Efficacy and safety of iguratimod <i>versus</i> methotrexate in the treatment of rheumatoid arthritis: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

LI Haixia ^1,2 , TIAN Fangyuan ¹ , SHI Yu ^1,2 ,  XU Ting ¹

1. Department of Clinical Pharmacy, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. West China College of Pharmacy, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

XU Ting, Email: tingx2009@163.com

Keywords：

Iguratimod; Methotrexate; Rheumatoid arthritis; Efficacy; Safety; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.201807052

Video：

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Objectives To systematically review the efficacy and safety of iguratimod compared with methotrexate in the treatment of rheumatoid arthritis.Methods PubMed, EMbase, The Cochrane Library, VIP, CBM, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) of the efficacy and safety of iguratimod compared with methotrexate in the treatment of rheumatoid arthritis from inception to June 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.Results A total of 10 RCTs involving 970 patients were included. The results of meta-analysis showed that: there was no statistical difference between iguratimod and methotrexate in ACR20 (RR=1.06, 95%CI 0.91 to 1.23, P=0.49), ACR50 (RR=0.93, 95%CI 0.73 to 1.19, P=0.55), ACR70 (RR=0.92, 95%CI 0.62 to 1.39, P=0.70), morning stiffness time (MD=0.45, 95%CI –0.26 to 1.16, P=0.22), tender joint count (MD=0.07, 95%CI –2.31 to 2.45, P=0.95), swollen joint count (MD=–0.30, 95%CI –1.44 to 0.84, P=0.61), health assessment questionnaire (MD=0.01, 95%CI –0.05 to 0.07, P=0.73) and the rate of adverse effects (RR=0.66, 95%CI 0.41 to 1.07, P=0.09). Meta-analysis of 2 RCTs using double-blind method showed that, iguratimod was superior to methotrexat in the patient (MD=4.11, 95%CI 0.11 to 8.10, P=0.04) and physician (MD=4.81, 95%CI 0.93 to 8.69, P=0.01) global assessment of disease activities.Conclusions Current evidence shows that the efficacy and safety of iguratimod in the treatment of rheumatoid arthritis are similar to methotrexate. And iguratimod is superior in global assessment of disease activities by patients and doctors. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.

Citation： LI Haixia, TIAN Fangyuan, SHI Yu, XU Ting. Efficacy and safety of iguratimod versus methotrexate in the treatment of rheumatoid arthritis: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2019, 19(5): 550-556. doi: 10.7507/1672-2531.201807052 Copy

1.	Gibofsky A. Epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis: a synopsis. Am J Manag Care, 2014, 20(7 Suppl): S128-S135.
2.	Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet, 2016, 388(10055): 2023-2038.
3.	中华医学会风湿病学分会. 类风湿关节炎诊断及治疗指南. 中华风湿病学杂志, 2010, 14(4): 265-270.
4.	池里群, 周彬, 高文远, 等. 治疗类风湿性关节炎常用药物的研究进展. 中国中药杂志, 2014, 39(15): 2851-2858.
5.	Lü LJ, Teng JL, Bao CD, et al. Safety and efficacy of T-614 in the treatment of patients with active rheumatoid arthritis: a double blind, randomized, placebo-controlled and multicenter trial. Chin Med J (Engl), 2008, 121(7): 615-619.
6.	Cipriani P, Ruscitti P, Carubbi F, et al. Methotrexate: an old new drug in autoimmune disease. Expert Rev Clin Immunol, 2014, 10(11): 1519-1530.
7.	Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum, 1988, 31(3): 315-324.
8.	Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions (version 5.1.0). The Cochrane Collaboration, 2011. Available at: http://www.cochrane-handbook.org.
9.	李永红. 艾拉莫德治疗类风湿性关节炎临床疗效观察. 中国现代医生, 2014, 52(24): 43-45.
10.	饶彦婷, 谭军, 吴殿臣. 艾拉莫德治疗类风湿关节炎的临床疗效观察. 中国医药指南, 2014, 12(29): 41-42.
11.	巴哈尔古丽·力提甫, 照日格图. 艾拉莫德治疗类风湿性关节炎42例效果观察. 中国社区医师, 2016, 32(2): 58, 60.
12.	杨利娜. 艾拉莫德对难治性类风湿关节炎患者血清TNF-α与VEGF水平的影响. 临床医学, 2017, 37(9): 127-128.
13.	杨红, 林杉, 杨宏, 等. 艾拉莫德对类风湿关节炎患者血管内皮生长因子及色素上皮衍生因子表达的影响. 中国临床药理学与治疗学, 2017, 22(1): 68-71.
14.	赵文敏, 姚冬云, 霍河水, 等. 艾拉莫德治疗活动性类风湿关节炎的临床研究. 中国医师进修杂志, 2016, 39(5): 450-452.
15.	许百洁, 莫守崎, 薛晓倩. 甲氨蝶呤联合艾拉莫德治疗类风湿关节炎的临床研究. 实用临床医药杂志, 2015, 19(1): 120-122.
16.	吕婧. 联合应用艾拉莫德和甲氨蝶呤对活动性类风湿关节炎的治疗作用. 济南: 山东大学, 2014.
17.	Lu LJ, Bao CD, Dai M, et al. Multicenter, randomized, double-blind, controlled trial of treatment of active rheumatoid arthritis with T-614 compared with methotrexate. Arthritis Rheum, 2009, 61(7): 979-987.
18.	Zhao L, Jiang ZY, Zhang YD, et al. Analysis of efficacy and safety of treatment of active rheumatoid arthritis with iguratimod and methotrexate. Bio Res, 2017, 28(5): 2353-2359.
19.	张晓攀, 李艳贞, 李珊珊, 等. 类风湿性关节炎治疗药物研究进展. 药物评价研究, 2018, 41: 1906-1910.
20.	Tanaka K, Yamaguchi T, Hara M. Iguratimod for the treatment of rheumatoid arthritis in Japan. Expert Rev Clin Immunol, 2015, 11(5): 565-573.
21.	赵颖, 王贯红, 孟立平. 甲氨蝶呤联合来氟米特治疗活动性类风湿关节炎疗效观察. 山西大同大学学报(自然科学版), 2012, 28: 52-55.
22.	Katchamart W, Trudeau J, Phumethum V, et al. Methotrexate monotherapy versus methotrexate combination therapy with non-biologic disease modifying anti-rheumatic drugs for rheumatoid arthritis. Cochrane Database Syst Rev, 2010, (4): CD008495.
23.	Mucke HA. Iguratimod: a new disease-modifying antirheumatic drug. Drugs Today (Barc), 2012, 48(9): 577-586.
24.	Du F, Lü LJ, Teng JL, et al. T-614 alters the production of matrix metalloproteinases (MMP-1 andMMP-3) and inhibits the migratory expansion of rheumatoid synovial fibroblasts, in vitro. Int Immunopharmacol, 2012, 13(1): 54-60.
25.	Hara M, Ishiguro N, Katayama K, et al. Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: an open-label extension of a randomized, double-blind, placebo-controlled trial. Mod Rheumatol, 2014, 24(3): 410-418.

1. Gibofsky A. Epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis: a synopsis. Am J Manag Care, 2014, 20(7 Suppl): S128-S135.
2. Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet, 2016, 388(10055): 2023-2038.
3. 中华医学会风湿病学分会. 类风湿关节炎诊断及治疗指南. 中华风湿病学杂志, 2010, 14(4): 265-270.
4. 池里群, 周彬, 高文远, 等. 治疗类风湿性关节炎常用药物的研究进展. 中国中药杂志, 2014, 39(15): 2851-2858.
5. Lü LJ, Teng JL, Bao CD, et al. Safety and efficacy of T-614 in the treatment of patients with active rheumatoid arthritis: a double blind, randomized, placebo-controlled and multicenter trial. Chin Med J (Engl), 2008, 121(7): 615-619.
6. Cipriani P, Ruscitti P, Carubbi F, et al. Methotrexate: an old new drug in autoimmune disease. Expert Rev Clin Immunol, 2014, 10(11): 1519-1530.
7. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum, 1988, 31(3): 315-324.
8. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions (version 5.1.0). The Cochrane Collaboration, 2011. Available at: http://www.cochrane-handbook.org.
9. 李永红. 艾拉莫德治疗类风湿性关节炎临床疗效观察. 中国现代医生, 2014, 52(24): 43-45.
10. 饶彦婷, 谭军, 吴殿臣. 艾拉莫德治疗类风湿关节炎的临床疗效观察. 中国医药指南, 2014, 12(29): 41-42.
11. 巴哈尔古丽·力提甫, 照日格图. 艾拉莫德治疗类风湿性关节炎42例效果观察. 中国社区医师, 2016, 32(2): 58, 60.
12. 杨利娜. 艾拉莫德对难治性类风湿关节炎患者血清TNF-α与VEGF水平的影响. 临床医学, 2017, 37(9): 127-128.
13. 杨红, 林杉, 杨宏, 等. 艾拉莫德对类风湿关节炎患者血管内皮生长因子及色素上皮衍生因子表达的影响. 中国临床药理学与治疗学, 2017, 22(1): 68-71.
14. 赵文敏, 姚冬云, 霍河水, 等. 艾拉莫德治疗活动性类风湿关节炎的临床研究. 中国医师进修杂志, 2016, 39(5): 450-452.
15. 许百洁, 莫守崎, 薛晓倩. 甲氨蝶呤联合艾拉莫德治疗类风湿关节炎的临床研究. 实用临床医药杂志, 2015, 19(1): 120-122.
16. 吕婧. 联合应用艾拉莫德和甲氨蝶呤对活动性类风湿关节炎的治疗作用. 济南: 山东大学, 2014.
17. Lu LJ, Bao CD, Dai M, et al. Multicenter, randomized, double-blind, controlled trial of treatment of active rheumatoid arthritis with T-614 compared with methotrexate. Arthritis Rheum, 2009, 61(7): 979-987.
18. Zhao L, Jiang ZY, Zhang YD, et al. Analysis of efficacy and safety of treatment of active rheumatoid arthritis with iguratimod and methotrexate. Bio Res, 2017, 28(5): 2353-2359.
19. 张晓攀, 李艳贞, 李珊珊, 等. 类风湿性关节炎治疗药物研究进展. 药物评价研究, 2018, 41: 1906-1910.
20. Tanaka K, Yamaguchi T, Hara M. Iguratimod for the treatment of rheumatoid arthritis in Japan. Expert Rev Clin Immunol, 2015, 11(5): 565-573.
21. 赵颖, 王贯红, 孟立平. 甲氨蝶呤联合来氟米特治疗活动性类风湿关节炎疗效观察. 山西大同大学学报(自然科学版), 2012, 28: 52-55.
22. Katchamart W, Trudeau J, Phumethum V, et al. Methotrexate monotherapy versus methotrexate combination therapy with non-biologic disease modifying anti-rheumatic drugs for rheumatoid arthritis. Cochrane Database Syst Rev, 2010, (4): CD008495.
23. Mucke HA. Iguratimod: a new disease-modifying antirheumatic drug. Drugs Today (Barc), 2012, 48(9): 577-586.
24. Du F, Lü LJ, Teng JL, et al. T-614 alters the production of matrix metalloproteinases (MMP-1 andMMP-3) and inhibits the migratory expansion of rheumatoid synovial fibroblasts, in vitro. Int Immunopharmacol, 2012, 13(1): 54-60.
25. Hara M, Ishiguro N, Katayama K, et al. Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: an open-label extension of a randomized, double-blind, placebo-controlled trial. Mod Rheumatol, 2014, 24(3): 410-418.

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Efficacy and safety of iguratimod versus methotrexate in the treatment of rheumatoid arthritis: a meta-analysis

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