Leeds Musculoskeletal Biomedical Research Unit, LTHT and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
University of Western Ontario, London, ON, Canada.
Adv Ther. 2018 Oct;35(10):1535-1563. doi: 10.1007/s12325-018-0757-2. Epub 2018 Aug 20.
Despite recommendations suggesting that biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) should be used in combination with methotrexate in the treatment of rheumatoid arthritis (RA), up to one-third of patients with RA are treated with monotherapy. The objective of the systematic literature review reported here was to evaluate the clinical evidence regarding the efficacy of b/tsDMARDs as monotherapy in the treatment of RA. MEDLINE, Embase, and the Cochrane Central Trials Register (to April 11, 2017) and the American College of Rheumatology and European League Against Rheumatism conference proceedings (2010-2016) were searched for randomized controlled trials evaluating the efficacy of b/tsDMARDs as monotherapy for RA in adults. Forty-four monotherapy studies of abatacept, adalimumab, baricitinib, certolizumab pegol, etanercept, sarilumab, sirukumab, tocilizumab, and tofacitinib reported in 71 publications were identified. Tocilizumab had the most studies (14), followed by etanercept (10) and adalimumab (9). These b/tsDMARDs were consistently shown to be efficacious treatments, regardless of whether patients were intolerant of or had never used conventional synthetic (cs) DMARDs. However, better treatment outcomes were usually achieved with combination therapy, and this was observed for all b/tsDMARDs assessed by this review. Only a few studies provided a head-to-head comparison between b/tsDMARD treatments or between b/tsDMARD monotherapy and combination therapy, and as many were initial RA treatments they were not generalizable to usual care. In conclusion, evidence from randomized trials suggests that the b/tsDMARDs studied are effective as monotherapy. In general, some patient responses seem better with combination therapy and the durability of monotherapy is less than combination therapy. There is, however, a need for longer-term head-to-head trials to establish positioning of these interventions in the treatment algorithm for RA.
Pfizer.Plain Language Summary: Plain language summary available on the journal website.
尽管建议在类风湿关节炎(RA)的治疗中生物制剂和靶向合成的疾病修饰抗风湿药物(b/tsDMARDs)应与甲氨蝶呤联合使用,但多达三分之一的 RA 患者接受单药治疗。本系统文献综述的目的是评估 b/tsDMARDs 作为 RA 单药治疗的临床证据。检索了 MEDLINE、Embase 和 Cochrane 中心临床试验注册库(截至 2017 年 4 月 11 日)以及美国风湿病学会和欧洲抗风湿病联盟会议记录(2010-2016 年),以评估 b/tsDMARDs 作为 RA 成人单药治疗的疗效。在 71 篇文献中报告了 44 项关于阿巴西普、阿达木单抗、巴利昔单抗、依那西普、托珠单抗和托法替布的单药治疗研究。在评估的 b/tsDMARDs 中,托珠单抗研究最多(14 项),其次是依那西普(10 项)和阿达木单抗(9 项)。无论患者是否对传统合成(cs)DMARDs 不耐受或从未使用过,这些 b/tsDMARDs 均被证明是有效的治疗方法。然而,联合治疗通常会获得更好的治疗效果,这在本综述评估的所有 b/tsDMARDs 中均观察到。只有少数研究对 b/tsDMARD 治疗进行了头对头比较,或对 b/tsDMARD 单药治疗与联合治疗进行了比较,并且由于许多研究是初始 RA 治疗,因此它们不能推广到常规护理。总之,随机试验的证据表明,所研究的 b/tsDMARDs 作为单药治疗是有效的。一般来说,一些患者的反应似乎通过联合治疗更好,而单药治疗的持久性不如联合治疗。然而,需要进行更长时间的头对头试验,以确定这些干预措施在 RA 治疗方案中的定位。
辉瑞。
类风湿关节炎。