Introduction: Early biological treatment of rheumatoid arthritis (RA) may reverse the autoimmune response in some patients resulting in favorable long-term outcomes. Although the cost-effectiveness of this strategy has been questioned, biosimilar entries warrant the revision of clinical and pharmaco-economic evidence. Areas covered: We conducted a systematic review of randomized controlled trials (RCTs) published up to 24 May 2018 in Pubmed, EMBASE and Cochrane CENTRAL, comparing infliximab with non-biological therapy in patients with RA naïve to methotrexate. We performed meta-analyses for efficacy outcomes at month 6 and years 1 and 2. Six RCTs were identified, involving 1832 patients. At month 6 ACR70 response and remission, and at year 1 ACR20/ACR70 responses and remission were improved significantly with first-line infliximab versus control. The differences were not significant at year 2. We reviewed cost-utility studies, up to 31 October 2018 in PubMed, Cochrane CENTRAL and the CRD HTA databases. Four studies indicated that first-line use of originator infliximab calculated at 2005-2008 prices was not cost-effective. Expert opinion: We demonstrated the efficacy benefits of first-line infliximab therapy up to 1 year in methotrexate-naïve RA. We highlighted the need for standardized reporting of outcomes and conducting cost-effectiveness analyses of first-line biosimilar therapy in RA.

中文翻译：

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英夫利昔单抗作为类风湿关节炎的一线治疗的长期疗效和成本效益：系统评价和荟萃分析。

简介：类风湿关节炎（RA）的早期生物学治疗可能会逆转某些患者的自身免疫反应，从而带来良好的长期效果。尽管该策略的成本效益受到质疑，但生物仿制药的进入仍需要对临床和药物经济学证据进行修订。涵盖领域：我们对截至2018年5月24日在Pubmed，EMBASE和Cochrane CENTRAL上发表的随机对照试验（RCT）进行了系统评价，比较了英夫利昔单抗与单纯性RA甲氨蝶呤患者的非生物疗法。我们对第6个月以及第1和第2年的疗效进行了荟萃分析，确定了6项RCT，涉及1832例患者。一线英夫利昔单抗与对照组相比，在第6个月的ACR70反应和缓解以及在第1年的ACR20 / ACR70响应和缓解都得到了显着改善。在第2年时，差异并不显着。我们审查了截至2018年10月31日在PubMed，Cochrane CENTRAL和CRD HTA数据库中的成本效用研究。四项研究表明，以2005-2008年价格计算的鼻祖英夫利昔单抗一线使用并不划算。专家意见：我们证明了在未使用甲氨蝶呤的RA中长达一年的英夫利昔单抗一线治疗的疗效。我们强调需要对结局进行标准化报告，并对RA一线生物仿制药进行成本效益分析。我们证明了在未使用氨甲蝶呤的RA中长达一年的英夫利昔单抗一线治疗的疗效。我们强调需要对结局进行标准化报告，并对RA一线生物仿制药进行成本效益分析。我们证明了在未使用氨甲蝶呤的RA中长达一年的英夫利昔单抗一线治疗的疗效。我们强调需要对结局进行标准化报告，并对RA一线生物仿制药进行成本效益分析。