生物疗法:在变化的环境中从复杂性到临床实践

V. Lane
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引用次数: 0

摘要

本次研讨会为全球专家提供了一个讨论引入生物仿制药所带来的挑战的机会。讨论了制造过程对临床结果的影响,长期维持治疗反应,以及在不断变化的环境中围绕患者管理的问题。研讨会由Panaccione教授开场,他介绍了过去20年来炎症性肠病(IBD)治疗的演变以及生物制剂如何改善了结果。D’haens教授解释了生物药物开发的复杂性,以及制药商在确保高质量和长期稳定的产品时面临的障碍。Panaccione教授讨论了平衡从诱导治疗到维持治疗过渡的临床挑战,以提供临床相关和持续的治疗反应。他还讨论了阿达木单抗治疗IBD的长期结果的证据。Feagan教授强调了临床医生用生物制剂治疗患者所面临的问题,包括在不丧失疗效或影响安全性的情况下在生物制剂之间切换的能力,以及考虑生物疗法之间的互换性和免疫原性的潜在风险和影响的必要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Biologic Therapies: From Complexity to Clinical Practice in a Changing Environment
This symposium provided an opportunity for global experts to discuss the challenges posed by the introduction of biosimilars. The impact of the manufacturing process on clinical outcomes, maintaining treatment responses over the long term, and issues surrounding patient management in a changing environment were addressed. The symposium was opened by Prof Panaccione describing the evolution of inflammatory bowel disease (IBD) treatment in the last 20 years and how biologics have improved outcomes. Prof D’Haens provided an explanation of the complexity surrounding biologic drug development and the hurdles facing drug manufacturers when ensuring high quality and consistently performing products over time. Prof Panaccione discussed the clinical challenges in balancing the transition from induction to maintenance therapy in order to provide a clinically relevant and sustained response to therapy. He also discussed the evidence for long-term outcomes with adalimumab for IBD. Prof Feagan highlighted the issues faced by clinicians treating patients with biologics, including the ability to switch between biologics without loss of efficacy or impact on safety, and the need to consider interchangeability between biologic therapies and the potential risk and impact of immunogenicity.
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