Background Iguratimod (IGU) is a small-molecule antirheumatic drug that was approved in Japan in September 2012. IGU suppressed tumor necrosis factor-alpha-induced production of interleukin (IL)-6, IL-8, and monocyte chemoattractant protein 1 via inhibition of nuclear factor kappa B activation in cultured human synovial cells and human acute monocytic leukemia cells. We reported the clinical efficacy of IGU at ACR2014 and EULAR2015. However there is still few studies of improvement of ultrasonographic findings in RA treated with IGU.
Objectives To evaluate the clinical efficacy of IGU therapy patients with rheumatoid arthritis (RA) using ultrasonography (US).
Methods Participants comprised 51 Japanese RA patients who had recently received IGU. All patients with a diagnosis of RA according to the 2010 ACR/EULAR criteria. Patients underwent clinical and laboratory assessments every 4 weeks from baseline to 24 weeks, and US assessments at baseline, 12 and 24 weeks. Gray scale (GS) and power doppler (PD) signals were scored using a semi-quantitative scale from 0 to 3 at 26 (0–78) synovial sites (22 joints) in the following joints: bilateral first to fifth metacarpopharangeal (MCP) joints (dorsal recess); first interphalangeal (IP) and second to fifth proximal interphalangeal (PIP) (dorsal recess) joints; and the wrists (dorsal radial, median and ulnar). We evaluated the improvement of GS and PD score from baseline to week 24.
Results The patients included 15 males and 36 females. The mean age was 65.4±11.6 years; the mean disease duration was 9.1±11.0 years; and the number of MTX combination, other DMARD excluded combination, IGU monotherapy and Biologics combination were each 30, 9, 8 and 4 cases.
Clinical findings related to RA were as follows: tender and swollen joint count, 4.2±2.9 and 3.2±2.2; patient's and physician's global assessment of disease activity, 39.7±23.3 and 39.7±18.9mm; CRP, 1.1±1.3 mg/dL; ESR, 31.4±18.6 mm/h; DAS-ESR, 4.37±0.85; DAS-CRP, 3.80±0.74; CDAI, 15.3±6.4 and SDAI, 16.4±6.8. The mean CRP improved to 0.7±1.0 and 0.5±0.8 at Week 12 and 24 (p<0.001, p<0.001), mean MMP3 improved to 147.7±140.4 and 161.8±254.5 at Week 12 and 24 (p<0.001, p=0.003), the mean DAS-ESR improved to 3.39±0.93 and 2.91±0.83 at Week 12 and 24 (p<0.001, p<0.001) and the mean SDAI improved to 8.6± 6.0 and 5.8±4.8 at Week 12 and 24 (p<0.001, p<0.001) significantly. The mean GS score changed from 16.8±12.4 at baseline to 15.7±11.0 (p=0.158) and 14.5±9.8 (p=0.043) at week12 and 24. The mean PD score changed from 7.9±6.8 at baseline to 6.0±6.1 (p=0.001) and 5.3±5.5 (p=0.006) at week12 and 24 (Fig.1).
In the with MTX (n=30) and monotherapy or with csDMARD patients (n=17), the respective changes in GS and PD scores from baseline to 12 or 24 weeks were as follows: ΔGS score: -2.3±7.0 vs 1.3±5.8 (p=0.118) at 12 weeks and -3.9±9.2 vs 0.3±8.8 (p=0.158) at 24 weeks; and ΔPD score: -2.8±6.7 vs -0.5±2.6 (p=0.053) at 12 weeks and -4.0±6.8 vs 0.1±5.0 (p=0.016) at 24 weeks (Fig.2).
Conclusions The present study provides evidence supporting the IGU therapy improved not only the disease activity not also the inflammatory synovitis. Especially MTX combination patients could expect higher efficacy of IGU treatment.
Disclosure of Interest None declared
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