We estimated the relative efficacy and safety of iguratimod combination therapy compared with methotrexate monotherapy for the treatment of rheumatoid arthritis.
We identified parallel randomized controlled trials from the Cochrane Central Register of Controlled Trials in The Cochrane Library (CENTRAL), MEDLINE, Embase, and other databases and trial registries for January April 2020. Independent assessment of the risk of bias and grading of the certainty of evidence was performed for the selected trials. We operated RevMan 5 software to compute the meta-analysis. We applied the random-effects model. The statistical methods applied were the Mantel-Haenszel method and the inverse-variance method for dichotomous and continuous outcomes, respectively.
We included 12 trials involving 1095 participants. Based on our result, patients on iguratimod combination are likely to have 3.53 (95% CI 2.22 to 5.60, moderate-certainty), 3.24, and 2.73 times higher odds for attaining American College of Rheumatology criteria (ACR) 20, 50, and 70, respectively, than methotrexate monotherapy. Disease state measured using DAS28 score (MD -0.71 score, 95% CI -1.03 to -0.39, very low certainty) and functional ability indicated by HAQ (Health Assessment Questionnaire) (MD -0.23, 95% CI -0.34 to -0.11, very low certainty) may also be better. The combination therapy also produced better results for C-reactive protein, erythrocyte sedimentation rate, pain intensity, and patient's and physician's global assessment of disease state. Incidence of adverse events were similar between the groups (OR 1.30, 95% CI 0.92 to 1.83, moderate-certainty).
Iguratimod combined with methotrexate may be considered a promising alternative for treating RA. Key Points • Iguratimod combination therapy produced better results in all the efficacy outcomes than methotrexate monotherapy. • Iguratimod combination therapy may be as safe as methotrexate monotherapy. • We recommend future clinical trials of iguratimod combination therapy in RA with iguratimod combined with DMARDs other than methotrexate and conducted in diverse population.