Clinical effectiveness of iguratimod based on real-world data of patients with rheumatoid arthritis.

Background:Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and joint destruction. Iguratimod (IGU) is a novel conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with good efficacy and safety for the treatment of active RA in China and Japan. However, the long-term effects of IGU on the progression of bone destruction or radiographic progression in patients with active RA remain unknown. We aimed to investigate the efficacy and safety of iguratimod (IGU), a combination of methotrexate (MTX) and IGU, and IGU in patients with active rheumatoid arthritis (RA) who were naïve to MTX.Methods:This multicenter, double-blind, randomized, non-inferiority clinical trial was conducted at 28 centers for over 52 weeks in China. In total, 911 patients were randomized (1:1:1) to receive MTX monotherapy (10–15 mg weekly, n = 293), IGU monotherapy (25 mg twice daily, n = 297), or IGU + MTX (10–15 mg weekly for MTX and 25 mg twice daily for IGU, n = 305) for 52 weeks. The patients’ clinical characteristics, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), disease activity score in 28 joints-C-reactive protein (DAS28-CRP) level, and disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) were assessed at baseline. The primary endpoints were the proportion of patients with ≥20% improvement according to the American College of Rheumatology (ACR20) response and changes in the van der Heijde-modified total Sharp score (vdH-mTSS) at week 52.Results:The proportions of patients achieving an ACR20 response at week 52 were 77.44%, 77.05 %, and 65.87% for IGU monotherapy, IGU + MTX, and MTX monotherapy, respectively. The non-inferiority of IGU monotherapy to MTX monotherapy was established with the ACR20 (11.57%; 95% confidence interval [CI], 4.35–18.79%; P <0.001) and vdH-mTSS (−0.37; 95% CI, −1.22–0.47; P = 0.022). IGU monotherapy was also superior to MTX monotherapy in terms of ACR20 (P = 0.002) but not the vdH-mTSS. The superiority of IGU + MTX over MTX monotherapy was confirmed in terms of the ACR20 (11.18%; 95% CI, 3.99–18.37%; P = 0.003), but not in the vdH-mTSS (−0.68; 95% CI, −1.46–0.11; P = 0.091). However, the difference in the incidence rates of adverse events was not statistically significant.Conclusions:IGU monotherapy/IGU + MTX showed a more favorable clinical response than did MTX monotherapy. IGU may have some clinical benefits over MTX in terms of radiographic progression, implying that IGU may be considered as an initial therapeutic option for patients with active RA.Trial Registration:https://classic.clinicaltrials.gov/, NCT01548001.

Background:The management of Rheumatoid arthritis (RA) is characterized by a “treat-to-target” approach with regular assessment of disease activity. Therefore, various RA composite disease activity scores have become important tools in...

Composite indices to assess disease activity in rheumatoid arthritis: need of the hour

SAT0137 Disease Activity Measures Associate Differently with Demographics and Comorbidities in Patients with Rheumatoid Arthritis in Routine Practice Settings

BackgroundBy OMERACT, a core-set definition of minimal disease activity (MDA) required a tender joint count (TJC) of 0, swollen joint count (SJC) of 0, and erythrocyte sedimentation rate (ESR) ≤10...

FRI0119 A proposal for a SDAI, CDAI, and RAPID3-based definition of minimal disease activity for use in routine care of rheumatoid arthritis: results from a japanese national database

BackgroundRoutine Assessment of Patient Index Data 3 (RAPID3) is a patient-reported outcome (PRO) that can be used to assess the condition of rheumatoid arthritis (RA) patients using only a questionnaire...

AB0172 Assessment of disease activity in rheumatoid arthritis by routine assessment of rheumatoid arthritis disease activity index (radai) and its relation with disease activity score 28 (das28), clinical disease activity...

BackgroundRemission has become a key target in the management of rheumatoid arthritis (RA) patients[1]. In 2022, American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) has revised the...

To determine the effects of tocilizumab on rheumatoid arthritis (RA) disease activity and remission assessment, using measures that do or do not comprise acute-phase reactants. Simplified Disease Activity Index (SDAI) scores, Clinical Disease Activity Index (CDAI) scores, and the Disease Activity Score in 28 joints (DAS28) were calculated using data from tocilizumab trials in patients with RA in whom disease had remained active despite treatment with disease-modifying antirheumatic drugs. The CDAI does not contain an acute-phase reactant component. Disease activity states, including remission, were defined using established cut points; for the DAS28, an alternative cut point of <2.4 was also used. Changes in the DAS28, the SDAI score, and the CDAI score among patients receiving tocilizumab were significantly higher than those among patients receiving placebo, and the magnitude of these changes was similar for the SDAI and the CDAI. Among patients who achieved 50% improvement in disease activity according to the American College of Rheumatology criteria, only ∼20% required a reduction in acute-phase reactant values in order to fulfill the criteria. However, DAS28 remission rates were higher (even when using the lower cut point) than the SDAI and CDAI remission rates. Only a minority of tocilizumab-treated patients with DAS28 remission also had disease remission according to the SDAI (26%) or CDAI (∼21%). With infliximab treatment, SDAI and CDAI remission rates were of the same magnitude as those observed with tocilizumab treatment, and DAS28 remission rates were lower. Tocilizumab-treated patients with DAS28 remission but without CDAI remission had significantly higher swollen joint counts but lower erythrocyte sedimentation rates (ESRs) compared with patients with SDAI or CDAI remission. Disease activity in RA is reduced by tocilizumab treatment, irrespective of the type of composite measure used to evaluate disease activity. Remission rates were much higher using the DAS28 compared with the SDAI and CDAI, due to the high weight of the ESR in the DAS28 and the effect of tocilizumab on the ESR. Using the stringent SDAI and CDAI criteria, however, remission rates in patients treated with tocilizumab were in the same range as those seen in patients treated with tumor necrosis factor inhibitors.

AB1070 Comparison of Ultrasound Disease Activity Score in Assessing Joint Inflammation in RA: Comparison with CDAI

Objective. Iguratimod (IGU) is a new synthetic disease-modifying antirheumatic drug intended to treat patients with rheumatoid arthritis (RA). We conducted a 24-week study on the efficacy of IGU in RA patients with daily clinical use.Methods. Forty-one patients were enrolled in this study, and the improvement in RA was evaluated every 4 weeks during the 24 weeks.Results. The patient's global assessment of the disease activity with a scale (Pt VAS) was significantly decreased beginning at week 4. The disease activity score (DAS) 28-erythrocyte sedimentation rate, DAS28-C-reactive protein (CRP), simplified disease activity index and clinical disease activity index all significantly decreased at week 24. The matrix metalloproteinase-3 level was significantly decreased by the combination treatment with methotrexate at week 24. According to a logistic regression analysis, the factor which was most associated with the achievement of low disease activity (DAS28-CRP < 2.7) at week 24 was the DAS28-CRP at week 0.Conclusions. IGU had significant clinical effects on the RA patients within 24 weeks. IGU might therefore represent a new practical choice to treat RA patients.

Objective To compare disease activity score 28 joints DAS28, simplified disease activity index(SDAI) and clinical disease activity index(CDAI) for assessing disease activity in patients with rheumatoid arthritis (RA). Method Total of 423 patients with RA hospiltalized in the department of the first Affiliated Hospital of Anhui Medical University between January 2006 and December 2014 were enrolled in this study.DAS28, CDAI and SDAI were used to evaluate disease activity.According to the classification criteria of RA, patients were divided into three groups: group of remission or low-disease activity, group of moderate-disease activity and high-disease activity. Results ①According to classification criteria of DAS28, the patients in the above three groups were respectivelly accounted for 4.14%(17/423), 38.2%(157/423) and 57.66%(237/423). For CDAI, the ratios were 6.86%(29/423), 29.79%(126/423) and 63.36%(268/423). For SDAI, to ratio were 5.26%(22/423), 32.78%(137/423) and 61.96%(259/423). There were good correlations among CDAI, SDAI and DAS28 (Spearman correlation=0.812, 0.796; both P<0.05), and both CDAI and SDAI had well consistency with DAS28 (Kappa=0.719, 0.740, both P<0.05). ② Correlation analyses showed that CDAI and SDAI were positively correlated with DAS28(r=0.913, 0.912, both P<0.05), and there was a higher positive linear correlation between CDAI and SDAI(r=0.973, P<0.05). ③There was significant difference regarding swollen joint count, tender joint count, healthy assessment questionnaive(HAQ) score, blood platelet count, erythrocyte sedimentation Rate(ESR), C-reaction protein(CRP), rheumatoid factor(RF) among patients with different disease activity(P<0.05). All of the above indexes increased along with the rising disease activity.Serum hemoglobin(HB) levels(P<0.05) decreased along with the rising disease activity.④DAS28, CDAI and SDAI positively correlated with swollen joint count, tender joint count, HAQ score, blood platelet count, ESR, CRP and RF(P<0.05). DAS28, CDAI and SDAI negatively correlated with HB levels(P<0.05). Conclusion CDAI, SDAI and DAS28 have good association and consistency.SDAI and CDAI have better correlations with disease activity in RA. Key words: Rheumatoid arthritis; Disease activity index; Disease activity score 28 joint; Clinical disease activity idex; Simplified disease activity index

AB0296 The Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) Scores as Alternatives to the Current DAS28 Score

We prospectively evaluated whether the addition of iguratimod (IGU) could sustain clinical remission in rheumatoid arthritis (RA) patients after tapering of methotrexate (MTX). The study included 47 patients; 25 patients in the MTX maintenance group, and 22 patients in the IGU addition group who were treated with additional IGU and tapering of MTX dose. Clinical efficacy and safety were evaluated at 12, 24, and 36weeks. In the IGU addition group, the dose of MTX could be reduced from 8.6 ± 2.4 mg/week at baseline to 4.7 ± 2.2 mg/week at 36 weeks (p < .001). Clinical remission was maintained (disease activity score [DAS]28-ESR 1.48 ± 0.63 at baseline and 1.69 ± 0.76 at 36weeks, p = .911), and disease activity remained low (clinical disease activity index [CDAI] 2.4 ± 1.5 at baseline and 3.1 ± 3.4 at 36weeks, p = .825). The US-GLOSS score significantly decreased from 9.2 ± 5.3 at baseline to 6.4 ± 4.3 at 36weeks (p = .034). In the IGU addition group, two patients discontinued IGU because of stomatitis and three patients relapsed during the follow-up period (flare rate: 15.0%). There was no significant difference in RA disease activity at 36 weeks between the two groups. Additional use of IGU can effectively reduce the MTX dose required by patients during clinical remission without inducing a flare.