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：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

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.	中華醫學會風濕病學分會. 類風濕關節炎診斷及治療指南. 中華風濕病學雜志, 2010, 14(4): 265-270.
4.	池里群, 周彬, 高文遠, 等. 治療類風濕性關節炎常用藥物的研究進展. 中國中藥雜志, 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.	李永紅. 艾拉莫德治療類風濕性關節炎臨床療效觀察. 中國現代醫生, 2014, 52(24): 43-45.
10.	饒彥婷, 譚軍, 吳殿臣. 艾拉莫德治療類風濕關節炎的臨床療效觀察. 中國醫藥指南, 2014, 12(29): 41-42.
11.	巴哈爾古麗·力提甫, 照日格圖. 艾拉莫德治療類風濕性關節炎42例效果觀察. 中國社區醫師, 2016, 32(2): 58, 60.
12.	楊利娜. 艾拉莫德對難治性類風濕關節炎患者血清TNF-α與VEGF水平的影響. 臨床醫學, 2017, 37(9): 127-128.
13.	楊紅, 林杉, 楊宏, 等. 艾拉莫德對類風濕關節炎患者血管內皮生長因子及色素上皮衍生因子表達的影響. 中國臨床藥理學與治療學, 2017, 22(1): 68-71.
14.	趙文敏, 姚冬云, 霍河水, 等. 艾拉莫德治療活動性類風濕關節炎的臨床研究. 中國醫師進修雜志, 2016, 39(5): 450-452.
15.	許百潔, 莫守崎, 薛曉倩. 甲氨蝶呤聯合艾拉莫德治療類風濕關節炎的臨床研究. 實用臨床醫藥雜志, 2015, 19(1): 120-122.
16.	呂婧. 聯合應用艾拉莫德和甲氨蝶呤對活動性類風濕關節炎的治療作用. 濟南: 山東大學, 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.	張曉攀, 李艷貞, 李珊珊, 等. 類風濕性關節炎治療藥物研究進展. 藥物評價研究, 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.	趙穎, 王貫紅, 孟立平. 甲氨蝶呤聯合來氟米特治療活動性類風濕關節炎療效觀察. 山西大同大學學報(自然科學版), 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. 中華醫學會風濕病學分會. 類風濕關節炎診斷及治療指南. 中華風濕病學雜志, 2010, 14(4): 265-270.
4. 池里群, 周彬, 高文遠, 等. 治療類風濕性關節炎常用藥物的研究進展. 中國中藥雜志, 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. 李永紅. 艾拉莫德治療類風濕性關節炎臨床療效觀察. 中國現代醫生, 2014, 52(24): 43-45.
10. 饒彥婷, 譚軍, 吳殿臣. 艾拉莫德治療類風濕關節炎的臨床療效觀察. 中國醫藥指南, 2014, 12(29): 41-42.
11. 巴哈爾古麗·力提甫, 照日格圖. 艾拉莫德治療類風濕性關節炎42例效果觀察. 中國社區醫師, 2016, 32(2): 58, 60.
12. 楊利娜. 艾拉莫德對難治性類風濕關節炎患者血清TNF-α與VEGF水平的影響. 臨床醫學, 2017, 37(9): 127-128.
13. 楊紅, 林杉, 楊宏, 等. 艾拉莫德對類風濕關節炎患者血管內皮生長因子及色素上皮衍生因子表達的影響. 中國臨床藥理學與治療學, 2017, 22(1): 68-71.
14. 趙文敏, 姚冬云, 霍河水, 等. 艾拉莫德治療活動性類風濕關節炎的臨床研究. 中國醫師進修雜志, 2016, 39(5): 450-452.
15. 許百潔, 莫守崎, 薛曉倩. 甲氨蝶呤聯合艾拉莫德治療類風濕關節炎的臨床研究. 實用臨床醫藥雜志, 2015, 19(1): 120-122.
16. 呂婧. 聯合應用艾拉莫德和甲氨蝶呤對活動性類風濕關節炎的治療作用. 濟南: 山東大學, 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. 張曉攀, 李艷貞, 李珊珊, 等. 類風濕性關節炎治療藥物研究進展. 藥物評價研究, 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. 趙穎, 王貫紅, 孟立平. 甲氨蝶呤聯合來氟米特治療活動性類風濕關節炎療效觀察. 山西大同大學學報(自然科學版), 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.

Previous Article
The prevalence of rosacea in China: a meta-analysis
Next Article
Efficacy and safety of ciprofloxacin for non-cystic fibrosis bronchiectasis: a meta-analysis

Chinese Journal of Evidence-Based Medicine

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

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content