A. Weel

Diagnostic performance of the ACR/EULAR 2010 criteria for rheumatoid arthritis and two diagnostic algorithms in an early arthritis clinic (REACH)

Introduction An ACR/EULAR task force released new criteria to classify rheumatoid arthritis at an early stage. This study evaluates the diagnostic performance of these criteria and algorithms by van der Helm and Visser in REACH. Methods Patients with symptoms ≤12 months from REACH were used. Algorithms were tested on discrimination, calibration and diagnostic accuracy of proposed cut-points. Two patient sets were defined to test robustness; undifferentiated arthritis (UA) (n=231) and all patients including those without synovitis (n=513). The outcomes evaluated were methotrexate use and persistent disease at 12 months. Results In UA patients all algorithms had good areas under the curve 0.79, 95% CI 0.73 to 0.83 for the ACR/EULAR criteria, 0.80, 95% CI 0.74 to 0.87 for van der Helm and 0.83, 95% CI 0.77 to 0.88 for Visser. All calibrated well. Sensitivity and specificity were 0.74 and 0.66 for the ACR/EULAR criteria, 0.1 and 1.0 for van der Helm and 0.59 and 0.93 for Visser. Similar results were found in all patients indicating robustness. Conclusion The ACR/EULAR 2010 criteria showed good diagnostic properties in an early arthritis cohort reflecting daily practice, as did the van der Helm and Visser algorithms. All were robust. To promote uniformity and comparability the ACR/EULAR 2010 criteria should be used in future diagnostic studies.

Treatment decisions and related costs differ significantly depending on the choice of a disease activity index in RA, according to 1987 and 2010 classification criteria

OBJECTIVE To evaluate the therapeutic and economic consequences of various disease activity indices (DAIs) in RA according to 1987 and 2010 criteria. METHODS Data on disease activity states from all sustained visits were assessed from all patients who participate in the treatment in the Rotterdam Early Arthritis Cohort (tREACH) study, a stratified randomized trial to evaluate different treatment strategies in patients with a symptom duration of <1 year. Frequencies of treatment adaptations, based upon exclusive thresholds of various DAIs, were visualized in reclassification tables. The Stuart-Maxwell test was applied to analyse any significant differences between treatment decisions according to the different DAIs. Simulated annual median medication costs were estimated using the tREACH medication protocol with standard national costs. RESULTS DAIs perform similar in RA according to 1987 and 2010 criteria. A total of 1104 DASs per DAI were available from 296 patients. DAIs differ significantly, compared with DASs, in classifying a patients disease state. Consequently, treatment intensifications occur more frequently with SDAI, CDAI and DAS-28 usage, compared with DAS. Tapering treatment occurs less frequently with SDAI and CDAI and more frequently with DAS-28 usage. Simulated annual median medication costs are significantly higher if DAS-28, SDAI and CDAI are used compared with DAS usage. CONCLUSION Usage of various DAIs in a single patient leads to inconsistent disease state categorizations. Consequently, these inconsistencies significantly influence therapeutic decisions and accompanying costs. As DAI usage is imperative to uphold current European League Against Rheumatology (EULAR) treatment recommendations, physicians should consider these therapeutic and economic consequences before choosing a particular DAI.

THU0108 No Clear Association Between the Presence of Subclinical Synovitis and Patient Reported Outcomes in RA Patients in Remission

Background Several studies assessed disease activity with ultrasound in rheumatoid arthritis (RA) patients who were in clinical remission. These studies found subclinical synovitis in 48-73% of the patients. Subclinical synovitis is associated with radiographic progression and predicts short-term relapse in RA patients. So far, little is known about the association between subclinical synovitis and patient reported outcomes (PROs). Objectives We evaluated the frequency of subclinical synovitis detected by ultrasound in RA patients in clinical remission while they are continuing synthetic and biological DMARDs. Our second objective was to compare PROs between patients with and without subclinical synovitis. Methods Patients who are treated with the combination of a synthetic DMARD and biological DMARD (adalimumab or etanercept) and have low disease activity (DAS44<2.4 and SJC ≤1) were examined by ultrasound at baseline and after three months follow-up. Ultrasound examination included 26 joints (MCP2-5, PIP2-5, wrists, MTP2-5) graded on greyscale (GS; 0-3) and power Doppler (PD; 0-3). A joint with subclinical synovitis was defined as GS>1 and/or PD>0. Data on clinical and psychological characteristics, demographics, pain scores, functional ability (HAQ) and health-related quality of life (SF-36) were collected at baseline and at three months. Coping (Pain Coping and Cognition List [PCCL]), depression/anxiety symptoms (Hospital Anxiety and Depression Scale [HADS]) and fatigue (Bristol RA Fatigue Multi-Dimensional Questionnaire [BRAF-MDQ] and Fatigue Assessment Scale [FAS]) were collected at three months follow-up. Ultrasound subclinical synovitis positive and negative patients were compared on their PROs using the Wilcoxon-Mann-Whitney test and Chi-square test. Results At baseline, 89 patients were included of which 71 patients had had their three months evaluation. Ultrasound revealed subclinical synovitis in 64% of the patients at baseline and in 68% at three months. In 44% of the patients subclinical synovitis was detected at both measurements. figure 1 shows baseline characteristics and patient reported outcomes at baseline and after three months. No clear pattern emerged on the PROs scores between subclinical synovitis positive and negative patients. At baseline functional ability differed between the two groups while health-related quality of life was similar. At three months similar levels were observed for functional ability, health-related quality of life, coping, depression symptoms and fatigue. HADS anxiety differed at 3 months. Conclusions Subclinical synovitis is common in RA patients in clinical remission while they continue synthetic and biological DMARDs. In our study population we could not find a clear association between subclinical synovitis and PROs. Disclosure of Interest None declared

FRI0562 Ultrasound Enthesitis in Primary Care Psoriasis Patients with Musculoskeletal Complaints

Background Psoriasis patients with enthesitis can classify as psoriatic arthritis since the introduction of the CASPAR classification criteria in 2006. However, clinical assessment of the entheses could be challenging. In addition, the presence of a tender enthesis is not necessarily indicative for underlying inflammatory disease as it could be related to overuse, metabolic disease or ageing. Therefore, we need a better way to identify the inflammatory component of entheseal involvement in psoriasis. To detect these inflammatory components in the entheses, ultrasound (US) examination can be used to identify inflammatory disease at the entheses. Objectives Our aims were to determine the prevalence of US abnormalities among psoriasis patients in primary care and to determine the concordance of clinical and US information at individual entheseal sites. Methods Adult patients with psoriasis were invited to participate in the SENSOR study. Patients who reported pain in joints, entheses or the lower back were eligible for clinical evaluation. If physical examination indicated a painful enthesis on the LEI/MASES or if arthritis was present, US examination of the entheses was performed. The six entheses of the Madrid Sonographic Enthesis Index (MASEI) and the lateral epicondyle tendon insertion (elbow) were evaluated according to the MASEI scoring system. Enthesitis was defined as US inflammation (positive power Doppler (PD) signal or a thickened enthesis of the plantar fascia) in combination with one clinical feature at the same enthesis. Structural changes detected by ultrasound were calcifications, increased thickness, irregular fibre structure and erosions. Results Of 524 patients who participated in the SENSOR study, 111 patients were assessed both by physical examination and by US. In 106 (95%) patients we detected US abnormalities. In 56 (50%) patients we found structural changes without indication for inflammatory disease. In 50 (45%) patients we found US abnormalities indicating inflammatory disease at the enthesis (positive PD: n=35; thickened plantar fascia: n=15). When we combined the US data with the clinical information, 36% of US inflammatory disease were confirmed [Figure 1]. Conclusions We found US abnormalities in 95% of the primary care psoriasis patients with musculoskeletal complaints, which is a combination of both structural and inflammatory US components. In 45% of primary care psoriasis patients we observed US inflammatory disease, which was confirmed in 36% of the patients by clinical information. Acknowledgements This study was financially funded by an investigator-initiated grant from Pfizer bv. Disclosure of Interest None declared

THU0445 Validation of The Contest Questionnaires To Screen for Psoriatic Arthritis in Primary Care Psoriasis Patients

Background Various screening tools have been developed and validated over the years in order to enhance early recognition of psoriatic arthritis (PsA) among psoriasis patients, but their performance remains suboptimal. In 2014 the CONTEST-group developed a new screening tool consisting of the most discriminating questions from 3 existing tools (PEST, PASE, TOPAS) which was externally validated in 2 psoriasis cohorts from dermatology. Validation in a primary care setting has yet to be performed. Objectives To externally validate the CONTEST questionnaire in psoriasis patients in primary care. Methods Data from the SENSOR study was used, a cross-sectional study in adult psoriasis patients with regular spells of musculoskeletal complaints from primary care. In this study, patients completed the PEST and PASE screening-questionnaires before clinical evaluation. Within CONTEST 3 TOPAS questions are used that were not included in our study. These questions were therefore replaced by similar questions: ToPAS 2A was replaced by PEST 3, ToPAS 2B by nail assessment by a dermatologist and ToPAS 7 by data from the manikin in the PEST. We calculated sensitivity, specificity and area under the curve (AUC) for the CONTEST with a cutoff of 4, as well as the CONTEST-w (weighted version, cutoff of 8) and the CONTEST-jt (including the PEST manikin, cutoff of 5). Performance was also calculated selecting the patients in the same way as the CONTEST study, i.e. only inviting patients with a positive PEST and/or PASE questionnaire for clinical evaluation. As a reference standard we used a clinical diagnosis of PsA made by a rheumatologist and enthesitis confirmed by ultrasound (presence of Power Doppler). Results from our dataset were compared with data from the development cohort and with the performance of the PEST. Results For this analysis 473 psoriasis patients at risk for PsA were available. Compared with the development cohort sensitivity was considerably lower in our dataset (0.30–0.51) than in the development of the CONTEST (0.86). Specificity was higher in our dataset (0.75–0.87) compared with the CONTEST development (0.35–0.48). While AUCs were around 0.7 for all three versions, comparable with the AUCs found in the development of CONTEST. Comparing these results with the performance of the PEST in our population, it shows that the sensitivity is lower for the CONTEST (0.30–0.51) than for the PEST (0.68), while the specificity is slightly higher (0.75–0.87 vs 0.71). Conclusions External validation of the CONTEST questionnaire in primary care psoriasis patients with regular spells of musculoskeletal symptoms resulted in lower sensitivity and higher specificity compared to the development cohort, while AUCs were comparable. When only selecting patients with at least one positive screeningtool, the sensitivity slightly increases while the specificity slightly decreases. However, the performance of the CONTEST questionnaires does not seem to exceed the performance of the PEST in a primary care setting. Acknowledgement This study was financially funded by an investigator-initiated grant from Pfizer bv. Disclosure of Interest None declared

THU0404 The Prevalence of Axial and Peripheral Spondyloarthritis in Inflammatory Bowel Disease: A Systematic Review & Meta-Analysis

Background Inflammatory Bowel Disease (IBD) is a chronic disease that affects up to 0.5% of the population, comprising both Crohns Disease (CD) and ulcerative colitis (UC). Various extra-intestinal manifestations can occur, among which spondyloarthritis (SpA). SpA can manifest with both axial and peripheral manifestations, but prevalence estimates of these manifestations differ widely. Objectives To provide a pooled estimate of the prevalence of axial and peripheral manifestations of SpA in patients with IBD and to identify factors that might influence the prevalence estimates. Methods We systematically searched Embase, Pubmed, OvidSP, Scopus and Web-of-science databases from inception to May 2014. All articles addressing the prevalence of axial and/or peripheral manifestations of spondyloarthritis in adult IBD patients were included. Risk of bias was assessed using a quality assessment tool including items on selection bias, non-response bias, sample size and misclassification of SpA diagnosis. Results Out of 4846 studies, 60 studies were included. Sample size varied from 9 to 4454. Methodological quality of the included studies was moderate, with only a slight majority scoring positively on the individual items of the quality assessment tool. With regard to axial manifestations, the pooled prevalence of sacroiliitis was 0.11 (95% CI 0.08–0.014), whereas the pooled prevalence for ankylosing spondylitis was 0.03 (95% CI 0.03–0.04). For peripheral arthritis the pooled prevalence was 0.14 (95% CI 0.12–0.16). Few estimates were available for the prevalence of enthesitis (range from 0.01 to 0.54) and dactylitis (range from 0 to 0.04). For both axial and peripheral manifestations, the prevalence was higher in patients with CD than in patients with UC. Heterogeneity between studies was large, which might be explained by methodological quality as well as difference in geographic area, clinical setting and the use of criteria for case ascertainment as shown in figure 1 for the prevalence of SI and AS. Conclusions Spondyloarthritis is a common extraintestinal manifestation in IBD. Peripheral arthritis is slightly more common with a pooled prevalence of 0.14 than axial manifestations as sacroiliitis (pooled prevalence 0.11) and ankylosing spondylitis (pooled prevalence 0.03). For both axial and peripheral manifestations, the prevalence is higher in patients with CD than in patients with UC. Disclosure of Interest None declared

FRI0087 Predictors for Attaining Remission at Two Consecutive Visits in Newly Diagnosed Early RA Patients

Background Early and intensive treatment with DMARDs are essential for remission induction in newly diagnosed RA patients. However, demographic, psychosocial and disease related factors may play a role as well. Objectives To investigate which demographic, psychosocial and disease related factors are associated with attaining remission at two consecutive visits in early RA patients treated in a treat-to-target manner Methods We used 12 months follow-up data from patients participating in the tREACH trial1,2 in which induction therapy strategies were compared: (A) combination high dose conventional therapy ((MTX + sulfasalazine + hydroxychloroquine or (B) MTX. Both groups had glucocorticoid (GCs) bridging. Disease activity (DAS) was assessed every 3 months. Remission was defined as DAS<1.6 at 2 consecutive visits (3 months). Univariate and multivariate logistic and Cox regression analyses were performed including demographic, disease related and psychosocial factors evaluated at baseline as predictors for attaining remission during 12 months of follow-up. Results 281 patients (68% female; mean DAS 3.4, median HAQ 1.00) were included. During 1 year of follow-up, 129 of 281 (46%) patients (group A: 90 (49%), group B: 39 (40%)) attained remission at 2 consecutive visits. 76/281 (27)% achieved remission within 6 months. Univariate analyses revealed that female sex was associated with a lower chance of attaining remission (demographic factors). Similar relations were observed for higher DAS, HAQ and worse physical functioning (disease factors) and higher levels of anxiety, depression, fatigue and passive coping with pain and lower levels of mental functioning and internal locus of control (psychosocial factors). In multivariate analyses, female sex, treatment and higher levels of fatigue were associated with a lower chance to attain remission within 6 months, whereas older age, female sex and higher levels of depression were associated with increased time to remission within 12 months. Conclusions In the tREACH trial, 46% of early RA patients attained remission within 1 year of follow-up. Female sex, higher baseline DAS, HAQ, and several psychosocial factors were predictors for attaining remission, but in the final models age, sex, baseline DAS, fatigue and depression remained. Results suggest that high levels of fatigue and depressive symptoms may prevent patients from attaining remission despite treatment according to a tight control and treat-to-target strategy. References Claessen et al. BMC Musculoskelet Disord 2009:71. De Jong et al. Ann Rheum Dis. 2013 Jan;72. Disclosure of Interest None declared

SAT0572 Screening for PSA in Primary Care Psoriasis Patients with Musculoskeletal Complaints with Pest, Pase & Earp

Background Psoriatic Arthritis (PsA) is a progressive inflammatory joint disease that can lead to severe joint damage. New treatment strategies can be very effective in early stages of the disease [1]. This requires early recognition of the symptoms to be PsA. Several screening tools have been developed to enhance early recognition [1-4]. However, most were developed in secondary care [2,3], while early recognition should ideally take place in primary care. Objectives To evaluate the screening performance of the PEST [4], PASE [2,5] and EARP [3] to identify psoriatic arthritis among primary care psoriasis patients with recurrent spells musculoskeletal complaints (MSC). Methods We conducted a cross-sectional study in adult primary care patients with psoriasis who reported recurrent MSC spells. Patients were selected by ICPC code S91 for psoriasis and the presence of recurrent spells of MSC (joints, enthesis or low back pain) was determined by telephone interview. Patients completed the PEST, PASE & EARP questionnaires before clinical evaluation by a trained research nurse. Assessments included PASI, LEI/MASES, 66/68-joint count and the presence of nail-psoriasis. When patients reported a painful enthesis on LEI/MASES, an ultrasound of the entheses was performed. A PsA case fulfilled the CASPAR criteria. Sensitivity and specificity were determined for the PEST and EARP cut off ≥3 and PASE cut off ≥44 as well as ≥47. Results 473 psoriasis patients participated with a mean ± SD age of 55.7±13.9 years and 50.9% being male. Median PASI score was 2.3 (IQR 1-4) and 71 patients (15.0%) had nail abnormalities related to psoriasis. We found 17 new cases of PsA (3.6%) as diagnosed by a rheumatologist. Moreover, we found 36 cases of enthesitis, confirmed by ultrasound. The majority of these refrained from further evaluation by a rheumatologist, however most of them would classify as PsA according to the CASPAR criteria. Looking into all cases, including enthesitis, the EARP had a sensitivity of 87% and a specificity of 33%, for the PEST this was 68% and 71%. The PASE had a sensitivity of 66% and a specificity of 55% at the cut off of ≥44 and 59% and 64% at the cut off of≥47 (Table 2). Similar figures were observed if only axial manifestations and arthritis were taken into account. Conclusions Modest sensitivity was observed for the PEST and PASE with an acceptable specificity for the PEST, while the EARP had high sensitivity and low specificity, which is undesirable for screening. The performance of all screening tools was lower than previously reported in secondary care settings [1-4]. References Coates LC, et al. BMC Musculoskelet Disord, 2013. Husni ME, et al. J Am Acad Dermatol, 2007. Tinazzi I, et al. Rheumatology (Oxford), 2012. Ibrahim GH, et al. Clin Exp Rheumatol, 2009. Dominguez, PL, et al. Arch Dermatol Res, 2009. Acknowledgements This study was financially funded by an investigator-initiated grant from Pfizer bv. Disclosure of Interest None declared

OP0036 Fewer Patients on Biologicals and Better Functional Ability Two Years after Induction Therapy with Combination DMARD Therapy versus Methotrexate Monotherapy

Background Fewer patients on biologicals and better functional ability two years after induction therapy with combination DMARD therapy versus methotrexate monotherapy Objectives To assess differences in frequency of biological therapy use in early RA patients two years after starting induction therapy according to three different treatment regimens Methods Data were used from patients with recent-onset arthritis participating in a single-blinded clinical trial (Treatment in the Rotterdam Early Arthritis CoHort (tREACH)) [1,2] in which three induction therapy strategies were compared: (A) combination therapy (methotrexate (MTX) + sulfasalazine + hydroxychloroquine) with glucocorticoids (GCs) intramuscularly; (B) combination therapy with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. Disease activity scores (original DAS) were assessed every 3 months. Functional ability was assessed using the Health assessment questionnaire (HAQ). Actual medication use was obtained from medical charts and from patient diaries. Data were analysed using simple descriptive statistical techniques. Results 281 patients (91 men, 190 women; mean baseline DAS 3.4, median baseline HAQ 0.75) were initially randomized. Data on medication use at 2 years were available from 166 patients (59%). Mean DAS was 1.72 (95%CI 1.59-1.86) at 24 months with similar results for the initial treatment groups A-C. DAS remission (DAS<1.6) was achieved by 50% of patients. Median HAQ (min-max) was 0.38 (0-2) for all patients but varied in the treatment groups: A. 0.13 (0-1.6), B. 0.44 (0-2) and C. 0.63 (0-2). HAQ was significantly higher in group C versus A (p=0.042), while no significant difference was observed for group A versus B (p=0.39). Conventional DMARDs only were used in 58% of patients (A. 60%, B. 75% and C. 43%). Biological DMARDs only were used in 5% of patients (A. 8%, B. 2% and C 7.%). Thirteen percent of patients did not use any DMARD at all (A. 14%, B. 9% and C. 16%). Patients in group C used biological DMARDs more often compared to B (p=0.004), but no statistical difference was observed between groups A and B (p=0.241). Conclusions We observed lower use of biological therapy and better functional ability in induction triple therapy compared to induction monotherapy MTX with GC bridging at 2 years of follow-up in the treat-to-target tREACH study. No differences were found for disease activity scores. References Claessen et al. Use of risk stratification to target therapies in patients with recent onset arthritis; design of a prospective randomized multicenter controlled trial. BMC Musculoskelet Disord 2009;10:71. De Jong et al. Induction therapy with a combination of DMARDs is better than methotrexate monotherapy: first results of the tREACH trial. Ann Rheum Dis. 2013 Jan;72(1):72-8. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5357

FRI0089 Early glucocorticosteroid response predicts the effect of dmards after 3 months of therapy

Background The EULAR treatment guideline recommends rheumatologist to strive, in newly diagnosed rheumatoid arthritis (RA) patients, for remission or at least low disease activity within 3 months in order to obtain better functional and radiological outcomes. Since it takes 6-12 weeks to see the optimal effect of DMARDs, the right choice of induction DMARD therapy plays an important role in obtaining current treatment goals. Therefore it would be helpful to be able to predict DMARD response in a very early phase in order to obtain current treatment goals. Objectives To investigate if a glucocorticoid (GC) response at 2 weeks, defined with EULAR response criteria, can predict active disease (DAS≥2.4) after 3 months of DMARD therapy. Methods For this study data of the tREACH study, an ongoing clinical trial that evaluates different induction therapies in early RA, were used. Patients are stratified into probability tertiles (respectively low, intermediate and high) according to their likelihood of progressing to persistent arthritis based of the prediction model of Visser. The Visser algorithm and 2010 criteria for RA have similar discriminative abilities to identify patients at risk of persistent arthritis at 1 year. All patients within the high probability stratum, who had a baseline DAS>2.2 and a DAS assessment at 2 weeks after randomization, were included (n=120). In the high probability stratum patients were randomized into 3 induction therapy strategies: [A] Combination therapy (MTX 25 mg/wk + SASP 2 gr./day + HCQ 400 mg/day) with GCs im (Depomedrol 120mg), [B] Combination therapy with an oral GCs tapering scheme (starting dose 15 mg) and [C] MTX with oral GCs similar to B. Results GCs none-responders at 2 weeks have a 10.29 (95% CI;3.34 – 31.64) folded increase for active disease after 3 months of DMARD therapy compared to a GCs good-responder. If we stratify for induction therapy odds ratios (95% CI) were 4.2 (0.75 – 23.18); 10.7 (0.98 – 115.7) and infinite for respectively treatment arm [A], [B] and [C] (table 1). Conclusions Determining GC response at 2 weeks is a useful tool for recognizing those patients who will probably have active disease (DAS≥2.4) after 3 months of DMARD therapy. Funding Unrestricted grant from Pfizer bv. [0881-102217] Disclosure of Interest None Declared