Relative efficacy and safety of iguratimod monotherapy for the treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis

Objectives This study aims to compare the efficacy and the safety of the iguratimod with placebo and other disease-modifying antirheumatic drugs (DMARDs) in adults with rheumatoid arthritis. Methods Two authors independently searched and selected randomized controlled trials from Cochrane library, Medline (through Pubmed), and Chinese databases, and then assessed the risk of bias (using ROB 2 tool), and graded the certainty of evidence (using the GRADEpro GDT software). We applied the RevMan 5 software for performing meta-analyses of the final consensus data. Results We identified 12 trials involving 1938 participants. Ten trials had an overall high risk of bias. Although iguratimod had superior efficacy than placebo, the incidence of adverse events was also higher. Inferring to non-inferiority analysis with other DMARD therapy (primarily comprising methotrexate), iguratimod is likely to result in similar treatment response (20% (OR 1.04, 95% CI 0.79 to 1.36), 50% and 70% improvement in American College of Rheumatology criteria) and functional ability at 24 weeks. Although the disease state was slightly better with iguratimod (MD − 0.55, 95% CI − 0.85 to − 0.25), a clinically important improvement was not achieved. Iguratimod may have lower C-reactive protein and erythrocyte sedimentation rate values. Swollen joint count, tender joint count, pain intensity, and patient’s and physician’s global assessment of disease state may be comparable between the therapies. Both the therapies are likely to have similar odds (OR 0.91, 95% CI 0.67 to 1.26) of adverse events. Conclusion Our evidence suggests that iguratimod may be considered a potential alternative to methotrexate to treat rheumatoid arthritis. Key Points • The Asia Pacific League of Association for Rheumatology (APLAR) has recommended that iguratimod may be used a first-line drug for rheumatoid arthritis in specific cases. • Patients on iguratimod may have similar treatment response, functional ability, disease state, and adverse event profile at 24 weeks compared with those on methotrexate. • Iguratimod may be considered a better alternative to methotrexate in RA patients having high CRP and ESR values. • Future clinical trials in diverse population comparing the efficacy and safety of iguratimod in monotherapy or combination therapy with DMARDs (other than methotrexate) are warranted.