Sarilumab
Sarilumab 是一种与白介素-6 (IL-6) 受体结合的人源性单克隆抗体。它通过抑制 IL-6 受体介导的信号通路来发挥作用,有助于减轻风湿性关节炎的炎症。该药已被美国食品药品监督管理局 (Food and Drug Administration, FDA) 批准用于对一种或多种改善病情抗风湿药(例如甲氨蝶呤)反应不足或不耐受的类风湿性关节炎成年患者。[77]Genovese MC, Fleischmann R, Kivitz AJ, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III study. Arthritis Rheumatol. 2015;67:1424-1437.http://onlinelibrary.wiley.com/doi/10.1002/art.39093/fullhttp://www.ncbi.nlm.nih.gov/pubmed/25733246?tool=bestpractice.com[78]Huizinga TW, Fleischmann RM, Jasson M, et al. Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis. 2014;73:1626-1634.http://ard.bmj.com/content/73/9/1626.longhttp://www.ncbi.nlm.nih.gov/pubmed/24297381?tool=bestpractice.com
巴瑞克替尼 (Baricitinib)
巴瑞克替尼是一种阻滞 JAK-1 和 JAK-2 的 Janus 激酶 (Janus kinase, JAK) 抑制剂。它在某些国家/地区已被批准用作成人类风湿关节炎的二线治疗药物。[79]Lee YH, Bae SC. Comparative efficacy and safety of baricitinib 2 mg and 4 mg in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials. Z Rheumatol. 2017 Jan 17 [Epub ahead of print].http://www.ncbi.nlm.nih.gov/pubmed/28097393?tool=bestpractice.com[80]Emery P, Blanco R, Maldonado Cocco J, et al. Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis. RMD Open. 2017;3:e000410.http://rmdopen.bmj.com/content/3/1/e000410http://www.ncbi.nlm.nih.gov/pubmed/28405473?tool=bestpractice.com[81]Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374:1243-1252.http://www.nejm.org/doi/full/10.1056/NEJMoa1507247#t=articleDiscussionhttp://www.ncbi.nlm.nih.gov/pubmed/27028914?tool=bestpractice.com[82]Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017;76:88-95.http://ard.bmj.com/content/76/1/88.longhttp://www.ncbi.nlm.nih.gov/pubmed/27689735?tool=bestpractice.com FDA 现阶段已推迟批准该药在美国上市。英国国家卫生与临床优化研究所 (National Institute of Health and Care Excellence, NICE) 发布了一份有关巴瑞克替尼的指导,建议将它用作如下患者的治疗选择:有严重疾病(28 个关节的疾病活动度评分超过 5.1[18]van der Heijde DM, van 't Hof M, van Riel PL, et al. Development of a disease activity score based on judgment in clinical practice by rheumatologists. J Rheumatol. 1993;20:579-581.http://www.ncbi.nlm.nih.gov/pubmed/8478878?tool=bestpractice.com)且对使用传统改善病情抗风湿药 (disease-modifying antirheumatic drugs, DMARD) 的强化治疗反应不足的患者;有严重疾病且对其他 DMARD(包括至少一种生物性 DMARD 和利妥昔单抗)反应不足或不耐受的患者。[83]National Institute for Health and Care Excellence. Baricitinib for moderate to severe rheumatoid arthritis. Technology appraisal guidance [TA466]. August 2017. https://www.nice.org.uk/ (last accessed 11 August 2017).https://www.nice.org.uk/guidance/ta466