Search

Objective. To identify predictors for Simplified Disease Activity Index (SDAI) remission in established rheumatoid arthritis (RA) and to develop a predictive score for remission. Methods. Prospective 12-month observational study in ninety active RA receiving their first TNF-α inhibitor. Standard assessments consisted of disease activity scores (DAS28-ESR, SDAI) and immune parameters (total rheumatoid factor, RF; IGA-RF; anti-cyclic citrullinated peptide antibodies, ACPA). The primary outcome measure was SDAI remission (≤ 3.3) at 12 months. Univariate and multivariate logistic regression models were used to estimate association between baseline variables and SDAI remission. Results. 39.7% RA achieved remission, while 56.8% low disease activity. Significant association between SDAI remission and RA-onset before 50 (p = 0.000), history 0.05). Conclusion. SDAI remission can be predicted in established RA using a score based on age at onset, disease duration, titers of ACPA and RF isotype A. Such a simplified score may help clinicians to manage remission in RA patients according to the current treatment guidelines.

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.

Background The risk of infections, especially severe infections (SI), remains of particular interest in rheumatoid arthritis (RA), both defective immune response and therapeutic immunosuppression being responsible. The RABBIT Risk Score (RRS), an instrument developed and validated for RA in the German Biologics Register RABBIT and replicated in other RA settings (British Register), allows the estimation of SI occurring during 12 months according to patient characteristics, based on data from similar risk profiles. Objectives To evaluate the RSS reliability in a Romanian RA cohort under different biologics, considering the agreement between observed and expected rates of SI at 12 months. Methods Longitudinal study on 272 consecutive RA with moderate-to-severe active disease, starting their biologic according to local guidelines, enrolled between 2008 and 2016 in a single academic center. Along with disease activity and therapeutic response, baseline RRS (http://www.biologika-register.de/en/home/risk-score/)was applied for each case, based on multiple risk factors for infections including age, functional status, chronic lung and renal comorbidities, previous SI, number of treatment failures, current biologic (TNF or non-TNF inhibitors), mean corticosteroid dose. The predictive value of RRS was considered by comparing the number and rate of expected versus reported SI in the first year of biologics (ROC curve, p Statistical analysis (univariate, multivariate) was stratified according to different predictors of infection, patients being classified in two groups based on their recruitment before (2008–2012) and after (2013 up to date) implementation of national biologic register RRBR. Results The performance of RSS was previously established in a pilot study on 181 RA. Currently, the RSS was considered in 144 RA recruited to the first group and 128 to the second. The prescription pattern significantly changed (p 24.63% RA developed SI (a total of 67 episodes, 1.47% fatal outcomes). Irrespective of RA settings and scenarios, history of biologics, specific drug administered (TNF or non-TNF), RRS indicated an outstanding agreement between the observed and expected SI rates (p>0.05). In addition, the rate of SI was lower in RA recruited after 2013 (p Conclusions The RABBIT Risk Score is a consistent tool, able to predict serious infections in Romanian RA receiving biological therapy (TNF and non-TNF drugs), optimizing the selection of appropriate medication based of individual infectious risk profile in routine practice. Disclosure of Interest None declared

Background Although the orofacial manifestations are commonly reported among patients with systemic sclerosis (SSc), only few studies have adequately addressed the issue of oral health-related quality of life (QoL) in such pathobiological settings. Objectives The aim was to characterize the oral health status (OHS) of adults with SSc and to compare with the general population. Methods A cross-sectional prospective observational study in 37 consecutive SSc in a EUSTAR cohort (EUSTAR 162 center) and 37 gender and age-matched controls without SSc. A standardized oral exam meaning OHS (periodontal, dental, mucosal and microbial), oral health-related behaviors and oral HRQoL (Oral Health Impact Profile, OHIP) were evaluated in all recruited individuals, while oral manifestations such as size of oral aperture, oral dryness, manual dexterity for oral hygiene and HRQoL only in SSc. Multivariable regression analysis was done to evaluate association between SSc, oral abnormalities, oral health status and QoL. Results Overall, SSc had significantly reduced oral HRQoL compared with controls (p We demonstrated lower resting salivary flow rates (p 3 mm) (p Finally, SSc was documented as a significant independent predictor of OHIP, missing teeth, periodontal disease, interincisal distances as shown by multivariate regression (p Conclusions SSc patients are at risk to develop impaired oral health and oral HRQoL compared with the general population. Disclosure of Interest None declared

Background Early documentation of pulmonary arterial hypertension (PAH) related to systemic sclerosis (SSc) remains a challenge in daily clinical practice, with major prognostic and therapeutic implications. Although several screening algorithms specifically designed to optimize the detection of secondary PAH have already been proposed (e.g., DETECT, REVEAL), no precise approach received complete validation, especially the use of invasive diagnostic right heart catheterization (RHC). Objectives Main objective was to assess the risk of PAH in patients with SSc and to compare with PAH screening promoted by European Society of Cardiology/ European Respiratory Society (ESC/ERS) 2009 guidelines, while secondary one to identify predicting factors for developing PAH among clinical and immunological SSc variables. Methods Cross-sectional prospective single-center study, applying the DETECT calculator in patients with SSc recruited in EUSTAR 162 center cohort between January 2013- December 2016; all SSc completing at least two monitoring visits at 6 months were considered. Standard assessments included MEDS (minimal data set EUSTAR), annual echocardiography with systolic pulmonary artery pressure (sPAP), pulmonary function tests with forced vital capacity (FVC), percentage predicted/diffusing capacity for carbon monoxide (DLCO) % predicted, ECG, serum biomarkers (serum urate, NT-proBNP). PAH risk calculator (http://detect-pah.com/pah-risk-calculator), a tool developed and validated in the DETECT study, is able to identify patients requiring echocardiography (STEP 1) respectively RHC (STEP 2), and was systematically applied in our cohort. All sPAP ≥45 mmHg or between 35–45 mmHg in the presence of dyspnea were proposed for invasive testing. Statistical analysis was performed in IBM SPSS-19 version, p Results 41 out 56 SSc in our database were recruited: mainly women (85.36%) with diffuse cutaneous SSc (63.41%), anti-topoisomerase (up to half) and anti-centromere (about one third) positive disease; one out of four 4 SSc presented with digital ulcers and one of three with active capillaroscopic pattern. Using the DETECT PAH calculator, 14/ 41 (34.14%) were recommended for RH as follows: an initial value above 300 points in STEP 1 (with further indication of echocardiographic assessment) and subsequent STEP 2 over 35 were recorded. On the other hand, only 9/41 (21.95%) cases met the ultrasound criteria to be addressed to an invasive assessment when applying the ESC/ERS 2009 guidelines, the difference being statistically significant as compared to DETECT (p PAH was finally confirmed in 8/41 (19.51%) cases, supporting our preliminary results in a pilot study on a limited number of patients. Conclusions DETECT is a reliable algorithm for early detection of PAH in patients with SSc, optimizing PAH screening and prompting the rheumatologist-cardiologist collaboration. Disclosure of Interest None declared

Background Planning a pregnancy in rheumatoid arthritis (RA) meets several issues, mostly concerning potential drug toxicity and disease flares Objectives The purpose of this study is to evaluate pregnancy planning, RA activity during pregnancy and postpartum, pregnancy and fetal outcomes in a Romanian cohort of female patients diagnosed with RA. Methods This is an observational, ambispective study, including 58 RA Caucasian females with obstetric history after the onset of RA (20 females - prospective, 38 - retrospective). The cases were obtained from several Clinics of Rheumatology from Romania Results The mean age at inclusion was 37.1 years, age at RA diagnosis 3.9 years and mean age at conception 32.2 years. We recorded a total number of 96 pregnancies: 48 deliveries at term, 4 premature births, 15 elective abortions, 24 spontaneous abortions, and 5 ongoing. 34/96 (35.4%) had at least one unplanned pregnancy, while being on treatment. Concerning the exposure to synthetic DMARDs during the pregnancy: 6 patients received Leflunomide and 4 received Methotrexate during the first trimester, the pregnancy outcomes being: 3 spontaneous and 3 elective abortions, 3 normal birth (1- Cholestiramine wash-out), 1 premature twin pregnancy. Regarding biologic DMARDs: 5 were exposed to Etanercept - 3 less than 3 weeks, (2 normal births and one elective abortion- due to Methotrexate use), 2 treated in second trimester: 1 only in the 15th and 16th weeks due to relapse - normal birth, and the other one until week 20, pregnancy still ongoing. One patient was treated with Certolizumab until week 12, the pregnancy is ongoing, and one with Adalimumab until week 4, the fetus had intrauterine growth restriction, premature birth. 6 patients treated with Rituximab were included, last infusions were: 4 weeks before conception (1- spontaneous abortion and 1 normal birth), 48 weeks (2 normal births and 1 premature), and one at 4 weeks after conception - normal birth. In 4 cases the patients stopped the biological DMARD before conception: Etanercept 6 months and 2 years, Adalimu-mab,6 months with normal outcome, and for Tocilizumab 9 months (growth restriction) 81.25% of our patients were in Remission or Low Disease Activity (by DAS28CRP) at conception and generally this status was maintained, excepting several situations. The average pregnancy length was 36.36 weeks and the mean birthweight was 2878.90 grams.2 growth restriction was identified and several atopic dermatitis, no teratogenic effect. 13 patients never had a new flare postpartum and in the others the mean time of postpartum flare was 12.1 weeks Conclusions Patients with RA can have successful pregnancies. More than 60% of pregnancies have been planned. Pregnancy decreases disease activity, but many deliveries are followed by RA flares. No fetal abnormalities were diagnosed. References Ostensen M, et all. State of the art: Reproduction and pregnancy in rheumatic diseases: Autoimmun Rev. 2015 May;14(5):376–86. doi: 10.1016/j.autrev.2014.12.011. Epub 2014 Dec 30. Disclosure of Interest None declared

Objectives: The multisystem manifestations of SSc can greatly impact patients' quality of life. The aim of this study was to identify factors associated with disability in SSc. Methods: SSc patients from the prospective DeSScipher cohort who had completed the scleroderma health assessment questionnaire (SHAQ), a disability score that combines the health assessment questionnaire and five visual analogue scales, were included in this analysis. The effect of factors possibly associated with disability was analysed with multiple linear regressions. Results: The mean SHAQ and HAQ scores of the 944 patients included were 0.87 ( s . d . = 0.66) and 0.92 ( s . d . = 0.78); 59% of the patients were in the mild to moderate difficulty SHAQ category (0 ⩽ SHAQ < 1), 34% in the moderate to severe disability category (1 ⩽ SHAQ < 2) and 7% in the severe to very severe disability category (2 ⩽ SHAQ ⩽ 3). The means of the visual analogue scales scores were in order of magnitude: overall disease severity (37 mm), RP (31 mm), pulmonary symptoms (24 mm), gastrointestinal symptoms (20 mm) and digital ulcers (19 mm). In multiple regression, the main factors associated with high SHAQ scores were the presence of dyspnoea [modified New York Heart Association (NYHA) class IV (regression coefficient B = 0.62), modified NYHA class III (B = 0.53) and modified NYHA class II (B = 0.21; all vs modified NYHA class I)], FM (B = 0.37), muscle weakness (B = 0.27), digital ulcers (B = 0.20) and gastrointestinal symptoms (oesophageal symptoms, B = 0.16; stomach symptoms, B = 0.15; intestinal symptoms, B = 0.15). Conclusion: SSc patients perceive dyspnoea, pain, digital ulcers, muscle weakness and gastrointestinal symptoms as the main factors driving their level of disability, unlike physicians who emphasize objective measures of disability.

Despite recent advances in understanding the pathological pathways, clinical pattern and management opportunities for new-onset psoriasis as a paradoxical adverse event in patients receiving TNF inhibitors for their immune-mediated disorder, there is a subset of patients who are either partial responders or non-responders, whatever the therapeutic scenario. We present the case of new-onset psoriasis and severe alopecia development in a case study of long-standing rheumatoid arthritis (RA) treated with adalimumab (ADA) and leflunomide. Since skin lesions and alopecia are resistant to the classic protocol (topical treatment, ADA discontinuation) and RA becomes highly active, rituximab (RTX) was started. Dramatic improvement in joint disease, total remission of alopecia and partial remission of pustular psoriasis were described after the first RTX cycle. Although B-cell-depleting agents result in controversial effects on psoriatic skin lesions, this is the first case of ADA-induced psoriasis and alopecia that improved under RTX, suggesting a possible role in treating such a patient population.

SirA 66-year-old retired female patient, with a 30-year history of psoriasis, was seen in Dermatology in 2014 for severe plaque psoriasis associated with nail involvement and psoriatic arthritis. S...

The objective of this study was to identify predictors for remission or low disease activity (LDA) in established rheumatoid arthritis (RA) at 12 months of anti-TNF-α therapy. We have performed a prospective observational study in 90 consecutive patients with active RA receiving TNF-α inhibitors. Baseline and standard assessments were done every 3 months, including individual parameters (clinical and biological) and composite activity scores (28-joint disease activity score, DAS28). The primary outcome measure was DAS28-based EULAR response criteria. The multivariate logistic regression was used to analyze the association between disease activity and several RA baseline characteristics. Of the RA, 78.8 % was classified as good responders based on the EULAR-DAS28 criteria, 44.4 % RA achieving remission (DAS28 ≤ 2.6) and 34.4 %, LDA (DAS28 ≤ 3.2). Parameters associated with an increased likelihood of remission and LDA were initial DAS28-erythrocyte sedimentation rate ≤ 7 (odds ratio (OR) 3.3, 95 % confidence interval (CI) 2.03-5.81; OR 1.8, 95 % CI 1.09-6.68), Health Assessment Questionnaire Disability Index ≤ 2 (OR 7.0, 95 % CI 1.56-31.91; OR 1.3, 95 % CI 1.03-5.79), C-reactive protein level ≤ 20 mg/l (OR 1.5, 95 % CI 0.29-8.22; OR 0.5, 95 % CI0.08-2.97), rheumatoid factor ≤ 20 IU/ml (OR 18.9, 95 % CI 10.79-38.36; OR 32.9, 95 % CI 4.03-269), anti-cyclic citrullinated peptide antibodies ≤ 40 IU/ml (OR 3.5, 95 % CI 0.67-18.19; OR 1.2, 95 % CI 1.02-1.59), concurrent prednisolone (OR 0.2, 95 % CI 0.05-0.36; OR 0.2, 95 % CI 0.06-0.63), methotrexate or leflunomide (OR 1.6, 95 % CI 1.2-13.53; OR 2.9, 95 % CI 1.20-4.36). A predictive matrix for remission and LDA in established active RA patients receiving TNF-α inhibitors was proposed. Further studies are necessary to confirm the value of such matrix in particular RA settings, leading to optimization of the use of anti-TNF-α therapy.

OBJECTIVES: In agreement with other autoimmune diseases, systemic sclerosis (SSc) is associated with a strong sex bias. However, unlike lupus, the effects of sex on disease phenotype and prognosis are poorly known. Therefore, we aimed to determine sex effects on outcomes. METHOD: We performed a prospective observational study using the latest 2013 data extract from the EULAR scleroderma trials and research (EUSTAR) cohort. We looked at (i) sex influence on disease characteristics at baseline and (ii) then focused on patients with at least 2 years of follow-up to estimate the effects of sex on disease progression and survival. RESULTS: 9182 patients with SSc were available (1321 men) for the baseline analyses. In multivariate analysis, male sex was independently associated with a higher risk of diffuse cutaneous subtype (OR: 1.68, (1.45 to 1.94); p

Objective To assess intercentre variability in the ACR core set measures, DAS28 based on three variables (DAS28v3) and Routine Assessment of Patient Index Data 3 in a multinational study. Methods Seven thousand and twenty-three patients were recruited (84 centres; 30 countries) using a standard protocol in the Quantitative Standard Monitoring of Patients with RA study. Analysis of variance (ANOVA) and mixed-effect analysis of covariance models were used to model the relationship between study centre and different patient-reported and physician-reported RA activity measures. These models were built to adjust for the remaining ACR core set measure (for each ACR core set measure or each composite index), socio-demographics and medical characteristics. ANOVA and analysis of covariance models yielded similar results, and ANOVA tables were used to present variance attributable to recruiting centre. Results The proportion of variances attributable to recruiting centre was lower for patient reported outcomes (PROs: pain, HAQ, patient global) compared with objective measures (joint counts, ESR, physician global) in all models. In the full model, variance in PROs attributable to recruiting centre ranged from 1.53% for patient global to 3.71% for HAQ compared with objective measures that ranged from 5.92% for physician global to 9.25% for ESR; and was lower for Routine Assessment of Patient Index Data 3 (2.6%) compared with DAS28v3 (11.75%). Conclusion Intercentre variability in PROs is lower than objective measures of RA activity demonstrating that PROs may be more comparable across centres, and the need for standardization of objective measures.

The aim of our study was to evaluate serum VEcadherine (VE-CAD) in Rheumatoid Arthritis (RA) and to investigate the potential relations between VE-CAD and the demographic, clinical, biological and disease activity scores. Materials and method: prospective observational study on 64 consecutive RA patients, assessed according to a standard protocol including demographics, disease (clinical, inflammatory, immunological) characteristics, serum VE-CAD (ELISA) and disease activity score (DAS28). Results: a significant correlation was noticed between VE-CAD serum levels and the age of male RA patients; the serum levels of VE-CAD tend to increase in the second and third stage of RA and to decrease in the fourth stage; although the maximum VE-CAD serum levels were significantly lower in RA patients undergoing anti-TNF therapy, no conclusion that anti-TNF therapy might affect in any way the VE-CAD serum levels could be attained. Conclusions: VE-CAD could represent a new biomarker of disease activity, particularly in the subset of RA patients with normal CRP level.

Objective: Qualitative capillaroscopy patterns in juvenile- and adult-onset systemic sclerosis (SSc) were studied in adulthood using data from the EULAR Scleroderma Trials and Research (EUSTAR) database. Methods: Data collected between June 2004 and April 2013 were examined with focus on capillaroscopy. In this retrospective exploratory study, series of patients with juvenile-onset SSc were matched with series of adult-onset SSc having the same gender and autoantibody profile. Results: 30 of 123 patients with juvenile-onset and 2108 of 7133 with adult-onset SSc had data on capillaroscopy. Juvenile-onset SSc showed scleroderma pattern more frequently than adult-onset SSc (93.3% and 88%). The OR was 2.44 and 95% Cl 0.57-10.41. An active scleroderma pattern was present in 58% of juvenile- and 61% of adult-onset SSc. The OR was 0.91 and 95% Cl 0.28-2.93. The late scleroderma pattern was present in 61% of juvenile- and 55.5% of adult-onset SSc. The OR was 1.06 and 95% Cl 0.34-3.56. Conclusion: This is the first exploratory study on the comparison of capillaroscopy between juvenile- and adult-onset SSc in adulthood. Juvenile-onset SSc had an increase prevalence of sderoderma pattern, but a similar distribution of the three patterns was suggested. Further studies are needed to define this issue. (C) 2015 Elsevier Inc. All rights reserved.

Considering the multivalent role of interleukin-6 (IL-6) both in rheumatoid arthritis (RA) and in the metabolic processes, we aimed to evaluate the positive effect of subcutaneous tocilizumab (TCZ) on the probability of developing diabetes mellitus (DM). We recruited 56 consecutive patients with definite and active RA and assessed demographics, RA-related parameters and metabolic biomarkers, including the Homeostasis Model Assessment for insulin resistance (HOMA-IR) and the Quantitative Insulin Sensitivity Check Index (QUICKI). After 52 weeks of treatment, most of the patients showed a statistically significant reduction of HOMA-IR (3.61 � 1.21 at baseline vs. 2.45 � 1.46 at the end of the study, p[0.001), while QUICKI registered only a slight increase (0.32 � 0.01 at baseline vs. 0.33 � 0.01 at final evaluation, p[0.001). Our results strongly suggest that long-term IL-6 blockade has a beneficial effect in slowing the atherosclerotic process and reducing CV risk in active RA.

The optimal management of ankylosis spondylitis (AS) involves a combination of nonpharmacologic and pharmacologic treatment aiming to maximize health-related quality of life. The primary objective of our study was to demonstrate the benefits of an original multimodal exercise program combining Pilates, McKenzie and Heckscher techniques on pulmonary function in patients with AS, while secondary objectives were to demonstrate the benefits of the same program on function and disease activity. This is a randomized controlled study on ninety-six consecutive patients with AS (axial disease subset), assigned on a 1:1 rationale into two groups based on their participation in the Pilates, McKenzie and Heckscher (group I) or in the classical kinetic program (group II). The exercise program consisted of 50-min sessions performed 3 times weekly for 48 weeks. Standard assessments were done at week 0 and 48 and included pain, modified Schober test (mST) and finger-floor distance (FFD), chest expansion (CE) and vital capacity (VC), as well as disease activity Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), functional Bath Ankylosing Spondylitis Functional Index (BASFI) and metrology index Bath Ankylosing Spondylitis Metrology Index (BASMI). Groups were comparable at baseline; we demonstrated significant improvement between baseline and after 48 weeks of regular kinetic training for all AS-related parameters in both groups. However, significant improvement was found in pain, lumbar spine motility (mST, FFD), BASFI, BASDAI and BASMI in AS performing the specific multimodal exercise program at the end of study (p = 0.001). Although there were significant improvements in CE in both groups as compared to baseline (group I, p = 0.001; group II, p = 0.002), this parameter increased significantly only in group I (p = 0.001). VC measurements were not significantly changed at the end of the study (group I, p = 0.127; group II, p = 0.997), but we found significant differences within groups (p = 0.011). A multimodal training combining Pilates, McKenzie and Heckscher exercises performed regularly should be included in the routine management of patients with AS for better control of function, disease activity and pulmonary function.

Objective The aims of this study were to obtain cross-sectional data on capillaroscopy in an international multi-center cohort of Systemic Sclerosis (SSc) and to investigate the frequency of the capillaroscopic patterns and their disease-phenotype associations. Methods Data collected between June 2004 and October 2011 in the EULAR Scleroderma Trials and Research (EUSTAR) registry were examined. Patients' profiles based on clinical and laboratory data were obtained by cluster analysis and the association between profiles and capillaroscopy was investigated by multinomial logistic regression. Results 62 of the 110 EUSTAR centers entered data on capillaroscopy in the EUSTAR database. 376 of the 2754 patients (13.65%) were classified as scleroderma pattern absent, but non-specific capillary abnormalities were noted in 55.48% of the cases. Four major patients' profiles were identified characterized by a progressive severity for skin involvement, as well as an increased number of systemic manifestations. The “early” and “active” scleroderma patterns were generally observed in patients with mild/moderate skin involvement and a low number of disease manifestations, while the “late” scleroderma pattern was found more frequently in the more severe forms of the disease. Conclusion These data indicate the importance of capillaroscopy in SSc management and that capillaroscopic patterns are directly related to the extent of organ involvement.

Background The autoimmune myopathies (IM) comprise a broad spectrum of acquired muscular disorders characterized by autoimmune damage of skeletal muscle and complex visceral involvement, leading to chronic dysfunction and disability. Objectives The aim of our study was to assess the association between Raynaud9s phenomenon (RP) and capillaroscopic findings in patients with polymyositis (PM), dermatomyositis (DM) and anti-synthetasic syndrome (ASS), and to identify possible correlation with clinical and serological pattern. Methods Nailfold videocapillaroscopy (Optilia 200x) was performed in a cohort of 27 patients diagnosed with IM, 12 with RP and 15 age-, sex-, and disease-duration-matched without RP, and 19 healthy controls. Total number of capillaries, enlarged and giant capillaries, ramified capillaries, haemorrhages, haemosyderin deposits were each scored by a semiquantitative assessment, while the disorganization of the vascular array and avascular area were scored as present/absent. Data about IM activity (Myositis Disease Activity Assessment Tool), severity (Myositis Damage Index) and physical function (Stanford HAQ) were also collected. Findings were analysed using linear and logistic regression, adjusted for age and sex (SPSS-19 software). Results Patients with IM were frequently abnormal, with significant lower capillary density, higher dimensions, enlarged capillaries, haemorrhages and haemosyderin deposits as compared with healthy controls (p 80% of cases reported RP as the first manifestation of their disease, with frequently nailfold capillary abnormalities as compared to non-RP patients (p In addition, a scleroderma-like capillaroscopy pattern was identified in RP-positive patients, either DM or ASS. On the other hand, either normal or nonspecific capillaroscopy findings were found in RP-negative and PM. Pulmonary involvement (p We found an association between the presence of either active or late scleroderma pattern, elevated serum CK and disease activity: capillary loss was significantly associated high muscle and global disease activity, as well (p Anti-Jo-1 and anti-PL12 antibodies were associated with reduced capillary density (p Conclusions RP is associated with particular capillaroscopic findings in different IM subsets, suggesting that prognostic relevance of RP in myositis should be evaluated. Significant changes in the capillary pattern reported in IM, particulary reduced density, size abnormalities, haemorrhages, indicating that nailfold videocapillaroscopy may be useful as an outcome measure of microvascular disease in IM Disclosure of Interest None declared

Background Anti-drug antibodies (ADA) develop in up to one third of patients treated with biologic agents, immunogenicity being one of the main reasons for loss of efficacy and tolerance of the biodrug. Objectives To investigate the clinical relevance of anti-drug antibodies, drug levels and their relationship with disease outcomes in rheumatoid arthritis (RA) patients receiving TNF-inhibitors (TNF-i). Methods We performed a prospective observational study in a cohort of forty-eight consecutive RA treated with adalimumab (ADL; 24), infliximab (IFX; 15) or etanercept (ETN; 9). Disease activity, clinical outcomes and adverse events were evaluated at baseline and during study visit, while serum TNF-i and ADA levels collected as a single-point data in both bio-naive and bio-experimented patients. Lab assays (IgG-ADA, TNF-i) were measured following the manufacturer9s instructions using ELISA Progenika kits, with detection limit set at 10AU/mL for anti-ADL, 142AU/mL for anti-ETN and 5AU/mL for anti-IFX, 0.024μg/mL ADA, 0.035μg/mL ETN, 0.035μg/mL IFX. Statistical analysis was conducted in SPSS-19 (p Results ADA were detected in 8/48 (16.7%) patients (5/24 ADL, 20.8%; 3/9 IFX, 33.3%; while no anti-ETN) and associated with lower functional serum drug (2.17 vs 5.53μg/mL ADL; 2.10 vs 3.82μg/mL IFX; p Treatment failure was demonstrated in 12/48 (25%) cases, strongly associated with ADA status (p No difference in immunogenicity for ETN-treated cases (p>0.05), although lower levels of drug in non-responders (1.92 vs 2.89μg/mL, p Conclusions Immunogenicity to ADL and IFX but not to ETN have large impact on clinical practice (disease activity, treatment failure) and may represent key findings towards optimizing biological therapeutics in RA during long-term follow-up. References Arstikyte I et al. Influence of Immunogenicity on the Efficacy of Long-Term Treatment with TNFα Blockers in Rheumatoid Arthritis and Spondyloarthritis Patients. BioMed Research International 2015 Hoxha A, et al. The clinical relevance of early anti-adalimumab antibodies detection in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis: A prospective multicentre study. Joint Bone Spine 2015 Mazilu D et al. Monitoring Drug and Anti-drug Levels: A Rational Approach in Rheumatoid Arthritis Patients Treated with Biologic Agents Who Experience Inadequate Response While Being on a Stable Biologic Treatment. BioMed Research International 2014 Disclosure of Interest None declared

Background Up to one third of spondylarthritis (SpA) fail to respond to anti-TNF agents or experience drug toxicity leading to treatment withdrawal. Part of the treatment failure can be explained by the development of anti-drug antibodies (ADA). Objectives To evaluate the relation between immunogenicity, drug levels and clinical efficacy of TNF inhibitors (TNF-i) in ankylosing spondylitis (AS). Methods We performed a prospective observational study in a cohort of 47 consecutive AS patients receiving adalimumab (ADL) (13; 27.7%), infliximab (IFX) (13; 27.7%) or etanercept (ETN) (21; 44.7%). Disease Disease activity (BASDAI, ASDAS), outcomes and adverse events were evaluated at baseline and study visit, while serum TNF-i and ADA levels collected as a single-point data in both bio-naive (37, 78.7%) and bio-experimented patients. Serum drug levels were considered positive for IFX if >0.035 μg/mL, for ADL >0.024 μg/mL and for ETN >0.035 μg/mL, while the cut-off value for the ADA positivity to IFX was established at 5AU/ml, for ADL at 10AU/mL and ETN at 142 AU/mL (ELISA, Progenika). Statistical analysis was performed using SSPS version 19.0, p Results At baseline mean BASDAI was 7.69 and mean ASDAS-CRP 3.50, with no difference in disease activity between patients who did or did not later develop ADA (p ADA were detected in 8/47 (17%) and were more frequent in patients treated with ADL (5 cases; 38.5%) vs IFX (3 cases; 23.1%); no with ETN. Both ADL and IFX levels were significantly higher for ADA negative than for ADA positive patients (ADL: 3.92μg/mL vs 0.02μg/mL, p vs 0.03 μg/mL, p A significant association between clinical activity (ASDAS) and immunogenicity (ADA status) was reported: patients who had developed ADA had higher disease activity (3.10 vs 1.73, p Furthermore, a relation between clinical improvement (change in ASDAS) and immunogenicity was reported: ADA-positive AS achieved worse clinical response than ADA-negative cases, with a significant association between ADL respectively IFX levels and ASDAS (p Conclusions ADL and IFX levels are commonly influenced by ADA-positivity, and related to clinical response in AS, suggesting that therapeutic drug monitoring should be investigated as a possible tool to optimise treatment such patients. References Arstikyte I et al. Influence of Immunogenicity on the Efficacy of Long-Term Treatment with TNFα Blockers in Rheumatoid Arthritis and Spondyloarthritis Patients. BioMed Research International 2015 Hoxha A, et al. The clinical relevance of early anti-adalimumab antibodies detection in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis: A prospective multicentre study. Joint Bone Spine 2015 Disclosure of Interest None declared

To determine which of two referral strategies, when used by referring physicians for patients with chronic back pain (CBP), is superior for diagnosing axial spondyloarthritis (SpA) by rheumatologists across several countries.Primary care referral sites in 16 countries were randomised (1 : 1) to refer patients with CBP lasting3 months and onset before age 45 years to a rheumatologist using either strategy 1 (any of inflammatory back pain (IBP), HLA-B27 or sacroiliitis on imaging) or strategy 2 (two of the following: IBP, HLA-B27, sacroiliitis, family history of axial SpA, good response to non-steroidal anti-inflammatory drugs, extra-articular manifestations). The rheumatologist established the diagnosis. The primary analysis compared the proportion of patients diagnosed with definite axial SpA by referral strategy.Patients (N=1072) were referred by 278 sites to 64 rheumatologists: 504 patients by strategy 1 and 568 patients by strategy 2. Axial SpA was diagnosed in 35.6% and 39.8% of patients referred by these respective strategies (between-group difference 4.40%; 95% CI -7.09% to 15.89%; p=0.447). IBP was the most frequently used referral criterion (94.7% of cases), showing high concordance (85.4%) with rheumatologists' assessments, and having sensitivity and a negative predictive value of85% but a positive predictive value and specificity of50%. Combining IBP with other criteria (eg, sacroiliitis, HLA-B27) increased the likelihood for diagnosing axial SpA.A referral strategy based on three criteria leads to a diagnosis of axial SpA in approximately 35% of patients with CBP and is applicable across countries and geographical locales with presumably different levels of expertise in axial SpA.

The first abdominal radical hysterectomy has been performed by Ernst Wertheim, one of the most famous 19th century surgeons, and still remains the basis for many surgeons nowadays. The technique was then modified by Meigs in 1950s. Piver and colleagues have described five classes of surgery based on the estimated risk of cervical carcinoma involvement; moreover, a new classification has been recently proposed by Querleu (Jhingran & Levenback, 2007; Martinez & Ramirez, 2009).

Despite complex management of cervical cancer according to the risk stratification for recurrence and local guidelines (radical hysterectomy, meaning the removal of the uterus and cervix, one third of the vagina, the parametrial tissue at the pelvic sidewall and ligature of utero-sacrals with or without lymphadenectomy, followed by adjuvant radio and chemotherapy), up to 40% of patients still develop relapse of their cancer.

Objective. To assess the determinants of patients’ (PTGL) and physicians’ (MDGL) global assessment of rheumatoid arthritis (RA) activity and factors associated with discordance among them. Methods. A total of 7,028 patients in the Quantitative Standard Monitoring of Patients with RA study had PTGL and MDGL assessed at the same clinic visit on a 0 –10-cm visual analog scale (VAS). Three patient groups were defined: concordant rating group (PTGL and MDGL within 2 cm), higher patient rating group (PTGL exceeding MDGL by >2 cm), and lower patient rating group (PTGL less than MDGL by >2 cm). Multivariable regression analysis was used to identify determinants of PTGL and MDGL and their discordance. Results. The mean SD VAS scores for PTGL and MDGL were 4.01 2.70 and 2.91 2.37, respectively. Pain was overwhelmingly the single most important determinant of PTGL, followed by fatigue. In contrast, MDGL was most influenced by swollen joint count (SJC), followed by erythrocyte sedimentation rate (ESR) and tender joint count (TJC). A total of 4,454 (63.4%), 2,106 (30%), and 468 (6.6%) patients were in the concordant, higher, and lower patient rating groups, respectively. Odds of higher patient rating increased with higher pain, fatigue, psychological distress, age, and morning stiffness, and decreased with higher SJC, TJC, and ESR. Lower patient rating odds increased with higher SJC, TJC, and ESR, and decreased with lower fatigue levels. Conclusion. Nearly 36% of patients had discordance in RA activity assessment from their physicians. Sensitivity to the “disease experience” of patients, particularly pain and fatigue, is warranted for effective care of RA.

Objective CXCL10 (also known as interferon-γ–inducible 10-kd protein [IP-10]) is a chemokine that potentially plays a role in the immunopathogenesis of rheumatoid arthritis (RA). We undertook this phase II study to evaluate the efficacy and safety of MDX-1100, a fully human, anti-CXCL10 (anti–IP-10) monoclonal antibody, in RA patients whose disease responded inadequately to methotrexate (MTX). Methods Patients with active RA receiving stable doses of MTX (10–25 mg weekly) were randomized to receive intravenous doses of 10 mg/kg MDX-1100 (n = 35) or placebo (n = 35) every other week. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) on day 85, and patients were followed up for safety to day 141. Results The ACR20 response rate was significantly higher among MDX-1100–treated patients than among placebo-treated patients (54% versus 17%; P = 0.0024). Statistically significant differences in the ACR20 response rate between treatments were observed starting on day 43 (P < 0.05). The ACR50 and ACR70 response rates on day 85 did not differ between the groups. Overall, 51.4% of MDX-1100–treated patients and 30.3% of placebo-treated patients experienced at least 1 adverse event (AE). No study drug–related serious AEs were reported. Conclusion MDX-1100 was well tolerated and demonstrated clinical efficacy in RA patients whose disease responded inadequately to MTX. This is the first study to demonstrate clinical efficacy of a chemokine inhibitor in RA and supports the notion of a potential role of IP-10 in the immunopathogenesis of RA.

Polymyositis and dermatomyositis, the most important disease subsets in idiopathic inflammatory myopathies (IIMs), are heterogeneous conditions classically defined by a wide clinical spectrum including proximal skeletal muscle weakness, skin lesions and systemic organ involvement, particularly interstitial lung disease, in conjunction with biochemical and histopathological background of varying degrees of muscle inflammation (Gunawardena et al., 2008; Gunawardena et al., 2009; Mimori et al., 2007). Although the exact etiology is still controversial, there is increasing evidence of aberrant autoimmunity in both entities, closely linked to different patterns of myositis-specific (MSAs) and myositis-associated autoantibodies (MAAs) (Gunawardena et al., 2009; Mimori et al., 2007). Currently recognized as disease biomarkers, myositis-specific autoantibodies have been identified as key players in IIMs, promoting several pathogenic pathways as they target cytoplasmic and nuclear proteins involved in basic cellular processes (protein synthesis, nuclear transcription and translocation), but also being directly connected to phenotype disease profiles (Betteridge et al., 2007; Gunawardena et al., 2008; Gunawardena et al., 2009; Mimori et al., 2007). While several subsets of myositis-specific autoantibodies targeting both classic (aminoacyltRNA synthetases, ARSs, signal recognition particle, SRP, and Mi-2) and newly identified (MJ, PMS1, CADM140, p-155/p-140, SAE) autoantigens have been fully described in polymyositis and dermatomyositis (Gunawardena et al., 2009; Hengstman et al., 2004; Suber et al., 2008), the most widespread group of myositis-specific autoantibodies is represented by anti-aminoacyltRNA synthetase autoantibodies (Gunawardena et al., 2008; Gunawardena et al., 2009). Advancing knowledge in the field of synthetases, either antigenic or non-antigenic subtypes, has been reflected in critical association between genotype, serotype, clinical phenotype and

Background Planning a pregnancy in rheumatoid arthritis (RA) meets several issues, mostly concerning potential drug toxicity and disease flares. Objectives The purpose of this study is to evaluate pregnancy planning, RA activity during pregnancy and postpartum, pregnancy and fetal outcomes in a Romanian cohort of female patients diagnosed with RA. Methods We designed an observational ambispective study which included 36 RA Caucasian females with obstetric history after the onset of RA (14 - prospective, 22 - retrospective). The cases were obtained from several Clinics of Rheumatology from Romania. Results The mean age at inclusion is 39.88 years, age at RA diagnosis 24.97 years and mean age at conception 31.03 years. We recorded a total number of 65 pregnancies: 29 deliveries at term, 3 premature births, 12 elective abortions, 20 spontaneous abortions (attributed to trombophilia, methotrexate [MTX], Leflunomide and Toxoplasmosis gondii) and 1 ongoing. 24/36 (66.6%) had only one pregnancy after the onset of RA and 7/36 (19.4%) were multipares before the diagnosis. 47.6% had at least one unplanned pregnancy, while being on treatment with DMARDs. Concerning the exposure to synthetical DMARDs during the pregnacy: 5 patients received Leflunomide and 2 received MTX during the first trimester, the pregnancy outcomes being: 2 spontaneous abortion, 2 elective abortions, 2 normal birth, 1- premature twin pregnancy. In case of biologic DMARDs: 2 were exposed to Etanercept until weeks 2 and 3 (normal birth), and 1 to Infliximab – week 4 (elective abortion). In patients receiving Rituximab the washout period varied from 4 weeks in 2 pregnancies (1- spontaneous abortion and 1 normal birth) to 48 weeks (2 normal births and 1 premature). We registred 3 patients on biological therapy, which stopped the treatment with 2 years before the planned preganncy (Etanercept), respectivelly 6 months (Etanercept and Adalimumab) 66.6 of our patients were in Remission or Low Disease Activity (DAS28CRP) at preconception. Maintaing or improvement of the disease activity during the pregnancy were the principal trend in our population, excepting 2 situations. The average pregnancy length was 35.2 weeks, with 3 preterm deliveries and the mean birthweight was 2624 grams. No fetal abnormality was identified Five patients never had a new flare postpartum, while in the others the mean time to flare postpartum was 9 weeks Conclusions Patients with RA can have successful pregnancies. The pregnancy is planned in about half of cases. Pregnancy decreases disease activity, but many deliveries are followed by RA flares. No fetal abnormalities were diagnosed. References 1. Pregnancy in autoimmune rheumatic diseases: The importance of counselling for old and new challengesL.Andreoli, C Bazzani M.Tarabo-relli, R. Reggia, A. Lojacono, A. Brucato, P.L Meroni, A. Tincani, Autoimmunity Reviews 10 (2010) 51–54 Disclosure of Interest None declared

Background In the last decade, biologic therapy changed dramatically treatment options for rheumatoid arthritis (RA). However, a significant number of patients failed to maintain the initial response to a TNF blocker. More information is needed regarding efficacy and safety of multiple courses of biologics administered over extended periods of time. Objectives To assess the clinical benefit of subsequent courses with Rituximab (RTX) in patients with moderate to severe active RA after the failure to different TNF inhibitors used in routine clinical practice in Romania. Methods In this open-label, multicenter, prospective observational study started in 2010, patients were treated with RTX at each 6 months. Clinical efficacy was assessed at baseline and after each retreatment course at 6, 12, 18, 24, 30 and 36 months. Clinical assessments included disease activity (DAS-28), visual analogue scale (VAS) scores, Δ DAS-28 and Δ VAS. The previous anti-TNF treatments were; adalimumab (ADA), etanercept (ETA) and infliximab (INF). Statistical analyses: STATA SE 11.0 software, Comparison between all treatments and evaluations ANOVA and Kruskal-Wallis and Nptrend for trend across evaluations. Results A total of 1087 adult patients with active RA and inadequate response to at least one TNF inhibitor received initial RTX treatment. In our cohort, 929 (85.5%) patients had only one anti-TNF treatment (no switch); 210 (19.3%) patients received ADA, 318 (29.3%) received ETA and 401 (36.9%) received INF and the rest of 158 (14.5%) had more than one. As a second TNF inhibitor, 59 (5.42%) patients received ADA, 63 (5.79%) received ETA and 36 (3.31%) received INF. Median DAS-28 values for all patients (1087)and each groups ADA, ETA, INF as first TNF inhibitors were: 5.76; 6.05; 5.75; 5.66 at baseline, 3.98; 4.07; 4.11; 3.84 at 6 months, 3,43; 3.43;3.48; 3.33 at 12 months, 2.98; 3.00; 3.11; 2.89 at 18 months, 2.79; 2.72; 2.85; 2.75 at 24 months, 2.67; 2.55; 2.65; 2.69 at 30 months and 2.57; 2.56; 2.41; 2.6 at 36 months. The median DAS28 values for the group (158) who received a second TNF inhibitor, 5.66; 3.955; 3;56; 2.91; 2.85; 2.71 and 2.57 followed the same linear decrease across evaluations at baseline, 6;12;18;24;30 and 36 months. ANOVA test between treatment and evaluations P , between previous treatment P =0.0014 . DAS-28 score has been improved for all groups of patients, independent from the TNF – inhibitor used as previous treatment. The VAS score was improved in the same manner, independent to previous treatment. ANOVA test between treatment and evaluations P P , test between previous treatment P =0.0003 . Conclusions In our study, Rituximab have demonstrated to be a reliable therapeutic option for all patients regardless the TNF inhibitor used in first line (adalimumab, etanercept or infliximab). Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3504

Background Despite recent advances in classifying and diagnosing axial spondyloarthropathies (SpA), screening of patients with chronic low back pain and referral from the primary care settings remain unsatisfactory. Objectives RADAR study aimed to identify the best referral strategy for diagnosing axial SpA in patients with chronic back pain (CBP). Methods Hundred-and-six Romanian patients with CBP occurring before 45 years were assigned to either a simple (any of inflammatory back pain, HLA-B27 positivity or sacroiliitis on imaging) (38 patients) or a complex referral strategy (two of inflammatory back pain, HLA-B27, sacroiliitis, familial SpA history, extra-articular manifestations, good response to nonsteroidal antiinflammatory drugs) (68 patients). Primary end points were to compare the percentage of patients diagnosed with definite axial SpA by referral strategy and the degree of concordance of selection criteria between referring physicians and rheumatologists. Results Final analysis was performed in hundred-and-three patients (37 per strategy 1, 66 per strategy 2); definite axial SpA was established in 70.3% and 65.2% patients by referral strategies, mostly in the radiographic disease (56.8% and 54.5%). The first three commonly used for referral were inflammatory back pain (99.1%) with 83.2% concordance rate with rheumatologists, 89% positive predictive value, 94.2% sensitivity, 57.9% specificity; response to NSAIDs (50.9%) with 90.4% concordance rate, 79.7% positive predictive value, 80.9% sensitivity, 26.3% specificity; and sacroiliitis (48.1%), 72.9% concordance rate, 75% sensitivity Conclusions Both referral strategies showed comparable effectiveness in diagnosing patients with axial SpA; a simple screening strategy using three criteria should be routinely used in primary care settings in recognizing axial SpA. Acknowledgements This study was supported by a grant from Schering-Plough (presently Merck & Co Inc, Whitehouse Station, New Jersey, USA). Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5577

Background In recent years, emphasis has shifted in rheumatoid arthritis (RA) to early intervention in the disease course. We have shown that patients with MDA should be further divided in three subgroups (MDA1,2 and 3) according to DAS28 values, MDA1 ΔDAS28 and 3.2 , MDA2 3.5 and MDA3 3.8 . and those with 3.8 Objectives To describe the dynamics of response in MDA patients in terms of MDA1, MDA 2 and MDA 3 subgroups after the switch to rituximab (RTX) second line after the failure of TNF inhibitors. Methods REPEAT is an open-label, multicenter, prospective observational local study. From 1087 patients with active RA and inadequate response to at least one TNF inhibitor treated with initial RTX, for this analysis were selected only those patients with MDA at baseline. Patients were evaluated at baseline and at 6, 12, 18, 24, 30 and 36 months. The disease activity score DAS28 and ΔDAS28 calculated from baseline and between successive evaluations. Statistical analysis was performed using STATA SE 11.0 software and ANOVA, Nptrend and Kruskal-Wallis tests performed. Results From a total 1087 patients in study, 284 were with MDA at baseline evaluation before RTX treatment initiation. They were further split in MDA1 (47), MDA2 (31) and MDA3 (206) according to criteria described above. The dynamics of responses (%) across evaluations at baseline and at 6, 12, 18, 24, 30 and 36 months has shown a linear and constant increase of responders, for LDA group 0; 20.49; 26.67; 33.18; 33.72; 30.89; 31.03 (p Conclusions These findings support the decision to switch to RTX second line therapy the RA patients treated with TNF inhibitors and presenting a DAS value in (3.8-5.1) open interval, offering the opportunity to remission or LDA for patients in so called MDA3 subgroup. References Ancuta et al. Ann Rheum Dis 2013;72(Suppl3):218. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.2675

Background treat-to-target and tight control strategies are actually the two main paradigms in the treatment of rheumatoid arthritis (RA), aiming to improve patients outcome by achieving either remission or minimal disease activity status. There is actually no consensus regarding the right assessment tools for monitoring the magnitude of improvement and the absolute reached level in routine clinical practice. Objectives to compare EULAR-DAS28 with RAPID3 (a patient-reported outcome based on pain, patient global assessment of disease activity, and multidimensional HAQ)response criteria in patients with moderate to severe active RA treated with rituximab (RTX). Methods prospective observational study on 72 moderate to severe active RA (DAS28>3.2) receiving one cycle of RTX (two infusions of 1000 mg at two weeks interval). Response to treatment was appreciated at six months by: (i) EULAR-DAS28 response criteria, classified as EULAR good (decrease with 1.2 units), moderate (decrease of 0.6–1.2 units) or non-responder (decrease ≤0.6 units); and (ii) RAPID3 response categories defined as good (decrease with 3.6 units), moderate (decrease of 1.8–3.6 units) and poor (decrease ≤1.8 units). Statistical analysis was done in SPSS.16 (weighted kappa statistics, p Results up to 85% of RA has been classified as good and moderate responders based on RAPID3, while about 75% have been responders according to EULAR-DAS28; moreover, nearly 45% of the RAPID3 good responders have also been categorized as moderate EULAR-DAS28 responders. Statistical significant moderate agreement between the EULAR-DAS28 response criteria and RAPID3 has been demonstrated (p Conclusions Patient-centered tools such as RAPID3 allow more easily and quickly to quantify disease activity levels and patient responses to therapy, providing a more complex insight into the patient’s perception of disease status. Disclosure of Interest None Declared

Background It remains still unclear whether autoantibodies are useful biomarkers to tailor the choice of biological treatment in rheumatoid arthritis (RA). Objectives The main aim of our study was to identify predictive factors for response to TNF inhibitors in patients with established RA with a special focus on baseline levels of autoantibodies. Methods We performed a prospective observational 12 months study in 90 consecutive active established RA receiving their first anti-TNF agent: adalimumab (33), etanercept (30), infliximab (27). Standard assessments consisted of 28-joint counts, patient reported outcomes, inflammatory tests and activity scores (DAS28-ESR, SDAI) performed every three months, while total and IgA-RF and ACPA every six months. The primary outcome measure was SDAI remission (≤ 3.3). Univariate and multivariate logistic regression models were used to estimate the association between baseline variables and SDAI remission at 12 months, using SPSS-16 software, p Results 39.7% of RA achieved SDAI remission after 12 months of anti-TNFs. Baseline levels of autoantibodies in subgroup analysis were 182.3IU/ml for total RF, 14.4IU/ml for IgA-RF and 75.7 IU/ml for ACPA, respectively. Statistically significant moderate correlation between SDAI remission and baseline IgA-RF (Spearman: r=0.321, p=0.002), as well as weak correlation with ACPA (Sperman: r=0.194, p=0.047) were reported, while no correlation with total initial RF levels (Sperman: r=0.021, p=0.844). Furthermore, patients with baseline levels of total RF ≤100IU/ml (OR 1.09; IC95% 0.45-2.61), ACPA ≤40IU/ml(OR 1.99; IC95% 0.95-4.17) and IgA-RF ≤20IU/ml(OR 5.76; IC95% 1.43-23.23) were more likely to achieve SDAI remission. Conclusions The presence as well as the titer of IgA-RF isotype and ACPA before starting anti-TNFα therapy were significantly correlated with SDAI remission at 12 months. However, this correlation is not strong enough to allow a reliable prediction in individual patients. Disclosure of Interest None Declared

Objectives To examine associations of knee symptoms with self-reported physical function of individuals with knee osteoarthritis (OA). Methods We examined differences in pain, pain sensitivity, function, psychosocial variables, and physical activity between women and men with knee osteoarthritis. The knee symptoms was defined as pain, aching, or stiffness at least 3 months before inclusion into study. Physical function was assessed by the RAPID 3 (Routine Assessment of Patient Index Data) is a index of only the three Core Data Set patient self-report measures — physical function (from 0- to 3) converted to 0-10, pain 0-10, and patient global estimate (0- 10) for a total of 0-30 points. Separate multivariable logistic regression models examined associations between knee symptoms and physical function measures, by age, sex and geografic locality. The study was approved by local institutional review board, and all subjects gave written informed consent. Results In study cohort were included 123 patients with OA aged 40 years or older. Patients completed the RAPID 3 questionaire and visual analog scale for pain (VAS). Patient characteristics: the mean age was 64.3 years, 69,2% was female. For the entire sample, pain was present in 90.6% of patients. Women had significantly worse pain than men, VAS pain was 61.3 mm and men 58,6 mm, respectivily (p>0.05). The level of physical function did not differ significantly between women 3.7 and men - 4.1 points (p Conclusions Pain is very common in this sample of patients with knee osteoarthritis. Women continue to be as physically active as men even though higher levels of pain. The knee osteoarthritis estimate negatively affect the patient’s condition scoring RAPID 3 generally men worse than women. Disclosure of Interest None Declared