Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
CorEvitas, LLC, Waltham, MA, USA; University of Massachusetts Medical School, Worcester, MA, USA.
Semin Arthritis Rheum. 2023 Oct;62:152249. doi: 10.1016/j.semarthrit.2023.152249. Epub 2023 Aug 6.
To assess real-world comparative effectiveness studies of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) in adults with rheumatoid arthritis (RA) through a systematic review.
We searched Medline for journal articles (2001-2021) and Embase® for abstracts presented at the European Alliance of Associations for Rheumatology and American College of Rheumatology (ACR) 2020 and 2021 annual meetings on non-randomized studies comparing the effectiveness of b/tsDMARDs using ACR-recommended disease activity measures, measures of functional status, and patient-reported outcomes (HAQ, PROMIS PF, patient pain, Patient and Physician Global Assessment of disease activity). Methodological heterogeneity between studies precluded meta-analyses. Risk of bias was assessed using the Cochrane Risk Of Bias In Non-randomized Studies of Interventions-I tool.
Of 1283 records screened, 68 were selected for data extraction, of which 1 was excluded due to critical risk of bias. Most studies were multicenter observational cohort/registry studies (n = 60) and were published between 2011 and 2021 (n = 60). Mean or median reported RA duration was between 6 and 15 years. Disease Activity Score in 28 joints (46 studies), Clinical Disease Activity Index (37 studies), and Health Assessment Questionnaire-Disability Index (32 studies) were the most common outcomes used in clinical practice, with regional differences identified. The most common comparison was between tumor necrosis factor inhibitors (TNFis) and non-TNFi bDMARDs (35 studies). There were no evident differences between b/tsDMARDs in clinical effectiveness.
This systematic review summarizing real-world evidence from a very large number of global studies found there are many effective options for the treatment of RA, but relatively less evidence to support the use of any one b/tsDMARD or drug class over another. Treatment for patients with RA should be tailored to suit individual clinical profiles. Further research is needed to identify whether specific patient subgroups may benefit from specific drug classes.
通过系统评价评估生物(b)和靶向合成(ts)疾病修饰抗风湿药物(DMARDs)在类风湿关节炎(RA)成年患者中的真实世界比较效果研究。
我们在 Medline 上搜索了 2001 年至 2021 年的期刊文章,并在 Embase®上搜索了在欧洲风湿病联盟和美国风湿病学会(ACR)2020 年和 2021 年年会上提交的非随机研究摘要,这些研究比较了使用 ACR 推荐的疾病活动测量、功能状态测量和患者报告结果(HAQ、PROMIS PF、患者疼痛、患者和医生对疾病活动的全球评估)的 b/tsDMARDs 的有效性。研究之间存在方法学异质性,因此无法进行荟萃分析。使用 Cochrane 非随机干预研究风险偏倚工具评估风险偏倚。
在筛选的 1283 条记录中,有 68 条被选作数据提取,其中 1 条因关键风险偏倚而被排除。大多数研究为多中心观察性队列/登记研究(n=60),发表于 2011 年至 2021 年之间(n=60)。报告的 RA 持续时间的平均值或中位数为 6 至 15 年。28 个关节疾病活动评分(46 项研究)、临床疾病活动指数(37 项研究)和健康评估问卷残疾指数(32 项研究)是最常用于临床实践的最常见结局,并且确定了区域差异。最常见的比较是肿瘤坏死因子抑制剂(TNFis)和非 TNFi bDMARDs(35 项研究)之间的比较。b/tsDMARDs 在临床效果方面没有明显差异。
本系统评价总结了来自全球大量研究的真实世界证据,发现治疗 RA 有许多有效的选择,但支持使用任何一种 b/tsDMARD 或药物类别而不是另一种的证据相对较少。RA 患者的治疗应根据个体临床特征进行调整。需要进一步研究以确定特定患者亚组是否可能从特定药物类别中受益。