该研究旨在制定有关评估和使用生物仿制药治疗风湿病的循证建议。工作队由风湿病学专家组成的专家组,皮肤病学和胃肠病学,和药理学家,来自十个国家的患者和监管机构。通过讨论和共识,确定了有关生物仿制药的四个关键主题。使用Delphi过程,然后制定具体问题以指导系统的文献综述。使用Medline系统地搜索了截至2016年11月的相关英语出版物,以获取每个主题;对选定的论文和相关评论进行了其他相关参考检查;并在2015年和2016年美国风湿病学会(ACR)和欧洲抗风湿病联盟(EULAR)年度科学会议上发表的摘要中搜索了有关生物仿制药的摘要。专家们利用从这些研究中获得的证据来制定一套总体原则和共识建议。分别确定证据水平和推荐等级。根据搜索策略,已确定490个参考文献。其中,29篇全文论文被纳入系统综述。此外,从ACR和EULAR会议摘要数据库中检索到20篇摘要。产生了五项总体原则和八项共识建议,包括关于临床试验的考虑,免疫原性,适应症的推断,在生物起源者和生物仿制药之间以及在生物仿制药之间转换,和成本。每个证据的水平和建议的等级根据可用的已发布证据而有所不同。使用基于研究的证据和专家意见,制定了有关评估和使用生物仿制药治疗风湿病的五项总体原则和八项共识建议。
The study aimed to develop evidence-based recommendations regarding the evaluation and use of biosimilars to treat rheumatological diseases. The task force comprised an expert group of specialists in rheumatology, dermatology and gastroenterology, and pharmacologists, patients and a regulator from ten countries. Four key topics regarding biosimilars were identified through a process of discussion and
consensus. Using a Delphi process, specific questions were then formulated to guide a systematic literature review. Relevant English-language publications through November 2016 were searched systematically for each topic using Medline; selected papers and pertinent reviews were examined for additional relevant references; and abstracts presented at the 2015 and 2016 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) annual scientific meetings were searched for those about biosimilars. The experts used evidence obtained from these studies to develop a set of overarching principles and
consensus recommendations. The level of evidence and grade of recommendation were determined for each. By the search strategy, 490 references were identified. Of these, 29 full-text papers were included in the systematic review. Additionally, 20 abstracts were retrieved from the ACR and EULAR conference abstract databases. Five overarching principles and eight
consensus recommendations were generated, encompassing considerations regarding clinical trials, immunogenicity, extrapolation of indications, switching between bio-originators and biosimilars and among biosimilars, and cost. The level of evidence and grade of recommendation for each varied according to available published evidence. Five overarching principles and eight
consensus recommendations regarding the evaluation and use of biosimilars to treat rheumatological diseases were developed using research-based evidence and expert opinion.