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Background/aim: to evaluate treatment adherence and predictors of drug discontinuation among patients with inflammatory arthritis receiving bDMARDs within the first 100 days after the announcement of the COVID-19 pandemic. Materials and methods: a total of 1871 patients recorded in TReasure registry for whom advanced therapy was prescribed for rheumatoid arthritis (RA) or spondyloarthritis (SpA) within the 3 months (6-9 months for rituximab) before the declaration of COVID-19 pandemic were evaluated, and 1394 (74.5%) responded to the phone survey. Patients' data regarding demographic, clinical characteristics and disease activity before the pandemic were recorded. The patients were inquired about the diagnosis of COVID-19, the rate of continuation on bDMARDs, the reasons for treatment discontinuation, if any, and the current general disease activity (visual analog scale, [VAS]). Results: a total of 1394 patients (493 RA [47.3% on anti-TNF] patients and 901 SpA [90.0% on anti-TNF] patients) were included in the study. Overall, 2.8% of the patients had symptoms suggesting COVID-19, and 2 (0.15%) patients had PCR-confirmed COVID-19. Overall, 18.1% of all patients (13.8% of the RA and 20.5% of the SpA; p = 0.003) discontinued their bDMARDs. In the SpA group, the patients who discontinued bDMARDs were younger (40 [21-73] vs. 44 years [20-79]; p = 0.005) and had higher general disease activity; however, no difference was relevant for RA patients. Conclusion: although the COVID-19 was quite uncommon in the first 100 days of the pandemic, nearly one-fifth of the patients discontinued bDMARDs within this period. The long-term effects of the pandemic should be monitored., Hacettepe Rheumatology Society

Rheumatoid arthritis as one of the autoimmune diseases is more prevalent now than ever before. Being more common in women than men, RA has been focused by researchers to invent a therapeutic agent for effective clinical response. Various Diagnostic biomarkers are being used for early diagnosis of RA depending upon their selectivity and specificity. Certain indexes for RA disease activity evaluation are used for assessment of disease on a continuous scale. Disease activity Score combined with laboratory data result and imaging technologies makes the decision of treatment strategies easier than before. Traditionally, TNFi are the most used agents since a decade and first choice of treatment by clinicians, however, combination therapy with DMARD is used in inadequate responders. Despite all the advancements in treatment of RA and proved remission possibility using latest biological agents, studies are needed to ensure quick clinical outcomes and remission probability in larger fraction of people.

Introduction The aim of this work is to propose Boolean-defined low disease activity (LDA) and to test its utility in rheumatoid arthritis (RA). Methods We used data from a longitudinal academic clinical database of RA in Peking University First Hospital over a decade. The initial proposal of Boolean-defined LDA was proposed with ascending thresholds from 2 to 5 in steps of 1 (referred to as Boolean-LDA2/3/4/5). Agreement and residual swollen joint count (SJC) pattern with the index-based [Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI)] LDA was analyzed. To confirm discovery, we randomly classified RA patients in a 3:2 ratio into either analysis cohort or validation cohort. Results In total, 4881 visits of 672 patients were included in the analysis cohort. Of these visits, the frequencies of achieving LDA were 71.9% (SDAI), 73.6% (CDAI), 52.8% (Boolean-LDA2), 65.2% (Boolean-LDA3), 73.5% (Boolean-LDA4), and 80.7% (Boolean-LDA5). High consistency and similar SJC pattern with SDAI-LDA or CDAI-LDA were observed in Boolean-LDA3 (kappa = 0.796, 0.771). Further analysis found meeting SDAI-LDA but not Boolean-LDA3 was largely attributable to higher patient’s global assessment (PGA) scores (62.9%). In further modification of Boolean-LDA3, better agreement with SDAI-LDA or CDAI-LDA was reached when exclusively increasing PGA cutoffs to 4.0, 4.5 or replacing PGA by evaluator’s global assessment (EGA) with cutoff to 3.0. These findings were further replicated in randomly generated validation cohort of 449 patients with 3306 clinic visits. Conclusions Using cutoff of 3 to Boolean-LDA provides great clinical utility with index-based LDA, especially when exclusively increasing PGA cutoffs to 4.0, 4.5 or replacing PGA by EGA with cutoffs to 3.0. This may deserve being considered in clinical practice. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-020-00270-z.

Background Beta-2 microglobulin (β2M) is mainly released from activated lymphocytes. Increased serum β2M levels have been shown in autoimmune diseases. The aim of this study was to analyse the serum levels of β2M in rheumatoid arthritis (RA) patients and to evaluate its relationship with disease activity measures. Material and Methods This cross-sectional study included 137 RA patients, 102 ankylosing spondylitis patients (AS) and 50 healthy controls (HC). To assess the disease activity of RA patients, the 28-joint Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR), the 28-joint Disease Activity Score-C-Reactive Protein (DAS28-CRP), the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) were used. A p value of Results Serum β2M levels were significantly higher in RA patients (2.95±1.19 mg/L) compared with HC (2.21±0.54 mg/L) and AS patients (2.200.58 mg/L) (p Conclusion Our study revealed that serum β2M levels were higher in RA patients than in healthy controls, and, in contrast to other studies, we found positive correlations between β2M levels and RA disease activity measures.

Treatments aimed at maintaining sustained clinical remission in rheumatoid arthritis (RA) patients have been recommended by several groups. Improvement and maintenance of functional status are also important for RA patients. The purpose of this study was to investigate the factors for maintaining long-term functional remission.RA patients with usual care without specific protocols were included. Disease activity score using 28-joint count C-reactive protein (DAS28-CRP), simplified disease activity index (SDAI) score, and Health Assessment Questionnaire Disability Index (HAQ-DI) score was calculated every 3 months for 1 year. Patients were divided into the HAQ-DI remission (REM) group and the HAQ-DI non-remission (NO-REM) group; time-averaged values of these parameters were compared between groups.Of the 205 patients, 154 fulfilled the remission criteria. Time-averaged DAS28-CRP and SDAI score were significantly lower in the REM group than in the NO-REM group (1.66 vs 2.59, 3.54 vs 10.68, respectively; p0.001). Subsequent receiver-operating characteristic (ROC) analysis for estimation of remission indicated a cut-off value of 1.65 for time-averaged DAS28-CRP and 2.85 for time-averaged SDAI score.Previous reports showed that fulfillment of clinical remission increases the possibility of functional remission; the probability of which is higher in patients with sustained clinical remission. Sustained clinical remission is required to achieve sustained functional remission; the criteria for clinical remission may be more stringent. Key Points • Sustained deep clinical remission was required to achieve sustained functional remission.

Objective We aimed to standardize the definition of low disease activity in rheumatoid arthritis (RA) using the Outcome Measures in Rheumatology (OMERACT) group's proposed definition of minimal disease activity. Method Based on a nationwide RA database, we proposed new Boolean low disease activity criteria using OMERACT's core set definition of minimal disease activity that requires the fulfillment of at least five of the following seven core set measures: a pain score of 2 or less, a swollen joint count (SJC28) of 1 or fewer, a tender joint count of 1 or fewer, a Health Assessment Questionnaire score of 0.5 or less, a Physician's Global Assessment score of 1.5 or less, a Patient's Global Assessment score of 2 or less, and an erythrocyte sedimentation rate (ESR) of 20 mm/h or less. Using receiver operating characteristic analysis, we determined the cutoffs for the Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Routine Assessment of Patient Index Data 3 (RAPID3), and the Disease Activity Score in 28 joints (DAS28)-ESR. Results Of 8298 patients, 56.2% met the proposed Boolean low disease activity criteria. We determined an SDAI score of 5.5 or less and a CDAI score of 5 or less to be the new cutoffs, and we chose a DAS28 of 2.85 or less (the original cutoff for DAS-based minimal disease activity) and a RAPID3 score of 6 or less (the original cutoff for RAPID3-based low disease activity) with or without a swollen joint count (SJC) (SJC of 2 or fewer) as the cutoffs for DAS28 and RAPID3. The agreement between the new cutoffs for DAS28 of 2.85 or less vs. CDAI score of 5 or less, CDAI score of 5 or less vs. RAPID3 score of 6 or less (with SJC of 2 or fewer), and DAS28 of 2.85 or less vs. RAPID3 score of 6 or less (with SJC of 2 or fewer), was 0.619, 0.612 (0.702), and 0.474 (0.531), respectively. Conclusion OMERACT's minimal disease activity definition may be used to standardize the criteria for low disease activity.

Objectives In patients with rheumatoid arthritis (RA), remission may be assessed by various composite measures. We assessed achievement of remission as defined by Boolean criteria, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), and 28-joint Disease Activity Score using C-reactive protein (DAS28[CRP]) and determined the components that limit patients in SDAI, CDAI, or DAS28(CRP) remission from achieving Boolean remission. Methods The proportions of patients achieving Boolean, SDAI, CDAI, or DAS28(CRP) remission were calculated for 3 trials: PREMIER and OPTIMA in patients with early RA and DE019 in patients with established RA. At the first visit that remission was recorded during the first 52 weeks of the trial, the following were assessed: swollen/tender joint count at 28 and 66/68 joints, CRP, Patient's/Physician's Global Assessment (PGA/PhGA), SDAI, DAS28(CRP), and Health Assessment Questionnaire-Disability Index. Results The majority of patients (61–66%) who achieved SDAI or CDAI remission also attained Boolean remission. Although DAS28(CRP) remission was most frequently attained, 74–77% of patients in DAS28(CRP) remission did not achieve Boolean remission. Compared with patients in Boolean remission, patients in SDAI or CDAI remission but not Boolean remission had higher PGA scores, while patients with DAS28(CRP) remission but not Boolean remission had higher joint counts, and PGA and PhGA scores. Conclusions Differences in PGA limit patients in SDAI/CDAI remission from meeting the Boolean remission criteria, suggesting that these criteria otherwise can be used interchangeably. In contrast, patients in DAS28(CRP) remission are limited by differences in multiple disease activity measures from achieving Boolean remission.

ObjectivesThis study aimed to evaluate different patient global assessment (PGA) cut-offs required in the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission definition for their utility in rheumatoid arthritis (RA).MethodsWe used data from six randomised controlled trials in early and established RA. We increased the threshold for the 0–10 score for PGA gradually from 1 to 3 in steps of 0.5 (Boolean1.5 to Boolean3.0) and omitted PGA completely (BooleanX) at 6 and 12 months. Agreement with the index-based (Simplified Disease Activity Index (SDAI)) remission definition was analysed using kappa, recursive partitioning (classification and regression tree (CART)) and receiver operating characteristics. The impact of achieving each definition on functional and radiographic outcomes after 1 year was explored.ResultsData from 1680 patients with early RA and 920 patients with established RA were included. The proportion of patients achieving Boolean remission increased with higher thresholds for PGA from 12.4% to 19.7% in early and 5.9% to 12.3% in established RA at 6 months. Best agreement with SDAI remission occurred at PGA cut-offs of 1.5 and 2.0, while agreement decreased with higher PGA (CART: optimal agreement at PGA≤1.6 cm; sensitivity of PGA≤1.5 95%). Changing PGA thresholds at 6 months did not affect radiographic progression at 12 months (mean ꙙsmTSS for Boolean, 1.5, 2.0, 2.5, 3.0, BooleanX: 0.35±5.4, 0.38±5.14, 0.41±5.1, 0.37±4.9, 0.34±4.9, 0.27±4.7). However, the proportion attaining HAQ≤0.5 was 90.2%, 87.9%, 85.2%, 81.1%, 80.7% and 73.1% for the respective Boolean definitions.ConclusionIncreasing the PGA cut-off to 1.5 cm would provide high consistency between Boolean with the index-based remission; the integer cut-off of 2.0 cm performed similarly.

Introduction Reactive oxygen metabolites (ROMs) are metabolite hydroperoxides in the blood, and their serum levels were associated with the disease activity score 28 (DAS28) in patients with rheumatoid arthritis (RA). In this study, we aimed to investigate whether ROMs would be predictive of the clinical disease activity index (CDAI) remission, simplified disease activity index (SDAI) remission, or Boolean remission. Materials and methods Fifty-one biologic agents (BA)-naïve RA patients were included in this observational study. Associations between ROMs, C-reactive protein, matrix metalloproteinase-3, DAS28-erythrocyte sedimentation rate (ESR), CDAI, SDAI, and health assessment questionnaire (HAQ) at 12 weeks and the DAS28, CDAI, SDAI, and Boolean remission rates at 52 weeks were investigated. Results The DAS28, CDAI, SDAI, and Boolean remission rates at 52 weeks were 66.7, 52.9, 54.9, and 54.9%, respectively. A multivariate logistic regression analysis revealed that ROMs and HAQ at 12 weeks were associated with the CDAI, SDAI, and Boolean remission at 52 weeks. Receiver operating characteristic analyses demonstrated that the cut-off value for CDAI, SDAI, and Boolean remission was 389.5 U.Carr. Conclusion Reactive oxygen metabolites at 12 weeks of initial treatment with BAs was a predictor for CDAI, SDAI, and Boolean remission at 52 weeks. Serum levels of ROMs may be a useful biomarker in the current treatment strategy aiming at early remission of RA.

The American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) preliminary criteria for remission in rheumatoid arthritis (RA) have found widespread endorsement and adoption since their publication in 2011 (box 1).1 Patients that fulfil the criteria are almost indistinguishable from healthy persons and live a normal life.2 Nevertheless, the criteria are also seen as too strict,3 as not including enough patient-important outcomes4; and their application in patient care, as advised by guideline committees, has problems. Most of the criticism focuses on the inclusion of patient global assessment (PGA) and its threshold. Box 1 ### American College of Rheumatology–European League Against Rheumatism remission criteria.1 #### Boolean-based definition At any time point, patient must satisfy all of the following: Tender joint count ≤l* Swollen joint count ≤l* C reactive protein ≤1 mg/dL Patient global assessment (PGA) ≤1 (on a 0–10 scale)† #### Index-based definition At any time point, patient must have a Simplified Disease Activity Index Score of ≤3.3‡

Tofacitinib has only been available in China for 2 years to treat rheumatoid arthritis (RA). Our purpose was to compare real-world effectiveness of tofacitinib with that of disease-modifying anti-rheumatic drugs (DMARDs) in Chinese patients with RA. The records of patients with RA treated at Guangdong Provincial People’s Hospital between July 2017 and September 2019 were retrospectively reviewed. Patients were divided into those treated with tofacitinib, biological DMARDs (bDMARDs), and conventional synthetic DMARDs (csDMARDs). Clinical disease activity index (CDAI), simplified disease activity index (SDAI), health assessment questionnaire-disability index (HAQ-DI), visual analog scale (VAS) pain score, patient global assessment of disease activity (PtGA), physician global assessment of disease activity (PhGA), and swollen joint and tender joint count were compared among the groups up to 12 months of treatment. A total of 150 patients were included: 63 were treated with tofacitinib, 48 with bDMARDs, and 39 with csDMARDs. Tofacitinib was first-line treatment in 26.98% of patients, second-line treatment in 49.21%, and third-line treatment in 26.98%. Patients in the tofacitinib group had significantly higher disease duration (6.11 ± 6.97 years) than those in the other groups. All disease indices in the three groups decreased with time, indicating improvement of symptoms, with no differences among the groups at 12 months. Tofacitinib appeared to improve symptoms more rapidly than other treatments; however, differences in disease indices were not significant. This real-world study suggests that tofacitinib is rapidly effective and that the effects are sustained after 12 months in Chinese patients with RA.

Background/Aims: The objective of this study was to compare changes in the simplified disease activity index (SDAI) between biologic (b) and conventional (c) disease-modifying antirheumatic drugs (DMARD) users with seropositive rheu matoid arthritis (RA) in daily clinical practice. Methods: This was a nationwide multicenter observational study. Patients who had three or more active joint counts and abnormal inf lammatory marker in blood test were enrolled. The selection of DMARDs was determined by the attending rheumatologist. Clinical parameters, laboratory findings, and Health Assessment Questionnaire (HAQ) scores were obtained at baseline and at 6 and 12 months. Se rial SDAI changes and clinical remission rate at 6 and 12 months were assessed. Results: A total of 850 patients participated in this study. The mean baseline SDAI score in bDMARD group was higher than that in cDMARD group (32.08 ± 12.98 vs 25.69 ± 10.97, p < 0.0001). Mean change of SDAI at 12 months was -19.0 in the bDMARD group and -12.6 in the cDMARD group (p < 0.0001). Clinical remission rates at 12 months in bDMARD and cDMARD groups were 15.4% and 14.6%, re spectively. Patient global assessment and HAQ at 12 months were also significantly improved in both groups. Multivariate logistic regression showed that baseline HAQ score was the most notable factor associated with remission. Conclusions: There was a significant reduction in SDAI within 12 months after receiving DMARDs in Korean seropositive RA patients irrespective of bDMARD or cDMARD use in real-world practice. Clinical remission was achieved in those with lower baseline HAQ scores.

Objective of this study is to evaluate the construct validity and the interpretability of the shortened Disability of Arm, Shoulder and Hand Questionnaire (QuickDASH) in the assessment of rheumatoid arthritis (RA) hand disability. Consecutive RA patients were assessed through the QuickDASH and other function and disease activity indices, respectively, the Health Assessment Questionnaire-Disability Index (HAQ-DI) and the Recent-Onset Arthritis Disability questionnaire (ROAD). For each patient were evaluated the tender and swollen 28-joints counts. Interpretability was defined determining cut-off points of impairment in accordance to the Simplified Disease Activity Index (SDAI) definition of disease activity states. A total of 440 patients (89 men and 351 women, mean age of 57.0 ± 12.7 years) were enrolled. Following the SDAI definition, 98 patients (22.3%) resulted in REM, 115 subjects (26.1%) in LDA, 74 patients (16.8%) in MDA, and 153 subjects (34.8%) in HDA. Mean QuickDASH differed significantly between patients classified as remission (REM), low disease activity (LDA), moderate disease activity (MDA), or high disease activity (HDA) (p 0.001). High correlations were found comparing QuickDASH to composite indices of disease activity and of physical health function: of special interest are the correlations between the comparable dimension of the QuickDASH and the ROAD Upper Extremity Function (rho = 0.876; p 0.001). The cut-off points for functional categories (SDAI categories as external criterion) resulted: no impairment ≤ 13, 13 low impairment ≤ 18.5, 18.5 moderate impairment ≤ 31.5, and high impairment 31.5. QuickDASH is useful in clinical practice, for its ease of administration, and positively correlates with the disease activity. It may be a surrogate for evaluating upper extremity impairment, disability index and disease control in RA patients.

Objective To predict the next-year status in patients with rheumatoid arthritis using big data. Methods Joint index (JI) of upper/large (UL), upper/small (US), lower/large (LL), and lower/small (LS) was calculated as the sum of tender and swollen joint counts divided by the number of evaluable joints in each region of interest. Joint index vector V (x, y, z) was defined as x = JIUL + JIUS, y = JILL + JILS, and z = JIUL + JILL − JIUS − JILS. Low disease activity was defined as |Vxy| (= √x2 + y2) ≤ 0.1. Patients with |Vxy| > 0.1 were further classified into three groups: evenly affected (EVN): |z| ≤ 0.2, small joint dominant (SML): z 0.2. To predict the next-year V (x, y, z) of each patient, a transformation matrix was computed from the mean vectors of the EVN, SML, and LAR groups and their translation vectors. Results |Vxy| was correlated with Simplified Disease Activity Index (SDAI) (r = 0.82). Z of mean vector increased as the disability index of the Health Assessment Questionnaire (HAQ-DI) and the Steinbrocker class worsened. The LAR group had the worst HAQ-DI and the second highest SDAI after those in the SML group. Positive predictive value and likelihood ratio in predicting the LAR group were 58.7% and 5.9, respectively. Likelihood ratio was greater with treatment, at 7.2, 7.4, and 8.6 when targeted patients were treated with methotrexate, biologics, and both drugs, respectively. Conclusions Patients with high disease activity and poor functional state were predicted with high probability using joint index vectors.

Objectives:Elderly-onset rheumatoid arthritis (EORA) is reported to differ from young-onset rheumatoid arthritis (YORA) with regard to patient background and drug treatment. We examined the amount of drug administered to patients who achieved low disease activity (LDA) for rheumatoid arthritis at our hospital., Methods:Demographics, clinical history, and treatments were compared between patients with EORA (n = 70) and YORA (n = 190)., Results:There was a significant difference in the average age (73.8 vs. 57.8 years), disease duration (6.66 vs. 14.7 years), and sex (62.9% males vs. 83.7% females), but no difference in rheumatoid factor positivity (85.3% vs. 80.7%), anti-citrullinated peptide antibody positivity (86.5% vs. 87.7%), simplified disease activity index (4.28 vs. 4.59), or disease activity score 28-CRP (1.99 vs. 2.04) in the EORA and YORA groups, respectively. There were also no significant differences in prednisolone use (37.1% vs. 36.3%), amount of methotrexate administered (MTX) (1.45 vs. 1.41 mg), and MTX use (55.7% vs. 65.3%). However, the MTX dose (2.89 vs. 4.09 mg/week, p = .011) and overall biologics use (32.9% vs. 56.3%, p = .0012) were significantly lower in patients with EORA than in those with YORA., Conclusion:Patients with EORA may be able to achieve LDA with lower drug dosage than those with YORA.

This prospective one-year follow-up study was conducted from 835 visits in 178 rheumatoid arthritis (RA) patients. Tender-/swollen-joint count, Health Assessment Questionnaire Disability Index (HAQ-DI), Disease Activity Score 28-ESR (DAS28-ESR), DAS28-CRP, Simplified Disease Activity Index (SDAI) and DAS28-monocyte chemotactic protein-1 (DAS28-MCP-1) scores were obtained every 3 months. Radiographs of hands and feet were acquired at baseline and one year. We evaluated the correlation and accuracy of activity scores in predicting remission, HAQ-DI changes and radiographic changes. DAS28-MCP-1 correlated strongly with DAS28-ESR, DAS28-CRP and SDAI scores (0.830, 0.899 and 0.931, respectively, with all P P P = 0.002) and 0.98, respectively (and DAS28-MCP-1 with DAS28-CRP

Objectives We explored rheumatoid arthritis (RA) disease activity before, during, and after pregnancy in patients treated with tight control and investigated the association between disease activity in the postpartum period and those before and during pregnancy. Methods We retrospectively reviewed disease activity and medications of 27 patients before pregnancy, at every trimester, and in the postpartum period. Results Prednisolone was administered to 33% of patients with a median dose of 0 (0-2.5) mg/day and biologic agents was 78% in the third trimester. The median remission rates during all periods were the Disease Activity Score-28-C-reactive Protein assessed with three variables (DAS28-CRP-3) 85%, Simplified Disease Activity Index (SDAI) 55%, and Clinical Disease Activity Index (CDAI) 54%. Although SDAI and CDAI decreased significantly from before pregnancy to the first trimester and increased from the third trimester to the postpartum period, DAS28-CRP-3 did not change during all periods. Although SDAI and CDAI before and during pregnancy were significantly correlated with those in the postpartum period, DAS28-CRP-3 was not. Conclusions Tight control before pregnancy suppressed RA disease activity during pregnancy and in the postpartum period. SDAI/CDAI before and during pregnancy were predictive for disease activity in the postpartum period.

Fatigue is a symptom that affects the 40-80% of patients with rheumatoid arthritis (RA) and impairs the quality of life. The aim of this study was to assess multidimensional fatigue scales, the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ) and the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS) and to evaluate their relationship with disease activity in Turkish RA patients. The study included 180 patients with RA. The Disease Activity Score (DAS28), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index (SDAI) were used to evaluate disease activity. The participants comprised of 142 females and 38 males. The mean ± standard deviations of DAS28, CDAI, and SDAI were 3 ± 1.24, 9.51 ± 7.96, and 10.5 ± 8.38 respectively. All scales except the emotional subscale were correlated with disease activity. The emotional subscale correlated with CDAI and SDAI but not with DAS28. The results of the study indicated that fatigue and disease activity were correlated. Fatigue is a symptom that impairs the quality of life but it can be easily coped with by controlling disease activity. Thus, it should be assessed in a multidimensional perspective.

Objective.We examined agreement between the American College of Rheumatology (ACR), European League Against Rheumatism (EULAR), and Simplified Disease Activity Index (SDAI) response criteria in rheumatoid arthritis (RA) and tested whether discordant responses were associated with patients’ baseline characteristics or changes in RA activity encapsulated by the different criteria.Methods.In a prospective longitudinal study, we examined responses of 243 patients with active RA to escalation of antirheumatic treatment. We computed agreement between pairs of response criteria using κ coefficients and identified patient characteristics associated with unique responses to individual criteria.Results.We found that 110 patients (45.3%) had an ACR 20% improvement (ACR20) response, 135 (55.5%) had a EULAR moderate/good response, and 83 (34.1%) had an SDAI50 response. Agreement was moderate to good (ACR20/EULAR κ 0.57; ACR20/SDAI50 κ 0.64; EULAR/SDAI50 κ 0.59). All who had SDAI50 response also had a EULAR response. Patient characteristics at baseline generally did not distinguish those who responded to both, 1, or neither criterion. Discordance was most often because of improvements in the erythrocyte sedimentation rate or C-reactive protein level among EULAR and SDAI50 responders, which were not as common among ACR20 responders. Based on receiver-operating characteristic curves, SDAI35 response had a better balance of sensitivity and specificity relative to ACR20 and EULAR moderate/good responses than SDAI50.Conclusion.Discordant responses to RA improvement criteria are most often because of differences in responses of acute-phase reactants. SDAI35 response had higher sensitivity for improvement, as reflected by other response criteria, than SDAI50 response.

Background Clinical remission is an attainable goal for Rheumatoid Arthritis (RA). However, data on RA remission rates from multinational studies in the Asia-Pacific region are limited. We conducted a cross-sectional multicentric study to evaluate the clinical remission status and the related factors in RA patients in the Asia-Pacific region. Methods RA patients receiving standard care were enrolled consecutively from 17 sites in 11 countries from APLAR RA SIG group. Data were collected on-site by rheumatologists with a standardized case-report form. Remission was analyzed by different definitions including disease activity score using 28 joints (DAS28) based on ESR and CRP, clinical disease activity index (CDAI), simplified disease activity index (SDAI), Boolean remission definition, and clinical deep remission (CliDR). Logistic regression was used to determine related factors of remission. Findings A total of 2010 RA patients was included in the study, the overall remission rates were 62•3% (DAS28-CRP), 35•5% (DAS28-ESR), 30•8% (CDAI), 26•5% (SDAI), 24•7% (Boolean), and 17•1% (CliDR), respectively, and varied from countries to countries in the Asia-Pacific region. Biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) prescription rate was low (17•9%). Compared to patients in non-remission, patients in remission had higher rates of b/tsDMARDs usage and lower rates of GC usage. The favorable related factors were male sex, younger age, fewer comorbidities, fewer extra-articular manifestations (EAM), and use of b/tsDMARDs, while treatment with GC was negatively related to remission. Interpretation Remission rates were low and varied in the Asia-Pacific region. Treatment with b/tsDMARDs and less GC usage were related to higher remission rate. There is an unmet need for RA remission in the Asia-Pacific region. Funding Macao science and technology development fund (0094/2018/A3) (partial).

The aim of the study is to assess the factors associated with clinical remission of patients with rheumatoid arthritis (RA) in daily clinical practice.This analysis was based on the data of 304 RA patients in our center between May 2014 and March 2015. The following information was included: tender, swollen, and symptomatic joint counts, patient's and physician's global assessments, functional disability, laboratory and radiographic data, and RA treatments received.The patients were predominantly female (77.6%), with a median age of 71 years and a median disease duration of 5.8 years. Clinical remission rate, determined using the simplified disease activity index (SDAI), was 49.7%. Patient's and physician's global assessments (/10cm) showed a higher score among patients who did not achieve SDAI remission than among those who did (median: 3.2 versus 0.3, p0.0001; and median: 1.8 versus 0.3, p0.0001, respectively). The contribution of serum C-reactive protein values (mg/dL) to SDAI was limited (median: 0.19 versus 0.06; p0.0001), as well as tender or swollen joint counts (median = 0 or 1). On multivariate analysis of factors not directly related to the disease activity, age was an independent risk factor for non-remission, and global assessment scores by patients and physicians showed an age-dependent increase, while counts of tender, swollen and symptomatic joints were comparable among elderly and non-elderly patients.Global assessment of disease activity was age-dependent and independent of joint counts, and it provides a critical determinant of clinical non-remission.

We aimed to compare composite indices with Ultrasound Global Synovitis Score (GLOESS) for remission in rheumatoid arthritis (RA). RA patients in remission according to the clinician were investigated with Disease Activity Score28 (DAS28), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and RAPID-3 (Routine Assessment of Patient Index Data 3). Ultrasonography was performed using the GLOESS scores. Patients in CDAI-remission had lower GLOESS (median (IQR), 5(3-9.75) vs 7(4-11.75), p = 0.048) with a similar trend in SDAI (5(3-9.25) vs 7(4-11.25), p = 0.064). This was not observed with DAS28-CRP and RAPID3. Our results show that CDAI is superior to other indices to assess remission in RA.

We read with great interest the article by Curtis et al on etanercept or methotrexate withdrawal in rheumatoid arthritis. They have taken patients in sustained and deep remission- fulfilling the stringent Simplified Disease Activity Index (SDAI) criteria and simulated near-ideal conditions, before withdrawing either methotrexate or etanercept from the regimen. They have then observed the proportion of patients who maintained SDAI remission at week 48.

Background:Therapeutic decisions in RA patients should be based on regular disease activity assessment using scores like the Simplified Disease Activity Index (SDAI) or the Clinical Disease Activity Index (CDAI) [1]. The CDAI has the benefit of being immediately available, while the SDAI encompasses with the C-reactive protein (CRP) an acute phase reactant and therefore is the recommended score for the use in clinical trials. However, CRP determination takes hours to days, thus hindering the treat-to-target concept using the SDAI. Quick quantitative CRP (qCRP) tests allow CRP measurement within a few minutes. Therefore, qCRP based SDAI (SDAI-Q) could combine the advantages of both scores.Objectives:To validate the SDAI-Q in a prospective, multicenter study of RA patients.Methods:The study was conducted in five centers in Berlin, Germany. Consecutive adult (≥ 18 years) RA patients were included. In addition to a rheumatological assessment, including patient reported outcomes, routine CRP was measured in the local labs. Additionally, a qCRP testing with the „QuikRead go instrument“ (Aidian Oy, Finland) was performed locally (measurement range 0.5 - 200 mg/l). Statistical analysis included descriptive statistics, cross tabulation and weighted Cohen´s kappa comparing disease activity categories, Bland-Altman plots and intraclass correlation coefficient (ICC) for CRP, qCRP, SDAI, SDAI-Q and CDAI.Results:In this study 100 RA patients were included (mean age: 60.9 years, mean disease duration: 11.4 years, 73.0% were female, 63.0% RF positive, 57.0% ACPA positive, 49.0% positive and 29% negative for both parameters). 75.0% were treated with csDMARD, 15% with tsDMARDs, 39.0% with bDMARDs and 40% with glucocorticoids (mean prednisolone equivalent: 5.4 mg prednisolone/d). Mean CRP and qCRP-levels were 6.97 and 7.89 mg/l, respectively (ICC 0.992; 95%CI: 0.987; 0.995). Comparing SDAI-Q and SDAI, all patients (100%) achieved the same disease activity status (Table 1A); weighted Cohen´s kappa was 1.000 (95%CI: 1.000; 1.000). ICC for SDAI-Q- and SDAI-values was 1.000 (95%CI: 1.000; 1.000). The agreement of SDAI-Q and SDAI is shown in a Bland-Altman plot (Figure 1). When comparing the CDAI with the SDAI-Q 93 patients (93%) were assigned to the same disease activity category (Table 1B); weighted Cohen´s kappa was 0.929 (95%CI: 0.878; 0.981). ICC for numerical values of SDAI-Q and CDAI was 0.989 (95%CI: 0.978; 0.994).Conclusion:SDAI-Q showed an absolute agreement with SDAI on the assignment to disease activity categories with the important advantage of time. With SDAI-Q, rheumatologists could base their clinical decision-making immediately on an index-based disease activity measurement by using a composite score considering acute phase reactants. Consequently, SDAI-Q can be integrated in clinical routine and clinical trials and could be implemented into the treat-to-target concept in RA patients.References:[1]Smolen JS, et al. Ann Rheum Dis. 2016 Jan; 75(1):3-15.Table 1.A) Disease activity categories by SDAI-Q vs. SDAI; B) Disease activity categories by SDAI-Q vs. CDAIASDAI-Q (n = 100)Remission (≤ 3.3)Low Disease Activity (> 3.3 and ≤ 11)Moderate Disease Activity (> 11 and ≤ 26)High Disease Activity (> 26)SDAIRemission (≤ 3.3)28 (28.0%)Low Disease Activity (> 3.3 and ≤ 11)31 (31.0%)Moderate Disease Activity (> 11 and ≤ 26)35 (35.0%)High Disease Activity (> 26)6 (6.0%)BSDAI-Q (n = 100)Remission (≤ 3.3)Low Disease Activity (> 3.3 and ≤ 11)Moderate Disease Activity (> 11 and ≤ 26)High Disease Activity (> 26)CDAIRemission (≤ 2.8)26 (26.0%)Low Disease Activity (> 2.8 and ≤ 10)2 (2.0%)28 (28.0%)2 (2.0%)Moderate Disease Activity (> 10 and ≤ 22)3 (3.0%)33 (33.0%)High Disease Activity (> 22)6 (6.0%)Fields highlighted in red indicate that disease activity categories do not match.SDAI = Simplified Disease Activity Index;SDAI-Q = SDAI calculated with a quick quantitative CRP assay;CDAI = Clinical Disease Activity Index.Figure 1.Bland-Altman plot for SDAI and SDAI-Q AcknowledgementsThe authors would like to deeply thank Braun T, Doerwald C, Deter N, Höppner C, Lackinger J, Lorenz C, Lunkwitz K, Mandt B, Sron S and Zernicke J for their practical support and coordinating the study.Funding statement:The AQUA study was supported by an unrestricted research grant from Novartis. Testing kits were provided free of charge from Aidian Oy, Finland.Disclosure of Interests:None declared

Background:Routine Assessment of Patient Index Data 3 (RAPID3) is a pooled index of 3 patient-reported measures: patient global assessment, pain, and physical function. RAPID3 was shown to correlate with other composite measures of disease activity1 and is recommended by the American College of Rheumatology for use in clinical practice.2Objectives:To evaluate the impact of upadacitinib (UPA) versus comparators on RAPID3 over 60 weeks, as well as the correlation of RAPID3 scores with other disease measures in the UPA phase 3 SELECT clinical program.Methods:This post hoc analysis included placebo-controlled (SELECT-NEXT, -BEYOND, and -COMPARE) and active comparator-controlled (SELECT-EARLY, -MONOTHERAPY, and -COMPARE) trials. Patients received UPA as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Mean change from baseline in RAPID3 and the proportion of patients reporting RAPID3 remission (≤3), low (LDA, >3 to ≤6), moderate (MDA, >6 to ≤12), and high disease activity (HDA, >12) were assessed. Correlations between absolute scores for RAPID3 and Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and 28-joint Disease Activity Score with C-reactive protein (DAS28[CRP]) were assessed using Spearman correlation coefficients. All data are as observed.Results:A total of 661, 498, 648, 1629, and 945 patients were included from SELECT-NEXT, -BEYOND, -MONOTHERAPY, -COMPARE, and -EARLY. At baseline, the majority of patients across all studies were in RAPID3 HDA (mean baseline RAPID3 [across all studies], 17.2–19.2) (Table 1 and Figure 1). Improvements from baseline in RAPID3 were observed with UPA 15 mg and 30 mg through Week 60, with numerically greater improvements observed with UPA compared with active comparators (Table 1). Across studies, mean improvements in RAPID3 exceeded the minimal clinically important difference (MCID) with UPA and adalimumab (ADA) treatment (MCID=3.83). By Week 60, approximately one-half of UPA-treated patients were in RAPID3 remission or LDA, with only 10–25% remaining in HDA, except for the more refractory population in SELECT-BEYOND, in which ~38% of patients remained in HDA (Figure 1). RAPID3 scores moderately to strongly correlated with CDAI (ρ=0.69–0.83), SDAI (ρ=0.69–0.82), and DAS28(CRP) (ρ=0.58–0.77), across all studies, at Week 60 (all pConclusion:UPA, as monotherapy or in combination with csDMARDs, was associated with improvements in patient-reported disease activity, pain, and physical function, as assessed by RAPID3 over 60 weeks in the phase 3 SELECT clinical program. RAPID3 continues to be an important tool in clinical practice to assess disease activity, as it was shown to correlate to other disease activity measures and allows for rapid scoring.References:[1]Pincus T, et al. Arthritis Care Res (Hoboken) 2010;62:181–9.[2]England BR, et al. Arthritis Care Res (Hoboken) 2019;71:1540–55.[3]Ward MM, et al. J Rheumatol 2019;46:27–30.Table 1.Change from BL in RAPID3 at Week 60 (as observed)Phase 3 studyGroupnaMean (SD) BL scoreMean (SD) change from BLbSELECT-EARLYc(MTX-naïve)MTX23618.5 (5.6)−9.6 (7.5)UPA 15 mg QD26918.9 (5.6)−12.0 (7.6)UPA 30 mg QD25318.2 (5.6)−13.4 (7.2)SELECT-NEXT(csDMARD-IR)UPA 15 mg QD17217.7 (5.1)−11.1 (7.3)UPA 30 mg QD17217.6 (5.3)−10.4 (6.8)SELECT-MONOTHERAPY(MTX-IR)UPA 15 mg QD17217.4 (5.8)−9.6 (7.4)UPA 30 mg QD18017.2 (5.9)−10.6 (7.2)SELECT-COMPAREc(MTX-IR)UPA 15 mg QD55218.5 (5.5)−10.2 (7.1)ADA 40 mg EOW26418.7 (5.4)−8.8 (6.7)SELECT-BEYOND(bDMARD-IR)UPA 15 mg QD13319.2 (5.1)−8.6 (6.8)UPA 30 mg QD11818.5 (5.3)−9.3 (7.3)b, biologic; BL, baseline; EOW, every other week; IR, inadequate response; MTX, methotrexate; QD, once daily; SD, standard deviationaNumber of patients with RAPID3 values at both BL and Week 60. bNegative values indicate improvement from BL. cObserved data include patients rescued to UPA and/or ADA; treatment effect may include both the randomized and switch treatments in these patientsAcknowledgements:AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and participated in the writing, review, and approval of the abstract. No honoraria or payments were made for authorship. Medical writing support was provided by Grant Kirkpatrick, MSc, of 2 the Nth (Cheshire, UK), and was funded by AbbVie.Disclosure of Interests:Martin Bergman Shareholder of: Johnson & Johnson, Speakers bureau: AbbVie, Celgene, GSK, MSD, Novartis, Pfizer, and Sanofi/Regeneron, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Genentech/Roche, Gilead, Horizon, Janssen, MSD, Novartis, Pfizer, Sandoz, Sanofi/Regeneron, and Scipher, Maya H Buch Consultant of: AbbVie, Eli Lilly, Merck-Serono, Pfizer, Sandoz, and Sanofi, Grant/research support from: Pfizer, Roche, and UCB, Yoshiya Tanaka Speakers bureau: AbbVie, Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, GSK, Janssen, Mitsubishi Tanabe, Novartis, Pfizer, Sanofi, Takeda, UCB, and YL Biologics, Grant/research support from: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Mitsubishi Tanabe, MSD, Ono, Taisho Toyama, and Takeda, Gustavo Citera Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Genzyme, Pfizer, and Roche, Sami Bahlas: None declared, Ernest Wong Consultant of: AbbVie, Chugai, Eli Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, Chugai, Novartis, and UCB, Yanna Song Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Namita Tundia Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Jessica Suboticki Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Vibeke Strand Consultant of: AbbVie, Amgen, Arena, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Gilead, Ichnos, Inmedix, Janssen, Kiniksa, MSD, Myriad Genetics, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Scipher, Setpoint, and UCB.

Objectives:Rheumatoid arthritis (RA) is a chronic inflammatory disease that involves various joints in whole body. For evaluation of daily life activities (ADL), modified Health Assessment Questionnaire (mHAQ) is usually used. This index configures eight ADL functions these are separated by predominant extremities. This study aimed to evaluate how involved joint affect ADL predominantly in real world setting.Methods:A total of 24,450 times of consultation with RA patient were visited in the institute. Here, patient with RA was interviewed every another visit, and involved joint in whole body, pain score with visual analog scale (PS-VAS), and mHAQ were recorded. Involved joints were divided by four regions in accordance with joint size and part; small joint in upper extremities (US), large joint in upper extremities (UL), small joint in lower extremities (LS), and large joint in lower extremities (LL). mHAQ was also separately evaluated in accordance with predominant regions; upper extremities predominant mHAQ (mHAQ_UE), and lower extremities predominant mHAQ (mHAQ_LE). Adding to these parameters, as an index for disease activity monitoring, components of the simplified disease activity index score (SDAI) was also recorded. Relationship between mHAQ for each predominant extremities, and these parameters and sex, age, disease duration of RA, anti-cyclic citrullinated polypeptide antibodies (ACPA), rheumatoid factor (RF), and Sharp/van der Heijde score (SHS), were statistically evaluated using linear regression analysis.Results:mHAQ_UE significantly correlated with age, ACPA and RF titre, SHS, tenderness joint count (TJC), patient’s global assessment (PGA), evaluator’s global assessment (EGA), C-reactive protein (CRP), US, UL, LL, and PS-vas, whereas mHAQ-LE significantly correlated with all parameters that demonstrated significant correlation with mHAQ-UE and disease duration. mHAQ also correlated with all parameters those that demonstrated significant correlation with mHAQ-LE. Interestingly, all of mHAQ-UE, mHAQ-LE, and mHAQ did not correlated significantly with swollen joint count (SJC) and LS.Conclusion:mHAQ is influenced by various factors, however, SJC and involvement of small joint in lower extremities did not affect mHAQ.Disclosure of Interests:None declared

Background/Purpose To compare the performance of Disease Assessment Score of 28 joints – C-reactive protein (DAS-28-CRP), Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) composite measures to assess status of patients with rheumatoid arthritis (RA) on methotrexate, versus DAS-28 CRP as the gold standard. Methods One hundred and thirty-five patients with RA as per the 2010 American College of Rheumatology/European League Against Rheumatism criteria were included in the prospective study. The disease activity was assessed at baseline and at every 6 weeks for 24 weeks, by DAS-28-CRP, CDAI and SDAI. Patients were divided into groups of remission, low, moderate and high activity on the basis of predefined cut-offs for DAS-28-CRP, CDAI and SDAI. A Spearman correlation between composite measures and inter-group comparison of the measures was performed. Results There was an excellent positive correlation between DAS-28-CRP and CDAI (linear weighted κ baseline – 0.545), DAS-28 CRP and SDAI (linear weighted κ – 0.689) at baseline. There was moderate agreement between DAS-28-CRP and CDAI (linear weighted κ final visit – 0.458) at final visit. There was moderate correlation between SDAI and DAS-28-CRP at final visit (linear weighted κ – 0.470). However, correlation between CDAI versus SDAI remained excellent at baseline and final visit. Patients in remission as per DAS-28-CRP had significantly more residual disease activity compared to SDAI and CDAI remission criteria. Conclusion The study shows an excellent strong positive correlation between DAS-28-CRP, CDAI and SDAI at initial evaluation but not at final visit. SDAI- and CDAI-based remission criteria seem to be better than DAS-28-CRP-based remission criteria.

Objective The objective of this study was to confirm the efficacy of low-dose mizoribine (MZR), an inhibitor of inosine monophosphate dehydrogenase, as part of synchronized methotrexate (MTX) therapy for rheumatoid arthritis (RA) patients with an inadequate response to various combination therapies of MTX, other synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biological DMARDs. Methods Low-dose MZR was administered to 56 uncontrolled RA patients being treated with MTX and various biological DMARDs. The observation period was 12 months, and the disease activity was evaluated based on the Disease Activity Score in 28 joints (DAS28)-ESR, Simplified Disease Activity Index (SDAI) and serum MMP-3 level. Results All of the disease activity indices were significantly improved within three months, and the serum MMP-3 levels were also significantly decreased around four months after starting low-dose MZR therapy. No patients experienced any adverse effects. Conclusion The present preliminary findings suggest that low-dose MZR therapy with MTX should be considered for the treatment of RA patients with an inadequate response to various combination therapies including MTX, other synthetic DMARDs and biological DMARDs or in whom increasing the dose of MTX is difficult for reasons such as adverse effects and complications.

Background Current recommendations on the treatment of Rheumatoid Arthritis (RA) are based on a treat to target approach, nevertheless which biologic drug should be used in an unresponsive patient is not clarified (1). Such a strategy is essentially justified by the fact that no biotechnological drug has proved to be superior to any other (2). Recent studies have reported some disease or patient features that are associated with a greater or lesser likelihood of response (3). Nevertheless, an adapted therapy to the single patient and based on physiopathological mechanisms has not been acquired yet. Objectives Aim of this study was to evaluate if the choice of a tailored therapy, based on patient and disease features, would be an effective strategy. Methods From April 1st 2017, at our Department of Rheumatology of the University of Campania, each patient with RA has been characterized, at enrolment, for demographic and disease features, and started a biological Disease-modifying antirheumatic drug based on an established algorithm (Figure 1). Attainment of the targeted end point i.e. remission (R) as assessed by Simplified Disease Activity Index (SDAI) Results Forty-nine patients were admitted to our centre from April 1st2017 to December 31st2018. Out of them, 36 patients have been followed up at least for 3 months and were included in the study (algorithm+ patients). Out of them, 26 (72.2%) reached 6 months of treatment, while 16 (44.4%) 12 months of treatment. Among the 26 patients evaluated at 6 months, 23(88.5%) achieved the targeted end point. At 12 months, 16/16 patients (100%) preserved a status of remission or at least low disease activity. We compared our results to those registered, from January 2015 to September 2016, in a RA cohort of 79 patients (RA general cohort). We found a significant difference in regard to attainment of the target at 6 months (23/26 patients, 88.5% algorithm+ vs 45/67 patients, 67.2% RA general cohort; p=0.04) and at 12 months (16/16 patients, 100% algorithm+ vs 40/57 patients, 70.2% RA general cohort; p=0.01) (Table 1). Notably, 32 out of the 79 patients had undergone a biological drug which didn’t follow the predefined algorithm. These patients (algorithm- patients) presented a further lower incidence of response with regard to those enrolled according to the algorithm: 22/32 patients (68.7%) at 3 months; p=0.4; 17/29 (58.6%) at 6 months; p=0.001; 17/24 (70.8%) at 12 months; p=0.03). Conclusion The choice of a personalized approach toward treatment of RA might be an effective strategy to achieve the targeted end point of remission or at least low disease activity in every patient. References [1] Smolen JS et al. Ann Rheum Dis 2017;76:960–77 [2] Pierreisnard A et al. Joint Bone Spine. 2013;80:386-92. [3] Daien CI et al. Mediators of Inflammation 2014;2014:386148 Disclosure of Interests DANIELA IACONO Speakers bureau: PFIZER company, Ilenia Pantano: None declared, SERENA FASANO: None declared, GIUSEPPE SCALISE: None declared, Francesco Ciccia Grant/research support from: CELGENE, PFIZER, Consultant for: UCB, NOVARTIS, CELGENE, PFIZER, LILLY, Paid instructor for: UCB, NOVARTIS, CELGENE, PFIZER, LILLY, JANSSEN, Speakers bureau: UCB, NOVARTIS, CELGENE, PFIZER, LILLY, JANSSEN, MSD, ROCHE, AMGEN

Choosing between the different disease activity indices used for rheumatoid arthritis RA evaluation in clinical practice and research is often difficult. The aim of the current study was to compare clinical disease activity index (CDAI) to simplified disease activity index (SDAI), and disease activity score 28 (DAS28) regarding inter-observer reliability and correlation to the modified health assessment questionnaire (MHAQ) in a cohort of Egyptian RA patients. This study included one hundred RA patients. Every patient had an independent clinical evaluation made by two rheumatologists (professor and candidate) to evaluate disease activity using DAS28 with its 4 types, CDAI and SDAI. We used Cohen’s weighted kappa coefficient to measure the inter-observer agreement between the professor and candidate in different disease activity measures. Correlation between MHAQ and disease activity measures was made with Spearman’s rho test. Inter-observer agreement in CDAI and DAS28 values was almost perfect. A strong positive correlation was found between professor and candidate regarding the tested activity indices (p

Background Previous studies suggest that RA activity is sensitive to seasonal changes. This study explored the influence of season on RA activity, particularly the distribution of affected joints, using a nationwide database in Japan. Methods We investigated 12,839 patients whose RA activity was recorded in spring (n = 3250), summer (n = 916), fall (n = 1021), and winter (n = 7652). Disease activity score (DAS) 28-CRP, simplified disease activity index (SDAI), and clinical disease activity index (CDAI) were used as indices of disease activity. Disease activity was also assessed according to DAS28-CRP scores (remission, low, moderate, or high). The affected joint distribution was investigated using novel joint indices (x, y, z), where x and y are indices for the upper and lower joints, respectively, and z is the index for large joint predominance. Results Mean DAS28-CRP and median SDAI and CDAI scores were highest in spring and lowest in fall. There was a significant difference in the DAS28-CRP for fall versus spring and winter. Fall was associated with a higher remission rate, and spring and winter with high and moderate RA activity, respectively. Significant differences in x, y, SDAI, and CDAI scores were found for spring versus summer, fall, and winter, in addition to fall versus winter (except in y). There was no seasonal difference in the z index. Conclusions RA activity in the upper and lower extremities may be highest in spring, followed by winter. Seasonal changes should be considered in patients with RA to better understand their symptoms.

Objective.It has been proposed that remission should be maintained throughout the course of rheumatoid arthritis (RA); however, the evidence supporting this is limited. Physical function measured by the Health Assessment Questionnaire (HAQ) is a major outcome in RA, and HAQ is shown to be one of the strongest predictors of longterm outcomes. The purpose of this study was to investigate the physical function over a long time in patients with RA who achieved sustained remission (SR) compared with that of patients occasionally achieving remission [non-sustained remission (NSR)].Methods.Patients with RA treated with antitumor necrosis factor and included in the South Swedish Arthritis Treatment Group register were eligible for this study. We identified patients with a Disease Activity Score at 28 joints (DAS28) < 2.6 or Simplified Disease Activity Index (SDAI) ≤ 3.3 at some point and those who achieved SR, i.e., remission during consecutive visits for at least 6 months. The course of functional status was assessed using the HAQ at each visit.Results.Of the 2416 patients, 1177 (48.7%) reached DAS28 remission at some point. SR was achieved by 382 (15.8%) for the DAS28 and 186 (7.7%) for the SDAI criteria. Comparing the SR and NSR groups, HAQ improved during the first 12 months in the DAS28 remission. HAQ continued to improve relatively as long as SR was maintained. A higher proportion of patients in SR reached full physical function.Conclusion.In patients with established RA, physical function measured by the HAQ improves in patients reaching SR compared with patients who only occasionally reach remission. The improvement continues while in remission, which supports that maintaining remission should be a treatment goal.

To evaluate the efficacy of switching the route from intravenous tocilizumab (TCZ) infusion (TCZ-IV) to subcutaneous TCZ injection (TCZ-SC) in a real-world setting through a comparison of the clinical response.Fifty-eight rheumatoid arthritis (RA) patients, for whom TCZ-SC was initiated following TCZ-IV between June 2013 and August 2014, were consecutively enrolled. Disease activity score (DAS)28-ESR, simplified disease activity index (SDAI), and clinical disease activity index (CDAI) were examined at baseline and after switching from TCZ-IV to TCZ-SC for 3 months. We investigated whether body weight and body mass index (BMI) affected the efficacy of TCZ-SC.Most of the patients had achieved remission or low disease activity at baseline (77.6% examined by DAS28). Fifty-seven patients (98%) continued the TCZ-SC treatment, and the disease activity was well controlled after 3 months. ΔDAS28 tended to be worsened after switching to TCZ-SC in the high-body-weight groups (≥60 kg) as compared with the groups with body weight 60 kg, although no statistical significance was found. BMI did not affect the efficacy of TCZ-SC.Caution should be exercised in the high-body-weight subjects, but these data indicate that TCZ-SC maintains the favorable RA disease activity established using TCZ-IV.

Background:We previously reported that glucocorticoid (GC) use was an independent risk factor for developing sarcopenia in patients with rheumatoid arthritis (RA)1. On the other hand, sarcopenia was not associated with deterioration of muscle function (dynapenia)2.Objectives:Factors associated with deterioration of muscle quality and function were prospectively investigated.Methods:Muscle quality and function were examined by measuring power, speed, and balance in standing-up motion using an exercise functional analysis device (BM-220, Tanita, Japan) at baseline and at 2-year follow-up in the prospective, observational CHIKARA study. Associations between changes in these parameters (Δ muscle quality, Δ muscle function) and body composition, disease activity, treatment, physical function, and history of falls and fractures were investigated by univariate and multivariate analyses.Results:Eighty-one RA patients completed the survey. Their average age was 66 years, disease duration was 5.3 years, the simplified disease activity index (SDAI) was 5.3, and the modified Health Assessment Questionnaire (mHAQ) was 0.25 at baseline. Of the patients, 12.3% used GCs at an average dose of 3.08 mg/day over 2 years. The average GC dose was negatively correlated with changes in muscle quality (r=-0.25, p=0.03), power (r=-0.23, p=0.04), and speed (r=-0.24, p=0.03). The SDAI at baseline was negatively correlated with power (r=-0.23, p=0.04) and speed (r=-0.22, p=0.05) (Table 1). No factor was associated with the mHAQ and a history of falls. No independent factor was identified on multiple regression analysis.Table 1.Associations between changes in muscle quality and function and body composition, disease activity, treatment, physical function, and history of falls and fracturesΔ muscle qualityΔ muscle functionpowerspeedbalancerprprprpage, years-0.210.063-0.110.337-0.230.0410.180.105GC dose, mg/day-0.250.025-0.230.041-0.240.032-0.020.883CRP, mg/dl0.010.9100.030.7810.030.7990.200.067MMP-3, ng/ml-0.250.022-0.130.249-0.170.1340.020.847DAS28ESR-0.090.441-0.050.665-0.090.4350.010.961SDAI-0.140.216-0.230.041-0.220.0480.010.917mHAQ-0.130.248-0.040.728-0.060.578-0.060.585SMI, kg/m20.030.7640.9980.030.7610.240.034BMR, kcal/day0.050.2780.010.960.110.3220.180.111fall0.070.5310.120.2860.020.871-0.020.852fracture0.9730.989-0.050.677-0.190.097Δ, changes from baseline; GC, glucocorticoid; CRP, C-reactive protein; MMP-3, matrix metalloproteinase 3; DAS, Disease Activity Score; ESR, erythrocyte sedimentation rate; SDAI, simplified disease activity index; mHAQ, modified Health Assessment Questionnaire; SMI, skeletal muscle index; BMR, basal metabolic rate.Conclusion:GC use was associated with deterioration in muscle quality and function, as well as sarcopenia development. GC use adversely affected muscle mass, quality, and function. In addition, since high disease activity led to low exercise function, disease activity control is important to prevent deterioration of exercise function.References:[1]Y Yamada, M Tada, K Mandai et al. Glucocorticoid use is an independent risk factor for developing sarcopenia in patients with rheumatoid arthritis: from the CHIKARA study. Clin Rheumatol 2020 Jan 14. Epub ahead of print.[2]M Tada, Y Yamada, K Mandai et al. Correlation between frailty and disease activity in patients with rheumatoid arthritis: Data from the CHIKARA study. Geriatr. Gerontol. Int. 2019;19:1220-25.Disclosure of Interests:Yutaro Yamada: None declared, Masahiro Tada: None declared, Koji Mandai: None declared, Noriaki Hidaka: None declared, Kentaro Inui Grant/research support from: Janssen Pharmaceutical K.K., Astellas Pharma Inc., Sanofi K.K., Abbvie GK, Takeda Pharmaceutical Co. Ltd., QOL RD Co. Ltd., Mitsubishi Tanabe Pharma, Ono Pharmaceutical Co. Ltd., Eisai Co.,Ltd.,, Speakers bureau: Daiichi Sankyo Co. Ltd., Mitsubishi Tanabe Pharma, Janssen Pharmaceutical K.K., Astellas Pharma Inc., Takeda Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Abbvie GK, Pfizer Inc., Eisai Co.,Ltd., Chugai Pharmaceutical Co., Ltd., Hiroaki Nakamura Grant/research support from: Astellas Pharma Inc. and Asahi Kasei Pharma Co.

ObjectivesRheumatoid arthritis (RA) is one of the most common systemic inflammatory diseases, but its etiology is still not fully known. The aim of this preliminary study was to assess what particular comorbidities are involved in the progression of RA and determine the influence that the aforementioned diseases have on each other.Material and methodsForty patients with diagnosed RA according to EULAR/ACR criteria from 2010 were included in the study. The majority of the group was female (n = 35; 87.5%). Patients were tested using routine laboratory and imaging methods allowing diagnosis and assessment of disease activity. Dual energy X-ray absorptiometry was also evaluated for mineral density. The activity of the disease was assessed using the disease activity score DAS28 (ESR) and SDAI (Simplified Disease Activity Index).ResultsAmong studied patients, based on the DAS28 index, 9 patients were in the remission phase (22.5%) and 12 (30%) had high disease activity. Increased values ​​of CRP were observed in the majority of patients (65%). The group analysis demonstrated the most common comorbidities in patients with RA, as follows: hypertension (n = 14; 35%) and osteoporosis or osteopenia (n = 13; 32.6%).ConclusionsPatients with rheumatoid arthritis (RA) are more susceptible to developing hypertension and osteoporosis. We did not observe a significant association between other comorbidities and activity of RA. The next study will assess a larger number of patients.

Background Rheumatoid factor (RF) is involved in the pathology of rheumatoid arthritis (RA) and its titer varies during the course of treatment with biological or synthetic DMARD. Objectives In this study, we examined the relationship between RF change rate and disease activity. Methods We analysed 287 RA patients (mean age 62.3 years; mean disease duration 13.1 years) in our hospital between 2015 and 2017, who were able to confirm the RF, and 3 groups were classified according to the change rate of RF for 1 year (92 in decreasing less than 80%, 114 in unchanged 80% or more, less than 120% and 81 in increasing 120% or more). We evaluated disease activity by simplified disease activity index(SDAI). Results The drugs used are: MTX usage rate 63.1%, mean amount 3.81 mg, PSL usage rate 37.3%, mean amount 1.47 mg, biological drugs usage rate 48.8%. Disease activity change amount in 1 year (delta SDAI) was −0.88 (from 6.90 to 6.02). The median RF titer at baseline was 76 (27.5–178.5), the median RF change rate was 96% (71.5–125) and delta SDAI was significantly improved in the decreasing group (−1.97, 0.005,–0.04, p=0.0011). The swollen joint counts, tender joint counts, global assessment of evaluator and CRP were similarly improved significantly in this group. Conclusions Although RF dose not decrease in all cases, it suggested that reduction rate of RF reflects disease activity. Disclosure of Interest None declared

Background: Assessments of disease activity in rheumatoid arthritis (RA) determine the course of treatment. Physician global assessments of disease activity (MD globals) are important outcomes in trials as they are part of the CDAI and SDAI composite scores. MD globals may vary between physicians based on their age, sex, practice setting, experience, and years in practice. Objectives: Our research goal was to determine which factors contribute to the variability of MD globals. We expected assessments to be lower as physician experience increased. Methods: After obtaining ethics approval, we surveyed rheumatologists who were members of the Canadian Rheumatology Association with RA patient scenarios where each was rated as a MD global for disease activity from 0 – 10. The cases covered a range of disease activity; to determine extreme cases and cases in between. There were some scenarios where a change in status was given (i.e. a rating with one disease state and then the patient returned and another rating was given by each participant when the patient was obviously better or worse). Kappa, Intra-class correlation (ICC) coefficients, and linear mixed models were used to analyze the data Results: We received 145 responses from eligible physicians spanning the above categories (approximately 40% response rate). Contrary to our original hypothesis, MD global assessments were not significantly different between physicians in any category (number of RA patients seen per year, years of experience, age, sex, type of practice [community vs. university], and self-reported expertise in RA). Moreover, the range of answers for the same scenario was as high as 7.6 out of a possible 10, indicating vast discrepancies between physicians. We checked to ensure the questions were not answered backwards by individuals using the scenarios where a patient changed disease activity over time. The agreement was highest in the extreme scenarios (very low and very high disease activity, but in the spectrum in between agreement was extremely poor). Some scenarios outlined changes in individual patients, however physicians surveyed were often in disagreement as to how well the patient recovered or worsened. The change in MD globals between one time and the next in the cases had better agreement than the actual scores. Conclusions: This research emphasizes the need to establish stringent evaluation criteria of disease activity as rated by the physician in RA; particularly if remission and low disease activity is used clinically by CDAI or SDAI. Perhaps a catalogue examples of patient scenarios of MD globals that range from 0 to 10 should be developed, standardized and agreed upon; to decrease the wide variability of ranking by rheumatologists. References 1. Aletaha D, Smolen J. The Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI): a review of their usefulness and validity in rheumatoid arthritis. Clin Exp Rheumatol2005;23:S100–108. 2. Her M, Kavanaugh A. Patient-reported outcomes in rheumatoid arthritis. Curr Opin Rheumatol2012;24:327–34. 3. Smolen JS, Breedveld FC, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatol Oxf Engl2003;42:244–57. Disclosure of Interest: None declared

To explore the performance of routine assessment of patient index data 3 (RAPID3) in reflecting disease activity in Chinese rheumatoid arthritis (RA) patients.The clinical data of 189 consecutive RA patients, including RAPID3 questionnaire, Disease Activity Score based on 28-joint count (DAS28), clinical disease activity index (CDAI) and simplified disease activity index (SDAI), and ultrasonography of hand and wrist joints were collected. The consistency between RAPID3 and DAS28, CDAI, SDAI in RA patients with different disease activities was performed by Spearman's correlations, kappa and/or weighted kappa coefficients.RAPID3 score was significantly associated with DAS28 and erythrocyte sedimentation rate (ESR), DAS28 with C-reactive protein (CRP), CDAI, SDAI (r = 0.797, 0.786, 0.784, and 0.760 respectively, P 0.001 for all). RAPID3 was also significantly correlated with tender joint count, swollen joint count, ESR and CRP. The agreement of RAPID3 with DAS28 scoring systems was better in patients with moderate/high disease activity than those in remission/low disease activity. Ultrasonographic subclinical synovitis was presented in 42.3%-48.6% of patients in remission/low disease activity defined by various scoring criteria including RAPID3 with no significant difference observed (P = 0.22,0.05).RAPID3 showed good correlation with DAS28 scoring systems, especially in patients with moderate/high disease activity. RAPID3 is a reliable and convenient tool to monitor disease activity.

Objectives: The classification of disease activity states in rheumatoid arthritis (RA) can be achieved through disease activity indices, such as the Disease Activity Score in 28 joints erythrocyte sedimentation rate (DAS28-ESR), the Simplified Disease Activity Index (SDAI), and the Clinical Disease Activity Index (CDAI). Subjective measurements, such as patient reported outcomes have been incorporated into several of these indices alongside more objective assessments, such as increases in the ESR and C-reactive protein. Moreover, while they use similar criteria, different indices weight these criteria to different extents. Therefore, the classifications based on each evaluation may not always be the same. We aim to compare the performance of the three indices and their individual components in two different populations. Methods: Data from Dutch and Portuguese adherent centers were extracted from the METEOR database, a multinational collaboration on RA. We included a total of 24,605 visits from Dutch centers (from 5,870 patients) and 20,120 visits from Portuguese centers (from 3,185 patients). We compared the disease activity states as evaluated by the DAS28-ESR, CDAI, and SDAI across the two populations. In addition, we analyzed the individual components of each evaluation, including their respective contributions to the outcome, in each population. Results: We found significant differences in the disease activity states classified with the DAS28-ESR between the two populations. SDAI and CDAI had more congruous results. While the proportion of visits to Dutch and Portuguese centers that were classified as "in remission" was very similar between the CDAI and SDAI, the DAS28-ESR gave discordant results. Dutch patients had lower ESRs, which is more heavily weighted in the DAS28-ESR. In addition, even though the mean physicians' global assessment values did not vary significantly for Dutch vs Portuguese physicians, we found that doctors at Portuguese centers overall scored the physician's global assessment lower than Dutch physicians for patient visits classified by disease activity state. Conclusion: While the CDAI and SDAI assigned disease activity states that were largely similar, the DAS28-ESR was often discordant across the two populations. Moreover, we found that physicians, more than patients, evaluated disease activity differently among the Portuguese and Dutch populations. (c) 2018 Canhão, Rodrigues, Gregório, Dias, Melo Gomes, Santos, Faustino, Costa, Allaart, Gvozdenovic, van der Heijde, Machado, Branco, Fonseca and Silva.

Objective Patient-reported outcomes (PROs) such as pain, patient global assessment (PGA) and fatigue are regularly assessed in RA patients. In the present study, we aimed to explore the reliability and smallest detectable differences (SDDs) of these PROs, and whether the time between assessments has an impact on reliability. Methods Forty RA patients on stable treatment reported the three PROs daily over two subsequent months. We assessed the reliability of these measures by calculating intraclass correlation coefficients (ICCs) and the SDDs for 1-, 7-, 14- and 28-day test-retest intervals. Results Overall, SDD and ICC were 25 mm and 0.67 for pain, 25 mm and 0.71 for PGA and 30 mm and 0.66 for fatigue, respectively. SDD was higher with longer time period between assessments, ranging from 19 mm (1-day intervals) to 30 mm (28-day intervals) for pain, 19 to 33 mm for PGA, and 26 to 34 mm for fatigue; correspondingly, ICC was smaller with longer intervals, and ranged between the 1- and the 28-day interval from 0.80 to 0.50 for pain, 0.83 to 0.57 for PGA and 0.76 to 0.58 for fatigue. The baseline simplified disease activity index did not have any influence on reliability. Lower baseline PRO scores led to smaller SDDs. Conclusion Reliability of pain, PGA and fatigue measurements is dependent on the tested time interval and the baseline levels. The relatively high SDDs, even for patients in the lowest tertiles of their PROs, indicate potential issues for assessment of the presence of remission.

Objective : Sex-specific medicine has attracted attention in recent years, but no report on rheumatoid arthritis (RA) has examined sex differences in the effectiveness of biologics on activities of daily living (ADL), quality of life (QOL), or depressive state. Methods : The study subjects were 161 RA patients (female: 138; male: 23) attending regular doctor visits at our hospital. We compared the changes in disease activity, which was evaluated using the simplified disease activity index (SDAI), ADL (using the modified health assessment questionnaire; mHAQ), QOL (using short form-36; SF-36), and the Hamilton Depression Rating Scale (HAM-D) for RA patients between each sex over a six-month observation period while administering biologic treatment. Results : The female patients reported significant improvements in the following metrics: SDAI: from 22.1 ± 11.9 to 8.9 ± 7.8 (p < 0.001); mHAQ: from 0.46 ± 0.50 to 0.32 ± 0.45 (p < 0.001); and HAM-D: from 6.2 ± 4.8 to 3.8 ± 4.1 (p < 0.001). Moreover, all eight items of the SF-36 were significantly improved (p < 0.01). In contrast, the male patients improved on the SDAI (from 27.9 ± 11.7 to 12.7 ± 8.6 (p < 0.001)), but we did not observe significant improvements in the mHAQ or HAM-D scores or in any items on the SF-36. Conclusion : Both male and female patients with RA improved when using a biological drug. Sex differences in the improvement of depressive state were observed.

The aim of this study was to assess the impact of tocilizumab on bone oedema in rheumatoid arthritis (RA) as shown by magnetic resonance imaging (MRI). In this longitudinal study, patients with rheumatoid arthritis according to the American College of Rheumatology (ACR) 2009 criteria with inadequate response or intolerance to disease-modifying anti-rheumatic drugs (DMARDs), treated with tocilizumab, were included. Sociodemographic characteristics and clinical and laboratory data for the disease were collected at baseline (M0) and 06 months (M6) of treatment. Disease activity was assessed using disease activity score in 28 joints (DAS28), simplified disease activity index (SDAI) and clinical disease activity index (CDAI). MRI of the dominant hand was performed at baseline and M6 of treatment. The primary outcome measure was the assessment of bone oedema by rheumatoid arthritis MRI scoring system (RAMRIS) bone oedema. Secondary outcomes included RAMRIS synovitis, DAS28, C-reactive protein (CRP) and SDAI at baseline and M6. Twenty-two patients with RA were included, 19 females (86.4 %), with a mean of age 42 ± 13.7. The mean disease duration was 8 ± 5.2 years. The mean DAS28 was 5.78 ± 0.87. The median CRP was 16 mg/l (6.7 to 36.3). The average SDAI was 90 ± 34. Three patients were excluded from the study for serious side effects. At baseline, bone oedema was present in 41 % of patients (N = 9), with a median bone oedema RAMRIS 0 (0 to 7.2). At M6, bone oedema decreased or disappeared in 32 % (N = 7) with a significant improvement in the RAMRIS bone oedema score (p = 0.04). Moreover, there is a significant improvement in RAMRIS synovitis (p < 0.0001) as well as in activity parameters: DAS28 (p < 0.0001), CRP (p < 0.0001) and SDAI (p < 0.0001). This study suggests that tocilizumab is associated with a significant improvement on MRI-determined bone oedema in the short term. This improvement in bone oedema is correlated with improved parameters of disease activity, in which early structural effect could be discussed. Further studies are needed to confirm these results.

Objectives. To identify predictors for Simplified Disease Activity Index (SDAI) remission in patients with established rheumatoid arthritis (RA) under 12 months of anti-TNF therapy combined with synthetic disease modyfing antirheumatic drugs (sDMARD). Methods. We performed a prospective observational study in 90 RA patients with a high active disease refractory to sDMARDs, starting anti-TNFs. Patients were assessed every 3 months based on a well-defined protocol, including individual parameters (clinical, inflammatory) and composite tools (simplified disease activity index SDAI, functional index HAQ-DI); total and IgA-isotype rheumatoid factor (RF) as well as anti-citrullinated peptide antibodies (ACPAs) were measured at baseline, 6 and 12 months. Therapeutic response was evaluated according to EULAR criteria. The primary endpoint was SDAI remission (≤ 3.3) at 12 months of treatment. Univariate and multivariate logistic regression analysis (Forward LR method) were used to assess the manner and intensity in which several parameters (demographics, disease-related, labs and medication) power SDAI remission. Results. SDAI remission was reported in 39.7% cases. We identified nine relevant predictors for SDAI remission at 12 months of therapy by univariate analysis, including: age ≤ 50 years, disease onset ≤ 5 years, RA stages I and II, functional capacity stages I and II, HAQ-DI ≤ 2, concomitent sDMARD, baseline CRP ≤ 20 mg/l, IgA-RF ≤ 20 IU/ml and ACPAs ≤ 40 IU/ml. A mathematical model was further generated, based only on six out of nine parameters: age, disease stage, functional capacity, concomitent sDMARDs, CRP and ACPA. This model expresses a solid approximation for the analysed casess (the Hosmer-Lemeshow test λ² = 0.931, p = 0.920 ≥ 0.05, Cox and Snell R2 0.399). Finally, three significant factors were recognized (age under 50, disease stages I and II, ACPA levels ≤ 40 IU/ml), predicting SDAI remission with an overall constant precision of 83.3%. However, no significant impact on SDAI remission prediction was reported when adding other parameters to the above mentioned model. Conclusion. SDAI remission can be predicted in established RA patients using three major predictors, including age ≤ 50 years, disease stages I and II and baseline ACPA levels ≤ 40 IU/ml.

OBJECTIVE The aim of this study was to explore the clinical utility of the clinical disease activity index (CDAI). We compared the disease control with protocolized treatment adjustment following a tight control strategy utilizing either the simplified disease activity index (SDAI) or the CDAI. METHODS In a prospective 12 month study, DMARD-naive RA patients were randomized to either a CDAI or SDAI arm and were treated with traditional DMARDs, increased on a monthly basis according to a predefined protocol to achieve low disease activity. RESULTS Of 102 patients (84 females, 96 Black Africans), the mean symptom duration was 3.0 years (s.d. 3.8) and the mean 28-joint DAS (DAS28) at baseline was 6.2 (s.d. 1.2). By 12 months, the proportion of patients in the CDAI and SDAI groups achieving low disease activity (30% and 32%) and remission (33 and 34%) were similar. There were no significant differences in the mean DAS28 or its components or in HAQ Disability Index or health-related quality of life scores. Baseline predictors of low disease activity at 12 months were shorter symptom duration (P = 0.03) and lower HAQ-DI score (P = 0.04). CONCLUSION Given that the CDAI performed as well as the SDAI, and considering the cost savings and convenience because no acute phase reactant test is necessary, we suggest the CDAI may be an appropriate tool for monthly disease activity monitoring as part of a tight control strategy in developing countries.

This study aimed to evaluate whether normal serum matrix metalloproteinase-3 (MMP-3) levels can be used to predict clinical remission and normal physical function at a single time point when treating patients with rheumatoid arthritis (RA) in daily practice settings. Subjects were all 1321 RA patients who were treated at our hospital. The accuracy of serum MMP-3 levels was larger than those of C-reactive protein (CRP) levels for predicting clinical remission [Simplified Disease Activity Index (SDAI) ≤ 3.3], normal function [Disability Index of the Health Assessment Questionnaire (HAQ-DI) ≤ 0.5], and both in clinical remission and with normal function (clinical remission + normal function) using receiver operating characteristic curve analysis. Serum MMP-3 levels were significantly correlated with CRP levels [r 0.229 (men), r 0.476 (women)] using Pearson’s correlation coefficients. Among patients with normal CRP levels (n = 807), the percentage of patients in clinical remission, with normal function, and with clinical remission + normal function having normal serum MMP-3 levels was significantly higher than those with abnormal serum MMP-3 levels. In addition, among patients with the 28-point count Disease Activity Score-CRP (DAS28-CRP) remission (DAS28-CRP

Background Based on the totality of evidence, SB2 has shown to be similar with reference infliximab (INF) and has been approved as a biosimilar by the European Medical Agency. It is, however, hitherto unknown, if SB2 also shares similar structural efficacy in the different disease activity states when compared with INF. Objectives To evaluate the disease activity by simplified disease activity index (SDAI) and clinical disease activity index (CDAI) at weeks 14, 30 and 54 in patients with rheumatoid arthritis (RA) treated with SB2 or INF from a phase III study and to assess the radiographic progression at week 54 in patients by disease activity states (remission, low disease activity [LDA], moderate disease activity [MDA], or high disease activity [HDA]). Methods Patients with RA were randomised to receive either SB2 or INF 3 mg/kg at weeks 0, 2, 6, and then every 8 weeks thereafter until week 46 with background methotrexate. Dose increments were allowed after week 30 by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg. Disease activities by SDAI, and CDAI were compared at weeks 14, 30, and 54. The radiographic progression was measured by modified Total Sharp Score (mTSS) at weeks 0 and 54. Results Up to week 54, comparable proportions of patients achieved ACR-EULAR-index remission between SB2 and INF (by SDAI: 13/279 [4.7%] vs. 13/283 [4.6%] at week 14; 24/250 [9.6%] vs. 29/263 [11.0%] at week 30; 34/226 [15.0%] vs. 24/224 [10.7%] at week 54; by CDAI: 12/279 [4.3%] vs. 12/283 [4.2%] at week 14; 22/253 [8.7%] vs. 31/265 [11.7%] at week 30; 33/227 [14.5%] vs. 24/225 [10.7%] at week 54 in SB2 and INF, respectively). The proportions of radiographic non-progressors (defined as change in mTSS ≤0) by disease activity were comparable between SB2 and INF at week 14, 30 and 54 (Table 1). Patients treated with SB2 as well as INF also exhibited the lowest progression of radiographic damage in remission and the largest progression in HDA, but also very small increases in mTSS in LDA and MDA, in line with previous findings on INF. Conclusions The proportion of patients achieving remission or LDA was comparable up to week 54 upon treatment with both SB2 and INF. Inhibition of radiographic progression was also comparable in each disease activity state. The proportion of radiographic non-progressors was also similarly high in patients achieving remission, and overall very low radiographic progression rates were seen even in LDA and MDA in both treatment arms. These data further confirm the comparability of SB2 and INF. Disclosure of Interest J. S. Smolen Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Glazo, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung Bioepis, Sanofi, UCB, J.-Y. Choe Consultant for: Samsung Bioepis, E. Keystone Consultant for: Pfizer, Roche, Janssen, Amgen - consultant/Pfizer, Roche, Janssen, Amgen, BMS, Merck. Merck, Celltrion, Samsung Bioepis, Y. H. Rho Employee of: Samsung Bioepis, Y. Lee Employee of: Samsung Bioepis, S. Lee Employee of: Samsung Bioepis

Objectives We compared remission rates, according to different definitions of remission in rheumatoid arthritis (RA) and investigated the potential predictors of sustained remission at the 2-year follow-up. Methods We obtained data on 291 RA outpatients, seen from July 2009 to September 2012. Sociodemographic data and answers to questionnaires were collected in face-to-face interviews. Remission was defined according to the Disease Activity Score in 28 joints (DAS28)-ESR, DAS28-CRP, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), and ACR/EULAR Boolean definition. Sustained remission was defined as when the patient continued in remission at two consecutive annual assessments. Predictors of sustained remission according to the DAS28-CRP were assessed by univariate and multivariate analyses. Results For the 291 RA patients, the remission rates of RA were 17.9% (DAS28-ESR), 54.3% (DAS28-CRP), 10.3% (SDAI), 10.0% (CDAI), and 5.8% (Boolean). On follow-up for 2 years, the sustained remission rates of RA were 46.5% (DAS28), 55.0% (DAS28-CRP), 37.5% (SDAI), 32.0% (CDAI), and 30.8% (Boolean). RA patients who achieve sustained remission according to the DAS28-CRP were younger, and had more education, higher monthly income, lower Health Assessment Questionnaire (HAQ) score, lower physician global assessment, lower patient global assessment, lower patient pain assessment, and higher EQ-5D. In multivariate analysis, only the HAQ score predicted sustained remission according to DAS28-CRP (OR=0.257, 95% CI 0.067–0.980, p =0.047). Conclusions The remission rates of RA patients differed according to the definition of remission, and the highest sustained remission rate was classified by the DAS28-CRP. A lower HAQ score was an independent predictor of sustained remission over 2 years, according to the DAS28-CRP. Disclosure of Interest None declared

Background When initiating therapy with disease-modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA), treatment adoptions are recommended if no improvement in disease activity is seen within 3 months, or if the treatment target has not been reached by 6 months. 1 A pooled analyses from several pivotal RCTs showed that RA patients who did not achieve a minor treatment response by 3 months were unlikely to reach the treatment target by 6 months. 2 Objectives To examine what level of treatment response is needed after 3 months of therapy in order to achieve the treatment target of remission (REM) or low disease activity (LDA) by 6 months in a routine clinical setting. Methods Data were provided by NOR-DMARD, a prospective, multicentre, observational study. We selected RA-patients enrolled between December 2000 and November 2012, who were biological DMARD-naive and had a moderate or high disease activity (MDA or HDA, respectively) according to the Simplified Disease Activity Index (SDAI) when initiating therapy. All analyses were performed for the total group of included patients (n=1610), as well as for the following sub-groups: disease duration over (n=895) or under (n=681) 12 months, baseline SDAI MDA (n=825) or HDA (n=785), DMARD-naive patients starting methotrexate (MTX) (n=537) and patients starting tumour necrosis factor inhibitor (TNFi) (n=248). We used a diagnostic test approach, created receiver operating characteristic curves and generated sensitivities, specificities and likelihood ratios (LRs) for all improvement cut-points (0–100%) at the 3-month visit. Furthermore, we tested the ability of established response criteria (SDAI 50/70/85 response) at 3 months to predict the desired target of SDAI remission or SDAI LDA at 6 months. Results At inclusion median (IQR) disease duration was 2 (0.2–8.8) years and mean (SD) SDAI was 28.3 (12.8). At 6 months 46.8% of all patients had achieved LDA and 10.8% had reached remission. Not achieving a minor treatment response (SDAI 50% response) by 3 months was associated with decreased probability of reaching remission at 6 months (LR- 0.27), but gave little prognostic information regarding the probability of reaching LDA (LR- 0.49). Patients with HDA at baseline who did not achieve at least 50% improvement in disease activity by 3 months had very low probability of reaching the treatment target by 6 months (LR- 0.15 for remission and LR- 0.30 for LDA). SDAI 85% response at 3 months was predictive of reaching the treatment target at 6 months (LR+ 6.56 for remission and LR+ of 6.45 for LDA). For the total group of patients, a reduction in SDAI of 60.2% was needed at 3 months to predict LDA at 6 months with 80% specificity, while 69.2% improvement was necessary to predict remission. Conclusions These results from a routine clinical setting confirm results from RCTs demonstrating a predictive association between treatment response at 3 months and achievement of the treatment target by 6 months in RA-patients. Assessments at 3 months can inform clinicians to continue or adjust ongoing DMARD-therapy in a treat-to-target strategy aiming for remission or LDA by 6 months. References Smolen JS, et al. Ann Rheum Dis 2014;73(3):492–509. Aletaha D, et al. Ann Rheum Dis 2016;75(8):1479–85. Disclosure of Interest V. Norvang: None declared, I. Olsen: None declared, E. Kristianslund: None declared, T. Uhlig: None declared, T. Kvien Consultant for: AbbVie, Biogen, BMS, Boehringer, Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Norvartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, UCB, D. Aletaha Consultant for: Abbvie, BMS, Eli Lilly, Janssen, MSD, Pfizer Inc, Roche, UCB, Speakers bureau: Abbvie, BMS, Eli Lilly, Janssen, MSD, Pfizer Inc, Roche, UCB, J. Smolen Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Celltrion, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, UCB, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Celltrion, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, UCB, E. Haavardsholm Grant/research support from: AbbVie, Pfizer, Roche, MSD, UCB, Consultant for: AbbVie, Pfizer, Roche, Eli Lilly, Celgene, UCB

Background The association between physical functioning and rheumatoid arthritis (RA) disease activity is well established. In randomized controlled trials (RCTs) of RA treatment, reductions in disease activity result in improved physical functioning. The mental health benefits associated with reductions in disease activity are less well recognized. Objectives Investigate the association between reductions in RA disease activity and measures of mental health status. Methods A systematic review of the published literature of RCTs in RA was conducted. The search was limited to those published in the last 10 years that included the Short-Form (SF)-36 Health Survey as an outcome measure. Results The search strategy yielded 77 articles of which 38 were excluded for the following reasons: not RCT (23); focus exclusively on early RA (9); psychometric evaluation (4); review study (1); and off topic (1). Of the 39 articles reporting mean changes in scores on the SF-36 mental health (MH) and role emotional (RE) domains by treatment group, 3 articles also presented these changes in association with reductions in RA disease activity measures.1–3 In relation to American College of Rheumatology (ACR) response criteria, small to moderate (0.2–0.5 standard deviation [SD]) effect size changes in RE and MH domain scores were observed among RA patients whose ACR responses ranged from 20–49%. Moderate to large effect sizes (0.5–0.8 SD) were reported in RE and MH domain change scores among ACR50 responders. Similar changes in RE and MH domain scores were reported by patients with reductions in Simplified Disease Activity Index (SDAI) of ≥10 points. Conclusions The benefits of clinically meaningful reductions in disease activity among RA patients not only include improved physical functioning but also meaningful improvements in overall mental health status. The improvement in mental health is positively associated with reduction in disease activity, with only small to moderate improvements associated with less than ACR50 responses. Additional work is needed to investigate the incremental effects of RA therapies on mental health beyond the effects related to improvements in disease activity. References Emery P, et al. J Rheumatol. 2006;33(4):681–689. Russell AS, et al. Ann Rheum Dis. 2007;66(2):189–194. Strand V, et al. Health Qual Life Outcomes. 2014;12:31. Disclosure of Interest V. Strand Consultant for: Abbvie, Amgen, AstraZeneca, BiogenIdec, Boehringer Ingelheim, Celltrion, Crescendo, Genentech/Roche, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sanofi and UCB, R. Rendas-Baum Employee of: Optum, M. Kosinski Employee of: Optum, D. Brooks Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, R. Ganguly Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline

Objectives:The Simplified Disease Activity Index (SDAI) 50 has good agreement with European League Against Rheumatism (EULAR) response measures for early Rheumatoid Arthritis (RA). There have been reports on early RA, but not on long-established RA. In this study, we analysed the relationships between various baseline factors and SDAI 50 after three months of treatment with biological disease-modifying antirheumatic drugs (bDMARDs) to determine the prognostic factors for long-established RA.Methods:Subjects were 260 RA patients who had been treated with bDMARDs for 3 months. The following characteristics were investigated: Patient backgrounds, the erythrocyte sedimentation rate (ESR), C-reactive protein and serum matrix metalloproteinase-3 levels, SDAI scores, and health assessment questionnaire disability index and short form-36 scores. As a primary outcome index, the SDAI response was defined as a 50% reduction in the SDAI score between baseline and 3 months (SDAI 50).Results:Baseline values of disease duration (odds ratio: 0.942, 95% CI: 0.902-0.984), smoking history (odds ratio: 2.272, 1.064-4.850), 28-tender joint count (odds ratio: 0.899, 0.827-0.977), evaluator's global assessment (odds ratio: 1.029, 1.012-1.047) and ESR (odds ratio: 1.015, 1.001-1.030) were determined to be significant factors based on logistic regression analysis.Conclusion:Our study demonstrated that RA patients with shorter disease duration, no smoking, and higher RA disease activity are more likely to achieve SDAI 50 through bDMARD treatment.