Background/Purpose:  To evaluate the safety and efficacy of iguratimod, a novel DMARD, in active rheumatoid arthritis patients.

Methods:  Patients with active rheumatoid arthritis received iguratimod treatment for 24 weeks. During the study, eligible patients could continue to use their anti-rheumatic drugs which were taken in stable dose for at least 3 months before the trial. The investigator could adjust the regimen according to disease activity after 12 weeks treatment. The efficacy and safety of iguratimod were assessed at week 2、4、8、16 and 24. The primary endpoints of efficacy were ACR 20/50/70 response rates at the end of 12^th and 24^th week; the secondary endpoint of efficacy included changes of DAS28-ESR, HAQ and emotion score from baseline, clinical remission rates at the end of 12^th and 24^thweek. AEs, laboratory/physical examination, and vital signs were investigated to analyze the safety.

Results:  The trial was conducted in 48 centers in China. 1759 patients were enrolled in this study, among them 1751 were included in safety analysis, and 1597 patients were evaluated for efficacy. At the end of the 12 ^th week, ACR 20/50/70 response rates were 62.2% (994/1597), 29.5% (471/1597) and 11.0% (176/1597) respectively. At the end of 24^th week, ACR20/50/70 response rates were 71.9% (1148/1597), 47.4% (757/1597) and 24.0% (384/1597). DAS28-ESR score was significantly reduced since Week 4 compared to baseline(P＜0.001). The proportions of patients who obtained clinical remission or low disease activity were 22.6% and 34.5% at the end of 12^th and 24^th week,according to DAS28-ESR score. The disease remission rate by the 2011 ACR/EULAR remissin criteria was 5.7% (79/1379) at the end of 12 ^th week, and 13.3% (187/1403) at the end of 24^thweek. 38.5% (674/1751) of the patients experienced at least one ADR.Increased ALT 10.8% (189/1751) and AST 9.8% (171/1751), abdominal discomfort 6.3% (111/1751), abdominal pain 4.5% (78/1751), leukopenia 3.9% (69/1751), nausea 2.7% (47/1751), bloating 2.6% (45/1751), dizziness 2.3% (41/1751), diarrhea 2.1% (37/1751).

Conclusion:  Iguratimod was effective and well tolerated in active RA patients in this large sample phase IV clinical trial. No unexpected adverse drug reaction was found.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-efficacy-of-iguratimod-in-patients-with-active-rheumatoid-arthritis-a-multicenter-single-arm-open-label-real-world-study/