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Biosimilars in the Treatment of Inflammatory Bowel Disease: current trends and future perspectives
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O aumento crescente da incidência da Doença Inflamatória Intestinal (DII), particularmente na população mais jovem e ativa, constitui um desafio claro na gestão e prevenção desta doença crónica. Ainda que com uma etiologia de carácter idiopático, não deixa de apresentar diversos focos terapêuticos, que permitem desenvolver abordagens inovadoras e direcionadas. A terapêutica biológica encontra-se na vanguarda do tratamento de doenças crónicas auto-imunes, nomeadamente a DII, com vantagens evidentes no que toca à comodidade dos regimes terapêuticos, bem como nos resultados clínicos promissores. No entanto, trata-se de uma abordagem terapêutica dispendiosa, que põe em causa a sustentabilidade dos sistemas de saúde e o acesso à medicação por parte dos doentes.
Com base numa revisão científica extensa, os biossimilares surgem como uma solução a este problema. Tratando-se de moléculas obtidas por biotecnologia, à semelhança dos seus parentes biológicos, asseguram a efetividade da terapêutica biológica na gestão da DII, com encargos financeiros consideravelmente inferiores. Atualmente, existem diversos medicamentos biológicos aprovados para o tratamento da Doença de Crohn e Colite Ulcerosa, nomeadamente o Infliximab, Adalimumab, Golimumab, Certolizumab, entre outros, servindo de base para o potencial desenvolvimento dos respetivos biossimilares. No entanto, à data, apenas o Infliximab e Adalimumab têm biossimilares disponíveis no mercado. A sua eficácia, segurança, imunogenicidade, entre outros parâmetros, foram comprovadas em ensaios clínicos de fase III e IV, de carácter essencialmente comparativo, o que permitiu também inferir acerca da possibilidade de alternar entre um biológico e o seu biossimilar durante o regime terapêutico dos doentes.
É importante reforçar o impacto farmacoeconómico do desenvolvimento de biossimilares, tanto no setor, como para os próprios doentes. Ainda que a oferta biossimilar para o tratamento da DII seja limitada a duas moléculas biológicas, vários têm sido os estudos realizados no sentido de avaliar a vantagem económica que esses biossimilares apresentam. A partir dos estudos compilados nesta monografia, é possível depreender que a introdução primária de um biossimilar no regime terapêutico de um doente com DII, ou até a substituição de um biológico pelo seu biossimilar, contribui para uma maior sustentabilidade dos sistemas de saúde e permite tratar mais doentes, devido ao acesso facilitado ao medicamento.
The increasing incidence of Inflammatory Bowel Disease (IBD), particularly in the younger and more active population, constitutes a clear challenge in the management and prevention of this chronic disease. Despite having an idiopathic etiology, it still presents several therapeutic targets, allowing the development of innovative and targeted approaches. Biological therapy is at the forefront of the treatment of chronic autoimmune diseases, namely IBD, with clear advantages regarding the convenience of the therapy regimen itself, as well as promising clinical results. However, it is an expensive therapeutic approach, which questions the sustainability of health care systems and patients' access to medication. Based on an extensive scientific review, biosimilars emerge as a solution to this problem. Because they are molecules obtained by biotechnology, like their biological relatives, they ensure the effectiveness of biological therapy in the management of IBD, with considerably lower financial costs. Currently, there are several biological medicines approved for the treatment of Crohn's Disease and Ulcerative Colitis, namely Infliximab, Adalimumab, Golimumab, Certolizumab, among others, serving as a starting point for the potential development of their respective biosimilars. However, to date, only Infliximab and Adalimumab have biosimilars available on the market. Their efficacy, safety, immunogenicity, among other parameters, were proven in phase III and IV clinical trials, of an essentially comparative character, which also allowed to infer about the possibility of switching between a biological and its biosimilar during the therapeutic regimen of the patients. It is important to reinforce the pharmacoeconomic impact of the development of biosimilars, both for health care systems and for the patients themselves. Although the biosimilar offer for the treatment of IBD is limited to two biological molecules, several studies have been carried out to evaluate the economic advantage that these biosimilars present. From the studies compiled in this monograph, it is possible to conclude that the primary introduction of a biosimilar in the therapeutic regimen of an IBD patient, or even the replacement of a biological medicine by its biosimilar, contributes to a greater sustainability of health care systems and allows more patients to be treated, due to easier access to the medication.
The increasing incidence of Inflammatory Bowel Disease (IBD), particularly in the younger and more active population, constitutes a clear challenge in the management and prevention of this chronic disease. Despite having an idiopathic etiology, it still presents several therapeutic targets, allowing the development of innovative and targeted approaches. Biological therapy is at the forefront of the treatment of chronic autoimmune diseases, namely IBD, with clear advantages regarding the convenience of the therapy regimen itself, as well as promising clinical results. However, it is an expensive therapeutic approach, which questions the sustainability of health care systems and patients' access to medication. Based on an extensive scientific review, biosimilars emerge as a solution to this problem. Because they are molecules obtained by biotechnology, like their biological relatives, they ensure the effectiveness of biological therapy in the management of IBD, with considerably lower financial costs. Currently, there are several biological medicines approved for the treatment of Crohn's Disease and Ulcerative Colitis, namely Infliximab, Adalimumab, Golimumab, Certolizumab, among others, serving as a starting point for the potential development of their respective biosimilars. However, to date, only Infliximab and Adalimumab have biosimilars available on the market. Their efficacy, safety, immunogenicity, among other parameters, were proven in phase III and IV clinical trials, of an essentially comparative character, which also allowed to infer about the possibility of switching between a biological and its biosimilar during the therapeutic regimen of the patients. It is important to reinforce the pharmacoeconomic impact of the development of biosimilars, both for health care systems and for the patients themselves. Although the biosimilar offer for the treatment of IBD is limited to two biological molecules, several studies have been carried out to evaluate the economic advantage that these biosimilars present. From the studies compiled in this monograph, it is possible to conclude that the primary introduction of a biosimilar in the therapeutic regimen of an IBD patient, or even the replacement of a biological medicine by its biosimilar, contributes to a greater sustainability of health care systems and allows more patients to be treated, due to easier access to the medication.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2020, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
IBD Biological Biosimilar Efficacy Immunogenicity Pharmacogenomics Mestrado integrado -2020