Objectives To investigate whether MTX should be combined with an additional DMARD and bridging glucocorticoids as initial treatment for patients with early RA to induce an effective long-term response. Methods The Care in early RA study is a two-year investigator-initiated pragmatic multicentre randomized trial. Early RA patients, naïve to DMARDs and glucocorticoids, were stratified based on prognostic factors. High-risk patients were randomized to COBRA-Classic (n = 98): MTX, sulfasalazine, prednisone step-down from 60 mg; COBRA-Slim (n = 98): MTX, prednisone step-down from 30 mg; or COBRA-Avant-Garde (n = 93): MTX, leflunomide, prednisone step-down from 30 mg. Low-risk patients were randomized to COBRA-Slim (n = 43); or Tight Step Up (TSU) (n = 47): MTX without prednisone. Clinical/radiological outcomes at year 2, sustainability of response, safety and treatment adaptations were assessed. Results In the high-risk group 71/98 (72%) patients achieved a DAS28-CRP < 2.6 with COBRA-Slim compared with 64/98 (65%) with COBRA-Classic and 69/93 (74%) with COBRA-Avant-Garde (P = 1.00). Other clinical/radiological outcomes and sustainability of response were similar. COBRA-Slim treatment resulted in less therapy-related adverse events compared with COBRA-Classic (P = 0.02) or COBRA-Avant-Garde (P = 0.005). In the low-risk group, 29/43 (67%) patients on COBRA-Slim and 34/47 (72%) on TSU achieved a DAS28-CRP < 2.6 (P = 1.00). On COBRA-Slim, low-risk patients had lower longitudinal DAS28-CRP scores over 2 years, a lower need for glucocorticoid injections and a comparable safety profile compared with TSU. Conclusion All regimens combining DMARDs with glucocorticoids were effective for patients with early RA up to 2 years. The COBRA-Slim regimen, MTX monotherapy with glucocorticoid bridging, provided the best balance between efficacy and safety, irrespective of patients’ prognosis. Trial registration ClinicalTrials.gov, http://www.clinicaltrials.gov, 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 (DAS28CRP<2.6) from week 16 until year 1 after starting the first RA treatment. Feeling well was assessed at year 1, using five patient-reported outcomes (PROs): pain, fatigue, physical functioning, RA-related quality of life and sleep quality. K-means clustering assigned patients to a cluster based on these PROs. Cohen’s d effect size estimated cluster differences at treatment initiation and week 16, for the five clustering PROs, coping behaviour, illness perceptions and social support.ResultsAnalyses 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.

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.

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 <2.6. Linear regression analyses including these response profiles and treatment type were constructed to predict the SF-36 dimensions of vitality, social functioning, role emotional, and mental health, and the IPQ-R illness perception subscales of consequences, treatment control, and illness coherence at year 1.Results. A total of 333 patients were available for the main analyses, including 140 early persistent responders. Variation in each of the psychosocial outcomes at year 1 was explained mostly by baseline values, followed by the clinical response profiles. Patients with an early persistent response reported significantly higher vitality, more positive beliefs about disease consequences and treatment effect. Treatment type did not matter.Conclusion. Rapid and persistent disease control and not treatment type were associated with favorable patientreported health and illness perceptions at year 1, but baseline psychosocial variables mattered most. Our data indicate opportunities to broaden the scope of the treat-to-target principle in early RA.

ObjectivesTo compare outcomes of different treatment schedules from the care in early rheumatoid arthritis (CareRA) trial over 5 years.MethodsPatients with RA completing the 2-year CareRA randomised controlled trial were eligible for the 3-year observational CareRA-plus study. 5-year outcomes after randomisation to initial methotrexate (MTX) monotherapy with glucocorticoid bridging (COBRA-Slim) were compared with MTX step-up without glucocorticoids or conventional synthetic disease-modifying antirheumatic drug (DMARD) combinations with glucocorticoid bridging, per prognostic patient group. Disease activity (Disease Activity Score based on 28 joints calculated with C reactive protein (DAS28-CRP)) and functionality (Health Assessment Questionnaire (HAQ)) were compared between treatment arms using longitudinal models; safety and drug use were detailed.ResultsOf 322 eligible patients, 252 (78%) entered CareRA-plus, of which 203 (81%) completed the study. Treatments for high-risk patients resulted in comparable DAS28-CRP (p=0.539) and HAQ scores over 5 years (p=0.374). Low-risk patients starting COBRA-Slim had lower DAS28-CRP (p<0.001) and HAQ scores (p=0.041) than those starting only on MTX. At study completion, 114/203 (56%) patients never had their original DMARD therapy intensified, with comparable rates between all treatments. Safety was comparable between treatments in high-risk patients. In low-risk patients, there were 18 adverse events in 10 COBRA-Slim and 36 in 17 patients treated with initial MTX monotherapy (p=0.048). Over 5 years, 22% of patients initiated biologics, 25% took glucocorticoids for >3 months and 17% for >6 months outside the bridging period.ConclusionsAll intensive treatments with glucocorticoids bridging demonstrated excellent 5 year outcomes. Initiating COBRA-Slim was comparably effective as more complex treatments for high-risk patients with early RA and more effective than initial MTX monotherapy for low-risk patients with limited need for biologics and chronic glucocorticoid use.

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 analogue 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 (Ph) and Patient's (Pa) global health (GH)) were recorded at every visit (n=10). Pearson correlation and exploratory factor analyses (EFAs), using multiple imputation (15 times) and outputation (1000 times), 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 with principal component extraction and oblimin rotation to determine which variables belong together. Results We included 379 patients. EFAs 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 EFAs 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's assessment, Factor 2: Clinical assessment (PhGH, SJC and TJC), and Factor 3: Laboratory (ESR/CRP). Conclusion PaGH, pain, fatigue, and physical function represent a separate aspect of the disease burden of ERA patients, that could be further explored as a target for care apart from disease activity.

OBJECTIVES To investigate how psychosocial aspects affect the probability of achieving sustained remission in early RA, and to explore the directionality of this relationship. METHODSData were analyzed from the randomized controlled CareRA-trial. Sustained remission was defined as continued DAS28-CRP <2.6 from weeks 16 to 104. Patients completed the Short Form 36 (SF-36), Revised Illness Perception Questionnaire (IPQ-R) and Utrecht Coping List (UCL). These psychosocial variables were studied at baseline and week 16 as predictors of sustained remission with logistic regression. Next, subgroups of patients in remission at week 16 were identified by Latent Profile Analysis (LPA) based on these psychosocial indicators. Time to first loss of remission was then compared between groups by Cox-proportional-hazards regression. Finally, directionality of associations between psychosocial indicators and DAS28-CRP was explored with cross-lagged panel models (CLPM).RESULTS Sustained DAS28-CRP-remission was associated with higher SF-36-scores and less passive coping at baseline, and with higher SF-36-scores and more positive IPQ-R-outcomes at week 16. Among patients in DAS28-CRP-remission at W16 (n=287), two subgroups were identified: a low-psychosocial-burden group (n=231/287) and high-psychosocial-burden group (n=56/287). The low-psychosocial-burden group retained remission longer ). In the CLPM, temporal relationships between psychosocial wellbeing and DAS28-CRP were complex, bidirectional and disease-phase dependent.CONCLUSION Suboptimal psychosocial wellbeing and negative illness perceptions predicted lower probability of sustained remission in an early RA cohort. Illness perceptions appeared to become more clinically relevant with time. Finally, one-in-five patients showed worse

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