Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, , Boston, Massachusetts, USA.
Ann Rheum Dis. 2014 Mar;73(3):595-9. doi: 10.1136/annrheumdis-2013-203302. Epub 2013 May 30.
We conducted a systematic review to assess the design and 'failure definition' in studies of biologic discontinuation in rheumatoid arthritis (RA).
We found 403 studies on PubMed, and included nine published papers and five abstracts from scientific meetings. We used a structured extraction form to collect information regarding study design and outcome (failure) definition.
Three types of studies were found: randomised controlled trials, long-term extension studies of clinical trials and prospective discontinuation studies. The largest study had 196 subjects in the discontinuation arm. Most studies allowed concomitant use of non-biologic drugs at biologic discontinuation. Heterogeneity was also found in the failure definition. Although all studies used measures of disease activity, the threshold for failure and the time point of assessment differed among studies. Few studies incorporated changing use of non-biologic drugs or glucocorticoids into the failure definition.
Although many studies have examined the outcome of biologic discontinuation, they have all been relatively small. Typical practice studies from registries may add important information but will likely need to rely on a broader failure definition.
我们进行了一项系统评价，以评估类风湿关节炎（RA）生物制剂停药研究的设计和“失败定义”。
我们在 PubMed 上找到了 403 项研究，并纳入了 9 篇已发表的论文和 5 篇科学会议摘要。我们使用结构化的提取表格收集有关研究设计和结局（失败）定义的信息。
发现了三种类型的研究：随机对照试验、临床试验的长期扩展研究和前瞻性停药研究。最大的研究中停药组有 196 名受试者。大多数研究允许在生物制剂停药时同时使用非生物制剂药物。失败定义也存在异质性。虽然所有研究都使用了疾病活动的衡量指标，但失败的阈值和评估的时间点在研究之间有所不同。很少有研究将非生物制剂药物或糖皮质激素的使用变化纳入失败定义。
尽管许多研究都检查了生物制剂停药的结局，但它们都是相对较小的研究。来自登记处的典型实践研究可能会提供重要信息，但可能需要依赖更广泛的失败定义。
