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The short-term positive effects of intermittent fasting during the month of Ramadan on rheumatic inflammatory diseases have been previously evaluated. The objective of this study was to assess the sustainability of these effects on rheumatoid arthritis (RA) activity. This prospective study included 35 patients with RA, who observed fasting during Ramadan 2019. The disease activity was assessed and compared between three time points: T1 (6 months before the beginning of Ramadan), T2 (during the month between the 7th day of fasting and the 7th day after Ramadan), and T3 (averagely 3.4 months after fasting). The disease activity score 28 (DAS28) was used to evaluate the disease activity. After a significant decrease of all disease activity parameters between T1 and T2, a gradual increase of clinical and biological outcomes was seen between T2 and T3. Except for CRP, which was significantly higher at T3 (p = 0.02), the changes of the other disease activity parameters were not statistically significant. By reference to baseline data (T1), the decrease of ESR, DAS28 CRP, and DAS28 ESR induced after Ramadan fast was maintained until T3, with statistically significant differences. We can therefore conclude that this study has been conducted at the beginning of the fading-out of the effects of Ramadan fast, and that the duration of 3 months may be the recommended interval between fasting periods to maintain the positive effects of intermittent fasting on RA activity. Key Points • Intermittent fasting can induce a rapid improvement of rheumatoid arthritis activity. • The positive effects of this model of fasting can last up to 3 months. • The recommended interval between fasting periods may be estimated at 3 months.

The reliability and clinical usefulness of the different composite disease activity scores and their individual components in Rheumatoid Arthritis (RA) are still debated. This study investigated which measures of disease activity were preferred by rheumatologists. A mixed-method study was performed. First, ten Belgian rheumatologists were invited for individual interviews on their current practice and preferences for measurement of RA disease activity. Results of this qualitative study and evidence from literature served as input for developing a survey. This survey asked rheumatologists to rate preferred standard disease activity score(s), their individual components, ultrasound and related patient-reported outcomes (PROs), by maximum difference scaling. The relative importance score (RIS) for each indicator was calculated using hierarchical Bayes modeling. The qualitative study included 6/10 invited rheumatologists. Composite scores and components were perceived as useful, while PROs were found subjective. Interestingly, ultrasound was used to mediate discrepancies between physician and patient. The survey based on this was sent to 244 Belgian rheumatologists, 83/244 (34%) responded, including 66/83 (80%) complete and 17/83 (20%) incomplete surveys (two missing essential information). Most rheumatologists (75/81, 93%) used a disease activity score and 68/81 (84%) preferred the DAS28-CRP. Swollen joint count obtained the highest mean ± SD RIS (22.54 ± 2.64), followed by DAS28 ESR/CRP (20.61 ± 4.06), ultrasound (16.47 ± 7.97), CRP (13.34 ± 6.11) and physician's global assessment (12.59 ± 7.83). PROs including fatigue, pain, and patient's global assessment, and Health Assessment Questionnaire, obtained the lowest mean RIS (0.34-2.54). Rheumatologists place more faith in self-assessed disease activity components or in laboratory tests. Trust in PROs to evaluate disease activity is low in clinical practice. ispartof: RHEUMATOLOGY INTERNATIONAL vol:42 issue:5 pages:815-823 ispartof: location:Germany status: published

OBJECTIVE The aim of this study was to compare the performance of angiogenesis-specific 68Ga-RGD2 PET/CT with Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) in assessing disease activity and treatment response in rheumatoid arthritis (RA). METHODS This was a prospective study comparing the performance of 68Ga-RGD2 PET/CT and DAS28-ESR in 30 RA patients. All of them underwent 68Ga-RGD2 PET/CT scan from head to toe and clinical examination at the baseline. A repeat scan and clinical examination were done in 27 patients after 3 months of treatment with disease-modifying antirheumatic drugs ± steroids. Three PET parameters, that is, PJC (PET-positive joint count), aSUVmax (average SUVmax), and hSUVmax (highest SUVmax), of positive joints were compared with the DAS28-ESR for disease activity assessment and response evaluation. RESULTS Among the 3 PET parameters, PJC showed a significant correlation with the DAS28-ESR (0.64, P < 0.01). A significant change was observed with treatment in the DAS28-ESR and PET parameters of 27 patients at follow-up. There was significant correlation between percentage changes in DAS28-ESR and scan parameters such as PJC (0.689, P < 0.001), aSUVmax (0.712, P < 0.001), and hSUVmax (0.555, P = 0.003) values. The absolute change in aSUVmax value could accurately discriminate (area under the curve, 0.98; P = 0.001) European League Against Rheumatism responders from nonresponders. CONCLUSIONS 68Ga-RGD2 PET/CT is a promising tool for objective assessment of disease activity and treatment response in patients with RA.

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 European League Against Rheumatism updates the recommendations for managing rheumatoid arthritis. Again, it is not specified which DAS28 is there in view (with erythrocyte sedimentation rate or C-reactive protein). Aim: The aim of the study is to check whether Disease Activity Score-28 (erythrocyte sedimentation rate) and Disease Activity Score-28 (C-reactive protein) represent equally the activity of rheumatoid arthritis in the course of treatment with biological agents. Materials and methods: In a retrospective study we analyzed the database of real clinical practice over a 12-month period of biological treatment of rheumatoid arthritis. Disease Activity Score-28 (erythrocyte sedimentation rate) and (C-reactive protein) are compared at the start and at the end of the study. Results: The mean difference between the two variants of disease activity scores at baseline and at the end of the study is significant (p < 0.001). The Disease Activity Score-28 (erythrocyte sedimentation rate) represents a remarkably small proportion of patients with remission and low activity ( Conclusion: The two DAS28 variants are not interchangeable with the same threshold for low activity in measuring the response to biological therapy.

IntroductionRheumatoid arthritis (RA) is a chronic inflammatory arthritis that may lead to severe joint pain. There are several scores to evaluate the disease activity of RA. This study aimed to evaluate if clinical factors which representing activity scores and health assessment score.Material and methodsThis study was conducted prospectively by including adult patients with RA. Clinical factors and 5 RA disease activity and health assessment scores were evaluated. Each activity score was executed for clinical predictors by using multivariate linear regression analysis.ResultsThere were 33 female adult patients in the study. The average (SD) age was 52.33 (11.11) years, while the duration of RA was 7.65 years. The DAS28 ESR had 1 predictor: RA duration with a coefficient of –0.04. For DAS28 CRP, CDAI, and SDAI scores, body mass index (BMI) and RA duration were independent factors for the scores with negative coefficient values. For the HAQ score, both age and rheumatoid duration were positively associated with the score. The coefficients of both factors were 0.02 and 0.03, respectively.ConclusionsAge, RA duration, and BMI were associated with RA activity and functional score. Body mass index is a potential modifiable factor that may be associated with RA activities.

To compare long-term clinical, immunological, and radiographic outcomes between five sets of remission criteria (four clinical and one ultrasound (US)-based) in a cohort of RA patients in a clinical care setting.RA patients in remission (DAS28-ESR2.6) were selected. Hand US assessments were made, and serum levels of inflammation/angiogenesis biomarkers were determined at baseline. Changes in baseline treatment and radiographic progression, defined as the variation in the modified Sharp van der Heijde score (mSHS) at 5 years, were analyzed. Five concepts were used to define remission: DAS28-ESR2.6, SDAI3.3, CDAI2.8, Boolean criteria and Power Doppler score (PD)=0.Eighty-seven patients with DAS28-ESR2.6 were included. One-third fulfilled SDAI (33.3%), CDAI (31%), and Boolean (35.6%) remission criteria, and 25.3% had no PD signal in the US evaluation. 26 patients (29.9%) changed therapy, ranging from 13.6% (PD remission) to 33.3% (CDAI remission) (p=0.11). Serum levels of ANG (p=0.015) and TNFa (p=0.025) were significantly lower in patients with Boolean remission, whereas IL-18 levels were significantly lower in those with PD remission (p=0.049). Patients without PD in the US assessment had significantly-lower mSHS erosion progression (p=0.014) at 5 years.Patients with established RA in DAS28-ESR remission had comparable clinical and radiographic outcomes in SDAI, CDAI, and Boolean definitions in a clinical care setting. US remission remained the closest to structural damage abrogation. Key Points • This study provides real world data on long-term outcomes of five clinical and imaging remission criteria in rheumatoid arthritis. • DAS28-ESR remission criteria had comparable radiographic progression and clinical prognosis than more stringent criteria in clinical practice. • US-based remission was closest to structural damage abolishment.

Objective To compare long-term clinical and radiographic outcomes among five sets of remission criteria [four clinical and one Ultrasound (US)-based] in a cohort of RA patients in a clinical care setting. Methods RA patients in remission (DAS28-ESR

Background The determination of rheumatoid arthritis (RA) activity remains an important clinical task nowadays and it is a long and difficult process. There is no single approach to assess the activity of RA. The gold standard for evaluating RA activity is composite indexes, for example, DAS28. However, composite indices are not reliable in evaluation of the disease activity in patients with RA, as having a subjectity assessment. New biomarkers that reflect the immune inflammatory process in joints in RA is of great scientific importance. 14-3-3η and calprotectin markers in plasma are considered as promissing. Objectives To assess the value of 14-3-3η and calprotectin in plasma as additional markers in RA activity determination. Methods 48 patients were examined with reliable diagnosis of RA, according to the ACR 2010 criteria. The mean age was 59 years, mean duration of the disease was 12.8 years. 4 patients in the group were in remission, 2 had low degree of RA activity, 20 - moderate, 22 – high. RA activity was determined according to the DAS28 ESR index. The concentrations of 14-3-3η and calprotectin in the blood plasma were determined by ELISA (LLC «SPF «Abris+»). The obtained results were compared with laboratory (ESR, CRP) and clinical (tender joint count (TJC), swollen joint count (SJC), VAS, DAS28) parameters of RA activity. Results 14-3-3η and calprotectin proteins in plasma and ESR highly correlated with DAS28 (r = 0.84; r = 0.65; r = 0.53), while CRP had moderate correlation with RA activity (r = 0.34). 14-3-3η and calprotectin proteins had high correlation with TJC (r = 0.68; r = 0.61) and moderate correlation with SJC (r = 0.56; r = 0.41); ESR and CRP had weaker correlation (r = 0.15; r = 0.13; r = 0.02; r = 0.08) respectively. The ROC analysis showed that sensitivity, specificity, and diagnostic accuracy of high RA activity determination are significantly higher for 14-3-3η (AUC = 0.98, p It was also found, that calprotectin (AUC = 0.8, p Conclusion 14-3-3η and calprotectin proteins in plasma are new promising biomarkers of immunoinflammatory process in joints in RA assessment, because they are more sensitive and specific markers of the disease activity, than conventional acute-phase proteins ESR and CRP. Disclosure of Interests None declared

Background:For treating Rheumatoid Arthritis (RA) it’s clear that Treat to Target has presented the best strategy. The best outcome for patients has been attained by accepting clinical remission as the final objective in treatment. The development of new drugs for the treatment of RA has dramatically modified the approach clinicians have on the disease, however, the treatment of inflammatory conditions represents a challenge due to the multiple factors can affect its response.It is known that non-adherence represents an increase in mortality, morbidity and healthcare costs.1,2.Emphasis should be made on one of the most simple and effective variables that impact the effectiveness of treatment: adherence to treatment itself.Objectives:This work aimed to evaluate the impact of methotrexate adherence on treatment outcome in patients with RA.Methods:An observational, cross sectional study was performed using medical records from the Rheumatology Clinic at University Hospital from UANL Jose Eleuterio Gonzalez, Monterrey, México; the data was collected from 03/16/2018 to 01/29/2020. RA patients visits included fulfilled the 2010 ACR/EULAR classification, had their disease activity measured by Disease Activity Score 28 ESR (DAS28 ESR) and were treated with methotrexate as their primary disease modifying antirheumatic-drug (DMRAD). Patient disease activity was classified in 4 groups according to the DAS28 ESR score as 3.2-5.1 moderate activity, >5.1 high activity.Adherence to medication was evaluated utilizing a self-reported assessment that was applied per patient’s visit. Patients were classified into 4 groups according to the percentage of the prescribed doses of Methotrexate that they abided to. Statistical analysis was performed using IBM SPSS 21 statistical package. Descriptive analyses were performed with frequencies (%) and the correlation between the calculated disease activity versus patient adherence to treatment was calculated using Pearson correlation coefficient.P-values Results:A total of 795 patients visits were included. They were 92.33% female, mean (SD) age was 52.44 (±12.99) (Table 1). The most frequent routes for methotrexate were Oral 603 (75.84%), Subcutaneous 113 (14.21%) and Intramuscular 79 (9.93%). A significant correlationr(795) =0.-183, (pTable 1.Baseline CharacteristicsN= 795Age, mean SD52.44 (±12.99)Sex, n (%) Female734 Male61Methotrexate (mg/week)Average Dose19.94Median Dose20Intramuscular79 (9.93%)Subcutaneous113 (14.21%)Oral603 (75.84%)Disease Activity accordingto DAS28 ESR, n (%)Remission343 (42.3)Low activity101 (12.5)Moderate activity292 (36.0)High activity59 (7.3)Adherence classification according to prescribed doses taken, n (%)Absent (20 (2.5%)Poor (25-49%)19 (2.3%)Regular (50-74%)55 (6.8%)Adequate (>75%)701 (86.5%)Conclusion:Adherence to treatment with methotrexate therapy has a direct impact on RA treatment outcome. The evaluation of adherence to the prescribed treatment should be addressed before modifications in DMRAD therapy in patients with Rheumatoid Arthritis. Before considering treatment failure in a patient treated with methotrexate, adherence to treatment must be evaluated. According to our results, self-reported adherence appears to be a cost and time effective method to care for patients.References:[1]Monchablon C, et. al. Assessment adherence to disease-modifying anti-rheumatic drugs in rheumatoid arthritis. Clinical Rheumatology. 2019;39(1):207-216.[2]Scott DL, et al. (2010) Rheumatoid arthritis. Lancet 376:1094–1108.Disclosure of Interests:None declared

Background:Tight control of rheumatoid arthritis (RA) is essential and we need a validated, objective and reproducible disease measure to achieve it. There is not gold standard in RA. There is a rising interest in evaluating disease activity on the patient’s point of view using patient-reported outcomes like RAPID3. Furthermore, some new biomarkers have appeared, like serum calprotectin, with promising results on its analyzing.Objectives:To evaluate correlation between disease activity measures usually used in patients with RA (DAS28 ESR/CRP, SDAI and CDAI) and other alternative tools (RAPID3 and calprotectin). To analyze correlation between RAPID3 and serum calprotectin levels.Methods:A cross-sectional study was performed. RA-patients (n=114) according to the ACR/EULAR 2010 classification criteria were consecutively enrolled from Rheumatology department at Hospital de Figueres during the period from February to June 2019. Disease activity, biomarkers and the assessment of the patient’s health status with RAPID3 data were collected. Modified RAPID3 (mRAPID3) was calculated by subtracting the questions about the mood included in the questionnaire (k,l,m questions) to the results of the RAPID3 as if it were a response of the HAQ test. Coefficient Spearman’s correlation (r) was used to assess the relationship between the variables, and coefficient of determination (r-squared=r2and adjusted r2) was used to show the strength of correlation.Results:114 patients were included: 71% women, mean (SD) age 60(11) years, median disease duration 13(8) years. 80% had positive RF and 70% positive ACCP antibodies. 52% had erosions. 89% patients had been receiving treatment with csDMARDs, 38% with bDMARDs o dsDMARS and 66% with glucocorticoids. Disease activity measures’ median values were DAS28ESR 3.07, DAS28CRP 2.76, SDAI 9.62 and CDAI 8.99 and showed low activity. The mean values of RAPID3 y mRAPID3 showed moderate activity (8.95 and 8.68 respectively). Median serum calprotectin level was 1.48μg/ml.All correlations between variables were statistically significant and directly proportional although with different values (table).Spearman’s correlation coefficient between mRAPID3, serum calprotectin, disease activity scores and laboratory parametersmRAPID3CalprotectinCRPESRDAS28ESRDAS28PCRSDAICDAImRAPID31Calprotectin0.231CRP0.330.591ESR0.230.390.541DAS28-ESR0.620.320.410.621DAS28-CRP0.690.320.420.280.831SDAI0.740.310.350.270.820.911CDAI0.730.250.240.210.800.890.991DAS28: Disease Activity Score, SDAI: Simplified Disease Activity Index, CDAI: Clinical Disease Activity Index, RAPID3m: Routine Assessment of Patient Index Data 3 modificative with k,l,m questions. CRP: C-reactive protein. ESR: erythrocyte sedimentation rateCoefficient of determination found a weak association between RAPID3 and mRAPID3 with DAS28ESR (r2=0,38) and moderate with DAS28CRP, SDAI and CDAI (r2=0,47, 0,55 y 0,53). Determination serum calprotectin levels together with RAPID3 or mRAPID3 increased strength of correlation between DAS28ESR, DAS28CRP, SDAI and CDAI with RAPID3 (adjusted r2=0,40, 0,49, 0,56, 0,52) and with mRAPID3 (adjusted r2=0,41, 0,50, 0,56, 0,53). Correlation between RAPID3 and serum calprotectin levels was very weak (r2=0,05).Conclusion:Correlation between disease activity measures and mRAPID3 was strong, but it was weak with serum calprotectin levels. Correlation strength between RAPID3 and DAS28ESR was low and it was moderate with other composite indices, it maintained with RAPID3m and improved by adding serum calprotectin levels although modestly. There was a very weak correlation between RAPID3 and serum calprotectin levels suggesting that these two variables give us different information about the disease activity.Acknowledgments:Mrs. Dolors Ragolta. Mr. Carlos Sanchez Piedra and Mr. Fernando Sanchez AlonsoDisclosure of Interests:None declared

Objectives To evaluate determinants of discordance between DAS28-ESR and DAS28-CRP and resulting impact on disease activity stratification in RA. Methods Paired DAS28-ESR and DAS28-CRP readings (n = 31 074) were obtained from the British Society for Rheumatology Biologics Register for RA. Factors influencing discordance between DAS28-ESR and DAS28-CRP were evaluated alongside the resulting effect on disease activity stratification. The impact of gender adjustment to the DAS28-CRP was evaluated. Results DAS28-CRP scores were ∼0.3 lower than DAS28-ESR overall, with greatest differences for women (−0.35) and patients over 50 years old (−0.34). Mean male DAS28-CRP scores were 0.15 less than corresponding DAS28-ESR scores. Discordance between DAS28-ESR and DAS28-CRP significantly impacted disease activity stratification at low disease activity and remission thresholds (32.0% and 66.6% concordance, respectively). Adjusting DAS28-CRP scores by gender significantly (P < 0.001) improved agreement with the DAS28-ESR. Conclusion Discordance between DAS28-ESR and DAS28-CRP is greatest for women and patients over 50 years of age, and influences disease activity stratification. The proposed gender-adjusted DAS28-CRP improves inter-score agreement with DAS28-ESR, supporting more reliable disease activity stratification in treat-to-target approaches for RA.

Background The Routine Assessment of Patient Index Data 3 (RAPID3) is a patient reported outcome (PRO) proposed to conveniently measure disease activity in rheumatoid arthritis (RA) based on functioning, pain and global health scores. DAS28 (including PRO and objective measures) is the most frequently used score in clinical practice and research for that purpose[1]. It has been suggested that composite scores measuring PROs only (e.g. RAPID3) might add to the assessment of disease activity over time but this claim is yet to be formally tested. Objectives In this study we evaluated a possible longitudinal association between RAPID3 and DAS28-ESR (including individual components) in patients with RA from daily clinical practice. Methods Adult patients with RA on stable treatment with either conventional synthetic disease modifying drugs (csDMARDs) and/or biologic DMARDs (bDMARDs), followed in one centre, were included. Patients were followed every 3 months up to 3 years and in each visit both clinical and medication data was collected by rheumatologists/research nurses. The longitudinal association between RAPID3 (range: 0–30) with DAS28-ESR and its individual components [tender joint count (TJC; 0–28); swollen joint count (SJC; 0–28); patient global assessment (PGA; 0–10) and ESR (mm/h)] was tested (in separate models) by longitudinal generalised estimating equations (GEE) with auto-regression. Interactions between RAPID3 with gender (male vs female), VAS pain (≥5 vs Results In total, 330 patients were included [mean (SD) age: 6212 years, 68% female, baseline mean (SD) DAS28: 3.3 (1.4) and RAPID3: 11.5 (6)]. The mean (SD) follow-up period was 10.7 (9.7) months. Although, statistically significant, we only found a poor association between RAPID3 and DAS28-ESR over time (table 1). An increase of one unit in RAPID3 (0–30) was associated with an increase of only 0.1 units of DAS28-ESR. Gender, age, PGA and VAS pain were not found to meaningfully modify the association between RAPID3 and DAS28. A far stronger association was found between RAPID3 and the ‘subjective components’ [TJC: β=0.30 (95%: 0.20; 0.39); and PGA: β=0.31 (95%: 0.28; 0.35)] of DAS28-ESR, as compared to the ‘objective components’ (i.e., SJC and ESR; the latter only significant in males) (table 1). Conclusions There is no meaningful longitudinal association between RAPID3 and DAS28. DAS28 captures objective signs of disease activity over time in RA while RAPID3 only captures subjective symptoms of RA. Reference [1] Van der Heijde DM, et al. Development of a disease activity score based on judgment in clinical practice by rheumatologists. J Rheumatol1993.20:579–581. Disclosure of Interest None declared

Background DAS28-ESR is the most widely used instrument to assess remission in rheumatoid arthritis (RA) patients. Nonetheless, substantial residual disease activity can be present in RA patients fullfilling DAS28-ESR remission. Therefore, more stringent criteria for remission have been developed. While it is known that patients can fulfil DAS28-ESR but fail ACR/EULAR Boolean remission criteria, the existence of the reverse is less known. Objectives To test the possibility to loose DAS28-ESR remission while staying in ACR/EULAR remission in patients with RA Methods Data were obtained from the prospective randomised RETRO study (EudraCT: 2009–015740–42), which recruits RA patients in stable remission. Remission was assessed by the following instruments every three months: DAS28-ESR, DAS28-CRP, CDAI, SDAI, PAS, and ACR/EULAR criteria. In the group of patients, escaping DAS28-ESR remission, but fulfilling ACR/EULAR Boolean remission, the individual components of DAS28-ESR were analysed that determined their escape from remission. Results 142 patients analysed, which were all in DAS28-ESR remission at baseline. Of them, 140 (98.59%) were in DAS-CRP-remission, 131 (92.25%) in CDAI-remission, 130 (91.55%) in SDAI-remission, 109 (76.76%) in ACR/EULAR remission and 66 (46.48%) in PAS-remission. We analysed upon the 1 year follow up those patients loosing DAS28-ESR remission over time: 58 patients lost DAS-ESR remission at least once during the 4 follow-up visits. Surprisingly, 24% (3 months), 36% (6 months), 24% (9 months) and 28% (12 months) of the patients still fulfilled the Boolean remission criteria. The only plausible reason for failing DAS28-ESR remission but staying in ACR/EULAR remission is an isolated elevation of the ESR, not accompanied by increased signs and symptoms of disease. Indeed all patients loosing DAS28-ESR remission but staying in ACR/EULAR Boolean remission had an elevated ESR equal or higher than 15 mm. However, if DAS28 scores were calculated by C-reactive protein in the same patients, they all fulfilled remission criteria. Conclusions DAS28-ESR remission can be missed even if a patient fulfils the more stringent ACR/EULAR Boolean remission criteria. The reason for this remarkable constellation is an elevated erythrocyte sedimentation rate without any clinical symptoms. Hence, isolated elevations of erythrocyte sedimentation rate should be seen critical. These data show the limitations of individual instruments to assess remission in RA and show that interpretations of the erythrocyte sedimentation rate need to be done in the clinical context Disclosure of Interest None declared

Background In most patients with rheumatoid arthritis (RA), Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) is lower than DAS28 erythrocyte sedimentation rate (DAS28-ESR), suggesting that use of the DAS28-ESR cut-off to assess high disease activity (HDA) with DAS28-CRP may underestimate the number of patients with HDA. We determined the DAS28-CRP value corresponding to the validated DAS28-ESR cut-off for HDA. Methods Baseline data were pooled from 2 clinical studies evaluating etanercept (ETN) plus methotrexate (MTX) or MTX in early RA; DAS28-CRP and DAS28-ESR were obtained, allowing the determination of the DAS28-CRP HDA value best corresponding to the DAS28-ESR cut-off of >5.1. Results At baseline, as expected, fewer patients had HDA by DAS28-CRP than DAS28-ESR; DAS28-CRP>5.1 and DAS28-ESR>5.1 had only modest agreement (κ coefficients 0.45–0.54). Mean DAS28-CRP and DAS28-ESR were 5.7 and 6.2, respectively, in the ETN+MTX group (n=571), and 6.0 and 6.5 in the MTX group (n=262). A DAS28-CRP cut-off of 4.6 corresponded to a DAS28-ESR cut-off of 5.1. Conclusions We have shown that a DAS28-CRP of 4.6 corresponds to 5.1 for DAS28-ESR. Since this is substantially lower than the DAS28-ESR cut-off of 5.1, using 5.1 as the cut-off for DAS28-CRP underestimates disease activity in RA. Trial registration number NCT00195494; NCT00913458.

Resumo Introdução: O Disease Activity Score 28 (DAS28) e versões têm sido usados para medir atividade da artrite reumatoide (AR), mas não existe consenso sobre qual é o melhor. Objetivos: Determinar a correlação entre os índices (DAS28 VHS, DAS28 PCR, SDAI e CDAI) e avaliar a concordância dos estratos de atividade com o uso de diferentes pontos de corte. Métodos: Pacientes com artrite reumatoide foram avaliados transversalmente com coleta de dados para cálculo do DAS28 (VHS e PCR), SDAI e CDAI, com o uso de pontos de cortes diferentes para definição de remissão, atividade leve, moderada e alta. Correlações de Pearson foram calculadas para medidas contínuas e concordância (teste de kappa) para os estratos (remissão, atividade leve, moderada e alta). Resultados: De 111 pacientes incluídos, 108 foram mulheres, média de 55,6 anos, tempo de doença de 11 anos. DAS28 (VHS) foi significantemente maior do que DAS28 (PCR) (4 vs. 3,5; p < 0,001) e os valores permaneceram maiores após estratificação por idade, sexo, tempo doença, fator reumatoide e HAQ. Correlações entre índices variaram de 0,84 a 0,99, com melhor correlação entre SDAI e CDAI. Concordâncias entre estratos de atividade variaram de 46,8% a 95,8%. DAS28 (PCR) com ponto de corte para remissão de 2,3 subestimou atividade da doença em 45,8% quando comparado com DAS28 (VHS). SDAI e CDAI apresentaram concordância de 95,8%. Os quatro índices mostraram associação com tempo de doença e HAQ. Conclusões: Embora os índices de atividade apresentem boa correlação, mostram discrepâncias nos estratos de atividade. Tornam-se necessários mais estudos para definir melhor índice e melhores pontos de corte. Abstract Introduction: The Disease Activity Score 28 (DAS28) and its versions have been used to measure rheumatoid arthritis activity, but there is no consensus about which one is the best. Objectives: Determine the correlation among indexes (DAS28 ESR, DAS28 CRP, SDAI and CDAI) and evaluate agreement of activity strata using different cut-off points. Methods: Rheumatoid arthritis patients were cross-sectionally evaluated with data collection to calculate the DAS28 (ESR and CRP), SDAI and CDAI, using different cut-offs for defining remission, mild, moderate and high activity. Pearson correlations were calculated for continuous measures and agreement (kappa test) for the strata (remission, mild, moderate and high activity). Results: Of 111 patients included, 108 were women, age 55.6 years, 11-year disease duration. DAS28 (ESR) was significantly higher than DAS28 (CRP) (4.0 vs. 3.5; p < 0.001) and the values remained higher after stratification by age, gender, disease duration, rheumatoid factor and HAQ. Correlations among indexes ranged from 0.84 to 0.99, with better correlation between SDAI and CDAI. Agreements among activity strata ranged from 46.8% to 95.8%. DAS28 (CRP) with cut-off point for the remission of 2.3 underestimated disease activity by 45.8% compared with DAS28 (ESR). SDAI and CDAI showed agreement of 95.8%. The four indexes were associated with disease duration and HAQ. Conclusions: Although the activity indexes show good correlation, they show discrepancies in activity strata, thus requiring more researches to define a better index and better cut-off points.

OBJECTIVES To investigate whether a difference exists between DAS28 from CRP and DAS28 from ESR in patients with rheumatoid arthritis (RA) and secondary Sjogren's syndrome (sSS). MATERIAL AND METHODS One group comprised patients with RA and sSS, the control group comprised patients with RA. The inclusion criteria for the RA and sSS group have been specified as follows: presence of at least one symptom of dryness, and also presence of anti-SS-A and anti-SS-B or at least focus score of one in biopsy. RESULTS The disease activity score 28 (DAS28) was assessed using both ESR and CRP in 60 patients with RA and sSS and 59 patients with RA alone. However, concordance between these two methods was good (Cohen's κ coefficient κ = 0.60, 95% CI: 0.45-0.75 in the first group and κ = 0.71, 95% CI: 0.56-0.86 in the control group). In the group with RA and sSS, the mean value of DAS28-ESR = 5.2, whereas the mean value of DAS28-CRP = 4.7 (p < 0.0001). In the group with RA alone, mean DAS28-ESR = 4.7 while mean DAS28-CRP = 4.6; no significant difference was identified. Moreover, in RA patients with sSS, mean ESR = 39 mm/h compared with mean CRP at 25 mg/l. 79% of all patients demonstrated dysproteinaemia. There were connections between higher ESR and dysproteinaemia. In the control group there was no statistically significant difference between CRP and ESR. CONCLUSIONS Both DAS28-ESR and DAS28-CRP are useful outcome measures in RA. However, in patients with RA and sSS, DAS28 should be evaluated based on CRP.

Background Biologics have greatly improved the management of rheumatoid arthritis (RA), demonstrating efficacy and safety in alleviating symptoms, inhibiting bone erosion, and preventing loss of function. 1 The current study hypothesis was that despite significant improvement in patient (pt) outcomes since the introduction of biologics, significant unmet need and burden of illness remains. Objectives The main objective was to test our primary hypothesis. Secondary objectives were to explore patterns of physician use of disease activity measures and compare degree of reported unmet need as ascertained by subjective physician assessment and objective disease activity measures. Methods Descriptive analyses of the following outcomes were performed using ADELPHI RA Disease Specific Program (DSP) data for US and EU5 pts who had been receiving biologic therapy ≥3 months: remission based on DAS28 ESR ( Results After ≥3 months on biologics (n=1299), 56% of pts were in remission based on physician judgement, while 31% were in remission based on DAS28 ESR ( P Conclusions There are significant unmet needs among RA pts on biologic treatment, regardless of line of therapy, suggesting the need for biologics with novel mechanisms of action. Remission based on physician judgement appeared to be over-reported as compared to remission indicated by disease activity measure DAS28. Clinical disease activity measures were not used consistently by physicians. Future study is warranted to explore whether under-utilization of disease activity measures is associated with the discrepancy between physician subjective judgement and clinical measurement. References Smolen JS, et al. Ann Rheum Dis. 2014;73(3):492–509. Disclosure of Interest S. Peterson Shareholder of: Janssen, Employee of: Janssen, E. Sullivan Employee of: Adelphi Real World, D. Kielar Shareholder of: Janssen, Employee of: Janssen, N. Li Employee of: Janssen

Background Patient global assessment (PtGA) is included in all the current remission definitions for RA despite the fact that PtGA is not exclusively related to disease activity. Objectives In this study in order to objectively identify whether patient9s assessment is better than physician9s (Ph) or not, we compared disease activities assessed with ultrasound (US) of Boolean remission patients with PtGA and with PhGA. Methods RA patients in clinical remission (DAS28 ESR Results A total of 88 out of 389 RA patients (22.6%) in DAS28 remission were enrolled (F/M=55/33, mean age 53.4±12.0, disease duration 10.5±6.3 years, bDMARDs 44.3%, RF/Anti-CCP positivity 72%). Of 88 patients, 33 (37.5%) fulfilled the Boolean remission criteria. When PtGA was substituted with PhGA, Boolean remission rate increased to 61.4% (n=54) ( P grade 1 were taken into account, % of patients without PD, GS or both signals were also similar Table 1). US disease activity parameters of Boolean PtGA and Boolean PhGA remission and their counterpart nonremission patients were compared as well, Boolean remission either with PtGA or PhGA had significantly lower PD scores compared to Boolean nonremission groups with PtGA or PhGA (1 [0–4] vs 3 [1–7], P =0.016 and 1.5 [0–4] vs 4 [0.75–7], P =0.027, respectively). Conclusions RA patients in Boolean remission with PhGA do not have higher disease activity that is verified by US, compared to patients in Boolean remission with PtGA. Furthermore Boolean remission with PhGA differentiates patients with US evinced inflammation, especially PD scores, as good as PtGA. These data suggest that PtGA might be substituted with PhGA in Boolean criteria with higher remission achievement rates. Prospective follow up and recruitment of more patients will clarify the consistency of these results over time and impact of this substitution on functionality. Disclosure of Interest None declared

Background Disease activity in rheumatoid arthritis (RA) has traditionally been measured using the 28-joint count disease activity score (DAS28) using ESR. Use of DAS28 with CRP in place of ESR is increasing. Evidence suggests these scores are not truly interchangeable and agreement varies dependant on disease activity. This study uses the BSRBR-RA to investigate agreement between these scores, proposing an optimised method to calculate the estimated DAS28-ESR using CRP (mDAS28-CRP) that offers higher interscore agreement than currently. Objectives To investigate and optimise agreement between the DAS28-ESR and DAS28-CRP scores using the BSRBR-RA. Methods Patients with concurrent measures of ESR and CRP were identified from the BSRBR-RA, enabling paired calculation of DAS28-ESR and DAS28-CRP using existing formulae. A non-linear regression model enabled prediction of ESR from CRP. Resulting values were used in the existing DAS28-ESR formula to calculate estimated disease activity (mDAS28-CRP). A Bayesian approach was used to acknowledge the uncertainty associated with the predictions and correctly propagate it through to mDAS28-CRP. Inference, including constructing credible intervals for predicted ESR and mDAS28-CRP, was performed using Markov-Chain-Monte-Carlo. Bland-Altman analysis and agreement matrices were used to compare agreement levels between mDAS28-CRP, DAS28-CRP and DAS28-ESR. Results 5457 patients (mean age 56 yrs, 76% female) with 31,084 data entries were identified where paired DAS28-ESR/DAS28-CRP scores could be calculated. Mean DAS28-ESR was 0.3 points greater than DAS28-CRP (4.4 (SD 1.7), 4.1 (SD 1.6) respectively) compared with mean mDAS28-CRP of 4.6 (SD 1.6; Fig 1). mDAS28-CRP had superior agreement with DAS28-ESR across remission, low and moderate disease activity, with only a 6.8% reduction in agreement at high disease activity when compared with the DAS28-CRP (Table 1). Conclusions The mDAS28-CRP (online calculator pending) allows calculation of a disease activity score, using the same component parts of the DAS28-CRP, and has higher agreement levels with the original validated DAS28-ESR, than the current DAS28-CRP in this cohort. Disease activity scores are fundamental in clinical trials and practice, forming a central role in guiding availability of therapeutic agents. It is therefore essential that scores used are both valid and, if used interchangeably, have high agreement levels. Disclosure of Interest None declared

Background Disease activity in rheumatoid arthritis (RA) has traditionally been measured using the 28-joint count disease activity score (DAS28) using ESR. Use of DAS28 using C-reactive protein (CRP) in place of ESR is increasing. This study investigates the level of agreement between the DAS28-ESR and DAS28-CRP scores across different disease activity thresholds and identifies how patient characteristics may influence agreement. Objectives To identify the interscore agreement between the DAS28-ESR and DAS28-CRP scores and identify if gender or body mass index (BMI) influence the level of agreement. Methods Patients with concurrent measures of ESR and CRP were identified from the BSRBR-RA, enabling paired calculation of DAS28-ESR and DAS28-CRP. Paired scores were stratified by patients9 baseline BMI and gender. Agreement between the scores was compared using Bland-Altman statistics and agreement matrices. Results 5457 patients (mean age 56 yrs, 76% female) with 31,084 data entries were identified where paired DAS28-ESR/DAS28-CRP scores could be calculated. Mean DAS28-ESR was 0.3 points (95% CI -0.8 - 1.4) greater than DAS28-CRP (4.4 (SD 1.7) and 4.1 (SD 1.6) respectively). Men had a lower mean difference between the two scores compared with women (DAS28-ESR > DAS28-CRP by 0.2 points (95% CI -1.0 – 1.3) vs. 0.4 points (95% CI -0.7 – 1.4) respectively). The results stratified by BMI were similar to the overall mean difference. Agreement between the two scores according to disease activity thresholds are shown in Table 1. Conclusions Overall, the DAS28-ESR classifies fewer patients in remission (15.6% vs. 19.5%) giving a score, on average 0.3 points greater than the DAS28-CRP, with women having a greater difference between the two scores than men. When categorising scores by disease activity thresholds, the DAS28-ESR/DAS28-CRP have lowest agreement at LDA. 54.4% of DAS28-ESR scores were classified as MDA when the paired DAS28-CRP was LDA, which could influence results in clinical trial reporting. Conversely, 20% of patients were classified as being in MDA by DAS28-CRP when the paired DAS28-ESR demonstrated HDA. This is of importance given NICE biologics guidelines, and shows that up to 20% of patients may not satisfy the criteria for biologic therapy if DAS28-CRP were used instead of DAS28-ESR. These results highlight the impact of using the DAS28-ESR or DAS28-CRP interchangeably, and the importance of using a consistent version of the DAS28. Disclosure of Interest None declared

Background The ultimate goal of RA treatment is to achieve disease remission. Studies have shown that objective, measure-based treatment decision-making leads to improved patient outcomes. In addition, the National Quality Forum (NQF) recently endorsed three measures for RA, including assessment of disease activity using a standardized tool. However, in clinical practice physicians may still rely on subjective assessment of disease activity. Objectives To compare physician-reported and DAS28-based clinical assessments of RA disease remission. Methods Data were drawn from the Adelphi RA-DSP, a cross-sectional survey of United States rheumatologists and their RA patients between January and March 2014. Clinical remission status (DAS28 ESR Results Included in the analysis were 531 RA patients (75% female, mean age 56.4 years, 7.7 years since RA diagnosis, 53% treated with biologic) in the care of 78 rheumatologists (31% female, 37% practice only in office). 56% of physicians reported using only subjective criteria to assess remission; 30% of patients were evaluated using a standardized disease activity measure during last visit. While physicians reported 50% of patients were in remission, 32% were in remission by DAS28 criteria. Remission status was over-reported by physicians in 25% and underreported in 7% of patients. Regression analyses indicated that physician over-reporting was significantly higher among patients treated with biologics (Relative Risk Ratio (RRR)=2.01, P=0.003), those in the care of physicians with high RA workload (RRR=2.51, P=0.011), and patients considered by their physicians to have “satisfactory” RA control (RRR=6.09, P Physician under-reporting was significantly higher among obese patients (RRR=2.95, P=0.002), patients with average general health level (RRR=2.03, P=0.029), and those with more than 5 tender or swollen joints (RRR=2.72, P=0.019), but significantly lower among patients with medium to high current pain level (RRR=0.18, P=0.004) or those who saw physicians with high RA workload (RRR=0.43, P=0.029). Conclusions This study points out the need to increase the use of standardized measures of RA disease activity, and ensure consistency of use across clinical care. Addressing these gaps in care may help optimize treatment decisions, reduce variability in delivery of patient care and ultimately improve RA patient outcomes. Disclosure of Interest W. Wei Shareholder of: Sanofi, Employee of: Sanofi, C. Chen: None declared, E. Sullivan: None declared, S. Blackburn: None declared, J. Curtis Grant/research support from: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, Consultant for: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie

Objectives To compare the disease activity score (DAS)28- ESR versus DAS28 -CRP, and to determine the factors that might influence their difference. Methods Patients with RA were included in a cross-sectional study. We have collected the demographic characteristics and the characteristics of the RA: duration of evolution, morning stiffness in minutes, functional impact of the disease assessed by the HAQ (Health Assessment Questionnaire), and current corticosteroid dose. The disease activity was assessed by the DAS28-ESR and DAS28-CRP. A simple correlation between DAS28-ESR and DAS28-CRP was performed. We considered a difference between DAS28-ESR and DAS28-CRP as significant when it is greater than or equal to 0.6 [1]. Factors influencing this difference were tested by univariate then multivariate logistic regression. Results 103 patients were included with a female predominance (87.4%). Mean age was 49.7±11.4 years. Median disease duration was 8 years [3-14]. There was a strong positive correlation between the two indexes of 0.91 (p Conclusions Our study shows a strong positive correlation between the DAS28-ESR and DAS28 -CRP. But DAS VS 28 would be higher than the DAS28 CRP in patients with high pain intensity and significant functional impairment. References Are the C-reactive protein values and erythrocyte sedimentation rate equivalent when estimating the 28-joint disease activity score in rheumatoid arthritis? Clin Exp Rheumatol. 2008 Sep-Oct;26(5):769-75. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5807

Background The CAMERA II study (Computer Assisted Management in Early RA) demonstrated that the addition of prednisone versus placebo to a MTX-based tight-control strategy increased effectiveness of therapy and reduced need for biological treatment. Objectives The present study evaluated changes in biomarker levels over time with MTX+placebo and MTX+prednisone treatment, using the Multi-Biomarker Disease Activity (MBDA) blood test. Methods Clinical and biomarker assessments were performed at monthly visits to 1 year for 92 patients who had MBDA test results available at baseline and ≥ 1 subsequent visit. Average number of visits with non-missing disease activity measures was 3.7 per patient. Concentrations of 12 serum biomarkers were combined to produce a score between 1 and 100 using the MBDA algorithm, which generates a validated measure of disease activity. Biomarker levels were also assessed individually but only to 5 months, to avoid subsequent protocol-mandated exposures to non-MTX DMARDs for insufficient responders. Correlation between DAS28-ESR change and MBDA change was assessed using Spearman’s correlation. Changes from baseline and comparisons of change in disease activity scores over time for MTX+placebo versus MTX+prednisone were analyzed by t-tests. Biomarker concentrations were analyzed as fractions relative to baseline using Mann Whitney U tests. Results Changes from baseline to 1 year in DAS28-ESR and MBDA scores showed a significant correlation in the MTX+placebo arm (r = 0.57, p Conclusions Responses assessed with the biomarker-based MBDA test and DAS28-ESR were greater and more rapid for therapy with MTX+prednisone than MTX+placebo, even though individual biomarkers differed in their response profiles. The MBDA test may be useful in combination with clinical assessment to evaluate early response to therapy with MTX or MTX+prednisone. Disclosure of Interest M. Jurgens: None Declared, J. Bijlsma: None Declared, J. Jacobs: None Declared, M. Bakker: None Declared, F. Lafeber: None Declared, P. Welsing: None Declared, G. Cavet Consultant for: Crescendo Bioscience, Inc., D. Chernoff Employee of: Crescendo Bioscience, Inc., E. Sasso Employee of: Crescendo Bioscience, Inc., W. Li Employee of: Crescendo Bioscience, Inc., D. Haney Employee of: Crescendo Bioscience, Inc.

Background An essential element in the treat to target strategy is modification of treatment in the absence of achieving a target response by 12 weeks. A change in the Disease Activity Score (DAS28 ESR) of 1.2 and Simplified Disease Activity Index (SDAI) of 50% (SDAI50 based on a ACR20) are possible response measures (RM). Objectives To characterize patients (pts) failing to respond to either RM and determine a relationship between the two. Methods The study was carried out on the Canadian Early Arthritis Cohort (CATCH) - a multicentre early arthritis RA cohort comprising 1953 pts with disease of Results The cohort comprised 74.9% females, mean age: 52.6 years, mean disease duration: 5.7 months. Baseline (BSL) disease characteristics included a mean tender joint count: 9.0, swollen joint count: 8.2, DAS28: 5.2, HAQ: 1.1, SDAI: 29.7, ESR: 27.2, and CRP: 14.4. Of 419 pts evaluated, 198 pts failed to achieve a DAS28 1.2 and 206 pts failed to achieve a SDAI50 by 12 weeks. A strong relationship was observed between DAS28 1.2 and SDAI50 non-responders (Kappa 0.66) and Spearman Correlation (0.66) (p Conclusions SDAI50 and DAS28 1.2 RM are well correlated although at high disease states the likelihood of achieving an SDAI50 is lower than achieving a DAS28 1.2, while the reverse is true at lower disease states. Disclosure of Interest M. Omair: None Declared, P. Akhavan: None Declared, E. Keystone: None Declared, J. Xiong: None Declared, G. Boire: None Declared, J. Pope: None Declared, J. Thorne: None Declared, C. Hitchon: None Declared, B. Haraoui: None Declared, D. Tin: None Declared, D. Weber: None Declared, V. Bykerk Grant/research support from: The CATCH study was designed and implemented by the investigators and financially supported initially by Amgen Canada Inc. and Pfizer Canada Inc. via an unrestricted research grant since inception of CATCH. As of 2011, further support was provided by Hoffman-LaRoche Limited, United Chemicals of Belgium (UCB Canada Inc.)., Bristol-Meyers Squibb Canada Co., Abbvie Inc., and Janssen Biotech Inc. (a wholly owned subsidiary of Johnson & Johnson Inc.).