Efficacy and safety of iguratimod combined with methotrexate vs. methotrexate alone in rheumatoid arthritis: A systematic review and meta-analysis of randomized controlled trials; [Wirksamkeit und Sicherheit von Iguratimod in Kombination mit Methotrexat vs. Methotrexat allein bei rheumatoider Arthritis: Systematische Übersicht und Metaanalyse randomisierter kontrollierter Studien]

被引：0
作者：
Chen L.-J. [1 ]
Zhou Y.-J. [2 ]
Wen Z.-H. [1 ]
Tian F. [1 ]
Li J.-Y. [1 ]
机构：
[1] Department of Rheumatology and Immunology, The Affiliated ZhuZhou Hospital of XiangYa Medical College, Central South University, 116 South Changjiang Road, ZhuZhou, 412007, Hunan Province
[2] Department of Neurosurgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan
来源：
Zeitschrift für Rheumatologie | 2021年 / 80卷 / 5期
关键词：
Iguratimod; Meta-analysis; Methotrexate; Randomized controlled trials; Rheumatoid arthritis;
D O I：
10.1007/s00393-020-00944-7
中图分类号：
学科分类号：
摘要：
The current systematic review and meta-analysis aims to evaluate the efficacy and safety of iguratimod (IGU) combined with methotrexate (MTX) versus MTX alone in rheumatoid arthritis (RA). Two independent investigators searched for original randomized controlled trials (RCTs) related to the combination of IGU and MTX in RA published before November 1, 2019, in PubMed, Cochrane Library, Embase, the China National Knowledge Infrastructure (CNKI), the Chinese Biomedical Literature Database (CBM), and WanFang Data. Additionally, we searched clinical trial registry websites. We assessed the methodological quality of the included trials using the Cochrane Collaboration tool and the seven-point Jadad scale. Statistical analyses were performed using Review Manager (RevMan) 5.3 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). Meta-regression and publication bias analyses were performed using Stata version 14 software (StataCorp., College Station, TX, USA). A total of 7 RCTs consisting of 665 participants, with 368 participants in the active arm and 297 in the placebo arm, were included in the meta-analysis. The American College of Rheumatology (ACR) value was better in the IGU + MTX group than in the MTX alone group, with a pooled relative risk (RR) for ACR20 (American College of Rheumatology 20% improvement criteria), ACR50, and ACR70 of 1.40 (95% CI, 1.13–1.74), 2.09 (95% CI, 1.67–2.61), and 2.24 (95% CI, 1.53–3.28), respectively. The results of the meta-analysis demonstrated that there was no statistical significance in adverse events (1.06 (95% CI, 0.92–1.23)). The combined treatment is an effective, safe, and economical treatment option for patients who do not respond well to methotrexate alone or for patients who cannot afford expensive biologics that have no confirmed efficacy. © 2020, The Author(s).
引用
收藏
页码：432 / 446
页数：14
相关论文
共 42 条
[1]  
Xia Z., Lyu J., Hou N., Et al., Iguratimod in combination with methotrexate in active rheumatoid arthritis. Therapeutic effects, Z Rheumatol, 75, 8, pp. 828-833, (2016)
[2]  
Singh J.A., Saag K.G., Bridges S.L.J., Et al., 2015 American college of rheumatology guideline for the treatment of rheumatoidarthritis, Arthritis Care. Res., 68, 1, pp. 1-25, (2016)
[3]  
Mimori T., Harigai M., Atsumi T., Et al., Safety and effectiveness of 24-week treatment with Iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan, Mod Rheumatol, 27, 5, pp. 755-765, (2016)
[4]  
Du F., Lu L., Teng J., 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, 13, 1, pp. 54-60, (2012)
[5]  
Gan K., Yang L., Xu L., Et al., Iguratimod (T-614) suppresses RANKL-induced osteoclast differentiation and migration in RAW264.7 cells via NF-κB and MAPK pathways, Int Immunopharmacol, 35, pp. 294-300, (2016)
[6]  
Kohno M., Aikawa Y., Tsubouchi Y., Et al., Inhibitory effect of T-614 on tumor necrosis factor-alpha induced cytokineproduction and nuclear factor-kappaB activation in cultured human synovial cells, J Rheumatol, 28, 12, pp. 2591-2596, (2001)
[7]  
Kawakami A., Tsuboi M., Urayama S., Et al., Inhibitory effect of a new anti-rheumatic drug T-614 on costimulatory molecule expression, cytokine production, and antigen presentation by synovial cells, J Lab Clin Med, 133, 6, pp. 566-574, (1999)
[8]  
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 Tomethotrexate: an open-label extension of a randomized, double-blind,placebo-controlled trial, Mod Rheumatol, 24, 3, pp. 410-418, (2014)
[9]  
Moher D., Liberati A., Tetzlaff J., Et al., Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement, J Clin Epidemiol, 62, 10, pp. 1006-1012, (2009)
[10]  
Higgins J.P.T., Altman D.G., Gotzsche P.C., Et al., The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials, BMJ, 343, (2011)
12345