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.

中文翻译：

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使用生物仿制药治疗风湿病的共识建议


该研究旨在就评估和使用生物仿制药治疗风湿病提出基于证据的建议。该工作组由来自十个国家的风湿病学、皮肤病学和胃肠病学专家以及药理学家、患者和监管机构组成的专家组组成。通过讨论和达成共识的过程确定了有关生物仿制药的四个关键主题。然后使用德尔菲法制定具体问题来指导系统的文献综述。使用 Medline 系统地检索了截至 2016 年 11 月的相关英文出版物的每个主题；检查了选定的论文和相关评论以获取更多相关参考文献；检索了 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，以查找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制定了一套总体原则和共识建议。每项的证据水平和推荐等级均已确定。通过检索策略，确定了 490 篇参考文献。其中，29篇全文论文被纳入系统评价。此外，还从 ACR 和 EULAR 会议摘要数据库中检索了 20 篇摘要。产生了五项总体原则和八项共识建议，包括对临床试验、免疫原性、适应症外推、生物原创者和生物仿制药之间以及生物仿制药之间的转换以及成本的考虑。每个证据的水平和推荐等级根据可用的已发表证据而有所不同。 根据基于研究的证据和专家意见，制定了关于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。