Department of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
BioDrugs. 2012 Apr 1;26(2):65-70. doi: 10.2165/11631320-000000000-00000.
Rheumatoid arthritis (RA) affects an estimated 1.3 million Americans and is a complex inflammatory disease associated with synovitis and joint destruction. The development of biologic disease-modifying anti-rheumatic drugs (DMARDs) that target specific mediators of inflammation has led to several highly successful therapies for the treatment of RA. The imperfect efficacy of biologic DMARDs has resulted in the absence of clear guidelines on how biologic DMARDs should be used in the clinic to optimize treatment of RA patients. This makes it imperative that better data be available to physicians and RA patients about the comparative effectiveness of different biologic DMARDs. Prior to 2008, there were no randomized trials comparing biologic DMARDs for the treatment of RA. Since then, there have been published studies that directly compared biologic DMARDs for the treatment of RA, and several studies that estimated the relative efficacy of different biologic DMARDs by comparing published results of studies that included treatment of RA patients with biologic DMARDs who had previously experienced an inadequate response to methotrexate or tumor necrosis factor (TNF) antagonists. There are two recent studies that directly compared biologic DMARDs with optimal combinations of oral DMARDs and these are important because there are significant differences in costs and side effects between oral and biologic DMARDs. Among the studies that directly compared biologic DMARDs, it has been reported that RA patients who fail a TNF antagonist have a higher response rate (based on disease activity score [DAS28] measurements) to treatment with rituximab as compared with another TNF antagonist. In addition, in the ATTEST trial, the investigators found that, for RA patients with an inadequate response to methotrexate, treatment with abatacept versus infliximab resulted in response rates that were roughly equal. There are also several head-to-head studies of biologic DMARDs that are currently enrolling or about to enroll RA subjects. Pharmaceutical companies have taken more interest in comparative effectiveness studies, in part due to the emphasis that has been placed on this type of research by the US federal government and associated organizations including the Patient-Centered Outcomes Research Institute (PCORI). Therefore, while there is currently a relative lack of comparative effectiveness research to inform clinical decisions about biologic DMARDs for RA patients, it appears likely that there will be wider availability of such data in the near future.
类风湿关节炎（RA）影响了约 130 万美国人，是一种与滑膜炎和关节破坏相关的复杂炎症性疾病。生物疾病修饰抗风湿药物（DMARDs）的发展针对炎症的特定介质，为 RA 的治疗带来了几种非常成功的疗法。生物 DMARD 的疗效并不完美，导致临床上如何使用生物 DMARD 来优化 RA 患者的治疗没有明确的指导方针。这使得医生和 RA 患者获得关于不同生物 DMARD 比较有效性的更好数据变得至关重要。在 2008 年之前，没有比较生物 DMARD 治疗 RA 的随机试验。此后，已经发表了一些直接比较生物 DMARD 治疗 RA 的研究，以及一些通过比较包括生物 DMARD 治疗 RA 患者的研究结果来估计不同生物 DMARD 相对疗效的研究，这些患者先前对甲氨蝶呤或肿瘤坏死因子（TNF）拮抗剂治疗反应不足。有两项最近的研究直接比较了生物 DMARD 与口服 DMARD 的最佳组合，这很重要，因为口服和生物 DMARD 之间在成本和副作用方面存在显著差异。在直接比较生物 DMARD 的研究中，据报道，与另一种 TNF 拮抗剂相比，对 TNF 拮抗剂治疗反应不足的 RA 患者对利妥昔单抗治疗的反应率更高（基于疾病活动评分[DAS28]测量）。此外，在 ATTTEST 试验中，研究人员发现，对于对甲氨蝶呤治疗反应不足的 RA 患者，与英夫利昔单抗相比，阿巴西普治疗的反应率大致相同。目前还有几项生物 DMARD 的头对头研究正在招募或即将招募 RA 患者。制药公司对比较有效性研究更感兴趣，部分原因是美国联邦政府和相关组织（包括患者为中心的结果研究所[PCORI]）对这类研究的重视。因此，尽管目前关于生物 DMARD 治疗 RA 患者的临床决策的比较有效性研究相对较少，但在不久的将来，这类数据可能会更广泛地提供。
