Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, Massachusetts, USA.
Department of Internal Medicine, Centre for Rheumatic Diseases, Hietzing Hospital, Vienna, Austria.
Ann Rheum Dis. 2018 Feb;77(2):165-174. doi: 10.1136/annrheumdis-2017-211937. Epub 2017 Sep 2.
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.
本研究旨在针对评估和使用生物类似药治疗风湿性疾病制定基于证据的推荐意见。该工作组由 10 个国家的风湿病学、皮肤病学和胃肠病学专家以及药剂师、患者和监管机构的专家组组成。通过讨论和达成共识的过程确定了关于生物类似药的四个关键主题。然后使用 Delphi 流程制定了具体问题，以指导系统文献综述。使用 Medline 对每个主题进行了系统搜索，以查找截至 2016 年 11 月的相关英文出版物；对选定的论文和相关评论进行了检查，以寻找其他相关参考文献；并对 2015 年和 2016 年美国风湿病学会 (ACR) 和欧洲抗风湿病联盟 (EULAR) 年会的会议摘要进行了搜索，以查找有关生物类似药的摘要。专家们使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。确定了每个建议的证据水平和推荐等级。通过搜索策略，确定了 490 条参考文献。其中，29 篇全文论文被纳入系统综述。此外，还从 ACR 和 EULAR 会议摘要数据库中检索到 20 篇摘要。生成了五项总体原则和八项共识建议，涵盖了临床试验、免疫原性、适应症外推、生物原研药与生物类似药之间以及生物类似药之间的转换以及成本等方面的考虑因素。每个建议的证据水平和推荐等级都根据可用的已发表证据而有所不同。使用基于研究的证据和专家意见制定了五项评估和使用生物类似药治疗风湿性疾病的总体原则和八项共识建议。
