Abstract:
Inflammatory bowel diseases (IBD) currently impose an immense social and economic burden on society in terms of both direct and indirect healthcare costs. Their incurable and progressive nature results in an unavoidable lifetime expense. The introduction of infliximab more than two decades ago had revolutionized IBD treatment. Nowadays, while biologic drugs comprise various vital therapeutic options for patients, they can be associated to significant costs to healthcare systems. The most crucial benefit of biosimilars is that they bring more significant cost reduction and increase access to advanced therapies. They also allow the treatment of newly diagnosed patients and dose optimization for those who need it. There is an inverse relationship between price and demand for treatment with biologics. For a more significant reduction in cost to be possible, greater use of biosimilars is necessary. For this to occur, it is imperative not only to use biosimilars in naïve patients but also to switch to biosimilars in those patients who have started therapy with reference biologics. At present, randomized and observational studies have demonstrated effectiveness and safety results in recommending a single switch between a reference product and a biosimilar, and vice versa. The purpose of this manuscript is to review the literature and discuss whether scientific evidence is enough to support multiple switches of biologics and biosimilars in IBD patients.
摘要:
炎症性肠病(IBD)目前在直接和间接医疗费用方面给社会带来了巨大的社会和经济负担。它们无法治愈和进步的性质导致不可避免的终生费用。二十多年前英夫利昔单抗的引入彻底改变了IBD治疗。如今,虽然生物药物包括患者的各种重要治疗选择,它们可能与医疗保健系统的巨大成本相关。生物仿制药最关键的好处是,它们带来了更显著的成本降低,并增加了获得先进疗法的机会。它们还允许对新诊断的患者进行治疗,并为需要的患者进行剂量优化。生物制剂治疗的价格与需求之间存在反比关系。为了更显著地降低成本,有必要更多地使用生物仿制药。为了发生这种情况,不仅必须在未治疗的患者中使用生物仿制药,而且必须在已经开始使用参考生物制剂治疗的患者中转换为生物仿制药.目前,随机和观察性研究表明,在推荐参考产品和生物仿制药之间进行一次切换时,结果是有效和安全的,反之亦然。本手稿的目的是回顾文献,并讨论科学证据是否足以支持IBD患者中生物制剂和生物仿制药的多种转换。