Assessment of Iguratimod's Efficacy and Safety in Rheumatoid Arthritis: A Prospective, Open-Label Study

This study investigates the therapeutic effectiveness and safety profile of iguratimod (IGU) in patients with moderate to severe pain due to active rheumatoid arthritis (RA), utilizing the Disease Activity Score-28 Erythrocyte Sedimentation Rate (DAS28-ESR) as the primary assessment criterion.

A prospective, open-label study was carried out at the Department of Rheumatology, Saveetha Medical College and Hospital, to evaluate IGU over a period of 16 weeks. Patients diagnosed with moderate to severe pain due to active RA were recruited, with clinical parameters including swollen joint count (SJC), tender joint count (TJC), physician's global assessment (PHYSGA), and ESR recorded at baseline, 8 weeks, and 16 weeks. The study was conducted over a span of four months, from February to May 2020. Statistical analysis was performed using the Friedman test.

A total of 40 patients received iguratimod therapy. Significant reductions were noted across all DAS28-ESR parameters. The mean baseline DAS score was 4.74 ± 0.47, which declined to 3.36 ± 0.48 at 8 weeks and further to 2.59 ± 0.62 at 16 weeks (p=0.0001). Individual improvements included reductions in SJC (3.49 ± 1.79 to 0.38 ± 0.49), TJC (5.73 ± 2.18 to 0.49 ± 0.51), PHYSGA (5.89 ± 1.68 to 1.81 ± 1.18), and ESR (62.49 ± 21.57 to 27.16 ± 14.62) over 16 weeks (p=0.0001 for all comparisons).

Iguratimod significantly reduced disease activity in RA patients over 16 weeks, as evidenced by improvements in DAS28-ESR scores. These findings highlight IGU as an effective treatment option for RA. Further long-term research is required to determine its sustained efficacy and safety.

004/01/2020/IEC/SMCH.