Background Iguratimod (IGU) is newly synthetic DMARDs and under clinical use to the rheumatoid arthritis (RA) patients from 2012 in Japan.
Objectives We examined the effects of the IGU therapies for RA patients in our hospital.
Methods Forty one (15 males;16 females) patients who started receiving IGU from September, 2012 to April, 2013 in our hospital, were included in this study. The age of this cohort was 68.9±10.9 years, and the disease duration was 14.7±12.7 years. Methotrexate (MTX) combination rate was 59.2%, the mean dose of MTX; 9.0±3.1 mg/week, PSL combination rate; 52.4% and the amount of PSL; 4.9±2.6 mg/day. The biological drugs were administered to seven patients. During 12 weeks prior to the initiation of the IGU therapies and 24 weeks after IGU administration, there was not any change of drugs and operation procedures. The clinical therapeutic process after the initiation of IGU were analyzed at week 0, 4, 8, 12, 16, 20 and 24 (last observation carried forward: LOCF). Wilcoxon signed-rank test were performed to assess the differences in each parameter. The logistic regression analyses were performed to investigate the parameters associated with the improvement of the disease activity with IGU treatment.
Results Before IGU treatment; C-reactive protein (CRP) 1.4±1.7 mg/dl, erythrocyte sedimentation rate (ESR) 51.2±27.9 mm/h, matrix metalloproteinase-3 (MMP-3) 223.5±183.3 ng/ml, Disease activity score assessing 28-joint (DAS28) versions using ESR (4) 5.0±1.7, DAS28 versions using CRP (4) 4.1±1.7, Simplified Disease Activity Index (SDAI) 25.8±19.7 and clinical disease activity index (CDAI) 24.4±19.1. At week 24; CRP 1.1±1.9 mg/dl, ESR 44.3±28.0 mm/h, MMP-3 208.1±255.2 ng/ml, DAS28-ESR (4) 3.9±1.4, DAS28-CRP (4) 3.0±1.3, SDAI 13.0±12.7 and CDAI 11.9±2.0. The DAS28-ESR (4), DAS28-CRP (4), SDAI and CDAI significantly decreased at week 4. All parameters, with exception of MMP-3, were significantly reduced at week 24 of the IGU therapy. Twenty six cases continued the IGU therapies during 24 weeks, and 18 patients achieved the DAS28-CRP remission and 3 patients were classified into the low disease activity (LDA) of the DAS28-CRP (DAS28-CRP <2.7). The DAS28-CRP (4) were significantly reduced at week 4 with (n=24) or without (n=17) the use of MTX (LOCF). In addition, at week 24, DAS28-CRP (4) of each dosage of IGU, 25 mg/day (n=13) or 50 mg/day (n=13), was significantly decreased respectively. DAS28-CRP (4) at week 0 was associated with the achievement of remission or LDA of DAS28-CRP (4) at week 24 (Odds ratio 5.509, p=0.037).
Conclusions Our results suggest that IGU is clinically one of the useful synthetic DMARDs to RA patient.
Disclosure of Interest None declared