Change In mTSS Research Articles

Predictive value of baseline concomitant glucocorticoid for abatacept-mediated long-term inhibition of radiographic progression: insights from the KURAMA cohort

Abatacept (ABT) is a biological disease-modifying antirheumatic drug (bDMARDs) for rheumatoid arthritis (RA) when conventional synthetic DMARDs are ineffective. We aimed to evaluate the long-term effects of ABT on joint destruction in patients treated for over 2 years. Radiographic progression was evaluated using the van der Heijde-modified Total Sharp Score (mTSS) by two rheumatologists at ABT initiation and after 2 years. Multivariate logistic regression analysis was used to identify factors associated with structural remission, defined as the mean annual change in mTSS ≤0.5. Among the 111 patients included, 48 discontinued, and 63 continued ABT treatment until radiographic evaluation was performed. The rate of patients who achieved estimated TSS REM (yearly progression of van der Heijde modified total Sharp scores ≤0.5) was significantly lower in ABT-dropouts than in the ABT-continued group (69% vs. 48%, p = .0336 by Fisher’s exact test). Among the continued ABT cases, concomitant glucocorticoid treatment at ABT initiation was the strongest negative predictive factor of estimated TSS REM in univariate and multivariate logistic regression analyses. Radiographic progression after ABT administration should be evaluated separately for dropout and non-dropout cases. Glucocorticoids at the initiation of ABT may serve as a predictive factor for joint destruction in long-term ABT use.

Robust analyses for radiographic progression in rheumatoid arthritis

Demonstrating inhibition of the structural damage to joints as a statistically significant difference in radiographic progression as measured by the van der Heijde modified Total Sharp Score (mTSS) is a...

Baseline erythrocyte sedimentation rate level predicts long-term inhibition of radiographic progression by tocilizumab: the KURAMA cohort

The short-term effect of tocilizumab (TCZ) on the radiographic progression of rheumatoid arthritis has been reported; however, reports on its long-term effects are scarce. In this study, we aimed to evaluate its long-term effects on joint destruction in patients who had been treated with TCZ for at least two years and for whom X-rays were available. Radiographic progression was evaluated with modified Total Sharp Score (mTSS), and structural remission was defined as the mean annual change in mTSS ≤0.5. Of the 59 patients included in this study (median age, 62 years; female, 81.4%), 34 patients (57.6%) achieved structural remission. Patients who achieved structural remission were relatively younger (59 years vs. 64 years, p = .06), had relatively higher proportion of anti-citrullinated protein antibody positivity (91.2% vs. 72.0%, p = .08), relatively lower C-reactive protein level (0.6 mg/dL vs. 2.2 mg/dL, p = .05), and significantly lower erythrocyte sedimentation rate (ESR) level (28.0 mm/h vs 65.5 mm/h, p = .003) than those who did not. Multivariate logistic regression analysis demonstrated that the baseline ESR level was significantly associated with structural remission (odds ratio, 0.98; 95% confidence interval: 0.96–0.99, p = .049). The baseline ESR level is a critical determinant of the long-term effect of TCZ on joint destruction.

Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA).

Etanercept (ETN) has been shown to slow radiographic progression of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in clinical trials. This real-world, non-interventional study assessed radiographic progression in patients with RA or PsA treated with ETN for ≤ 36months in outpatient care in Germany (NCT01623752). Patients with RA or PsA attended ≤ 10 visits across two study phases (phase 1: seven visits, baseline to month 18; phase 2: three visits until month 36). Radiographs were taken at baseline (Rx1), months 12-18 (Rx2), and/or months 30-36 (Rx3). Historic radiographs (Rx0) taken 12-48months pre-baseline were also evaluated (if available). The primary endpoint was the change in modified total Sharp score (mTSS). The erosion score (ES) and joint space narrowing score (JSN) were also evaluated. Overall, 1821 patients were enrolled (RA: n = 1378; PsA: n = 440). In patients with Rx1 and Rx2 (RA: n = 511; PsA: n = 167), the mean mTSS remained stable for both disease groups, and the annualized median change in mTSS was 0. In patients with Rx0, Rx1, and Rx2 (RA: n = 180; PsA: n = 47), annualized radiographic progression in mTSS, ES, and JSN was larger in the pre-ETN treatment phase than during ETN treatment in both disease groups. The percentage of patients with radiographic non-progression was higher during ETN treatment versus pre-ETN. Improvement in clinical disease activity and patient-reported outcomes was also observed. This was the first real-world, non-interventional study to report systematically collected radiographic data in a large cohort of patients with RA or PsA under treatment with a biologic. In patients with available radiographic data, mean radiographic progression was lower and the proportion of patients without progression was greater during ETN treatment than in the pre-ETN period.

The Efficacy of Denosumab in Patients With Rheumatoid Arthritis: A Systematic Review and Pooled Analysis of Randomized or Matched Data.

ObjectiveThe purpose of this study was to evaluate the efficacy of denosumab treatment in patients with rheumatoid arthritis (RA).MethodsThe Medline, Embase and Cochrane Library databases were searched for relevant clinical studies. Studies that assessed the efficacy of denosumab in patients with RA were identified. The primary endpoints were the percent changes in bone mineral density (BMD), and the changes in modified total Sharp score (mTSS), modified Sharp erosion score and joint space narrowing (JSN) score. Pooled analyses were calculated using random-effect models.ResultsAfter searching the literature and performing further detailed assessments, 10 studies with a total of 1758 patients were included in the quantitative analysis. Pooled analyses showed that denosumab treatment significantly increased the percent changes in lumbar spine BMD [mean difference (MD): 5.12, confidence intervals (CI): 4.15 to 6.09], total hip BMD (MD: 2.72, 95% CI: 1.80 to 3.64) and femoral neck BMD (MD: 2.20, 95% CI: 0.94 to 3.46) compared with controls. Moreover, denosumab treatment significantly decreased the changes in mTSS (MD: -0.63, 95% CI: -0.86 to -0.41) and modified Sharp erosion score (MD: -0.62, 95% CI: -0.88 to -0.35). Subgroup analysis indicated that denosumab was superior to bisphosphonates for the improvement of BMD and the mitigation of joint destruction.ConclusionDenosumab treatment was associated with increased BMD and alleviated progression of joint destruction in RA patients, even when compared with bisphosphonates.

P173 Efficacy and safety of upadacitinib versus placebo and adalimumab in patients with active PsA and inadequate response to non-biologic DMARDs (SELECT-PSA-1): a double-blind, randomised controlled phase III trial

Abstract Background/Aims Upadacitinib (UPA) is a JAK inhibitor under evaluation for PsA treatment. We aimed to assess efficacy and safety of UPA vs placebo (PBO) and adalimumab (ADA) in patients with prior inadequate response (IR) or intolerance to ≥ 1 non-biologic DMARD. This research was previously presented at EULAR; published in Annals of Rheumatic Diseases. Methods Patients with active PsA (≥3 swollen, ≥3 tender joints), active/historical psoriasis, ≤2 non-bDMARDs were randomized 1:1:1:1 to once-daily UPA 15mg (UPA15), UPA 30mg (UPA30), ADA 40mg every other week, or PBO. Primary endpoint: proportion of patients achieving ACR20 for UPA vs PBO at Wk12. Secondary endpoints: change in HAQ-DI, FACIT-F, SF-36-PCS (Wk12), sIGA of Psoriasis 0/1, PASI75, change in Self-Assessment of Psoriasis Symptoms (Wk16), change in modified Sharp/van der Heijde Score (mTSS), proportion patients achieving MDA, resolution of enthesitis (LEI=0) and dactylitis (LDI=0) (Wk24), non-inferiority and superiority vs ADA for ACR20, superiority for HAQ-DI, patient assessment of pain NRS (Wk12). Additional secondary endpoints: ACR50/70 at Wk12 and ACR20 at Wk2. Treatment-emergent adverse events (TEAEs) through Wk24 reported for patients receiving ≥1 dose of study drug. Results 1,705 patients were randomised; 1,704 received study drug (mean age 50.8 yrs, mean duration of PsA diagnosis 6.1 yrs). 82% on ≥ 1 concomitant non-bDMARD. At Wk12, ACR20 rates were 70.6% with UPA15 and 78.5% with UPA30 vs 36.2% with PBO (p < 0.001 for UPA15/30 vs PBO) and 65.0% with ADA (non-inferiority, p < 0.001 for UPA15/30 vs ADA; superiority, p < 0.001 for UPA30 vs ADA). More patients achieved ACR50/70 with UPA15/30 vs PBO and UPA30 vs ADA. Improvements were observed with UPA15/30 vs PBO for all secondary endpoints and for UPA 15/30 vs ADA for HAQ-DI and UPA30 vs ADA for improvement in pain. At Wk24, change in mTSS was 0.25 for PBO, -0.04 for UPA15, 0.03 for UPA30, and 0.01 for ADA (p < 0.001 for UPA15/30 vs PBO). Rates of TEAEs and serious AEs, including serious infections, were similar in PBO, UPA15, and ADA arms and higher with UPA30. Herpes zoster rates were similar for PBO and UPA15/30. No MACE was reported with UPA. One malignancy occurred in both the PBO and UPA15 arms; 3 malignancies were reported in both UPA30 and ADA arms. VTE were reported in 1 PBO patient, 1 UPA30 patient and 2 ADA patients. One death occurred in the PBO arm. Conclusion In this non-bDMARD-IR PsA population UPA15/30 demonstrated improvement in musculoskeletal symptoms, psoriasis, physical function, pain, fatigue and inhibited radiographic progression; improvements observed by Wk2. At Wk12, UPA15/30 were non-inferior to ADA for ACR20, with superiority demonstrated for UPA30. Greater percentages of UPA vs PBO patients achieved stringent disease control measures (MDA, ACR50/70, sIGA 0/1). No new safety signals were identified compared to the safety profile observed in RA. Disclosure I. McInnes: Other; I.McI has received research grants and honoraria from Abbvie, BMS, Celgene, Novartis Lilly, Janssen, Pfizer, UCB. J. Anderson: Shareholder/stock ownership; J.A. may be a stock/ shareholder of AbbVie Inc. M. Magrey: Consultancies; M.M. has received consulting fees from Novartis, Eli Lilly, Pfizer, and Janssen. Grants/research support; M.M. has received grants/ research support from Amgen, AbbVie, and UCB Pharma. J.F. Merola: Consultancies; J.F.M. is a consultant for Merck, Abbvie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and Leo Pharma. Y. Liu: None. M. Kishimoto: Consultancies; M.K. has received consulting fees from AbbVie, Eli Lilly, Celgene, Pfizer, Gilead, Janssen, and UCB Pharma. Honoraria; M.K. has received honoraria/ speakers fees from AbbVie, Eisai, Celgene, Pfizer, Novartis, Eli Lilly, Tanabe-Mitsubishi, Ayumi, Janssen, Astellas, and UCB Pharma. S. Jeka: None. C. Pacheco-Tena: None. X. Wang: Shareholder/stock ownership; X.W. may be a shareholder of AbbVie Inc. L. Chen: Shareholder/stock ownership; L.C. may be a stock/shareholder of AbbVie Inc. P. Zueger: Shareholder/stock ownership; P.Z. may be a stock/shareholder of AbbVie Inc. A. Pangan: Shareholder/stock ownership; A.P. may be a stock/shareholder of AbbVie Inc. F. Behrens: Honoraria; F.B. has received honoraria and speakers fees from Pfizer, AbbVie, Sanofi, Lilly, Novartis, UCB, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche and Chugai. Grants/research support; F.B. has received grants/ research support from Pfizer, Janssen, Chugai, Celgene and Roche.

Tocilizumab can efficiently prevent bone destruction in patients with recent-onset rheumatoid arthritis

Objectives To assess whether tocilizumab (TCZ) can prevent bone destruction in patients with recent-onset rheumatoid arthritis (RA). Methods DAS28-ESR and van der Heijde-modified Sharp score (mTSS) were evaluated in 50 patients who received TCZ within 1 year from the onset of RA. TCZ was consecutively administered during the observation period within the first 2 years. In 15 patients, mTSS could be evaluated at 5 years. Results The mean DAS28-ESR at baseline, 1, 2, and 5 years was 4.86, 1.29, 1.19, and 1.18, respectively. The change in mTSS (ΔmTSS) between baseline and 2 years was −0.33. The structural remission rates (ΔmTSS/year ≤0.5) were 91.8% and 92.7% during the first and second years, respectively. Only one increase in erosion score was observed in the first year in 2 patients and the erosion score of all patients did not increase in the second year. In 15 patients, the ΔmTSS over 5 years was 0.80, corresponding to 0.16 per year. The structural remission rate at 5 years (ΔmTSS ≤2.5) was 93.3%. The erosion score was 0 in all 15 patients at 5 years, indicating that bone destruction did not become apparent. Conclusion TCZ can efficiently prevent bone destruction in patients with recent-onset RA.

Radiographic progression based on baseline characteristics from TNF inhibitor biosimilar studies in patients with rheumatoid arthritis

ObjectivePhase III clinical trials of the tumour necrosis factor inhibitors SB4, SB2, and SB5 (biosimilars to etanercept, infliximab, and adalimumab, respectively) have demonstrated efficacy in moderate-to-severe rheumatoid arthritis (RA). Data from these trials were used to identify baseline characteristics associated with radiographic progression and to build a matrix risk model for its prediction.MethodsPatients with radiographic progression and baseline demographic and disease characteristic data were pooled across the 3 phase III studies of each biosimilar and its reference product. Baseline demographics and disease characteristics were evaluated for their relationship with radiographic progression (1-year mean change in mTSS > 0); 3 factors were selected based on strongest Pearson’s correlation coefficient with the change in modified Total Sharp Score. Univariate logistic regression was performed to assess the association between each baseline factor and the rate of radiographic progression, with subsequent matrix model development performed using multivariate logistic regression.ResultsA total of 1371 patients were included in the analysis, with a radiographic progression rate of 27.4%. The 3 baseline predictors of radiographic progression, based on Pearson’s correlation coefficient, were 28 swollen joint count (SJC28), C-reactive protein (CRP), and physician global assessment (PhGA). A matrix model showed that the predicted risk of radiographic progression was higher with the increased level of SJC28, CRP, and PhGA (P < 0.001).ConclusionsIn this pooled analysis of phase III clinical trial data of biosimilars for RA, identifiable baseline factors (SJC28, CRP, and PhGA) associated with radiographic progression were similar to those described in prior studies. Even though radiographic progression was minimal, a small number of patients who have increased SJC28, CRP, and PhGA at baseline should be closely monitored and follow treat-to-target approach.Clinical trial registration numbersEudraCT 2012-005026-30. Registered 30 April 2013, https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-005026-30/resultsEudraCT 2012-005733-37. Registered 10 July 2013, https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-005733-37/resultsEudraCT 2013-005013-13. Registered 01 April 2014, https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-005013-13/results

Identifying the preferable rheumatoid arthritis subgroups for intervention with the anti-RANKL antibody denosumab to reduce progression of joint destruction

ObjectivesTo clarify which rheumatoid arthritis (RA) patients benefit most from the anti-receptor activator of nuclear factor-κB ligand antibody denosumab to reduce the progression of joint destruction.MethodsWe pooled patient data from...

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

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 &lt; 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)&lt;0.0010.96 (0.94-0.98)&lt;0.001mHAQ @baseline0.50 (0.36-0.69)&lt;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&lt;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.

SAT0145 EFFICACY AND SAFETY OF UPADACITINIB MONOTHERAPY IN MTX-NAÏVE PATIENTS WITH EARLY ACTIVE RA RECEIVING TREATMENT WITHIN 3 MONTHS OF DIAGNOSIS: A POST-HOC ANALYSIS OF THE SELECT-EARLY

Background:Early treatment of RA within the therapeutic window(0-3 months from symptom onset), has been associated with improved clinical outcomes and physical function. However, ≤42% of RA patients(pts) visit a rheumatologist within 90 days of symptom onset1,2.Objectives:To assess safety and efficacy of Upadacitinib(UPA), an oral, reversible, potent JAK-1 selective inhibitor3, in pts with moderate to severely active RA who were MTX-naïve or had an inadequate response to csDMARDs/bDMARDs4-6.Methods:In SELECT–EARLY, MTX-naïve pts with active RA and poor prognosis were randomized 1:1:1 to once-daily UPA monotherapy at 15 or 30 mg or weekly MTX (titrated up to 20 mg/week through Week 8). Efficacy (including ACR, DAS28(CRP), CDAI responses and change in mTSS) and safety outcomes from a post-hoc analysis of patients who received treatment within 90 days from diagnosis are reported here. The statistical significance defined asp&lt;0.05was exploratory in nature.Results:A total of 270 pts commenced treatment within 90 days from RA diagnosis (median: 44 days [11, 89]). Pts in each arm were mostly female (70%), had moderately to severely active RA with mean DAS28(CRP) =5.9±1.02, had structural joint damage (mean mTSS =7.7±21.5) and were seropositive for both ACPA and RF at baseline (72%)4. At Week 24, compared to MTX, significantly greater proportions of pts receiving UPA 15 or 30 mg monotherapy achieved efficacy outcomes including ACR20, 50 and 70 responses, DAS28CRP&lt;2.6, CDAI≤2.8 or Boolean remission. Improvements in physical function (HAQ-DI) and decrease in pain were also significantly greater in pts receiving UPA 15 and 30 mg vs MTX at Week 24. Treatment with UPA was also associated with a greater inhibition of structural joint damage compared with MTX (Figure 1). Safety outcomes were consistent with the full study and the integrated safety analysis (all phase 3 studies of UPA). Compared to MTX, higher frequencies of serious infections and herpes zoster were reported in both UPA groups. There were 2 deaths in total (UPA 30 mg: 1 due to cardiovascular death and 1 due to pneumonia and sepsis) (Figure 2).Conclusion:In RA pts, early initiation of treatment with UPA 15 mg and 30 mg monotherapy within 3 months from diagnosis was associated with clinically meaningful improvements in efficacy, including remission and inhibition of progression of structural joint damage compared to MTX. The safety profile was consistent with the overall study and the integrated phase 3 safety analysis7. UPA seems to be a promising treatment option for more patients to reach their treatment targets of remission or low disease activity when treated within 3 months of diagnosis.

Pooled analysis of TNF inhibitor biosimilar studies comparing radiographic progression by disease activity states in rheumatoid arthritis

ObjectiveTo evaluate the relationship between disease activity and radiographic progression in rheumatoid arthritis, three phase III studies of SB4, SB2 and SB5 (biosimilars of etanercept, infliximab and adalimumab) were pooled...

Efficacy and safety of sarilumab in combination with methotrexate in patients with active rheumatoid arthritis and inadequate effect of methotrexate monotherapy (results of phase III MOBILITY study)

Objective: to study the efficacy and safety of rheumatoid arthritis (RA) treatment with monoclonal antibodies to interleukin 6 receptors (IL6R) – sarilumab (SAR) in combination with methotrexate (MT).Subjects and methods. The study included adult patients with moderate or severe RA and inadequate effect of MT monotherapy. Patients were randomized in a 1:1:1 ratio to subgroups receiving SAR (at doses of 150 or 200 mg) or placebo (PL) every 2 weeks in combination with a weekly intake of MT for 52 weeks. The primary endpoints of the study included the achievement of ACR20 after 24 weeks, the change of HAQ-DI after 16 weeks and assessment of radiological progression of joint destruction (modified total Sharp score mTSS) after 52 weeks.Results and discussion. In general, the initial characteristics of patients were similar in all groups. A statistically significant improvement of all three primary endpoints was found in the groups of patients treated with SAR 150 and 200 mg compared to the group of PL. ACR20 response after 24 weeks was achieved in 53.6% (p&lt;0.0005), 65.9 and 19.6% of patients respectively (p&lt;0.0001), the average change in HAQ-DI after 16 weeks was 20.53; 20.55 and 20.29 respectively (p&lt;0.0001); the average change in mTSS after 52 weeks was 0.49; 0.11 and 2.30, respectively (p&lt;0.0001).Conclusion. Both doses of SAR (150 and 200 mg every 2 weeks) in combination with MT demonstrated sustained clinical efficacy in patients with RA, which was confirmed by a significant improvement in symptomatic, functional and radiographic outcomes. SAR therapy was generally well tolerated. The adverse events observed in this study were consistent with the effects of the IL6 blockade.

The efficacy of abatacept in Japanese patients with rheumatoid arthritis: 104 weeks radiographic and clinical results in clinical practice

Objective: We aimed to assess the efficacy of abatacept in Japanese patients with rheumatoid arthritis (RA) in clinical practice.Methods: We examined 92 patients who received abatacept for 104 weeks. Analysis of radiographic efficacy was conducted using van der Heijde-modified total Sharp score (mTSS). Disease activity score was assessed using disease activity score in 28 joints (DAS28) and simplified disease activity index (SDAI) by last observation carried forward.Results: The change in mTSS was 0.61 at 52 weeks and 0.27 at 52–104 weeks. Structural remission occurred in 64.9% at 52 weeks and 76.6% at 104 weeks. The significant risk factors for joint damage progression at 52 weeks were prednisolone use, baseline C-reactive protein level (CRP), and erythrocyte sedimentation rate (ESR), as well as average DAS28-CRP and DAS28-ESR scores, SDAI, CRP, ESR, and matrix metalloproteinase-3 (MMP-3) levels. The clinical remission rates were 47.8% by DAS28-CRP, 39.1% by DAS28-ESR, and 30.4% by SDAI at 52 weeks, were 59.8% by DAS28-CRP, 48.9% by DAS28-ESR, and 43.5% by SDAI at 104 weeks.Conclusion: This study suggested efficacy of abatacept treatment in Japanese patient with RA for 104 weeks in daily clinical practice. Abatacept lead to suppress joint destruction for 104 weeks.

Clinical and Radiographic Outcomes in Patients Diagnosed with Early Rheumatoid Arthritis in the First Years of the Biologic Treatment Era: A 10-year Prospective Observational Study.

To study short-term and longterm clinical and radiographic outcomes in patients with early rheumatoid arthritis (RA) in the first decade of the biologic treatment era. Patients with early RA diagnosed at a rheumatology outpatient clinic were consecutively enrolled between 1999 and 2001. Data were collected on demographic characteristics, disease activity, patient-reported outcomes, and treatments. Radiographs of hands and feet were performed at baseline and after 2, 5, and 10 years and scored according to the Sharp/van der Heijde method, yielding a modified total Sharp score (mTSS). Mean baseline age for the 94 included patients (36 men and 58 women) was 50.4 years and symptom duration 12.3 months; 67.8% were rheumatoid factor-positive. The proportion of patients in remission and in low, moderate, and high disease activity status was at baseline 4.3%, 1.1%, 35.1%, and 59.6% and at 10 years 52.1%, 20.5%, 27.4%, and 0.0%, respectively. For the period 0-2 years, 62.8% had used prednisolone, 91.5% synthetic disease-modifying antirheumatic drug (DMARD), and 18.1% biologic DMARD, and for the period 2-10 years the numbers were 50.6%, 89.3%, and 62.7%, respectively. At baseline, 70% of the patients had erosions on radiographs. Mean annual change in mTSS was for 0-2 years 3.4, 2-5 years 1.7, and 5-10 years 1.2. A large proportion of our patients with RA diagnosed and treated in the new biologic treatment era achieved a status of clinical remission or low disease activity and had only a minor increase in radiographic joint damage after the first years of followup.

Updated systematic review and meta-analysis of randomized controlled trials comparing low- versus high-dose rituximab for rheumatoid arthritis.

Thepurpose of this study is to update a systematic review and meta-analysis comparing low- (2 × 500 or 1 × 1000mg) and high-dose (2 × 1000mg) rituximab (RTX) for the treatment of rheumatoid arthritis (RA), considering the recent emergence of new evidence. The systematic literature review searching for randomized controlled trials (RCTs) was updated to November 6, 2014 using the PubMed, EMBASE, Cochrane Library, Web of Science databases, and hand searching. The primary outcomes were the American College of Rheumatology (ACR) criteria for 20% improvement (ACR20), ACR50, and ACR70 responses and the Disease Activity Score in 28 joints (DAS28) at 24 and 48/52weeks. The secondary outcomes were change in Health Assessment Questionnaire (HAQ) score, change in the radiographic modified Total Sharp Score (mTSS), levels of immunoglobulin G (IgG), and adverse events. In total, seven RCTs were identified, including two new full publication versions and one abstract of RCTs. There were no significant differences in the primary outcomes and change in HAQ, although the mean change in mTSS was 0.25 units (95% CI, 0.01 to 0.49; P = 0.04) higher in low-dose group at week 52. Two RCTs did not demonstrate difference between the RTX regimens for maintaining clinical response (obtained initially using high-dose RTX) in anti-TNF-experienced patients. IgG levels were significantly higher (P ≤ 0.02), and first infusion reactions were less frequent in the low-dose group (P = 0.02). Our updated results further support the similar efficacy of both RTX regimens in different subsets of RA patients, demonstrating a better clinical and laboratory safety profile of the low-dose scheme.

Efficacy and safety of tabalumab, an anti-B-cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: results from a phase III multicentre, randomised, double-blind study

ObjectivesRandomised, double-blind, placebo-controlled study to evaluate efficacy and safety of tabalumab in patients with rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX-IR).Methods1041 patients with moderate–severe RA despite ongoing MTX...

SAT0049 Dermal Temperature to Identify Rheumatoid Arthritis Patients with Erosive Progressive Disease in Less than 1 Minute

BackgroundThere is great debate regarding which patients to treat with expensive effective therapies for rheumatoid arthritis (RA).ObjectivesTo identify RA patients rapidly and easily who are destined to have progressive destructive...

FRI0326 Efficacy and Safety of Tabalumab, an Anti-B Cell Activating Factor Monoclonal Antibody, in Patients with Rheumatoid Arthritis Who HAD an Inadequate Response to Methotrexate Therapy: Results from A Phase 3 Multicenter, Randomized, Double-Blind Study

BackgroundTabalumab is a monoclonal antibody that neutralizes membrane-bound and soluble B cell activating factor (BAFF).ObjectivesEvaluate efficacy and safety of tabalumab, in RA pts who had an inadequate response to methotrexate...

Early response to certolizumab pegol predicts long-term outcomes in patients with active rheumatoid arthritis: results from the Japanese studies

Objectives. A post-hoc analysis was performed to determine the relationship between the timing and magnitude of DAS28(ESR) response and long term outcomes in Japanese patients after 1 year of CZP treatment.Methods. Our analysis included 82 J-RAPID trial patients treated with CZP 200 mg and methotrexate, and 116 HIKARI trial patients treated with CZP 200 mg alone or with disease-modifying agents other than methotrexate. Remission rates and changes in mTSS at year 1 were compared to the DAS28(ESR) response at week 12 of CZP treatment.Results. After 1 year of treatment, remission was achieved in 41.3% of the J-RAPID and 34.9% of the HIKARI patients with a week 12 DAS28(ESR) response of ≥ 1.2. In comparison, patients with a DAS28(ESR) response of < 1.2 at week 12 only had a < 7% probability of achieving remission and displayed higher change in mTSS after 1-year treatment.Conclusions. The likelihood of remission and extent of radiographic progression after 1 year was associated with the week 12 DAS28(ESR) response. The DAS28(ESR) response at 12 weeks could be beneficial for identifying patients that are unlikely to respond to prolonged CZP treatment.