Abstract
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.
Highlights
Rheumatoid arthritis (RA) is an inflammatory disease of synovial joints that affects approximately 1% of the population [1]
The inclusion criteria included the following: 1) studies conducted in a human population aged >18 years; 2) studies in which all patients were diagnosed with RA based on the American College of Rheumatology (ACR) or the European League Against Rheumatism (EULAR) classification criteria; 3) studies that evaluated the combination of IGU and MTX therapy in RA; 4) studies with outcome data including ACR20, ACR50, ACR70, and adverse events; 5) randomized placebo-controlled clinical trials or trials in which the treatment arm was compared with a control arm; and 6) studies that were available in all languages
A total of 7 randomized controlled trials (RCTs) consisting of 665 participants with 368 participants in the active arm and 297 in the placebo arm were included in the meta-analysis [1, 16,17,18,19,20,21]
Summary
Rheumatoid arthritis (RA) is an inflammatory disease of synovial joints that affects approximately 1% of the population [1]. Disease activity, prognostic factors, and prior experience with disease-modifying antirheumatic drug (DMARDs) in the treatment of RA, the American College of Rheumatology (ACR) 2015 guidelines recommend the use of traditional antirheumatic agents and biological DMARDs. If methotrexate (MTX) is not found to be effective, methotrexate in combination with other DMARDs such as biologics will be recommended. IGU has been considered a clinically useful DMARD with a unique mechanism of action, and its improvement rate of the ACR20 was not lower than that of sulfasalazine in patients with active RA (57.7% compared with 63.1%) [8]. The available study population is mainly East Asian (Japan and China up to date), and with the consequence that transfer of results to other ethnicities is questionable, we still need this research to show the effect of IGU on RA for rheumatologists around the world.
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