes com DII. Vinte e seis estudos relataram uma mudança do infliximabe para CT-P13, dois estudos envolveram uma mudança para o SB2, e as informações sobre a troca não estavam disponíveis em dois estudos. As taxas de descontinuação foram de 8%, 14% e 21% aos 6, 12 e 24 meses, respectivamente. Os principais motivos para a descontinuação do medicamento e seus respectivos riscos foram: agravamento da doença (2%), remissão (4%), perda de adesão (4%), eventos adversos (5%) e perda de resposta (7%). A qualidade da evidência variou de baixa a muito baixa, dependendo do resultado analisado. Os sintomas subjetivos que levaram à descontinuação do medicamento foram relatados com pouca frequência, e o efeito nocebo foi claramente avaliado em apenas um dos artigos incluídos. CONCLUSÃO: As taxas de descontinuação após a mudança para um biossimilar em pacientes com DII aumentam com o tempo. No entanto, não foi possível confirmar o efeito nocebo como motivo da descontinuação. Portanto, ainda são necessários estudos em longo prazo avaliando o uso de biossimilares para monitorar eventos adversos e potenciais efeitos nocebo na vigilância pós-comercialização.


Subject(s)
Humans , Inflammatory Bowel Diseases/drug therapy , Biosimilar Pharmaceuticals/therapeutic use , Infliximab/therapeutic use
2.
Rev. salud pública ; 21(4): e473686, jul.-ago. 2019. tab, graf
Article in Spanish | LILACS | ID: biblio-1127215

ABSTRACT

RESUMEN Los anticuerpos monoclonales son una poderosa herramienta para el diagnóstico de laboratorio y un instrumento cada vez más utilizado en el tratamiento de diversas enfermedades, siendo uno de los grupos más importantes de drogas en el tratamiento del cáncer. La revolución en el mundo de los anticuerpos ocurre en 1975 cuando Milstein y Köhler desarrollan la técnica de las hibridomas en Cambridge. Objetivo Hacer una revisión del uso de anticuerpos monoclonales en medicina y, en particular, en el tratamiento del cáncer. Se busca aportar una visión generalizada del concepto de anticuerpo monoclonal para explicar su aplicabilidad terapéutica y abordar un enfoque económico y sociosanitario de la obtención y acceso a las nuevas terapias. Método En la caracterización del fenómeno de investigación se empleó el estudio descriptivo, de recolección de datos documental y la correlación entre las distintas fuentes. Discusión Son aún elevados los costos tanto para el paciente como para los sistemas de salud pública, y se ha de optimizar la valoración costo-efectividad de modo que la rentabilidad y el acceso a tiempo para los pacientes puedan ser compatibles. Se deja abierto el reto del desarrollo de nuevos mAbs dirigidos a nuevas dianas, mejorar el perfil de seguridad, evitando o reduciendo las reacciones adversas inmunes y conseguir el abaratamiento del coste de producción mediante mejoras en la biotecnología.(AU)


ABSTRACT Monoclonal antibodies are a useful tool for laboratory diagnosis and an instrument used in the treatment of various diseases and represent one of the most important groups of new drugs for the treatment of cancer. The revolution in the world occured in 1975 when Milstein and Köhler discovered monoclonal antibodies in Cambridge. Objective To review the use of monoclonal antibodies in medicine and in the treatment of cancer. To provide a generalized vision of the concept of monoclonal antibody to explain its therapeutic applicability, and to approach an economic, health-care approach to obtaining and accessing new therapies. Method In the characterization of the research phenomenon, the descriptive study, the collection of documentary data and the correlation between the different sources were used. Discussion However, the costs for both the patient and the public health systems are still high, and the cost-effectiveness assessment must be optimized so that cost-effectiveness and access to time for patients can be compatible. And the challenge of developing new mAbs aimed at new targets, improving the safety profile, avoiding, or reducing adverse immune reactions and achieving lower production costs through improvements in biotechnology, is left open.(AU)


Subject(s)
Humans , Biological Therapy/instrumentation , Biosimilar Pharmaceuticals/therapeutic use , Antibodies, Monoclonal/therapeutic use , Neoplasms/drug therapy , Epidemiology, Descriptive , Data Collection/instrumentation
3.
Gastroenterol. latinoam ; 29(supl.1): S68-S72, 2018. tab, ilus
Article in Spanish | LILACS | ID: biblio-1117874

ABSTRACT

Biological therapies have been essential for the management of inflammatory bowel disease; however, their high cost results in many patients being unable to access them. With time, commercial patents of many "original" biologics are reaching or almost in the point of reaching the expiration date of their licenses, which has allowed for the development of new agents known as biosimilars leading to a reduction of the cost of these therapies. The objective of this review is to explain what biosimilars are and show evidence of their effectiveness and safety.


Las terapias biológicas son parte fundamental en el manejo de la enfermedad inflamatoria intestinal, sin embargo los costos de éstas han hecho que muchos de los pacientes que tienen indicación de su uso, no puedan utilizarlas. Con el paso del tiempo, muchos biológicos "originales" están alcanzando o a punto de alcanzar el vencimiento de sus patentes, lo que ha llevado al desarrollo de nuevos agentes conocidos como biosimilares, determinando una disminución en los costos de estas terapias. Esta revisión tiene como objetivo explicar en qué consisten los biosimilares y la evidencia actual con respecto a su eficacia y seguridad.


Subject(s)
Humans , Inflammatory Bowel Diseases/drug therapy , Biosimilar Pharmaceuticals/therapeutic use , Therapeutic Equivalency , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Chile , Interchange of Drugs
4.
Braz. j. med. biol. res ; 51(3): 7214, 2018. tab
Article in English | LILACS | ID: biblio-889052

ABSTRACT

A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the Brazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in oncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial burden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective alternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to support therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to expedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society.


Subject(s)
Humans , Biosimilar Pharmaceuticals/therapeutic use , Medical Oncology , Neoplasms/drug therapy , Antibodies, Monoclonal/therapeutic use , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/standards , Brazil , Clinical Trials as Topic , Evidence-Based Medicine , Neoplasms/immunology , Pharmacovigilance , Societies, Medical
5.
Clinics ; 71(10): 586-592, Oct. 2016. tab, graf
Article in English | LILACS | ID: lil-796864

ABSTRACT

OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa’s approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima¯).


Subject(s)
Humans , Female , Adult , Middle Aged , Biosimilar Pharmaceuticals/therapeutic use , Breast Neoplasms/drug therapy , Filgrastim/therapeutic use , Hematologic Agents/therapeutic use , Neutropenia/chemically induced , Neutropenia/prevention & control , Antineoplastic Agents/adverse effects , Biosimilar Pharmaceuticals/pharmacokinetics , Filgrastim/pharmacokinetics , Hematologic Agents/pharmacokinetics , Leukocyte Count , Reference Values , Reproducibility of Results , Severity of Illness Index , Statistics, Nonparametric , Treatment Outcome
6.
Gastroenterol. latinoam ; 27(supl.1): S22-S25, 2016.
Article in Spanish | LILACS | ID: biblio-907648

ABSTRACT

Ulcerative colitis is a chronic inflammation in the mucosa layer of the colon characterized by activity and remitting episodes of varying severity and extension. Most of the flares are mild to moderate. They require outpatient treatment and have a good prognosis. The severe crises can have a high mortality if not treated on time. The success of the therapy depends on a multidisciplinary team.


La colitis ulcerosa en una inflamación crónica de la mucosa del intestino grueso que se caracteriza por episodios de actividad y remisiones de gravedad y extensión variable. La mayoría de las crisis son leves a moderadas, requieren tratamiento ambulatorio y son de buen pronóstico. Las crisis graves pueden llegar a tener una alta mortalidad si no son tratadas a tiempo. El éxito de la terapia depende de un equipo multidisciplinario.


Subject(s)
Humans , Anti-Bacterial Agents/therapeutic use , Colitis, Ulcerative/therapy , Infliximab/therapeutic use , Patient Care Team , Biosimilar Pharmaceuticals/therapeutic use , Colitis, Ulcerative/physiopathology
7.
s.l; Argentina. Ministerio de Salud; 2016. [{"_e": "", "_c": "", "_b": "tab", "_a": ""}].
Monography in Spanish | LILACS, BRISA | ID: biblio-833528

ABSTRACT

Tecnología: La hormona de crecimiento (HC) o somatotrofina es una proteína compuesta por 191 aminoácidos, que es sintetizada en la adenohipófisis. La deficiencia de HC produce talla y/o velocidad de crecimiento bajas y su exceso, gigantismo en la infancia y acromegalia en la adultez. Algunas de las causas no nutricionales de retraso de crecimiento pueden ser tratadas con hormona de crecimiento exógena. Indicaciones: Actualmente en Argentina el uso de hormona de crecimiento está indicado en el déficit aislado de HC por secreción hipofisaria insuficiente, en el síndrome de Turner, en la Insuficiencia Renal Crónica y en la Restricción del Crecimiento Intrauterino10. Su uso está propuesto y aprobado, en otros países, para indicaciones adicionales como el Síndrome de Prader Willi, el Síndrome de Noonan y la baja talla idiopática, entro otros. Características de la tecnología: La terapéutica con hormona de crecimiento se inició hace más de medio siglo y pasó por diferentes etapas de obtención y producción. La hormona de crecimiento humana (original y biosimilares) que se utiliza en la actualidad, proviene del uso de tecnología de ADN recombinante y su molécula es exactamente igual a la hormona de crecimiento endógena. Se trata de una molécula relativamente sencilla, bien caracterizada y con un amplio historial de efectividad y seguridad. A pesar de ello, los especialistas se resisten al cambio entre las diferentes marcas comerciales fundamentando su preocupación en el desarrollo de inmunogenicidad y sus posibles consecuencias clínicas y terapéuticas. Existe una amplia variación en los costos relacionados el tratamiento en función del diagnóstico, la dosis y la marca comercial utilizada. Pregunta de investigación: 1. El cambio o switching entre marcas comerciales durante el tratamiento aumenta el riesgo de efectos adversos o disminuye la efectividad? 2. Los productos biosimilares de hormona de crecimiento tienen la misma efectividad que la molécula original en el tratamiento de pacientes pediátricos con indicación de recibir HC? 3. Los productos biosimilares de hormona de crecimiento disponibles, son seguros para su aplicación en pacientes pediátricos con indicación aprobada de su uso? Búsqueda y Análisis de la evidencia científica: Se realizó una búsqueda en las principales bases de datos bibliográficas (MEDLINE, TripDatabase, LILACS, Cochrane, BVS), en buscadores genéricos de Internet como google, Agencias de Evaluación de Tecnologías Sanitarias (HTAi, INAHTA, CADTH), en Agencias Nacionales e Internacionales reguladoras de alimentos y medicamentos (ANMAT, FDA, EMA), en financiadores de salud (NICE, AETNA, CIGNA) y en bases de literatura gris (Teseo, NCSU Conference Papers Index). Se priorizó la inclusión de revisiones sistemáticas y metanálisis, evaluaciones de tecnologías sanitarias e informes de seguridad. Se incluyeron además, ensayos clínicos controlados y aleatorizados. Se realizó, adicionalmente, una búsqueda del precio de la tecnología en el Manual Farmacéutico Kairos actualizado en Julio 2015. La calidad de los estudios incluidos en esta ETS (evaluación de posibles sesgos) se realizó mediante una estrategia de lectura crítica en base a herramientas. Para algunos estudios, de moderada a baja calidad que reportaron sus resultados en forma incompleta, se calcularon los desvíos estándar y los intervalos de confianza respectivos. Resumen de los resultados: La evidencia disponible para el abordaje de la pregunta de investigación acerca de switch entre biosimilares es escasa y proveniente de estudios de baja a moderada calidad metodológica. El bajo número de estudios y número total de pacientes constituye también una debilidad de la evidencia disponible. La baja frecuencia de efectos adversos relacionados al tratamiento se traduce en falta de poder estadístico para la detección de diferencias clínicas o estadísticamente significativas entre los grupos tratados. En cuanto a la efectividad de la HC, no se desprende del cuerpo de la evidencia que haya diferencias clínicas o estadísticas significativas en los parámetros de crecimiento entre los diferentes productos biosimilares, tanto cuando se realizaron comparaciones directas como cuando los pacientes cambiaron de marca comercial durante su tratamiento. Los escasos estudios que reportaron la frecuencia de aparición de anticuerpos anti-HC, lo hicieron de manera incompleta; sin embargo de su análisis no surge sospecha de influencia de este evento sobre el perfil de eficacia o seguridad de las droga. Tanto financiadores públicos como privados reconocidos mundialmente por sus decisiones basadas en evidencia científica, coinciden en que no hay evidencia científica de que existan diferencias en términos de efectividad y/o seguridad entre los biosimilares de hormona de crecimiento disponibles en el mercado pero sí en términos de costos. Conclusiones: No hay suficiente evidencia científica que permita establecer que el switching entre los diferentes biosimilares disponibles en el mercado aumente el riesgo de los pacientes en tratamiento en términos de efectividad y seguridad (Ib2b). No se encontró evidencia científica de superioridad de un biosimilar sobre otro en términos de efectividad y seguridad (IB-2B). Se requiere de un mayor número de estudios de buena calidad metodológica y sin conflictos de interés con la Industria Farmacéutica que permitan analizar más profundamente estos aspectos.(AU)


Subject(s)
Humans , Biosimilar Pharmaceuticals/therapeutic use , Growth Disorders , Human Growth Hormone/deficiency , Health Information Systems , Technology Assessment, Biomedical , Treatment Outcome
8.
Rev. panam. salud pública ; 36(6): 396-401, dic. 2014. tab
Article in English | LILACS | ID: lil-742269

ABSTRACT

This study describes the adverse drug reactions (ADRs) and their incidence in patients with rheumatoid arthritis who were treated in the Colombian health system. A retrospective cohort study was conducted using information from all patients who were diagnosed with rheumatoid arthritis and attended specialized health care centers in the cities of Bogotá, Cali, Manizales, Medellin, and Pereira between 1 December 2009 and 30 August 2013. The ADRs were obtained from medical records and the pharmacovigilance system registry and sorted by frequency and affected tissue according to World Health Organization Adverse Reaction Terminology (WHO-ART). A total of 949 reports of ADRs were obtained from 419 patients (32.8 ADRs per 100 patient-years); these patients were from a cohort of 1 364 patients being treated for rheumatoid arthritis and followed up for an average of 23.8 months (± 12.9). The cohort was mostly female (366, 87.4%) and had a mean age of 52.7 years (± 13.1). The highest numbers of ADRs were reported following the use of tocilizumab, rituximab, and infliximab (28.8, 23.1, and 13.3 reports per 100 patient-years respectively). The most frequently reported ADRs were elevated transaminase levels and dyspepsia. Overall, 87.7% of ADRs were classified as type A, 36.6% as mild, 40.7% as moderate, and 22.7% as severe. As a result, 73.2% of patients who experienced an ADR stopped taking their drugs. The occurrence of ADRs in patients treated for rheumatoid arthritis is common, especially in those associated with the use of biotechnologically produced anti-rheumatic drugs. This outcome should be studied in future research and monitoring is needed to reduce the risks in these patients.


Este estudio describe las reacciones adversas a medicamentos (RAM) y su incidencia en pacientes con artritis reumatoide y tratados en el sistema de salud colombiano. Se llevó a cabo un estudio retrospectivo de cohortes utilizando la información correspondiente a todos los pacientes con diagnóstico de artritis reumatoide que acudieron a centros especializados de atención de salud de las ciudades de Bogotá, Cali, Manizales, Medellín y Pereira entre el 1 de diciembre del 2009 y el 30 de agosto del 2013. Los casos de RAM se obtuvieron de las historias clínicas y del registro del sistema de farmacovigilancia, y se clasificaron por su frecuencia y el tejido afectado, según la Terminología de Reacciones Adversas de la Organización Mundial de la Salud ­ (WHO-ART). Se obtuvo un total de 949 informes de RAM en 419 pacientes (32,8 RAM por 100 pacientes-año); estos pacientes correspondían a una cohorte de 1 364 pacientes tratados por artritis reumatoide y seguidos durante un promedio de 23,8 meses (± 12,9). La cohorte estaba compuesta principalmente por mujeres (366, 87,4%) y la media de edad era de 52,7 años (± 13,1). El mayor número de casos de RAM se notificó tras el uso de tocilizumab, rituximab e infliximab (28,8, 23,1 y 13,3 notificaciones por 100 pacientes-año, respectivamente). Las RAM notificadas con mayor frecuencia fueron la elevación de los niveles de transaminasas y la dispepsia. En términos generales, 87,7% de las RAM se clasificaron como de tipo A, 36,6% como leves, 40,7% como moderadas y 22,7% como graves. Como consecuencia, 73,2% de los pacientes que presentaron una RAM dejaron de tomar sus medicamentos. La aparición de RAM en pacientes tratados por artritis reumatoide es frecuente, especialmente cuando se utilizan fármacos antirreumáticos de producción biotecnológica. Estos resultados deben ser objeto de estudio en futuras investigaciones y señalan la necesidad de actividades de vigilancia para reducir los riesgos en estos pacientes.


Subject(s)
Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Female , Humans , Male , Middle Aged , Young Adult , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/drug therapy , Antirheumatic Agents/therapeutic use , Biological Products/adverse effects , Biological Products/therapeutic use , Biosimilar Pharmaceuticals/adverse effects , Biosimilar Pharmaceuticals/therapeutic use , Colombia/epidemiology , Drug Eruptions/epidemiology , Drug Eruptions/etiology , Chemical and Drug Induced Liver Injury/epidemiology , Chemical and Drug Induced Liver Injury/etiology , Follow-Up Studies , Gastrointestinal Diseases/chemically induced , Gastrointestinal Diseases/epidemiology , Hematologic Diseases/chemically induced , Hematologic Diseases/epidemiology , Pharmacovigilance , Retrospective Studies , Retinal Diseases/chemically induced , Retinal Diseases/epidemiology
9.
Clinics ; 69(8): 547-553, 8/2014. tab, graf
Article in English | LILACS | ID: lil-718187

ABSTRACT

OBJECTIVES: Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available product currently used in Brazil (a biosimilar epoetin formulation). METHODS: The sample size needed to enable demonstration of noninferiority with a statistical power of 85% for a between-group difference in hemoglobin levels of no more than 1.5 g/dL was calculated. In total, 74 patients were randomly assigned to receive the epoetin formulation from Bio-Manguinhos (n = 36) or the biosimilar epoetin formulation (n = 38) in a double-blind fashion. The inclusion criteria were current epoetin therapy and stable hemoglobin levels for at least 3 months prior to the study. The primary and secondary outcomes were mean monthly hemoglobin levels and safety, respectively. The dose was calculated according to international criteria and adjusted monthly in both groups according to hemoglobin levels and at the assistant physicians' discretion. Iron storage was estimated at baseline and once monthly. Clinicaltrials.gov: NCT01184495. RESULTS: The study was conducted for 6 months after randomization. The mean baseline hemoglobin levels were 10.9±1.2 and 10.96±1.2 g/dL (p = 0.89) in the Bio-Manguinhos epoetin and biosimilar epoetin groups, respectively. During the study period, there was no significant change in hemoglobin levels in either group (p = 0.055, ANOVA). The epoetin from Bio-Manguinhos was slightly superior in the last 3 months of follow-up. The adverse event profiles of the two formulations were also similar. CONCLUSIONS: The epoetin formulations tested in this study are equivalent in efficacy ...


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Anemia/drug therapy , Biosimilar Pharmaceuticals/therapeutic use , Erythropoietin/therapeutic use , Anemia/complications , Brazil , Biosimilar Pharmaceuticals/administration & dosage , Biosimilar Pharmaceuticals/adverse effects , Double-Blind Method , Erythropoietin/administration & dosage , Erythropoietin/adverse effects , Follow-Up Studies , Hemoglobins/analysis , Iron/blood , Iron/therapeutic use , Renal Dialysis , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Renal Insufficiency, Chronic/complications , Treatment Outcome
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