背景:虽然生物制剂显著改善了炎性关节炎的治疗(类风湿性关节炎,银屑病关节炎,和轴向脊柱关节炎),高成本,严格的规定,严格的报销标准,和现有的专利限制了患者获得治疗的机会。虽然质量非常相似,安全,和生物参考产品的功效,生物仿制药可以减轻财政负担,防止药物利用不足。
目的:该计划的目的是建立一个以证据为基础的总体原则和建议的共识,旨在规范海湾地区使用生物仿制药治疗炎症性关节炎。
方法:实践风湿病专家的工作组,临床药师,一位健康经济学家,病人,监管者,来自海湾地区的付款人根据系统文献综述的结果制定了建议和总体原则,以解决针对使用生物仿制药治疗炎症性关节炎的关键挑战的患者干预-比较-结果(PICO)问题。在该地区。由于2017年之前的数据已经在另一份出版物中进行了审查,本综述集中于2017年1月至2022年8月期间公布的数据(PROSPEROIDCRD42022364002).每个声明的共识都需要70%或更高的协议水平。
结果:工作组就五项总体原则和九项建议达成了共识。这些原则强调了提高认识的重要性,理解,以及对生物仿制药的感知,以及需要规范的区域现实世界数据生成和协议,使生物仿制药成为所有患者可行和负担得起的治疗选择。共识建议主张在考虑生物仿制药时,风湿病学家和患者之间需要共享治疗决策。他们进一步建议,在单一适应症中确认生物仿制药的有效性和安全性足以外推到参考产品已被批准的其他疾病。最后,在整个地区的临床实践中,有必要制定药物警戒和国家卫生政策来管理生物仿制药的采用和处方。
结论:这些是基于系统文献综述和系统评价和荟萃分析(PRISMA)指南的首选报告项目的针对海湾地区的第一个共识建议。将临床证据与临床专业知识相结合,以优化炎性关节炎患者使用生物仿制药的决策。由于区域数据有限,它们是基于主要的国际数据制定的,因此可以推广为世界其他地区的医疗保健专业人员提供建议。
BACKGROUND: Though biologic agents have significantly improved the treatment of inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis), high costs, stringent regulations, strict reimbursement criteria, and existing patents have limited patient access to treatments. While being highly similar in quality, safety, and efficacy to biologic reference products, biosimilars can reduce the financial burden and prevent underutilization of medication.
OBJECTIVE: The objective of this initiative was to develop an evidence-based
consensus of overarching principles and recommendations aimed at standardizing the use of biosimilars in treating inflammatory arthritis in the Gulf region.
METHODS: A task force of practicing rheumatologists, a clinical pharmacist, a health economist, patients, regulators, and payors from across the Gulf region developed recommendations and overarching principles based on the outputs of a systematic literature review conducted to address Patient-Intervention-Comparison-Outcome (PICO) questions specific to key challenges regarding the use of biosimilars for the treatment of inflammatory arthritis in the region. As the data before 2017 have been previously reviewed in another publication, the current review focused on data published between January 2017 and August 2022 (PROSPERO ID CRD42022364002).
Consensus on each statement required a level of agreement of 70% or greater.
RESULTS: Consensus was reached for five overarching principles and nine recommendations by the task force. The principles emphasize the importance of improving the awareness, understanding, and perception of biosimilars, as well as the need for regulated regional real-world data generation and protocols to make biosimilars a viable and affordable treatment option for all patients. The consensus recommendations advocate the need for shared treatment decisions between rheumatologists and patients when considering biosimilars. They further recommend that confirmation of a biosimilar\'s efficacy and safety in a single indication is sufficient for extrapolation to other diseases for which the reference product has been approved. Finally, there is a need for pharmacovigilance and national health policies governing the adoption and prescription of biosimilars in clinical practice across the region.
CONCLUSIONS: These are the first
consensus recommendations for the Gulf region based on a systematic literature review and Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA)
guidelines, integrating clinical evidence with clinical expertise to optimize decision making for the use of biosimilars in patients with inflammatory arthritis. They were formulated based on predominantly international data because of the limited regional data and therefore can be generalized to serve as recommendations for healthcare professionals in other parts of the world.