Gartlehner Gerald, Hansen Richard A, Jonas Beth L, Thieda Patricia, Lohr Kathleen N
Cecil G. Sheps Center for Health Services, and School of Public Health, Health Policy and Administration, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, USA.
J Rheumatol. 2006 Dec;33(12):2398-408.
Biologics are an important therapeutic option for treating patients with rheumatoid arthritis (RA). However, they are associated with rare but severe adverse events such as serious infections, lymphoma, or chronic heart failure. In addition, dosing regimens and routes of administration differ substantially among biologics. In a systematic review, we assessed the comparative efficacy and safety of biologic agents for RA.
We searched electronic databases up to May 2006. We limited evidence to controlled trials for efficacy but included observational evidence for safety. Outcomes of interest were clinical response, radiographic progression, and quality of life. Given the paucity of head-to-head evidence, we conducted adjusted, indirect comparisons of placebo-controlled trials.
Twenty-six controlled trials provided efficacy data; 18 additional studies assessed safety. The only evidence directly comparing 2 biologic agents was a nonrandomized, open-label trial that found no differences in effectiveness and safety between etanercept and infliximab. Adjusted indirect comparisons indicate no significant differences in efficacy between anti-tumor necrosis factor (TNF) drugs. However, anti-TNF drugs appear to be more efficacious than anakinra, although not all comparisons reached statistical significance. Because of the lack of sound longterm safety data, evidence is insufficient to draw firm conclusions about the comparative safety of biologics.
Anti-TNF drugs appear to be more efficacious than anakinra but do not differ significantly among each other. Clinical considerations such as comorbidities, route of administration, dosing regimens, and specific side effect profiles may guide the choice of an anti-TNF drug.
生物制剂是治疗类风湿关节炎（RA）患者的重要治疗选择。然而，它们与罕见但严重的不良事件相关，如严重感染、淋巴瘤或慢性心力衰竭。此外，生物制剂之间的给药方案和给药途径差异很大。在一项系统评价中，我们评估了生物制剂治疗RA的相对疗效和安全性。
我们检索了截至2006年5月的电子数据库。我们将疗效证据限于对照试验，但纳入了安全性的观察性证据。感兴趣的结局是临床反应、影像学进展和生活质量。鉴于直接对比的证据匮乏，我们对安慰剂对照试验进行了校正后的间接比较。
26项对照试验提供了疗效数据；另有18项研究评估了安全性。唯一直接比较两种生物制剂的证据是一项非随机、开放标签试验，该试验发现依那西普和英夫利昔单抗在有效性和安全性方面无差异。校正后的间接比较表明，抗肿瘤坏死因子（TNF）药物之间在疗效上无显著差异。然而，抗TNF药物似乎比阿那白滞素更有效，尽管并非所有比较都达到统计学显著性。由于缺乏可靠的长期安全性数据，关于生物制剂相对安全性的证据不足以得出确凿结论。
抗TNF药物似乎比阿那白滞素更有效，但它们之间无显著差异。合并症、给药途径、给药方案和特定副作用等临床因素可能指导抗TNF药物的选择。
