我们是否准备好在参考产品和生物仿真产品之间进行多重切换?
Fabio Vieira Teixeira1, Laurent Peyrin-Biroulet2,3, Silvio Danese4
1IBD Center, GastroSaúde Clinic, Marilia, State of São Paulo, Brazil.
Arquivos de gastroenterologia
|July 24, 2024
概括
生物类似药可以节省成本,并改善人们获得炎症性肠病 (IBD) 治疗的机会. 本审查审查证据是否支持IBD患者在生物药物和生物类似药物之间进行多次切换.
科学领域:
- 胃肠病学 胃肠病学
- 药物经济学 药物经济学
- 免疫学 免疫学 免疫学
背景情况:
- 炎症性肠病 (IBD) 由于其慢性,渐进和无法治愈的性质,造成了重大的社会经济负担.
- 生物疗法虽然是革命性的,但却带来了大量的医疗费用,限制了获得和负担能力.
- 生物仿制药提供了一条降低成本,提高治疗可获得性和实现更广泛的患者护理的途径,包括新的诊断和剂量优化.
研究的目的:
- 审查关于生物仿制药在炎症性肠病 (IBD) 治疗中的有效性和安全性的现有文献.
- 评估科学证据,支持IBD患者在参考生物药物和生物类似药物之间进行多次切换.
- 讨论生物类似药物对医疗保健系统和患者获得先进疗法的影响.
主要方法:
- 随机对照试验和观察性研究的综合文献综述.
- 对单个和多个开关相关的疗效,安全性和免疫性数据的分析.
- 综合关于在IBD管理中采用生物类似药的临床和经济影响的证据.
主要成果:
- 目前的证据支持在参考生物药物和生物类似药物之间单次切换的安全性和有效性.
- 关于IBD患者多重切换的长期结果和安全概况的数据仍然有限.
- 生物仿制药的有效性和安全性与原始生物药物相比,可以降低成本.
结论:
- 生物药和生物类似药之间的单一切换得到了IBD管理的强有力的科学证据的支持.
- 需要进一步的研究来确定IBD患者多重开关的安全性和有效性.
- 增加生物类似药的使用对于降低成本和改善获得先进IBD疗法的机会至关重要.
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