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Abstract
Background Iguratimod (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 rheumatoid arthritis (RA) treated with IGU.
Objectives To evaluate the efficacy of IGU therapy in patients with RA using ultrasonography (US).
Methods Participants comprised 54 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 from baseline to 52 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).
Results The patients included 16 males and 38 females. The mean age was 65.4±11.6 years; the mean disease duration was 9.3±10.8 years; and the number of MTX combination, other DMARD excluded combination, IGU monotherapy and Biologics combination were each 32, 10, 8 and 4 cases.
Clinical findings related to RA were as follows: tender and swollen joint count, 4.2±2.9 and 3.2±2.1; patient's and physician's global assessment of disease activity, 40.2±24.0 and 40.2±19.9mm; CRP, 1.0±1.2 mg/dL; ESR, 31.2±18.2 mm/h; DAS28-ESR, 4.37±0.88 and SDAI, 16.4±7.0. The mean DAS28-ESR improved to 3.43±0.94 and 2.98±0.88 at Week 12 and 24 (p<0.001, p<0.001) and the mean SDAI improved to 8.8±6.1 and 6.3±5.2 at Week 12 and 24 (p<0.001, p<0.001) significantly. The mean GS score changed from 16.8±12.5 at baseline to 15.8±11.2 (p=0.458) and 14.8±10.3 (p=0.103) at week12 and 24. The mean PD score changed from 7.6±6.8 at baseline to 5.8±6.0 (p=0.053) and 5.3±5.4 (p=0.05) at week12 and 24. In the achieved remission for DAS28-ESR at Week52 (n=16) and not achieved or discontinued IGU patients (n=38), the respective changes in GS and PD scores from baseline to 12 or 24 weeks were as follows: ΔGS score: -3.7±0.8 vs 0.1±6.8 (p=0.068) at 12 weeks and -5.8±5.7 vs -0.4±9.8 (p=0.008) at 24 weeks; and ΔPD score: -3.4±5.6 vs -1.1±5.2 (p=0.065) at 12 weeks and -4.9±6.3 vs -1.2±6.1 (p=0.013) at 24 weeks (Fig.1). Areas under the receiver operating characteristic curves for the ΔGS and ΔPD score at each time point for remision achievement at 52 weeks were each 0.643 and 0.648 from week0 to 24 and 0.725 (cut-off index -3, odds ratio 5.60, sensitivity 0.74, specificity, 0.67) and 0.706 (cut-off index -1, odds ratio 4.71, sensitivity 0.63, specificity, 0.73) from week0 to 24 (Fig.2).
Conclusions The IGU therapy improved not only the disease activity not also the inflammatory synovitis. The present study provides evidence supporting t the improvement of GS and PD score from baseline to week24 may predict whether the achieved remission or not at Week 52.
Disclosure of Interest None declared