The combination of iguratimod and methotrexate is a safe, effective, and economical therapy choice for subjects who do not adequately respond to methotrexate alone or for subjects who cannot afford costly biologics with no confirmed efficacy.

A meta-analysis and systematic review were performed to assess the safety and efficacy of the combination of iguratimod and methotrexate versus methotrexate alone to treat patients suffering from rheumatoid arthritis.

The databases such as PubMed, the Chinese Biomedical Literature Database, Embase, Cochrane Library, the China National Knowledge Infrastructure, and WanFang Data were searched for the original randomized controlled trials linked to the combination of iguratimod and methotrexate in rheumatoid arthritis.

Furthermore, the clinical trial registry websites were searched. Utilizing seven-point Jadad scale and Cochrane Collaboration tool, the methodological quality of the incorporated trials was determined. Utilizing the Review Manager (RevMan) 5.3, statistical analyses were carried out. Utilizing the Stata version14 software, the meta-regression and publication bias analyses were carried out.

Overall, seven RCTs consisting of 665 individuals (active arm, n=368 subjects, placebo arm, n=297 subjects) were incorporated into this study. Compared to the methotrexate alone cohort, the American College of Rheumatology (ACR) value was better in the iguratimod + methotrexate cohort. The pooled relative risk for ACR20 (ACR 20% improvement criteria), ACR50, and ACR70 is shown in the following table:

Thus, compared to methotrexate alone, the combination of iguratimod and methotrexate has a positive impact on efficacy and safety in patients suffering from rheumatoid arthritis.