FRI0107 EFFECTIVENESS OF ABATACEPT ON CLINICAL DISEASE ACTIVITY AND RADIOGRAPHIC PROGRESSION IN RHEUMATOID ARTHRITIS PATIENTS IN DAILY CLINICAL PRACTICE IN JAPAN: COMPARISONS ACCORDING TO ACPA STATUS

Abstract

Background:The clinical effectiveness of abatacept (ABA) in rheumatoid arthritis (RA) patients has been reported to be higher when the patients’ anti-cyclic citrullinated peptide antibody (ACPA) status is positive. The report from the ORA registry demonstrated that the ACPA positivity was associated with a better response to ABA [1]. In a sub-analysis of the AMPLE trial, patients with very high ACPA titers who were treated with ABA had a statistically significant response compared to patients with lower titers [2]. However, these studies did not demonstrate the data regarding the structural progression.Objectives:This study aimed to evaluate the effectiveness of ABA on the clinical disease activity as well as the radiographic progression in patients with RA in the clinical settings.Methods:All eligible patients were registered in the TBCR, a Japanese multicenter registry system for RA patients treated with biologics [3]. The present study included 553 consecutive patients whose ACPA data were obtained, treated with ABA and observed for longer than 52 weeks. We primarily compared the status of disease activity (SDAI) and radiographic progression (van der Heijde modified total Sharp score: mTSS) between ACPA-positive [ACPA (+)] and ACPA-negative [ACPA (-)] RA patients. The ACPA positive was defined as ≥13.5 U/ml of anti-CCP antibody.Results:Number of cases was 446/ 107 [ACPA (+)/ ACPA (-)], respectively. Baseline characteristics between groups were quite similar; mean age was 68.0/ 67.3 years, rate of methotrexate (MTX) use rate was 41.2/ 50.0%, rate of bio-naive was 28.0/ 31.8%, and mean SDAI score was 22.2/ 20.8. Significant difference was observed in mean change in SDAI score from baseline to 52 weeks between the ACPA (+) and ACPA (-) group (-13.4 vs -9.9, p = 0.027) (Figure 1A). Proportion of patents that achieved low disease activity (LDA; SDAI ≤11) at 52 weeks was significantly higher in the ACPA (+) group compared to the ACPA (-) group (72.1 vs 56.0%, p < 0.01) (Figure 1B). In univariate and multivariate logistic regression analysis, ACPA positivity was an independent predictor for achievement of LDA at 52 weeks (Table). There observed no significant difference between ACPA (+) and ACPA (-) group in the proportion of patients that achieved structural remission (ΔmTSS ≤0.5) at 52 weeks (66.2 vs 62.1%) (Figure 2A) as well as mean change in mTSS (1.66 vs 1.17), erosion score (0.60 vs 0.53), and joint narrowing (JSN) score (1.06 vs 0.64) (Figure 2B).Table.UnivariateMultivariateVariablesOR (95%CI)p-valueadjusted OR (95%CI)p-valueAge0.99 (0.98-1.01)0.4391.00 (0.97-1.02)0.749male (vs female)1.12 (0.70-1.80)0.6340.79 (0.40-1.58)0.511disease duration0.99 (0.97-1.00)0.0530.99 (0.97-1.01)0.468Biologics-naïve1.23 (0.81-1.85)0.3351.18 (0.67-2.08)0.575Concomitant MTX use1.12 (0.75-1.69)0.5851.14 (0.66-1.95)0.649Concomitant PSL use0.82 (0.55-1.23)0.3290.97 (0.58-1.64)0.923SDAI @baseline0.96 (0.94-0.97)<0.0010.96 (0.94-0.98)<0.001mHAQ @baseline0.50 (0.36-0.69)<0.0010.57 (0.38-0.86)0.008ACPA positive2.03 (1.29-3.17)0.0022.61 (1.36-5.00)0.004Bold italic, p<0.05Conclusion:Consistent with previous reports, the ACPA-positive group demonstrated significantly higher LDA achievement rate at 52 weeks and indeed the ACPA positivity was significantly associated with LDA achievement in multivariate analysis. However, the ACPA-negative group demonstrated quite similar transition of SDAI score and LDA achievement rate except at 52 weeks compared with the ACPA-positive group. Additionally, there was no significant difference in the structural progression at 52 weeks between the groups. ABA treatment may be considered not only in the ACPA-positive RA patients but also in the ACPA-negative patients in the clinical practice.