Behrens Frank, Cañete Juan D, Olivieri Ignazio, van Kuijk Arno W, McHugh Neil, Combe Bernard
CIRI/Division of Rheumatology and Fraunhofer Institute IME, Translational Medicine and Pharmacology, Goethe University, Frankfurt/Main, Germany, Arthritis Unit, Rheumatology Department, Hospital Clinic and IDIBAPS, Barcelona, Spain, Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Italy, Rheumatology Department, Reade/Jan van Breemen Research Institute, Amsterdam, The Netherlands, Rheumatology Department, Royal National Hospital for Rheumatic Diseases, Bath, UK and Departement de Rhumatologie Hôpital Lapeyronie-Université Montpellier I, UMR 5535, Montpellier, France
CIRI/Division of Rheumatology and Fraunhofer Institute IME, Translational Medicine and Pharmacology, Goethe University, Frankfurt/Main, Germany, Arthritis Unit, Rheumatology Department, Hospital Clinic and IDIBAPS, Barcelona, Spain, Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Italy, Rheumatology Department, Reade/Jan van Breemen Research Institute, Amsterdam, The Netherlands, Rheumatology Department, Royal National Hospital for Rheumatic Diseases, Bath, UK and Departement de Rhumatologie Hôpital Lapeyronie-Université Montpellier I, UMR 5535, Montpellier, France.
Rheumatology (Oxford). 2015 May;54(5):915-26. doi: 10.1093/rheumatology/keu415. Epub 2014 Oct 27.
The aim of this study was to review the available evidence on TNF inhibitor monotherapy vs combination therapy with MTX in PsA.
A literature search was conducted up to and including October 2013 for randomized controlled trials (RCTs) and observational studies comparing TNF inhibitor monotherapy vs combination therapy with MTX in patients with PsA. Key information was extracted from the abstracts and/or full text of the articles retrieved.
Eleven published articles and three conference abstracts were retrieved, reporting on six RCTs of four TNF inhibitors. Most RCTs found no differences in efficacy for peripheral arthritis between patients treated with or without MTX. However, the studies were not powered to answer this question. Some data suggest that concomitant MTX may reduce the progression of structural damage. No significant differences in other outcomes have been reported. Data on TNF inhibitor monotherapy vs MTX combination therapy were reported from six registries. Three registries reported that the use of concomitant MTX did not affect the efficacy of TNF inhibitor therapy. Data from three European Union registries suggest that TNF inhibitor (especially mAbs) drug survival is superior in patients taking concomitant MTX, while one Canadian registry reported no difference.
Available evidence on the efficacy and safety of TNF inhibitor monotherapy vs add-on MTX therapy shows little or no improvement with combination therapy, although the use of concomitant MTX appears to prolong TNF inhibitor drug survival of mAb TNF inhibitors. Registries and observational studies have the potential to fill some of the knowledge gaps in this area.
本研究旨在回顾关于银屑病关节炎（PsA）中肿瘤坏死因子（TNF）抑制剂单药治疗与联合甲氨蝶呤（MTX）治疗的现有证据。
截至2013年10月进行文献检索，纳入比较PsA患者中TNF抑制剂单药治疗与联合MTX治疗的随机对照试验（RCT）和观察性研究。从检索到的文章摘要和/或全文中提取关键信息。
检索到11篇已发表文章和3篇会议摘要，报道了4种TNF抑制剂的6项RCT。多数RCT发现，接受或未接受MTX治疗的患者在外周关节炎疗效方面无差异。然而，这些研究尚无足够效力回答该问题。一些数据表明，联合MTX可能会减缓结构损伤的进展。未报道在其他结局方面有显著差异。6个登记处报告了TNF抑制剂单药治疗与MTX联合治疗的数据。3个登记处报告，联合使用MTX不影响TNF抑制剂治疗的疗效。来自3个欧盟登记处的数据表明，联合使用MTX的患者中TNF抑制剂（尤其是单克隆抗体）的药物留存率更高，而1个加拿大登记处报告无差异。
关于TNF抑制剂单药治疗与加用MTX治疗的疗效和安全性的现有证据显示，联合治疗几乎没有改善，尽管联合使用MTX似乎可延长单克隆抗体TNF抑制剂的药物留存时间。登记处和观察性研究有可能填补该领域的一些知识空白。
