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OBJECTIVE: This study investigated how psychosocial aspects of disease affect the probability of achieving sustained remission in early rheumatoid arthritis (RA) and explored the directionality of this relationship. METHODS: Data were analyzed from the randomized controlled Care in Early RA trial. Sustained remission was defined as a continued Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP) of

Although recommendations to manage women with rheumatoid arthritis (RA) during the reproductive phase have been established, there is further need for evidence-based information on drug treatment and safety during pregnancy.1 Registries are excellent data sources to address remaining questions. Therefore, a minimal core data set for registers studying pregnancy in rheumatology has been developed recently by an EULAR task force.2 We evaluated the feasibility of data collection according to this minimal core data set in the daily clinical management of pregnant women with RA within the rheumatology department of the University Hospital of Leuven (UHL). We performed a retrospective patient chart study in a population of 1072 patients (360 men and 712 women) with RA with a planned rheumatology outpatient visit at UHL between November 2019 and November 2020. Women were included if they were diagnosed with RA before getting pregnant, had a recorded pregnancy during the past 5 years and …

ispartof: RHEUMATOLOGY ADVANCES IN PRACTICE vol:7 issue:1 ispartof: location:England status: published

OBJECTIVES: Mind-body therapies (MBTs), including meditation, yoga, and mindfulness, create an interaction between the mind and body to enhance health. MBTs are perceived by both patients and healthcare professionals as valuable in the management of rheumatoid arthritis (RA), but the extent of this contribution is unclear, as are the patient subgroups who benefit most from MBTs. Therefore, this systematic literature review investigates the effects of meditation, mindfulness, and yoga in patients with RA. METHODS: We searched four databases (PubMed, Embase, Web of Science (core collection, Chinese and Korean collection), and CINAHL). All studies were screened by two independent reviewers via the title/abstract/full text. The studies included any form of meditation/mindfulness/yoga as an intervention for RA. Animal studies, case reports, non-English articles, qualitative studies, conference abstracts, and articles without full-text access were excluded. Each study was assessed for its quality. RESULTS: Out of 1527 potentially eligible records, 23 studies were included. All three MBTs showed various effects on patient-reported outcomes, such as vitality, functioning, and mental health, as well as on disease activity markers. Mindfulness-based interventions mainly reduced the subjective disease activity parameters (e.g., joint tenderness, morning stiffness, and pain), rather than the objective disease activity parameters (e.g., swollen joints and C-reactive protein (CRP)). RA patients with recurrent depression may benefit more from these non-pharmacological therapies than patients without recurrent depression. DISCUSSION: This systematic literature review found that MBTs show added value in RA management, especially for patients with depressive symptoms. These non-pharmacological approaches, when used in addition to medication, might diminish polypharmacy in specific RA patient populations. Lay Summary: In recent decades, more attention has been given to the management of rheumatoid arthritis (RA) with options other than solely using medication. Such alternative options for patients to increase their quality of life are, for instance, meditation, yoga, and mindfulness. These examples of mind-body therapies (MBTs) are techniques that create an interaction between the mind and the bodily functions in order to obtain relaxation and enhance overall health. Although it is believed that these mind-body techniques are valuable in the management of RA, the extent of their contribution is still unclear, as is the question of if certain subgroups of patients benefit more from these complementary therapies. This systematic literature review investigated the effects of meditation, mindfulness, and yoga in patients with rheumatoid arthritis. A literature search was systematically performed within four different scientific databases by two independent reviewers. Out of 1527 potentially eligible articles, 23 studies were included. All three MBTs showed beneficial effects, which were mostly on the vitality, functioning, and mental health of patients with RA, but also on symptoms related to disease activity. RA patients with recurrent depression seemed to benefit more from these non-pharmacological therapies than patients without recurrent depression. Hence, we can conclude that MBTs show added value in the management of RA. ispartof: JOURNAL OF PERSONALIZED MEDICINE vol:12 issue:11 ispartof: location:Switzerland status: published

ObjectivesAlthough eHealth tools are potentially useful for remote disease monitoring, barriers include concerns of low engagement and high attrition. We aimed to summarise evidence on patients’ engagement and attrition with eHealth tools for remotely monitoring disease activity/impact in chronic arthritis.MethodsA systematic literature search was conducted for original articles and abstracts published before September 2022. Eligible studies reported quantitative measures of patients’ engagement with eHealth instruments used for remote monitoring in chronic arthritis. Engagement rates were pooled using random effects meta-analysis.ResultsOf 8246 references, 45 studies were included: 23 using smartphone applications, 13 evaluating wearable activity trackers, 7 using personal digital assistants, 6 including web-based platforms and 2 using short message service. Wearable-based studies mostly reported engagement as the proportion of days the tracker was worn (70% pooled across 6 studies). For other eHealth tools, engagement was mostly reported as completion rates for remote patient-reported outcomes (PROs). The pooled completion rate was 80%, although between-study heterogeneity was high (I293%) with significant differences between eHealth tools and frequency of PRO-collection. Engagement significantly decreased with longer study duration, but attrition varied across studies (0%–89%). Several predictors of higher engagement were reported. Data on the influence of PRO-reporting frequency were conflicting.ConclusionGenerally high patient engagement was reported with eHealth tools for remote monitoring in chronic arthritis. However, we found considerable between-study heterogeneity and a relative lack of real-world data. Future studies should use standardised measures of engagement, preferably assessed in a daily practice setting.Trial registeration numberThe protocol was registered on PROSPERO (CRD42021267936).

BackgroundJAK-inhibitors (JAKi), recently approved in rheumatoid arthritis (RA), have changed the landscape of treatment choices. We aimed to compare the effectiveness of four current second-line therapies of RA with different modes of action, since JAKi approval, in an international collaboration of 19 registers.MethodsIn this observational cohort study, patients initiating tumour necrosis factor inhibitors (TNFi), interleukin-6 inhibitors (IL-6i), abatacept (ABA) or JAKi were included. We compared the effectiveness of these treatments in terms of drug discontinuation and Clinical Disease Activity Index (CDAI) response rates at 1 year. Analyses were adjusted for patient, disease and treatment characteristics, including lines of therapy and accounted for competing risk.ResultsWe included 31 846 treatment courses: 17 522 TNFi, 2775 ABA, 3863 IL-6i and 7686 JAKi. Adjusted analyses of overall discontinuation were similar across all treatments. The main single reason of stopping treatment was ineffectiveness. Compared with TNFi, JAKi were less often discontinued for ineffectiveness (adjusted HR (aHR) 0.75, 95% CI 0.67 to 0.83), as was IL-6i (aHR 0.76, 95% CI 0.67 to 0.85) and more often for adverse events (aHR 1.16, 95% CI 1.03 to 1.33). Adjusted CDAI response rates at 1 year were similar between TNFi, JAKi and IL-6i and slightly lower for ABA.ConclusionThe adjusted overall drug discontinuation and 1 year response rates of JAKi and IL-6i were similar to those observed with TNFi. Compared with TNFi, JAKi were more often discontinued for adverse events and less for ineffectiveness, as were IL-6i.

Background Shifts in treatment strategies for rheumatoid arthritis (RA) have made ambulatory care more labour-intensive. These developments have prompted innovative care models, including mobile health (mHealth) applications. This study aimed to explore the perceptions of mHealth-inexperienced stakeholders concerning these applications in RA care. Methods We performed a qualitative study by focus group interviews of stakeholders including RA patients, nurses specialised in RA care and rheumatologists. The qualitative analysis guide of Leuven (QUAGOL), which is based on grounded theory principles, was used to thematically analyse the data. In addition, the Persuasive Systems Design (PSD) model was used to structure recommended app-features. Results In total, 2 focus groups with nurses (total n = 16), 2 with patients (n = 17) and 2 with rheumatologists (n = 25) took place. Six overarching themes emerged from the analysis. Efficiency of care and enabling patient empowerment were the two themes considered as expected benefits of mHealth-use in practice by the stakeholders. In contrast, 4 themes emerged as possible barriers of mHealth-use: the burden of chronic app-use, motivational aspects, target group aspects, and legal and organisational requirements. Additionally, recommendations for an ideal mHealth-app could be structured into 4 domains (Primary Task Support, Dialogue Support, Social Support and System Credibility) according to the PSD-framework. Most recommended features were related to improving ease of use (Task Support) and System Credibility. Conclusions Although mHealth-apps were expected to improve care efficiency and stimulate patient empowerment, stakeholders were concerned that mHealth-app use could reinforce negative illness behaviour. For mHealth-apps to be successful in practice, challenges according to stakeholders were avoiding long-term poor compliance, finding the target audience and tailoring a legal and organisational framework. Finally, the ideal mHealth-application should above all be trustworthy and easy to use.

INTRODUCTION: Aside from an impact on health, obesity is also associated with higher social and economic costs such as impaired productivity, increased work absenteeism, and higher rates of unemployment. The aim of this study was to assess the effect of bariatric surgery on employment status in a large nationwide database, using data from all patients that underwent bariatric surgery in Belgium. METHODS: This is a retrospective analysis of all Belgian patients that underwent bariatric surgery between 2014 and 2015. The work status of these patients was examined yearly: 4 years before and 3 years after surgery. Increased employment after surgery was defined (1) as a reduction in days of unemployment and incapacity and (2) as the resumption of work among the unemployed. RESULTS: In total, 16,276 patients were included. The number of working people rose from 49.7% before to 61.2% 3 years after bariatric surgery, i.e., an increase of 11.5% between pre- and post-surgery. The largest improvement in reduction in unemployment was found in individuals who were absent from work for more than 9 months, namely, a reduction from 13.4 to 7.2%. In the population of unemployed patients, 20.9% became employed after bariatric surgery. CONCLUSION: We found an increase in employment rate and a decrease in work incapacity and unemployment after bariatric surgery. Higher rates of employment after bariatric surgery may also contribute to an increased cost-effectiveness of bariatric surgery. It would be interesting to research possible targeting strategies to increase the employment rate even more after bariatric surgery. ispartof: OBESITY SURGERY vol:32 issue:8 pages:2625-2631 ispartof: location:United States status: published

ObjectivesTo provide an update of the European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) management recommendations to account for the most recent developments in the field.MethodsAn international task force considered new evidence supporting or contradicting previous recommendations and novel therapies and strategic insights based on two systematic literature searches on efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) since the last update (2016) until 2019. A predefined voting process was applied, current levels of evidence and strengths of recommendation were assigned and participants ultimately voted independently on their level of agreement with each of the items.ResultsThe task force agreed on 5 overarching principles and 12 recommendations concerning use of conventional synthetic (cs) DMARDs (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GCs); biological (b) DMARDs (tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, sarilumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib). Guidance on monotherapy, combination therapy, treatment strategies (treat-to-target) and tapering on sustained clinical remission is provided. Cost and sequencing of b/tsDMARDs are addressed. Initially, MTX plus GCs and upon insufficient response to this therapy within 3 to 6 months, stratification according to risk factors is recommended. With poor prognostic factors (presence of autoantibodies, high disease activity, early erosions or failure of two csDMARDs), any bDMARD or JAK inhibitor should be added to the csDMARD. If this fails, any other bDMARD (from another or the same class) or tsDMARD is recommended. On sustained remission, DMARDs may be tapered, but not be stopped. Levels of evidence and levels of agreement were mostly high.ConclusionsThese updated EULAR recommendations provide consensus on the management of RA with respect to benefit, safety, preferences and cost.

Objective To unravel disease impact in early RA by separately quantifying patient-reported (PRF), clinical (CF) and laboratory (LF) factors. We propose a new indicator, the discordance score (DS), for early identification and prediction of patient’s unmet needs and of future achievement of sustained remission (SR) and RA-related quality of life (QoL). Methods Factor-scores obtained by factor analysis in the CareRA trial, allowed to compute DS, reflecting the difference between PRF and the mean of CF and LF. Improvement from baseline to week 104 (%) and area-under-the-curve (AUC) across time points per factor-score were calculated and compared between patients achieving/not achieving sustained (week 16–104) remission (DAS28CRP Results PRF, CF and LF scores improved rapidly within 8 weeks. PRF improved 57%, CF 90% and LF 27%, in those achieving SR, compared with 32% (PRF: P = 0.13), 77% (CF: P Conclusions All factor scores improved rapidly, especially in patients achieving sustained remission. Patient-reported burden improved less. Discordance scores could help predicting the need for additional non-pharmacological interventions to achieve sustained remission and decrease disease impact.

Background Smartphones provide opportunities for musculoskeletal research: they are integrated in participants’ daily lives and can be used to collect patient-reported outcomes as well as sensor data from large groups of people. As the field of research with smartphones and smartwatches matures, it has transpired that some of the advantages of this modern technology are in fact double-edged swords. Body In this narrative review, we illustrate the advantages of using smartphones for data collection with 18 studies from various musculoskeletal domains. We critically appraised existing literature, debunking some myths around the advantages of smartphones: the myth that smartphone studies automatically enable high engagement, that they reach more representative samples, that they cost little, and that sensor data is objective. We provide a nuanced view of evidence in these areas and discuss strategies to increase engagement, to reach representative samples, to reduce costs and to avoid potential sources of subjectivity in analysing sensor data. Conclusion If smartphone studies are designed without awareness of the challenges inherent to smartphone use, they may fail or may provide biased results. Keeping participants of smartphone studies engaged longitudinally is a major challenge. Based on prior research, we provide 6 actions by researchers to increase engagement. Smartphone studies often have participants that are younger, have higher incomes and high digital literacy. We provide advice for reaching more representative participant groups, and for ensuring that study conclusions are not plagued by bias resulting from unrepresentative sampling. Costs associated with app development and testing, data storage and analysis, and tech support are substantial, even if studies use a ‘bring your own device’-policy. Exchange of information on costs, collective app development and usage of open-source tools would help the musculoskeletal community reduce costs of smartphone studies. In general, transparency and wider adoption of best practices would help bringing smartphone studies to the next level. Then, the community can focus on specific challenges of smartphones in musculoskeletal contexts, such as symptom-related barriers to using smartphones for research, validating algorithms in patient populations with reduced functional ability, digitising validated questionnaires, and methods to reliably quantify pain, quality of life and fatigue.

ObjectiveTo unravel disease impact in early RA patients by separately quantifying patient reported (PRF), clinical (CF) and laboratory (LF) factors. We put forward a new indicator, the discordance score (DS), for early identification and prediction of unmet patient outcomes in terms of future achievement of sustained remission and RA-related quality of life (QoL).MethodsWe obtained factor scores via factor analysis in the CareRA trial, then calculated the DS between PRF and the mean of the other scores. We computed the improvement from baseline to week 104 (%) and area-under-the-curve (AUC) across time-points per factor score and compared these between patients achieving or not achieving sustained (week 16 to 104) remission (DAS28CRPResultsPRF, CF and LF scores improved rapidly within 8 weeks. In patients achieving SR; PRF improved 57%, CF 90% and LF 27%, compared to 32% PRF (p=0.13), 77% CF (pConclusionsAll factor scores improved rapidly, especially in patients achieving SR. Patient-reported burden improved less extensively. Discordance scores could help in predicting the need for additional non-pharmacological interventions to achieve SR and decrease disease impact.KEY MESSAGESWhat is already known about this subject?Early and intensive RA drug-treatment using disease activity as a target allows rapid disease control and prevents joint destruction.Including pain, fatigue and physical function when assessing patients with early RA broadens the evaluation of disease impact.What does this study add?Leveraging patient reported outcomes (pain, fatigue and physical function) and traditional disease activity measures, we introduce a new indicator (named discordance score) for unraveling disease impact and treatment efficacy.We show how the discordance score stands for current unmet patient reported outcomes and could be used to predict future sustained disease contol and quality of life (1 and 2 years after baseline).We demonstrate this effect both in patients with and without sustained remissionHow might this impact on clinical practice or future developments?The earlier detection of unmet needs despite good disease control could allow to perform timely interdisciplinary interventions other than medication adaptations and could promote psychosocial wellbeing for patients.

Background Self-efficacy, or patients’ confidence in their ability to control disease and its consequences, was recently prioritised in EULAR recommendations for inflammatory arthritis self-management strategies. However, it remains unclear which factors influence self-efficacy in early rheumatoid arthritis (RA). Methods Data were analysed from the 2-year RCT Care in early RA (CareRA), which studied remission-induction treatment regimens for early RA. Participants completed the Arthritis Self-Efficacy Scale (ASES), Short-Form 36 (SF-36), Revised Illness Perception Questionnaire (IPQ-R), Utrecht Coping List (UCL), RAQoL and Health Assessment Questionnaire (HAQ). Depending on time to first remission (DAS28-CRP < 2.6) and persistence of remission, treatment response was defined as persistent response, secondary failure, delayed response, late response or non-response. The association between ASES scores and clinical/psychosocial factors was explored with Spearman correlation and multivariate linear mixed models. Baseline predictors of week 104 ASES were identified with exploratory linear regression followed by multiple regression of significant predictors adjusted for DAS28-CRP, HAQ, treatment arm, treatment response, cumulative CRP/SJC28 and demographic/serologic confounders. Results All 379 patients had a recent diagnosis of RA and were DMARD-naïve at study initiation. Most patients were women (69%) and RF/ACPA-positive (66%), and the mean (SD) age was 52 (13) years. For all tested outcome measures, better perceived health correlated with higher self-efficacy. While patient-reported factors (HAQ, SF-36, RAQoL, IPQ-R, pain, fatigue and patient’s global assessment) showed moderate/strong correlations with ASES scores, correlations with physician-reported factors (physician’s global assessment, SJC28), TJC28 and DAS28-CRP were weak. Only more favourable outcomes on patient-reported factors and DAS28-CRP were associated with higher ASES scores at each time point. An earlier, persistent treatment response predicted higher ASES scores at both weeks 52 and 104. Significant baseline predictors of week 104 ASES included HAQ; SF-36 mental component score, vitality, mental health and role emotional; IPQ-R illness coherence, treatment control, emotional representations and consequences; UCL Passive reacting; and the RAQoL. Conclusions Patient-reported outcomes and treatment response were early determinants of long-term self-efficacy in an early RA trial. These results provide further relevance for the window of opportunity in an early treat-to-target strategy and could help to timely identify patients who might benefit from self-management interventions. Trial registration EudraCT 2008-007225-39

We thank Dr Dhir et al for their kind words and would like to address some of the points raised.1 First, in patients without markers of poor prognosis, the COBRA-Slim scheme with methotrexate (MTX) and prednisone bridging led to a more rapid response than initial MTX monotherapy in the first 16 weeks.2 Subsequently, remission rates did not differ until year 5, but patients starting a COBRA-Slim scheme had a lower disease activity and better functionality longitudinally over 5 years.3–5 This long-term effect of prednisone bridging seems counterintuitive to Dr Dhir, given the results of the 'BehandelStrategieen in Reumatoide Arthritis' (BeSt) study and the 'Treatment of Early Aggressive Rheumatoid Arthritis' (TEAR) trial, showing that long-term outcomes were essentially determined by treating-to-target.6 7 Unfortunately, differences in design and follow-up duration hamper direct comparisons of the Care in early Rheumatoid Arthritis (CareRA) study with these trials. The 2-year TEAR trial did not include a glucocorticoid bridging scheme in its MTX step-up arms, but 40% of patients were already on low-dose oral glucocorticoids at baseline, which was prohibited per protocol in the MTX-Tight-Step-Up (TSU) arm of CareRA. Moreover, only about one in …

ObjectivesRheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthritis (SpA) are chronic inflammatory rheumatic conditions with high levels of comorbidity requiring additional therapeutic attention. We aimed to compare the 3-year comorbidity incidence and pain medication prescription in patients diagnosed with RA, PsA or SpA versus controls.MethodsData between 1999 and 2012 were obtained from Intego, a general practitioner (GP) morbidity registry in Flanders, Belgium. Cases were identified by International Classification of Primary Care (ICPC-2) codes representing ‘rheumatoid/seropositive arthritis (L88)’ or ‘musculoskeletal disease other (L99)’. The registered keywords mapped to these ICPC-2 codes were further verified and mapped to a RA/SpA/PsA diagnosis. Controls were matched on age, gender, GP practice and diagnosis date. We analysed the 3-year comorbidity burden in cases and controls, measured by the Rheumatic Diseases Comorbidity Index (RDCI). All electronically GP-prescribed drugs were registered.ResultsIn total, 738, 229 and 167 patients were included with a diagnosis of RA, SpA or PsA, respectively. Patients with RA or PsA had comparable median RDCI scores at baseline, but higher scores at year 3 compared with controls (RA: p=0.010; PsA: p=0.008). At baseline, depression was more prevalent in PsA patients vs controls (pConclusionsThis study highlights the increasing comorbidity burden of patients with chronic inflammatory rheumatic conditions, especially for individuals with RA or PsA. The high opioid use in all populations was remarkable.

Objectives RA should be treated to target in a process of shared decision-making with patients. Person-centred care is essential to meeting specific patient needs. Nurse-led clinics, where a nurse is responsible for care, have demonstrated added value in some countries but are still not implemented widely. This study aimed to explore stakeholders’ perceptions of advantages, disadvantages and conditions for the implementation of nurse-led clinics for RA in Belgium. Methods We performed a cross-sectional qualitative study consisting of five semi-structured focus group interviews. Rheumatology nurses, patients with RA and rheumatologists were interviewed as stakeholders. The analysis was carried out by three researchers according to the Qualitative Analysis Guide of Leuven (QUAGOL), formulating a conceptual framework of overarching themes and deconstructing this into perceived advantages, disadvantages and conditions. Results Two focus groups with nurses (total n = 16), two with patients (n = 17) and one with rheumatologists (n = 9) were conducted. The interview synthesis resulted in five overarching themes across stakeholders: efficiency of care, disease management, legal and organizational requirements, the conventional role of the nurse and the extended role of the nurse. All stakeholders perceived additional education for nurses as essential, but rheumatologists debated nurses’ abilities to lead a rheumatology clinic. Furthermore, patients preferred care protocols to guide nurses, and care providers approached this reluctantly. Generally, patients with a well-controlled disease were perceived as the ideal candidates for nurse-led care. Conclusion Nurse-led clinics could provide many benefits but require additional nurse education and a legal and organizational framework before being implemented widely and successfully.

Objective.To explore the possibility of integrating patient-important outcomes like pain, fatigue, and physical function into the evaluation of disease status in early rheumatoid arthritis (ERA) without compromising correct disease activity measurement.Methods.Patients from the 2-year Care in Early Rheumatoid Arthritis (CareRA) trial were included. Pain and fatigue (visual analog scales), Health Assessment Questionnaire (HAQ), standard components of disease activity [swollen/tender joint counts (SJC/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), physician (PhGH) and patient (PaGH) global health] were recorded at every visit (n = 10). Pearson correlation and exploratory factor analyses (EFA), using multiple imputation (15×) and outputation (1000×), were performed per timepoint and overall, on standard components of disease activity scores with and without pain, fatigue, and HAQ. Each of the 15,000 datasets was analyzed using EFA with principal component extraction and oblimin rotation to determine which variables belong together.Results.We included 379 patients. EFA on standard composite score components extracted 2 factors with no substantial cross-loadings. Still, pain (0.83), fatigue (0.65), and HAQ (0.59) were strongly correlated with PaGH. When rerunning the EFA with the inclusion of pain, fatigue, and HAQ, the 2-factor model had substantial cross-loadings between factors. However, a 3-factor model was optimal, with Factor 1: patient assessment, Factor 2: clinical assessment (PhGH, SJC, and TJC), and Factor 3: laboratory assessment (ESR/CRP).Conclusion.PaGH, pain, fatigue, and physical function represent a separate aspect of the disease burden of patients with ERA, which could be further explored as a target for care apart from disease activity. [ClinicalTrials.gov: NCT01172639].

Additional file 1: Supplement 1. Standardised coefficients and bootstrapped CIs for direct and indirect effects of treatment response on self-efficacy.

ObjectiveTo explore non-steroidal anti-inflammatory drug (NSAID) and analgesic use in early rheumatoid arthritis (eRA) patients with a favourable risk profile initiating methotrexate (MTX) with or without glucocorticoid (GC) bridging.MethodsPatients with eRA (≤1 year) and favourable risk profile (no erosions, negative rheumatoid factor and anticitrullinated protein antibodiesor low disease activity) in the 2-year CareRA trial were randomised to MTX 15 mg with a step-down GC scheme (COBRA Slim), or MTX without oral GCs, Tight-Step-Up (TSU). Used analgesics were recorded, including frequency, start/end date and indication. Chronic intake (≥90 consecutive days in trial) of NSAIDs, acetaminophen, opioids including tramadol and antidepressants for the indication of musculoskeletal (MSK) pain was considered. Treatments were compared using χ2 and analysis of variance with Holm’s correction for multiple testing.ResultsIn total, 43 patients were randomised to COBRA Slim and 47 to TSU. At study inclusion, 33/43 (77%) of patients in the COBRA Slim and 32/47 (68%) in the TSU arm had been using analgesics (p=0.5). During the trial, 67 NSAID and analgesics were used for MSK pain in 26/43 (60%) COBRA Slim patients of which 9/43 (21%) daily chronically (DC), while 107 NSAID and analgesics were used in 43/47 (92%) TSU patients, of which 25/47 (53%) DC. The total number of patients on NSAID and analgesics at any time during the study (pConclusionIn eRA patients considered to have a favourable prognosis, initial oral GC bridging resulted in lower chronic NSAID and analgesic use.Trial registration numberNCT01172639.

To quantify the prevalence of co-morbidities in patients with early RA and determine their prognostic value for effectiveness outcomes in a randomized trial.We included patients from the 2-year pragmatic randomized CareRA trial, who had early RA (diagnosis 1 year), were DMARD naïve and then treated-to-target with different remission induction schemes. Prevalence of co-morbidities was registered at baseline and the Rheumatic Diseases Comorbidity Index (RDCI; range 0-9) was calculated. We tested the relation between baseline RDCI and outcomes including disease activity (DAS28-CRP), physical function (HAQ index), quality of life (SF-36 domains) and hospitalizations over 2 years, using linear mixed models or generalized estimating equations models.Of 379 included patients, 167 (44%) had a RDCI of minimum 1. RDCI scores of 1, 2 or ≥3 were obtained in 65 (17%), 70 (19%), and 32 (8%) participants, respectively. The most frequent co-morbidity was hypertension (22%). Patients with co-morbidities had significantly higher HAQ (β = 0.215; 95% CI: 0.071, 0.358), DAS28-CRP (β = 0.225; 95% CI: 0.132, 0.319) and lower SF-36 physical component summary scores (β =-3.195; 95% CI: -4.844, -1.546) over 2 years than patients without co-morbidities, after adjusting for possible confounders including disease activity and randomized treatment. Patients with co-morbidities had over time lower chances of achieving remission (OR = 0.724; 95% CI: 0.604, 0.867) and a higher risk of hospitalization (OR = 3.725; 95% CI: 2.136, 6.494).At disease onset, almost half of RA patients had at least one clinically important co-morbidity. Having co-morbidities was associated with worse functionality and disease activity outcomes over 2 years, despite intensive remission induction treatment.Clinical trials NCT01172639.

ObjectivesTo identify and characterise a subgroup of patients with early rheumatoid arthritis (RA) reporting not feeling well 1 year after treatment initiation despite achieving optimal disease control according to current treatment standards.MethodsThis observational study included participants of the Care in early RA trial with a rapid and sustained response (DAS28CRPResultsAnalyses revealed three clusters. Of 140 patients, 77.9% were assigned to the ‘concordant to disease activity’ cluster, 9.3% to the ‘dominant fatigue’ cluster and 12.9% to the ‘dominant pain and fatigue’ cluster. Large differences in pain and fatigue reporting were found at week 16 when comparing the ‘concordant’ with the ‘dominant pain and fatigue’ or the ‘dominant fatigue’ cluster. Small differences in reporting were found for the other PROs. Illness perceptions and coping style also differed in the ‘concordant’ cluster.ConclusionsAlthough most patients reported PRO scores in concordance with their well-controlled disease activity, one in five persistent treatment responders reported not feeling well at year 1. These patients reported higher pain and fatigue, and different illness perceptions and coping strategies early in the disease course.

OBJECTIVES To quantify the prevalence of co-morbidities in patients with early RA and determine their prognostic value for effectiveness outcomes in a randomized trial. METHODS We included patients from the 2-year pragmatic randomized CareRA trial, who had early RA (diagnosis

OBJECTIVE: Treating early, intensively, and to target leads to rapid disease control, preventing joint damage and loss of function in early rheumatoid arthritis (RA). We report the effect of such an approach on patient-reported outcomes and explore the contribution of rapid and persistent disease control to well-being after 1 year of treatment. METHODS: This study is part of the Care in Early RA trial, a prospective, 2-year, investigator-initiated, randomized controlled trial rooted in daily practice and implementing the treat-to-target principle. Short Form 36 (SF-36) health survey and Revised Illness Perception Questionnaire (IPQ-R) data were collected prospectively. We defined 4 clinical response profiles based on speed and consistency of the treatment response within the first year, defined as the Disease Activity Score in 28 joints using the C-reactive protein level

Objective In 2011 an ACR/EULAR collaboration developed new remission definitions for RA. In the present study, we evaluated the prevalence and predictive validity of these new ACR/EULAR remission criteria in 4 different European early rheumatoid arthritis cohorts. Method Data from a tot al of 722 patients with early RA were analysed. Presence of remission at 6 months, as defined by one of the 4 proposed ACR/EULAR remission definitions was used to predict good functional and radiological outcome between 1 and 2 years of follow-up. Results Remission rates at 6 months ranged from 2-17% (Boolean definition) between the four cohorts. The level of HAQ and radiological damage varied between cohorts. Patients in remission at 6 months have an increased likelihood of long-term good outcome in terms of HAQ stability, but not radiographic stability. The performance of the practice definitions of remission was highly similar to the trial definitions. CRP status seems to add little information to the classification of remission in early RA. Conclusion In clinical practice, a minority of patients with early RA achieves remission in the first 6 months of treatment. Remission at 6 months is predictive for good HAQ outcome between year 1 and 2 after inclusion, but not radiographic stability.

BackgroundPatients recently diagnosed with rheumatoid arthritis (RA) have specific educational and supportive needs. These could partly be addressed with mentoring by other patients living with RA. This qualitative study explores stakeholder perceptions towards peer mentoring in early RA care.MethodsTwo focus groups with patients with early RA (n=10), one with patient organisation representatives (n=5), one with rheumatologists (n=8) and one with rheumatology nurses (n=5) were held. Two patient research partners supported analysis and interpretation.ResultsFour overarching themes were found: added value, experience with peer mentoring, concerns and need in daily care. Patients and patient organisation representatives confirmed the potential of peer mentoring especially regarding sensitive topics not easily discussed with professionals. Patients felt it could provide additional understanding and recognition. Nurses and rheumatologists were less convinced of the added value of peer mentoring because patients never mentioned it and they were concerned about the loss of control over correct information provision. The need for peer mentoring was perceived as person and disease phase-dependent and should therefore be optional, rather than a care standard. The requirements for a peer mentorship programme remained challenging to define for stakeholders. However, all expressed the need for supervision by healthcare professionals and that peer mentors should be carefully selected, educated and matched to newly diagnosed patients.ConclusionPeer mentoring and its implementation remain vague concepts, especially for healthcare providers. However, patients are interested in mentoring by peers, and the current results may support in effectively implementing such programmes early in the disease.

Objectives Timely treatment of patients with Early Rheumatoid Arthritis (ERA) favors a beneficial disease outcome. However, individuals often delay their contact with a healthcare professional (HCP) after ERA-related symptom onset. This study investigates the patients’ perspective on the patient’s journey from RA symptom onset until referral to a specialist. Methods A subgroup of patients with ERA from the Care in ERA (CareRA) trial were retrospectively interviewed to discuss their initial ERA-related experiences preceding diagnosis, using a bespoke assessment form. The form’s first section focused on initial symptoms and patients’ help-seeking behavior. The second part probed the consulted HCPs’ actions. Additional notes derived from the patient stories were thematically analyzed. Results Among 94 patients, pain (97%), swelling (73%) and stiffness (52%), typically in multiple joints, were reported as initial ERA-symptoms. The general practitioner (GP) was generally the first contacted HCP (87%). Frequently reported reasons to visit a HCP were too intense pain (90.4%) and difficulties in performing daily activities (69%). In 44.1% of patients, the HCP suspected ERA at the first visit. Approximately 25% of patients needed >5 visits before ERA detection. GPs mainly referred patients to rheumatologists (71%). Thematic analysis uncovered that often multiple HCPs were involved in the journey to RA detection and referral. Conclusion Pain is the most commonly reported initial symptom of ERA and the main reason to visit a HCP, mostly a GP. These GPs play a pivotal role in early detection and correct referral. Furthermore, the patient’s journey seems complex with often multiple HCPs involved.

Background Seronegative rheumatoid arthritis (RA) patients have been historically considered to have a milder disease. This confers a potential risk for under treatment. The quality of their response to early intensive therapies has not been thoroughly studied. Objectives To compare the disease course in seronegative and seropositive patients from the Care in early RA (CareRA) trial treated with COBRA Slim. Methods The CareRA trial included 379 patients with early RA (≤1 year) fulfilling 1987 or 2010 ACR criteria and naive to disease modifying anti-rheumatic drugs (DMARDs). Patients were randomized to one of four different intensive treatment strategies based on methotrexate (MTX) monotherapy or synthetic (cs)DMARD combinations with or without glucocorticoid (GC) bridging. Before randomization, stratification into a high- or low-risk group according to classical poor prognostic markers (presence of erosions, positivity to rheumatoid factor (RF) and/or anti-citrullinated protein antibody (ACPA), and elevated disease activity) was conducted. One of these strategies, COBRA Slim, a combination of MTX and a prednisone remission induction scheme stepping-down from 30 mg QD, was initiated in 141 patients from both risk strata, of which 38 were negative for both RF and ACPA (seronegative). Following the treat-to-target principle, using the disease activity score in 28 joints with C-reactive protein (DAS28CRP), treatment adaptations were steered at low disease activity (≤3.2), while aiming for remission ( The “as observed” population was analysed for differences in disease activity and radiographic progression between seronegative and seropositive patients at several time points during the 2-year study using independent sample t-test, Man Whitney-U or adjusted X2 (Yate’s correction for small samples). Survival analysis using Kaplan Meier was employed for time to first response to treatment. First response to treatment was defined as achieving first remission (DAS28CRP 1.2) after screening. Sensitivity analyses were applied on the complete CareRA cohort. Results Seronegative patients starting COBRA Slim (n=38), had similar age (53 vs 51 years, p=0.52), body mass index (25.5 vs 26.7, p=0.08), symptom duration (7.9 vs 7.2 months, p=0.23), presence of erosions (24% vs 23%, p=0.99) and gender distribution (82% vs 63%, p=0.06), compared to seropositive patients (n=103). However, parameters of disease activity were higher in seronegative patients at screening: DAS28CRP (5.1 vs 4.5, p=0.01), 28 swollen joint count (8.2 vs 5.7, p=0.02) and 28 tender joint count (10.3 vs 6.9, p=0.006). These results were corroborated when analysing the entire CareRA cohort. The mean disease activity was significantly higher in seronegative patients at the first stages (week 8 and 16), but became comparable by year 1 and 2 (Table 1). There was a significant difference in time to first treatment response between seronegative and seropositive patients, despite being treated with the same strategy, as depicted in the inverted Kaplan Meier plot (Figure 1). Conclusion In conclusion, CareRA participants with seronegative RA had a higher initial disease activity, longer time to experience a first treatment response, but achieve comparable remission status as seropositive patients with COBRA Slim, a combination of MTX with moderate dose GC bridging. This provides further evidence that, seronegative RA can no longer be considered a milder form of disease and requires an equally intensive initial treat-to-target therapy as seropositive RA. Disclosure of Interests Sofia Pazmino: None declared, Annelies Boonen: None declared, Veerle Stouten: None declared, Diederik De Cock: None declared, Delphine Bertrand: None declared, Kristien Van der Elst: None declared, Johan Joly: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research

Background EULAR 2016 recommendations for the management of Rheumatoid Arthritis (RA) suggest to consider tapering of biological Disease-Modifying Antirheumatic Drugs (bDMARDs) in patients in sustained remission. More insight on the effect of tapering strategies is needed in daily practice. Objectives To investigate maintaining disease control after spacing dosages of etanercept 50mg from weekly to every other week (EOW) in a pragmatic randomized controlled trial (RCT). Methods Patients with RA who were in remission according to the disease activity score 28 (DAS28) remission criteria for at least 6 months and treated with etanercept 50mg weekly for at least a year were included in the one-year non-blinded multicentre TapERA (Tapering Etanercept in RA) RCT (EudraCTnumber 2012-004631-22). Patients were 1:1 randomly assigned to continue etanercept 50mg weekly or to taper to 50mg EOW. Patients who lost remission (DAS28 C-Reactive Protein (CRP) ≥ 2.6) received nonsteroidal anti-inflammatory drugs and if needed were re-escalated to etanercept weekly. If remission was still not reached, treatment had to be adapted, at the discretion of the treating rheumatologist. The outcomes were proportion of patients in DAS28 remission at 6 and 12 months, proportion in sustained remission and proportion regaining remission after reintroducing weekly etanercept (intention to treat analysis). Missing components of DAS28 were imputed using expectation maximization. Results In total, 69 patients (69.6% female) with a mean ± standard deviation (SD) age of 55.7 ± 11.3 years and a mean ± SD disease duration of 14.7 ± 8.0 years were included. The weekly and EOW group consisted of 35 and 34 patients respectively. At the month 6 visit 77.1% patients of the weekly and 76.5% of the EOW group were in remission (p=0.947) and 68.6% and 58.8% respectively maintained remission on every visit (p=0.400) (Table 1). Three (8.6%) patients of the weekly and 11 (32.4%) of the EOW group required a treatment adaptation, which was statistically significantly different (p=0.014). There was no difference between the weekly and EOW group in the mean ± SD DAS28 CRP at the first time of losing remission in patients flaring, namely 3.1 ± 0.6 and 3.1 ± 0.5 respectively (p=0.957). Eleven patients were re-escalated to a weekly treatment after a mean ± SD duration of 4.5 ± 3.1 months. Of these, 54.5% (6/11) regained remission after a mean ± SD duration of 4.7 ± 1.7 months. Of the 5 patients not regaining remission, 1 switched to a weekly regimen on the last trial visit, 1 required switching to another bDMARD and 3 patients had no additional treatment changes (mean ± SD DAS28 CRP at month 12: 3.4 ± 0.2). Two patients of the EOW group restarted weekly etanercept while still being in remission. Conclusion Approximately half of the EOW group was in sustained remission after 1 year and two thirds remained on their reassigned treatment. Furthermore, one in two patients were able to regain remission after reintroducing etanercept weekly. Therefore tapering of etanercept to EOW seems a feasible strategy in patients with RA in sustained remission, potentially leading to a beneficial cost-saving and safety profile. Disclosure of Interests Delphine Bertrand: None declared, Julie Mannaerts: None declared, Valerie Badot: None declared, Luk Corluy: None declared, Diederik De Cock: None declared, Kathleen De Knop: None declared, Isabelle de Wergifosse: None declared, Elke Geens: None declared, Ilse Hoffman: None declared, Johan Joly: None declared, Christine Langenaken: None declared, Jan Lenaerts: None declared, Joris Lenaerts: None declared, Sofia Pazmino: None declared, Veerle Stouten: None declared, Veerle Taelman: None declared, Mark Walschot: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research

Background Patients with autoimmune inflammatory rheumatic diseases (AIIRD) have an increased risk for acquiring infections. Vaccines were developed to diminish the prevalence of vaccine-preventable infections. The EULAR recommendations for vaccination in adult patients with AIIRD emphasise the importance of assessing the vaccination status of patients with AIIRD. Objectives To determine the vaccination status of patients with AIIRD, the reason for non-vaccination and the proportion of patients that are vaccinated according to the EULAR recommendations. Methods The single-centre cross-sectional COLOSSeUM study was conducted in a tertiary referral centre. Between August and December 2018, all consecutive patients with AIIRD including Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) and Juvenile Idiopathic Arthritis (JIA) who visited the outpatient clinic were included. The vaccination status (influenza winter season 2017-2018, pneumococcal, tetanus toxoid and hepatitis B vaccine) and history of varicella zoster virus infection was determined using a one-page questionnaire which was completed by the treating rheumatologist after discussion with the patient. The patients’ reason for non-vaccination was registered if applicable. Patients were classified as vaccinated according to the EULAR recommendations if they had a yearly influenza, an every-five-year pneumococcal and a decennial tetanus toxoid vaccine, the latter as recommended in the general population. Results The vaccination status of 633 consecutive patients was obtained. The group consisted of 489 (77.2%) patients with RA, 73 (11.5%) patients with PsA, 58 (9.2%) patients with AS and 13 (2.1%) patients with JIA with a mean ± standard deviation age of 59.8 ± 13.6, 55.8 ± 13.5, 45.2 ± 14.0 and 35.0 ± 13.9 respectively. Of all included patients with AIIRD, 69.2% were vaccinated for influenza, followed by vaccination rates of 55.0%, 32.1% and 30.5% for tetanus toxoid, pneumococcal and hepatitis B vaccination, respectively (Table 1). In addition, 70.6% of patients with AIIRD had a history of varicella zoster virus infection. Various reasons for non-vaccination were reported, of which ‘No specific reason’ was the most common, closely followed by non-awareness of the need for pneumococcal vaccination. The compliance with EULAR recommendations was 18.5%. Of the 429 patients with AIIRD not vaccinated according to the EULAR recommendations, 68 (15.9%) patients were not compliant with all three of the vaccines, 136 (31.7%) were not compliant with 2 vaccines (1: pneumococcal and 2: influenza or tetanus toxoid vaccine), 148 (34.5%) were not compliant with 1 vaccine (103 pneumococcal, 41 tetanus toxoid and 4 influenza vaccine) and 77 (17.9%) patients were unaware of their vaccination status for at least 1 vaccine. Conclusion In our patients with AIIRD, the highest vaccination rate for recommended vaccines was observed for influenza (nearly 70%). Not being vaccinated for pneumococcus was the main reason why patients did not comply with the EULAR recommendations. More attention is needed to determine and optimise the vaccination status of AIIRD patients and to increase the awareness regarding the pneumococcal vaccine. Disclosure of Interests: Delphine Bertrand: None declared, Sofie Coenen: None declared, Sofia Pazmino: None declared, Veerle Stouten: None declared, Diederik De Cock: None declared, Kristien Van der Elst: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Marc Ferrante Grant/research support from: Janssen, Pfizer, Takeda, Consultant for: Abbvie, Boehringer-Ingelheim, Ferring, Janssen, Mitsubishi Tanabe, Takeda, MSD, Pfizer, Speakers bureau: Abbvie, Boehringer-Ingelheim, Chiesi, Ferring, Janssen, Lamepro, Mitsubishi Tanabe, MSD, Pfizer, Takeda, Tramedico, Tillotts, Zeria, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research DOI: 10.1136/annrheumdis-2019-eular.3060

Background The Tool for Administrative Reimbursement Drug Information Sharing (TARDIS) is an electronic platform combining data collection from patients with Rheumatoid Arthritis (RA) on biologic and synthetic targeted therapy, together with the submission of a request for reimbursement of this medication. Objectives To present the first data ever of the TARDIS-RA registry concerning the use of biologic and synthetic targeted therapy across Belgium. Methods The Belgian TARDIS-RA registry started in April 2015. All Belgian rheumatologist were obliged after a transition period to insert patient data via the online portal when prescribing. If data of a patient are entered for the first time, previous and current use of classical synthetic (cs), targeted synthetic (ts) and biologic (b) disease modifying antirheumatic drug (DMARD) therapies is registered. Afterwards, every next bDMARD or tsDMARD initiation, prolongation and discontinuation is registered electronically in the system. Other data captured are basic demographic information such as age, gender and disease duration and disease characteristics including ESR, CRP, joint counts, disease activity scores and HAQ. Results At 18/01/2019, information on 80 098 drug prescriptions in 13 614 patients was collected in the TARDIS-RA registry. Of these 80 098 drug prescriptions, 30 434 (38.0%) were csDMARDs and glucocorticoids, and 49 664 (62.0%) were bDMARD or tsDMARD prescriptions. This last category consisted of 30 380 (61.2%) tumour necrosis factor inhibitor (TNFi) bDMARDs, 17 104 (34.5%) non-TNFi bDMARDs and 2 170 (4.3%) tsDMARDs. Only 642 (2.3%) TNFi biosimilar prescriptions were registered. Fig1 shows the yearly evolution of bDMARD and tsDMARD prescription in Belgium from 2015 to 2018. At first registered interaction with the rheumatologist, the 13 614 patients had a median (IQR) age of 59 (50-68) years with a median (IQR) disease duration of 9 (4-16) years; 9 666 (73.4%) were female. The clinical characteristics showed a median (IQR) DAS28CRP of 3.6 (2.1-4.8) and a median (IQR) HAQ of 1.1 (0.6-1.8). Of patients at first time registration, 37.6% could be validated as being bionaive and 62.5% as bioexperienced. Conclusion Approximately 70 000 individuals in Belgium are estimated to have a RA diagnosis. Corresponding to numbers of other western European countries, 20%-25% of them would be expected to receive ts/bDMARDs. This suggests that almost the entire Belgian RA population on biologic treatment is covered by TARDIS. The registration of initiation, prolongation and discontinuation of every ts/bDMARD since 2015 combined with the simultaneous collection of demographic and clinical data, will make the TARDIS-RA registry a useful and powerful tool for the long-term drug analyses in Belgian patients with RA. Disclosure of Interests Diederik De Cock: None declared, Patrick Durez Speakers bureau: Bristol-Myers Squibb, Eli Lilly, Sanofi, Celltrion, Dirk Elewaut: None declared, Bernard Lauwerys: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research

Background: Management and support by an interdisciplinary rheumatology team are essential for achieving optimal disease outcomes in rheumatoid arthritis (RA). Nevertheless, health professionals generally do not experience the disease themselves, and patients may have specific educational needs that can only be provided by other patients having gone through the same experience. Furthermore, patients with RA may benefit most from such additional care interventions in the early disease stage when they are particularly faced with threats to their normal life. Peer mentoring has been studied and successfully implemented in other chronic conditions, however, this is rather a new care concept in the field of rheumatology. Objectives: Among four key stakeholders in the management of early RA, we aimed (1) to uncover the current experience with, need for and attitude towards implementing peer mentoring in the care for patients with early RA in Flanders; (2) to gather ideas for the content and format of a peer mentor program. Methods: We conducted an explorative qualitative focus group study. In total, five focus groups were organized to capture the perspective of each of the following stakeholders: patients with early RA (n=10), representatives of patient organizations (n=5), rheumatologists (n=10) and rheumatology nurses (n=5). Data were analyzed using the constant comparison method as presented in the Qualitative Analysis Guide of Leuven. Two patient research partners helped to analyze and interpret the data. Results: Most stakeholders perceived a potential need for peer mentoring in early RA. However, they underscored that this would be largely person and disease phase dependent suggesting that peer mentoring should be presented as an option to patients, rather than a standard of care. The additional value of peer mentors would be foremost situated in providing disease perspective and a sense of recognition to newly diagnosed patients. For some stakeholders, it was difficult to get a clear picture of such a program, which made it difficult for them to formulate an opinion on a specific format. The health professionals particularly mentioned the current lack of a formal framework for collaborating with patient experts, and the need for carefully selected and well-trained peer mentors. Stakeholders shared the view that the development of a peer mentor program and its integration within the current care context should ideally take place in co-operation with and under supervision of health professionals. Conclusion: Our results underline that peer mentoring in early RA holds potential for certain patients under certain circumstances, yet a clear framework for all stakeholders is a prerequisite to ensure a chance for success of this complex intervention. Future research should thus focus on unfolding the facilitators and barriers of collaborating with patient experts in the daily care of patients with early rheumatoid arthritis. Acknowledgement: This work was supported by Fonds Wetenschappelijk Reuma Onderzoek (FWRO). Disclosure of Interests: Kristien Van der Elst: None declared, Lore Bangels: None declared, Lianne Peerlings: None declared, Lies De Caluwe: None declared, Ilse Langers: None declared, Veerle Stouten: None declared, Diederik De Cock: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research

Background Results from individual data collections on drug safety during pregnancy and outcomes of pregnancy in patients with inflammatory rheumatic diseases (IRD) are often limited due to small number of cases. Joint data analyses from different data sources could solve this problem. Objectives The aim of this EULAR task force was to define a core data set to facilitate joint analysis of pregnancy registers in rheumatology. Methods Scope and core areas of the core data set have been developed according to COS-STAD recommendations1 by consensus. An initial list of data items possibly relevant for pregnancy registers was generated based on (I) a systematic literature search, (II) data items already collected by European pregnancy registers and (III) a survey amongst patient representatives. Consensus about the importance of each data item to be included in a core data set was reached by applying a 2-round Delphi survey where each item was rated on a numeric scale (1-3 = low importance, 4-6 = important but not critical, 7-9 = critical importance). Any data item that was considered as ‘critical important’ by at least 70% of responders in Delphi round 2 was included in the core set. During a face-to-face meeting of the EULAR task force, the inclusion or exclusion of data items with no consensus was finally decided. Results The scope was defined as follows: ‘To develop a standardized core data set for data collection in prospective observational research and clinical care of pregnant women with IRD including the neonatal phase. All interventions the women receive will be covered. Patients should be enrolled at the earliest possible moment during pregnancy, and data should ideally be collected once every trimester. An additional visit should capture the neonatal phase’. Three core areas were described: ‘Maternal information’ (including demographics, IRD disease characteristics and comorbidities), ‘Pregnancy’ (including prior and current pregnancy(ies), delivery and neonatal outcomes) and ‘Treatment’ (including medication of IRD and other health conditions). 64 experts from 14 different European countries participated in the 2 rounds of Delphi (68% female; 84% physicians, 5% obstetricians, 5% epidemiologists, 3% patients, 3% midwives). Of the 148 data items, 85 were included in the final core set. The figure shows included items within the core areas. Conclusion The consensus process resulted in an extensive list of data items recommended by experts to be collected as a minimum by pregnancy registers in rheumatology. This core data set applies to all pregnant women irrespective of the underlying IRD. The EULAR task force plans to find consensus on additional disease specific advice. Reference [1] Kirkham et. al. PLoS med.2017;14(11):e1002447. Acknowledgement This work was supported by a research grant from FOREUM Foundation for Research in Rheumatology. Disclosure of Interests Yvette Meisner Speakers bureau: Pfizer, Rebecca Fischer-Betz Grant/research support from: GlaxoSmithKline and UCB Pharma for performing the LuLa-study., Laura Andreoli: None declared, Nathalie Costedoat-Chalumeau: None declared, Diederik De Cock: None declared, Radboud Dolhain Grant/research support from: UCB Pharma B.V, Frauke Forger: None declared, Doreen Goll: None declared, Anna Molto: None declared, Rebecca Ozdemir: None declared, Luigi Raio: None declared, Catherine Nelson-Piercy Consultant for: UCB, Speakers bureau: UCB, Sebastian C Rodriguez-Garcia: None declared, Savino Sciascia: None declared, Marianne Wallenius: None declared, Astrid Zbinden: None declared, Angela Zink Speakers bureau: Speakers fees from AbbVie, Janssen, Pfizer, Roche, Sanofi, Anja Strangfeld Speakers bureau: Speakers fees from Bristol-Myers Squibb, MSD, Pfizer, Roche

Background Treating to a predefined target is a principle adopted in guidelines to treat rheumatoid arthritis (RA). It is currently the most efficient strategy to control disease activity, but its implementation in daily clinical practice remains challenging. Objectives To evaluate rheumatologists’ adherence to a treat-to-target (T2T) approach at a threshold of low disease activity (DAS28CRP≤3.2) in patients with early RA during the 2-year Care in early RA (CareRA) study. Methods CareRA is an investigator-initiated pragmatic multicentre trial, in which patients with early RA and naive to conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) were included (n=379). Participants were randomized to different remission induction schemes consisting of a csDMARD combination or methotrexate (MTX) monotherapy with and without a prednisone tapering down scheme. Following the T2T approach, specific treatment adaptations had to be performed in case of DAS28CRP>3.2 during the first study year, unless a predefined reason not to intensify treatment was provided. As first step, dose of MTX had to be increased from 15mg to 20mg weekly. As second step, dose of the other csDMARD was escalated in the combination arms and leflunomide was added in the MTX monotherapy arms. From week (w)52 onwards, further T2T was advised but type of treatment adaptation was left at the rheumatologists’ discretion. Adherence to this T2T approach was defined as performing a dose escalation or changing/adding DMARD medication in case of DAS28CRP>3.2 and was evaluated at every study visit during 2 years. Additionally, remission (DAS28CRP Results The proportion of patients with DAS28CRP>3.2 was 26% (93/365) at w8, but decreased to a stable average of 16% on the following visits and further diminished to 10% (30/303) at w104. The frequency of T2T adherence in these patients varied from 59% (55/93) at w8 to 17% (5/30) at w104 (Figure 1). The most frequent reason not to intensify treatment during the first study year was that rheumatologists considered the disease already well-controlled. This reason was reported in 50% of non-adherent cases at w8, in 15% at w16, 14% at w28, and 24% at w40. The second most frequently given reason for non-adherence during the first study year was that giving glucocorticoids or NSAIDs temporarily was preferred over changing DMARDs, as reported in 3% of cases at w8, 15% at w16, 27% at w28, and 35% at w40. T2T was applied at all visits in 41 out of 110 (37%) patients needing at least 1 adaptation during the 2-year trial. Of these 41 patients, 36 (88%) were in remission at w104, while of the 69 patients not always treated to the T2T principle, 40 (58%) were in remission at the end of the 2-year trial (p=0.001). Conclusion This study shows the difficulty of applying T2T strictly, both with and without a fixed protocol to follow. In less than half of patients theoretically in need of a treatment adaptation, treatment was intensified at all visits during the first 2 years of treatment. In the majority of cases rheumatologists gave as reason for overruling the T2T guidance that they estimated disease activity to be sufficiently controlled. However, patients in which the T2T principle was applied strictly, showed higher remission rates after 2 years of treatment. Disclosure of Interests Veerle Stouten: None declared, Diederik De Cock: None declared, Sofia Pazmino: None declared, Kristien Van der Elst: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research

Background In rheumatoid arthritis (RA), good disease control without major joint damage, loss of function or disability can be achieved. Still, a substantial number of patients report poor wellbeing. A better understanding is needed on why some patients still feel unwell despite good disease control. Specific attention to this mismatch, especially early in the disease, could help to further optimize the clinical course of new patients with RA. Objectives To identify and characterize patients with early RA treated optimally to current standards but reporting not feeling well after 1 year of treatment. Methods We included participants of the Care in early RA trial with an early and persistently favorable treatment response, defined as having a disease activity score (DAS28CRP) Results Analyses revealed 3 distinct clusters. Details are depicted in Table 1. Of 140 patients, 77.9% were assigned to the ‘concordant to disease activity’ cluster, 9.3% to the ‘dominant fatigue’ cluster and 12.9% to the ‘dominant pain and fatigue’ cluster. When comparing the concordant cluster with both discordant clusters, differences at BL and w16 were shown, with small effects on patients’ evaluation of their disease at year 1, such as more negative beliefs about the consequences of RA at w16 in patients reporting dominant pain and fatigue at year 1. Few differences with medium effects were identified, such as a moderately higher use of avoidance as a coping style at w16 and a stronger belief that symptoms can be explained by RA at w16, in patients reporting dominant fatigue at year 1 compared to patients in the concordant cluster. Large differences between patients in concordant and discordant clusters were found for pain and fatigue levels, which were already higher after 4 months of treatment for those patients reporting persistent pain and fatigue at year 1. Conclusion Three distinct groups of persistent responders with early RA were identified based on their 1-year PRO profile. The majority of patients were well-synchronized, reporting very low pain and fatigue levels in concordance with their well-controlled disease activity. One in 5 persistent responders, however, seemed to have unmet needs. In view of early identification of patients at risk of poor wellbeing despite good disease control, early pain and fatigue levels and certain coping behavior and illness perceptions were recognized as potential targets for future interventions. Disclosure of Interests Kristien Van der Elst: None declared, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research, Diederik De Cock: None declared, An De Groef: None declared, Veerle Stouten: None declared, Sofia Pazmino: None declared, Johanna Vriezekolk: None declared, Johan Joly: None declared, Philip Moons: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead DOI: 10.1136/annrheumdis-2019-eular.3629