K. Van der Elst

Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial

Objectives To compare the efficacy and safety of intensive combination strategies with glucocorticoids (GCs) in the first 16 weeks (W) of early rheumatoid arthritis (eRA) treatment, focusing on high-risk patients, in the Care in early RA trial. Methods 400 disease-modifying antirheumatic drugs (DMARD)-naive patients with eRA were recruited and stratified into high risk or low risk according to classical prognostic markers. High-risk patients (n=290) were randomised to 1/3 treatment strategies: combination therapy for early rheumatoid arthritis (COBRA) Classic (methotrexate (MTX)+ sulfasalazine+60 mg prednisone tapered to 7.5 mg daily from W7), COBRA Slim (MTX+30 mg prednisone tapered to 5 mg from W6) and COBRA Avant-Garde (MTX+leflunomide+30 mg prednisone tapered to 5 mg from W6). Treatment modifications to target low-disease activity were mandatory from W8, if desirable and feasible according to the rheumatologist. The primary outcome was remission (28 joint disease activity score calculated with C-reactive protein <2.6) at W16 (intention-to-treat analysis). Secondary endpoints were good European League Against Rheumatism response, clinically meaningful health assessment questionnaire (HAQ) response and HAQ equal to zero. Adverse events (AEs) were registered. Results Data from 98 Classic, 98 Slim and 94 Avant-Garde patients were analysed. At W16, remission was reached in 70.4% Classic, 73.6% Slim and 68.1% Avant-Garde patients (p=0.713). Likewise, no significant differences were shown in other secondary endpoints. However, therapy-related AEs were reported in 61.2% of Classic, in 46.9% of Slim and in 69.1% of Avant-Garde patients (p=0.006). Conclusions For high-risk eRA, MTX associated with a moderate step-down dose of GCs was as effective in inducing remission at W16 as DMARD combination therapies with moderate or high step-down GC doses and it showed a more favourable short-term safety profile. EudraCT number: 2008-007225-39.

A detailed analysis of treatment delay from the onset of symptoms in early rheumatoid arthritis patients

Objectives: A treatment delay of more than 12 weeks can negatively affect treatment response in rheumatoid arthritis (RA). Our aim was to quantify the different stages of delay before RA treatment in different rheumatology centres and to explore influencing factors. Method: A total of 156 disease-modifying anti-rheumatic drug (DMARD)-naive early RA patients were included from eight practices: one academic hospital, five general hospitals, and two private practices. Eight different types of delay were defined from symptom onset until treatment initiation. Information on the duration of each stage of delay was collected from the patient, their general practitioner (GP), and patient files at the rheumatology practice. Patient/GP demographics and disease activity/severity parameters were recorded. Results: The median total delay from symptom onset until treatment initiation was 23 weeks whereas patient-, GP- and rheumatologist-related median delay was 10, 4, and 7 weeks, respectively. Only 21.6% of the patients had a total delay of less than 12 weeks. The total median delay in private rheumatology practices was less than in academic and general hospitals (p < 0.001). Furthermore, RA patients treated within 12 weeks of symptom onset showed a higher level of disease activity. The duration of rheumatologist-related delay was inversely correlated with disease activity parameters. Patients with morning stiffness were treated, on average, 3 weeks sooner than those without morning stiffness (p < 0.006). Conclusions: In only one out of five early RA patients was treatment initiated within 12 weeks of symptom onset, as recommended. Patient-related delay contributed most to overall delay. Disease activity and type of rheumatology centre are pivotal determinants of delay.

Factors influencing the prescription of intensive combination treatment strategies for early rheumatoid arthritis

Objectives: Despite the availability and demonstrated effectiveness of intensive combination treatment strategies (ICTS) for early rheumatoid arthritis (RA), a discrepancy seems to exist between theoretical evidence and actual prescription in daily practice. The purpose of this study was to explore and identify the factors influencing the prescription of ICTS. Method: This study involved rheumatologists and nurses participating in the Care for Rheumatoid Arthritis (CareRA) trial, a multicentre randomized controlled trial (RCT) comparing different ICTS for early RA with conventional disease-modifying anti-rheumatic drugs (DMARDs) plus step-down glucocorticoids (GCs). A qualitative study was carried out using individual semi-structured interviews. Each interview was recorded, transcribed literally, and analysed thematically. In addition, observations at outpatient clinics were used to clarify the interpretation of the results. Results: We interviewed 26 rheumatologists and six nurses and observed five outpatient visits. Identified facilitators included available scientific evidence, personal faith in treatment strategy, staff support, and low treatment costs. Rheumatologists had no doubts about the value of methotrexate (MTX) but some questioned the value of combination strategy, others the effectiveness and/or the dosage of individual compounds. Additional barriers for prescribing ICTS included need for patient education, fear for patients’ preconceptions, concerns about applicability to the individual patient, difficulties with breaking routine, interference with organizational structures and processes, time constraints, and lack of financial support. Conclusions: A heterogeneous set of factors highlights the complexity of prescribing ICTS for early RA in daily clinical practice. Future improvement strategies should stimulate the facilitators while at the same time addressing the barriers. The generalizability of these findings to other health care systems needs further examination.

OP0180 Remission Induction with Dmard Combinations and Glucocorticoids is not Superior to Remission Induction with MTX Monotherapy and Glucocorticoids: Week 52 Results of the High-Risk Group from the Carera Trial

Background To date, intensive DMARD combination therapy with glucocorticoids (GCs) is the most effective treatment approach for the management of early Rheumatoid Arthritis (eRA). The ideal content of the combination and the dose of GCs are however not yet known. Objectives To compare different intensive combination treatment strategies associated with GCs in eRA patients with a poor prognosis at week (W)52 in the CareRA trial. Methods CareRA is a two year prospective investigator-initiated multicenter RCT rooted in daily practice. DMARD naïve eRA patients were stratified into a high or low-risk group based on classical prognostic markers (presence of erosions, rheumatoid factor, anti-cyclic citrullinated protein and DAS28(CRP). High-risk patients (n=290) were randomized to 1 of 3 treatment strategies. 1) Cobra Classic (n=98): Methotrexate (MTX)+Sulphasalazine+60mg prednisone tapered weekly to 7.5mg daily from W7 2) Cobra Slim (n=98): MTX+30mg prednisone tapered to 5 mg daily from W6 3) Cobra Avant-Garde (n=94):MTX+Leflunomide +30mg prednisone tapered to 5 mg daily from W6 From W28, GCs were tapered in all patients and stopped at W34. A predefined treat to target approach was applied. From W40, we aimed for DMARD monotherapy. Efficacy measures were proportions of DAS28(CRP) remission, good EULAR response, clinically meaningful HAQ response, HAQ=0 (ITT analysis). Radiographic progression was measured via the Sharp Van der Heijde score. Adverse events related to therapy (AEs) were registered. Missing data were imputed by last observation carried forward. Results Remission rates were 64.3%, 60.2% and 62.8% in the Classic, Slim and Avant-Garde group respectively (p=0.837). Also no other efficacy outcomes did not differ between groups. 82% of X-ray images were available at baseline. Radiographic progression was minimal. SvH scores were 1.3±2.1, 1.3±2.5 and 1.0±1.4 at baseline and changed over 52 weeks 0.3±0.5, 0.4±1.1 and 0.3±0.6 in the Classic, Slim and Avant-Garde group respectively (p=0.581). The total numbers of AEs were 182 in 65 Classic patients, 125 in 64 Slim patients and 174 in 72 Avant-Garde patients (p=0.026). Serious AEs were reported in 3 Classic, 2 Slim and 3 Avant-Garde patients. Conclusions High rates of remission were achieved at week 52 with csDMARDs and GCs in all remission induction schemes. Cobra Slim showed comparable efficacy with less adverse events compared to DMARD combinations with moderate or high GC dosages. Disclosure of Interest None declared

THU0117 Low-Risk Patients Also Benefit from Remission Induction Treatment in Early Rheumatoid Arthritis: Week 52 Results from the Carera Trial

Background Early intensive treatment to target is recommended in severe early Rheumatoid Arthritis (eRA). However, data are lacking in patients presenting without markers of poor prognosis. Objectives To compare Methotrexate (MTX) with or without Glucocorticoid (GC) remission induction in a tight control setting over 52 weeks in low-risk patients with eRA. Methods CareRA is a two year prospective investigator-initiated multicenter RCT rooted in daily practice. DMARD naïve eRA patients were stratified into a high or low-risk group according to classical prognostic markers (presence of erosions, rheumatoid factor, anti-cyclic citrullinated protein and disease activity). In the low-risk arm, 43 patients were randomized to 15mg MTX monotherapy following a Tight Step Up (MTX-TSU) approach and 47 patients to a Cobra Slim schedule (MTX+30mg prednisone tapered to 5mg daily from W6). GCs were tapered from W28 and stopped at W34. A predefined treat to target approach was applied. Efficacy measures were proportions of DAS28(CRP) remission, good EULAR response, clinically meaningful HAQ response, HAQ=0 and Area Under the Curve (AUC) for DAS28(CRP) (ITT analysis). Radiographic progression was measured via the Sharp Van der Heijde (SvH) method. Adverse events related to therapy (AEs) were registered. No power was calculated in this explorative study. Missing data were imputed via last observation carried forward. Results Remission rates at week 52 were 57.4% and 67.4% in the MTX-TSU and Cobra Slim group respectively (p=0.329). MTX-TSU patients had a higher AUC for DAS28(CRP) than Cobra Slim patients over 52 weeks of treatment (p=0.017). No other efficacy scores differed between groups. 76% of X-ray images were available at baseline. Radiographic progression was minimal. SvH scores were 0.7±1.1 and 0.9±1.5 at baseline and changed over 52 weeks 0.2±0.3 and 0.3±0.4 in the MTX-TSU and Cobra Slim group respectively (p=0.184). The numbers of AEs were 48 in 27 MTX-TSU patients and 49 in 20 Cobra Slim patients (p=0.871). Two serious AEs (pulmonary infection and anemia) were registered in the Cobra Slim group. We observed numerically more treatment adaptations and IM/IA GC injections in MTX-TSU patients. Conclusions Both RA therapies achieved high remission rates in a tight control setting at week 52. However, remission induction with Cobra Slim resulted in a more rapid and sustained disease control. MTX with or without GC remission induction showed a comparable safety profile. Disclosure of Interest None declared

THU0137 Associated with A Glucocorticoid Bridging Scheme, Methotrexate is as Effective Alone as in Combination with Other DMARDS for Early Rheumatoid Arthritis, with Fewer Reported Side Effects: 16 Weeks Remission Induction Data from the Carera Trial

Background In line with the window of opportunity theory, intensive DMARD combination therapy with glucocorticoids (GCs) is probably the most effective treatment approach for early Rheumatoid Arthritis (eRA), but the ideal content of the combination and the dose of GCs is not yet known. Objectives To compare the efficacy and safety of intensive treatment strategies associated with GCs at week (W)16, focusing on high risk patients. Methods CareRA is a prospective two-year investigator-initiated multicenter RCT rooted in daily practice. In this trial, 400 DMARD naïve eRA patients were stratified into high or low risk according to classical prognostic markers such as the presence of erosions, RF/ACPA and disease activity. High risk patients were randomized to 1/3 treatment strategies: COBRA Classic (MTX+ Sulphasalazine + 60mg GCs tapered to 7.5mg daily from W7), COBRA Slim (MTX + 30mg GCs tapered to 5 mg from W6) and COBRA Avant-Garde (MTX + Leflunomide + 30mg GCs tapered to 5 mg from W6). Treatment modifications to target low disease activity were mandatory from W8 onwards, if desirable and feasible according to the rheumatologist. The primary outcome was remission (DAS28(CRP) <2.6) at W16 (ITT analysis). Secondary endpoints were good EULAR response, clinically meaningful HAQ response and HAQ=0. Area under the curve (AUC) for DAS28(CRP) and proportion of treatment adaptations and GC injections were calculated. Adverse events (AEs) were registered. Missing data were imputed by the maximum likelihood method. Results 290 patients were stratified as high risk: 98 Classic, 98 Slim and 94 Avant-Garde patients. Remission was achieved in 70.4% COBRA CLASSIC patients, 73.5% COBRA SLIM patients, 68.1% COBRA AVANT-GARDE patients (p=0.713) at W16. No significant differences between groups were shown in the proportion with a good EULAR response, clinically meaningful HAQ response and HAQ=0 (all p>0.05). The AUC for DAS28(CRP) in the 3 treatment arms was equal (p=0.521). No difference in treatment adaptions or GCs injections was found at W16.Until W16, therapy related AEs were reported in 61.2% of Classic, in 46.9% of Slim and in 69.1% of Avant-Garde patients (p=0.006). Conclusions At W16, MTX associated with a moderate step-down dose of GCs was as effective as DMARD combination therapies with moderate or even high step down GC doses in high-risk eRA. The short-term safety profile of MTX with GCs alone was more favorable. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.2137

OP0172 A Cost-Effectiveness Analysis of Different Intensive Combination Therapies for Early Rheumatoid Arthritis: 1 Year Results of The Carera Trial

Background The (Care in Early RA) CareRA trial compared different treatment strategies in patients with early Rheumatoid Arthritis (ERA) with or without markers of poor prognosis. No significant differences were shown between the treatment arms in terms of remission rate and functionality at 16 and 52 weeks. The differential cost-effectiveness of these therapeutic strategies could aid in determining the optimal approach for ERA. Objectives To compare the cost-effectiveness of different therapeutic strategies used in the CareRA trial during the first treatment year in patients with early Rheumatoid Arthritis. Methods The CareRA trial is a 2-year investigator-initiated randomized pragmatic superiority trial comparing remission induction regimens in a treat-to-target approach. DMARD naïve ERA patients were stratified into a high- or low-risk group based on prognostic markers. High-risk patients were randomized to a COBRA Classic (Methotrexate (MTX) + Sulphasalazine + prednisone step-down from 60mg), COBRA Slim (MTX + prednisone step-down from 30mg) or COBRA Avant-Garde (MTX + Leflunomide + prednisone step-down from 30mg) scheme. Low-risk patients were randomized to MTX tight step-up (MTX-TSU) or COBRA-Slim. The direct costs for each patient in the trial were calculated by summing the cost of a rheumatology consultation, per protocol CareRA study medication and RA-related medication such as biologicals and extra glucocorticoids not stipulated in the protocol. The incremental cost-effectiveness ratio (ICER) was calculated using these costs and the treatment efficacy as observed in CareRA. Efficacy parameters investigated were the proportion of patients in remission (DAS28(CRP) <2.6) and the proportion with a clinically meaningful improvement of Health Assessment Questionnaire (HAQ change >0.22) at week 52. Results 349 out of 379 patients had sufficient cost information to be evaluated at week 52. Remission was achieved in 65,6% Classic, 61.7% Slim (high-risk) and 64.1% Avant-Garde patients; and in 56.8% MTX-TSU and 70.0% Slim (low-risk) patients. A clinically meaningful HAQ response was reached in 66.7% Classic, 70.2% Slim (high-risk) and 75.6% Avant-Garde patients; and in 58.3% MTX-TSU and 60.0% Slim (low-risk) patients. Mean ±SD total costs during year one were €1044.3 ± €871.0 €859.7 ±€431.3 and €1267.7 ±€632.7 for the Classic, Slim (high-risk) and Avant-Garde respectively; and €880.6 ±€917.4 and €867.5 ±€364.0 for MTX-TSU and Slim (low-risk) patients. In MTX-TSU patients, the high average cost ±SD of €268.6 ±€876.5 was remarkable. Cost-effectiveness analysis in the high-risk arm showed a higher ICER for Classic (€47.3/1% remission) and Avant-Garde (€170.0/1% remission) compared to Slim (high-risk); In the low-risk arm, the cost-effectiveness of MTX-TSU was shown to be comparable to Slim (low-risk), with an ICER of €-0.99/1% remission. Conclusions Cobra Slim, a combination of MTX with a moderately dosed glucocorticoid remission induction showed favorable cost-effectiveness in both ERA patients with or without poor prognosis. Disclosure of Interest None declared

OP0301 Two year cost-effectiveness analysis of the carera trial in early ra: a piggy back study

Background Rheumatoid arthritis (RA) causes high individual, medical and societal costs. EULAR guidelines suggest treating early, intensively and to target using disease modifying anti-rheumatic drugs (DMARDs), preferably with initial glucocorticoid (GC) bridging. COBRA slim, a combination of methotrexate (MTX) with a moderate dose prednisone step down bridge scheme showed a positive efficacy/tolerability balance in the Care in early RA (CareRA) trial. COBRA Slim in comparison to DMARD combination therapy with GC bridging, has the necessary intensity to induce remission, but with a lower risk of severe discomfort or adverse events, decreasing the early need for biologic (b)DMARDs. Objectives Perform an economic evaluation on the 2 year pragmatic randomised CareRA trial. Methods Patients with early RA (≤1 year) naïve to DMARDs were randomised to monotherapy or synthetic (cs)DMARD combination with or without GC bridging, after risk stratification based on classical prognostic markers. Clinical and patient-reported data were collected at each visit (≥10 times in 2 years). Direct costs of visits and RA medication (systemic GCs, cs and bDMARDs) over 2 years were calculated for each patient from each of the 5 treatment arms (table 1). For cost-effectiveness analysis, benefits were expressed as the proportion of patients with DAS28CRP<2.6 at year 2. Missing data was imputed per item with expectation maximisation. For cost-utility analysis, utilities were calculated using a validated mapping algorithm reconstructing EQ-5D scores based on age, sex, HAQ and pain scores at relevant study visits. Quality-adjusted life years (QALYs) encapsulating the impact of treatment on a patient’s length of life and health-related quality of life, were calculated as the time-weighted average of all available EQ-5D scores (area under the curve). Incremental cost-effectiveness ratios (ICERs) from each strategy were calculated. ICERs compare the additional costs a strategy imposes over another with the additional benefits it delivers. Means and medians based methods were calculated with confidence intervals via bootstrapping. Results From the initial CareRA cohort (n=379),cost/benefit data of 326 patients was used for a 2 year economic analysis. The mayor driver of direct costs was bDMARDs (57%>87% of total costs). Number of consultations were comparable (±11) across all treatment strategies. The cost-effectiveness analysis in the high risk population showed a higher ICER for COBRA Avant Garde (mean €198.65/1%, median €78.41/1%) and a dominated ICER for COBRA Classic (mean €-181.40/1%, median €-35.01/1%) compared to the Slim. In the low risk arm, ICERs for COBRA Slim compared to Tight Step Up (TSU) were €46.75/1% (mean) and €43.64/1% (median). Cost-utility analysis in the high risk arm showed an incremental cost of €1 469.36 for an increased utility of 0.012555 QALYS for COBRA Classic compared to COBRA Slim, resulting in an ICER of €117 033.85/QALY. The ICER of COBRA Avant Garde vs COBRA Slim was €69 329.19/QALY. In the low risk arm, the comparison of COBRA Slim to TSU yields an ICER of €1 342.78 per QALY.Abstract OP0301 – Table 1 Conclusions COBRA Slim which consists of an initial combination of MTX and a moderate dosed GC remission induction scheme has a favourable cost-effective and cost-utility profile for patients with early RA independent of their prognostic factors. Disclosure of Interest S. Pazmino: None declared, R. Westhovens: None declared, J. Joly: None declared, V. Stouten: None declared, D. De Cock: None declared, K. Van der Elst: None declared, P. Verschueren Grant/research support from: Unrestricted Pfizer Chair in the management of early rheumatoid arthritis

FRI0726 Long term use of analgesics and nsaids in early ra: lessons from the carera study

Background One might consider pain accompanying musculoskeletal conditions as a separate illness entity deserving specific treatment. A subgroup of early Rheumatoid Arthritis (RA) patients has remaining pain despite adequate disease control and this might be reflected in the use of analgesics and NSAIDs. Objectives To investigate the usage of analgesics and antiphlogistics prospectively in the pragmatic randomized controlled CareRA trial and describe the users of such drugs taking into account body mass index (BMI), VAS pain and DAS28CRP. Methods This study utilized data from the CareRA trial, a 2-year prospective investigator-initiated multicentre pragmatic RCT in patients with early RA (≤1 year) comparing different early intensive treat to target strategies, including glucocorticoid (GC) bridging, aiming for remission in all participants. All concomitant medication for each patient was recorded, including: name, dose, frequency/timing, continuous/intermittent use, start/end date and indication (possibly/definitely RA-related or other). Meaningful sub-classifications were made (analgesics, cox2-selective and non-selective NSAIDs). We defined two subgroups with prolonged analgesic/NSAID use till w104: the pre-induction group starting before/at baseline (BL) and the post-induction group starting w28-w52, after GC step-down. Results From the CareRA cohort (n=379), 90% were on analgesics/NSAIDs at some time during the study and 84% had already started before inclusion (mean 24 weeks). In general, we observed a decreasing trend in the use of analgesics/NSAIDs, with a slight increase after GC step-down. Overall, 266 patients used non-selective and 131 cox2-selective NSAIDs, 154 paracetamol and 85 opioids. Of the total population, 15, 5% (53 patients) started long-term analgesics/NSAIDs before/at BL (pre-induction group) and 13% (45 patients) from w28-w52 (post-induction group). A detailed distribution of on-demand/daily analgesic/NSAID use is provided in the table below.Table 1 Group of long-term users NSAIDs Paracetamol Opioids Combined therapy Non-selective Selective COX2 Pre-induction (n=53) 26% (17%/d) 11% (4%/d) 45% (8%/d) 9% (6%/d) 9% (2%/d) Post-induction (n=45) 33% (16%/d) 20% (7%/d) 33% (4%/d) 13% (7%/d) 0% Proportionally more patients were using NSAIDs in the post-induction group and paracetamol in the pre-induction group. Mean DAS28CRP (BL-w104) in the pre-induction group was 3.11 (±0.70) and mean VAS pain 32.7 (±16.3). In this group 62.3% had sustained low disease activity while taking continuous analgesics/NSAIDs. Results in the post-induction group were comparable. Analgesic/NSAID use was not significantly associated with mean (BL-w104) BMI, DAS28CRP or VAS pain. Conclusions Analgesics/NSAID intake in early RA was high (90%) and remarkably about 30% continued using these drugs, despite overall low disease activity. This high consumption might be explained by the ambiguous nature of arthritis-related pain and the lack of differentiation between nociceptive and non-nociceptive pain. Therefore pain management in early RA deserves more attention. References Verschueren, P. et al. ffectiveness of MTX with step-down glucocorticoid remission induction (COBRA Slim) vs other intensive treatment strategies for early RA in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority trial. Ann Rheum Dis. Disclosure of Interest None declared

THU0757-HPR European qualitative research project on patient-preferred outcomes in early rheumatoid arthritis (EQPERA): rationale, design and methods of an ongoing multi-country, multi-center, multi-language, longitudinal qualitative study

Background Ample studies exist on outcome assessment from the patient perspective in Rheumatoid Arthritis (RA), but little is known about health and treatment preferences of recently diagnosed patients, and how these evolve over time. A Belgian qualitative study has set the scene (1), but knowledge on cross-cultural nuances in patient-preferred outcomes is lacking. To this end, EQPERA – European Qualitative research collaboration on Patient-preferred outcomes in Early Rheumatoid Arthritis– was founded. Objectives EQPERA aims to unravel longitudinally preferences for treatment and health outcomes among patients with early RA across Belgium, the Netherlands and Sweden. To yield sound results, specific preparations for this cross-country qualitative study are reported here. Methods Several steps have been undertaken to ensure trustworthiness of findings and consistency across countries in sampling, interviewing, analysis and project management: a detailed research protocol has been written; the interview guides have been translated following a structured forward-backward linguistic validation process; templates for data collection and a quality assurance reporting tool have been developed; and local staff has been trained and supervised by the project leader in implementing the study protocol. Each country will document changes with sufficient detail in their research logbook. Results EQPERA will be a qualitative, explorative, longitudinal study with active involvement of patient researchers. In each country, a purposive sample of patients with early RA will be individually interviewed 3–6 months after start of the initial RA treatment and subsequently, the same participants will be invited back to take part in a focus group 12–18 months after RA treatment initiation. Data collection and analysis will be independently conducted by the local research teams in their native language. The local teams will analyze their interview data using the constant comparison method as detailed in Qualitative analysis guide of Leuven, after which Saldanas guiding questions will be adopted for analyzing change over time. Afterwards, a meta-synthesis of all locally gathered and interpreted data will be conducted to explore and describe patterns, similarities and differences across countries. Conclusions This European project is a first step in gathering contextual findings on patient-preferred outcomes in early RA. Such knowledge is of crucial importance for tailoring therapeutic approaches in a timely and meaningful way. Our innovative, qualitative, longitudinal research design goes beyond the abilities of the frequently used cross-sectional designs in qualitative research. Large, multi-national qualitative projects are scarce in rheumatology research, thus applied data management and quality assurance strategies could be of interest to other researchers. References Van der Elst K, et al. Unraveling Patient-Preferred Health and Treatment Outcomes in Early Rheumatoid Arthritis: A Longitudinal Qualitative Study. Arthritis Care Res (Hoboken). Arthritis Care Res (Hoboken). 2016;68(9):1278–87. Disclosure of Interest None declared