Objective The aim of the current study was to evaluate the 2-year cost-utility ratio between tapering conventional synthetic disease-modifying antirheumatic drugs (csDMARD) first followed by the tumour necrosis factor (TNF)-inhibitor, or vice versa, in patients with rheumatoid arthritis (RA). Methods Two-year data of the Tapering strategies in Rheumatoid Arthritis trial were used. Patients with RA, who used both a csDMARD and a TNF-inhibitor and had a well-controlled disease (disease activity score ≤2.4 and swollen joint count≤1) for at least 3 months, were randomised into gradual tapering the csDMARD first followed by the TNF-inhibitor, or vice versa. Quality-adjusted life years (QALYs) were derived from the European Quality of life questionnaire with 5 dimensions. Healthcare and productivity costs were calculated with data from patient records and questionnaires. The incremental cost-effectiveness ratio and the incremental net monetary benefit were used to assess cost effectiveness between both tapering strategies. Results 94 patients started tapering their TNF-inhibitor first, while the other 95 tapered their csDMARD first. QALYs (SD) were, respectively, 1.64 (0.22) and 1.65 (0.22). Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10). Therefore, total costs (SD) were €38 833 (€39 616) for tapering csDMARDs first, and €39 442 (€47 271) for tapering the TNF-inhibitor (p=0.88). For willingness-to-pay (WTP) levels <€83 800 tapering, the csDMARD first has the highest probability of being cost effective, while for WTP levels >€83 800 tapering the TNF-inhibitor first has the highest probability. Conclusion Our economic evaluation shows that costs are similar for both tapering strategies. Regardless of the WTP, tapering either the TNF-inhibitor or the csDMARD first is equally cost effective. Trial registration number NTR2754.

Objective.Enthesitis is a manifestation of psoriatic arthritis (PsA), but its symptoms are difficult to interpret clinically. We investigated the associations of ultrasonographic changes in entheses with clinical characteristics in patients with PsA, and compared enthesis changes of patients aged 35 to 60 years with healthy volunteers of that age.Methods.Consecutive patients with PsA participated in this cross-sectional study, irrespective of enthesitis complaints and age. We collected data about complaints, physical activity and activity avoidance, medication, and clinical enthesitis. Inflammatory and structural enthesis changes were scored with the modified MAdrid Sonographic Enthesitis Index (MASEI). Among all patients, associations between ultrasound (US) scores and clinical characteristics were investigated using linear regression. We compared US scores of healthy volunteers and patients with PsA aged 35–60 years using Wilcoxon rank-sum tests.Results.Eighty-four patients with PsA and 25 healthy volunteers participated. In patients with PsA, we found a small association between higher inflammatory-modified MASEI score and older age (β 0.07, 95% CI 0–0.13) and current use of biologics (β 1.56, 95% CI 0.16–2.95). Patients who reported avoiding activities had significantly lower inflammatory-modified MASEI scores (β −1.71, 95% CI −3.1 to −0.32) than those who did not. The patients with PsA aged 35–60 years (n = 50) had similar inflammatory scores as healthy volunteers but higher structural scores (median 6 vs 2; p = 0.01).Conclusion.Within patients with PsA, avoiding physical activity, younger age, and not using biologics were associated with less enthesis inflammation. Patients with PsA and healthy volunteers aged 35 to 60 years displayed similar levels of inflammatory changes of the entheses, but patients had more structural damage.

Objectives. To compare responsiveness and longitudinal validity of Disease Activity Score 28 (DAS28), Disease Activity index for PSoriatic Arthritis (DAPSA), Composite Psoriatic Disease Activity Index (CPDAI), Psoriatic ArthritiS Disease Activity Score (PASDAS), GRAppa Composite scorE (GRACE) and Minimal Disease Activity (MDA) in usual care PsA patients, within 1 year after diagnosis. Methods. Data collected in the Dutch southwest early PsA cohort (DEPAR) were used. Responsiveness was assessed using effect size (ES), standardized response mean (SRM), and discrimination between different general health states. Longitudinal validity was tested using mixed models with outcomes health-related quality of life (HRQOL), productivity and disability. Results. Responsiveness was highest for PASDAS, with ES 1.00 and SRM 0.95, lowest for DAPSA, with ES 0.73 and SRM 0.71, and in between for DAS28, CPDAI and GRACE. Differences in general health were best discriminated with PASDAS and GRACE. Patients reporting stable or worsening general health could not be distinguished by DAS28 or CPDAI. Discrimination was better using DAPSA, but worse than when using PASDAS and GRACE. Longitudinal evolvement of HRQOL and productivity had the highest association with low disease activity according to GRACE, followed by PASDAS, MDA, DAPSA, DAS28, with the lowest association for CPDAI. Conclusion. PASDAS and GRACE were superior with respect to responsiveness, and together with MDA best related to longitudinal evolvement of HRQOL, productivity and disability. Responsiveness and longitudinal validity of most outcomes were inferior for DAS28, DAPSA and CPDAI. As alternatives to the continuous measure DAPSA, use of PASDAS or GRACE should be considered.

In a cohort of patients with newly diagnosed psoriatic arthritis (PsA) who received usual care, we investigated the impact of time elapsed to minimal disease activity (MDA) on health-related quality of life (HRQoL), work productivity, and radiographic damage throughout the first year after diagnosis.

Background:Methotrexate (MTX) is the preferred drug of most rheumatologists for treating psoriatic arthritis (PsA). Despite its widespread use in clinical practice, scientific evidence of methotrexate on the different manifestations of psoriatic disease is limited. Specifically, data of MTX use in usual care and in early PsA patients are lacking.Objectives:To describe the response to MTX for patients with PsA and an oligoarthritis or polyarthritis phenotype in usual care in the first year after diagnosis, and its impact on different aspects of the disease, including patients not achieving minimal disease activity (MDA) despite continuous exposure to MTXMethods:Data collected in the Dutch southwest Early Psoriatic Arthritis cohort (DEPAR) study were used. Patients with a new diagnosis of PsA who have not started disease-modifying antirheumatic drugs (DMARDs) for PsA were eligible to participate. In this analysis, only patients with a phenotype at time of diagnosis of oligoarthritis or polyarthritis (resp. 2-4 joints involved or 5 or more joints, as defined by the rheumatologist), and at least one year follow up were included. Research nurses collected clinical data and data on medication use every three months in the first year after diagnosis. The following outcomes were used to evaluate disease activity: MDA, EULAR active disease (at least one tender and swollen joint), disease activity index for PsA low disease activity (DAPSA-LDA: DAPSA≤14), and disease activity score 28 low disease activity (DAS28-LDA: DAS28≤3.2). Disease activity at six months of patients who started MTX within six months after diagnosis and have continued using MTX until one year after diagnosis was analyzed.Results:In April 2018, 219 patients had a phenotype of oligoarthritis (n=134, 61%) or polyarthritis (n=85, 39%) at time of diagnosis, and at least one year follow up. In 183 (84%) patients, MTX monotherapy was started within six months after diagnosis. Within the first year, 23 of these used MTX intermittently, 25 switched to a different DMARD, and 45 started a different DMARD while remaining on MTX therapy. The remaining 90 patients used MTX monotherapy throughout the first year and of these we assessed disease activity at 6 months after diagnosis. At 6 months, 38 patients out of these 90 were not in MDA despite continuous MTX treatment, while 44 achieved MDA. Major differences amongst the two groups included tender joint count, physical function, evaluation of pain and global disease activity and impact on health-related quality of life scores (Table 1). Conversely, 18% of all patients started MTX monotherapy were in sustained MDA at one year while continuing MTX monotherapy.Conclusion:The majority of patients with a new diagnosis of PsA with a phenotype of oligoarthritis or polyarthritis started MTX within a year after diagnosis. MTX is maintained as monotherapy in half of these patients, with 18% of them achieving sustained MDA using MTX monotherapy at one year. Interestingly, approximately half of the patients who had continued methotrexate monotherapy were not achieving MDA after six months and they report higher impact of disease on clinical and patient reported outcomes, suggesting need to consider improvement of therapy for these patients.Disclosure of Interests:Kim Wervers: None declared, Hannah den Braanker: None declared, Jolanda Luime: None declared, Ilja Tchetverikov: None declared, Andreas Gerards: None declared, Cathelijne Appels: None declared, Wiebo van der Graaff: None declared, Hans van Groenendael: None declared, Lindy-Anne Korswagen: None declared, Josien Veris-van Dieren: None declared, Johanna Hazes: None declared, Marc Kok: None declared, Marijn Vis Grant/research support from: Novartis

Objective. Acute anterior uveitis (AAU) is common in ankylosing spondylitis (AS). Golimumab (GOL), a tumor necrosis factor-α inhibitor (TNFi), has proven to be effective in the treatment of AS. To date, the effect of GOL on the incidence of AAU in AS is unknown. The objective was to study the AAU occurrence rate in patients with AS during GOL treatment and secondarily, the efficacy of GOL in daily clinical practice. Methods. The study was a multicenter prospective study in a real-world setting in patients with AS who were treated with GOL for 12 months. The occurrence of AAU was assessed in the year before the initial TNFi treatment and during GOL treatment and calculated for the period at risk for a new AAU. Measures for disease activity [Ankylosing Spondylitis Disease Activity Score (ASDAS)] and treatment response [Assessment of Spondyloarthritis international Society (ASAS20 score)] were collected. Results. In total, 93 patients (65% male, 55% TNFi-naive, 27% history of AAU) were included, with a median disease duration of 7 years and ASDAS score of 3.1. During GOL treatment, the AAU occurrence rate was reduced from 11.1 to 2.2 per 100 patient-years (rate-ratio 0.20, 95% CI 0.04–0.91). After 3 months of treatment, 41% of the patients experienced a clinically important improvement of the ASDAS score (p < 0.001) and 36% an ASDAS20 response (p < 0.001). At month 12, 49% had achieved an ASAS20 response (p < 0.001). Conclusion. In AS, the AAU occurrence rate and disease activity decreased significantly during GOL treatment. Therefore, GOL can be considered a good choice in patients with AS who need a TNFi, especially in cases of recurrent AAU. (EudraCT number: 2012-002458-21)

Objective. Psoriatic arthritis (PsA) is a multifaceted disease. Affecting joints, skin, entheses, and dactylitis, its effect on health-related quality of life (HRQOL) could be substantial. We aim to assess HRQOL in patients newly diagnosed with PsA and analyze its associations with disease manifestations. Methods. Data collected at time of diagnosis from patients with PsA included in the Dutch south-west Early Psoriatic Arthritis cohort (DEPAR) study were used. HRQOL was assessed using 8 domains of the Medical Outcomes Study Short Form-36 (SF-36) questionnaire. Patients were classified based on primary manifestation in arthritis subtypes (i.e., mono-, oligo-, or polyarthritis) and other subtypes (i.e., enthesitis, dactylitis, and axial disease). In all patients, presence of arthritis, enthesitis, dactylitis, psoriasis, and chronic inflammatory back pain was determined. Multivariable linear regression was used to determine associations of PsA manifestations with HRQOL. Results. Of 405 patients, primary manifestation was peripheral arthritis in 320 (78 monoarthritis, 151 oligoarthritis, and 91 polyarthritis), enthesitis in 37, axial disease in 9, and dactylitis in 39. Mean scores of SF-36 domains were lower than the Dutch reference population and similar across arthritis subtypes. A higher number of enthesitis locations and tender joints, and presence of chronic back pain, were independently associated with worse SF-36 scores. Psoriasis and dactylitis were not associated with worse scores. Conclusion. HRQOL was diminished in PsA at time of diagnosis compared to the Dutch reference population, and tender joints, enthesitis at clinical examination, and back pain as indicators of pain affected HRQOL.

OBJECTIVE:Treat-to-target strategies have improved outcomes in rheumatic diseases. In psoriatic arthritis (PsA), the proposed targets are the multidimensional target minimal disease activity (MDA) and the articular target Disease Activity index for PsA (DAPSA). The aim of this study was to compare the disease burden of PsA in patients with low disease activity according to the 2 definitions, MDA and DAPSA low disease activity (DAPSA-LDA), 1 year after diagnosis.METHODS:We obtained data on MDA, DAPSA-LDA and disease burden 1 year after diagnosis for patients included in the Dutch southwest early PsA cohort. Disease burden was assessed in 2 domains: "Body functions," including the Short Form 36 bodily pain (SF-36 BP) measure, and "Activity," including the Health Assessment Questionnaire (HAQ).RESULTS:Among the 292 patients included, 48% achieved MDA and 74% achieved DAPSA-LDA. Average scores for Body functions and Activity were better in patients who achieved MDA and those who achieved DAPSA-LDA. The scores were significantly better in the 46% of patients who achieved both MDA and DAPSA-LDA than in the 29% of patients who achieved only DAPSA-LDA. The average SF-36 BP score was higher in patients achieving both targets (73.8; 95% confidence interval [95% CI] 71.1-76.5) than in patients achieving only DAPSA-LDA (57.6; 95% CI 54.5-60.8). Similarly, mean HAQ scores measuring Activity were 0.21 (95% CI 0.15-0.26) and 0.63 (95% CI 0.53-0.72), respectively.CONCLUSION:Among patients with newly diagnosed PsA, 48% achieved MDA and 74% achieved DAPSA-LDA after 1 year of receiving usual care. The average disease burden was better in patients who achieved MDA and those who achieved DAPSA-LDA. Also, patients who achieved only DAPSA-LDA reported worse outcomes than those who also achieved MDA.

Background Enthesitis is one of the manifestations of psoriatic arthritis (PsA), but no clear definition for the diagnosis exists. To further evaluate the added value of sonographic evaluation of entheses in diagnosing enthesitis, more knowledge on factors associated with sonographic enthesitis is needed. Objectives We aim to evaluate which clinical characteristics are associated with sonographic enthesitis changes in a cross-sectional PsA population. Methods established PsA patients were asked to participate, irrespective of enthesitis complaints. Patients were interviewed on history of musculoskeletal complaints (MSC), more specifically if they had complaints during activities and whether they avoided physical activities (during exercise, work, household tasks, hobbies, chores). Tenderness was determined in the MASEI entheses and those in the Leeds Enthesitis Index (LEI) and Maastricht Ankylosing Spondylitis Enthesitis Score (MASES). Previously we showed that a modified Madrid Sonographic Enthesitis Index (MASEI, i.e. excluding knee enthesis thickness and scoring PD-signal semi-quantitatively) distinguishes entheses of PsA patients from those of healthy volunteers (1). A sonographist unaware of clinical findings scored the modified MASEI. Multivariable linear regressions of structural (erosions, calcifications, structure) and inflammatory (thickness, bursitis and PD) modified MASEI scores were performed (transformed for a better distribution). Variables included age, gender, PsA duration, medication use (non/nsaids vs. sDMARDs vs. bDMARDs), LEI + MASES and avoidance (no vs. yes). Results 84 PsA patients participated (45 males, mean age 55, median disease duration 8 years). Median modified MASEI was 12 (IQR 7.25–17), with a structural component score of 7 (3–10) and inflammatory component score of 6 (3.5–8.5). 8 patients used no medication or NSAIDs only, 36 used sDMARDs and 40 used bDMARDs. 45 patients reported avoiding activities. In a multivariable analysis, inflammatory modified MASEI was negatively associated with avoidance (i.e. fewer inflammatory changes in patients reporting avoidance) and positively associated with age, BMI and use of biologics. Structural MASEI was positively associated with age only. Conclusions Avoiding physical activities is associated with fewer inflammatory changes of the entheses. More inflammatory changes are seen in older or overweight patients and patients on biologicals, in the latter possibly due to more active disease. References Wervers K, Rasappu N, Vis M, Tchetverikov I, Kok MR, Gerards AH, et al. AB0733 Masei Shows Substantial Changes in The Entheses of Young Healthy Volunteers – Amending Its PD Score and Excluding Knee Entheses Thickness Provides Better Discrimination of Enthesitis in Psoriatic Arthritis Patients. Ann Rheum Dis 2016;75:1155. Disclosure of Interest None declared

ObjectivesAlthough RA patients achieve clinical remission, risk of flare still exists. Given the association between US synovitis and increased risk of flare, it is of clinical interest whether these patients report a different health status. Therefore, our aim was to evaluate the frequency of US remission in RA patients in clinical remission and to compare the health status of RA patients in clinical remission with those who were also in US remission.MethodsIn a prospective study, we included 89 RA patients (aged >17 years) treated with a synthetic DMARD and a TNF inhibitor who were in remission (DAS in 44 joints ⩽2.4 and swollen joint count ⩽1). Demographic characteristics, swollen and tender joints, laboratory variables, US (MCP2-5, PIP2-5, wrists and MTP2-5) and patient-reported outcomes (general health, functional ability, fatigue, depression and anxiety, pain and morning stiffness) were recorded at two consecutive visits (3 months apart). US remission was defined as grey scale grade ⩽1 and power Doppler = 0.ResultsAt visit 1, 39% of patients were in US remission. At visit 2, 32% of patients were in US remission. At visit 1, functional ability (HAQ) was scored lower by patients in US remission (P = 0.029). At visit 2, HAQ scores were similar (P = 0.928). At visit 2, Hospital Anxiety and Depression Scale anxiety score and visual analog scale pain were significantly higher in patients in US remission. Similar levels were found for the other patient-reported outcomes.ConclusionOne-third of RA patients in clinical remission were in US remission. In our study population, we could not find a clear association between health status of RA patients and being in US remission.

Objective. Ultrasonography (US) can be used for treatment decisions in RA patients. This study investigated the added value of US to clinical variables in predicting flare in RA patients with longstanding low disease activity when stopping TNF inhibitors (TNFi).Methods. Cox models with and without using US added to clinical variables were developed in the Potential Optimization of Expediency of TNFi-UltraSonography study. RA patients (n = 259), using > 1 year TNFi and csDMARD with DAS28 < 3.2 for 6 months prior to inclusion, were followed for 52 weeks after stopping TNFi. The added value of US was assessed in two ways: first, by the extent to which individual predictions for flare at 52 weeks with and without US differed; and second, by comparing how US information improved the prediction to classify patients at 52 weeks in the low risk (<33% flare), intermediate risk (33-50%) and high risk (50-100%) groups.Results. Although US was predictive of flare at group level (multivariate hazard ratio = 1.7; 95% CI: 1.1, 2.5), individual predictions for flare at 52 weeks with and without US differed little (median difference 3.7%; interquartile range: -7.8 to 6.5%). With US, 15.9% of patients were designated low risk; without US, 14.6%. In fact, 12.0% of patients were US-classified as low risk with/without knowing US.Conclusion. In RA patients with longstanding low disease activity, at time of stopping TNFi, US is a predictor for flare at group level, but at the patient level, US has limited added value when common clinical parameters are used already, though the predictive value of clinical predictors is modest as well.

OBJECTIVE:To evaluate direct and indirect costs per quality adjusted life year (QALY) for different initial treatment strategies in very early RA.METHODS:The 1-year data of the treatment in the Rotterdam Early Arthritis Cohort trial were used. Patients with a high probability (>70%) according to their likelihood of progressing to persistent arthritis, based on the prediction model of Visser, were randomized into one of following initial treatment strategies: (A) initial triple DMARD therapy (iTDT) with glucocorticoids (GCs) intramuscular (n = 91); (B) iTDT with an oral GC tapering scheme (n = 93); and (C) initial MTX monotherapy (iMM) with GCs similar to B (n = 97). Data on QALYs, measured with the Dutch EuroQol, and direct and indirect cost were used. Direct costs are costs of treatment and medical consumption, whereas indirect costs are costs due to loss of productivity.RESULTS:Average QALYs (sd) for A, B and C were, respectively, 0.75 (0.12), 0.75 (0.10) and 0.73 (0.13) for Dutch EuroQol. Highest total costs per QALY (sd) were, respectively, €12748 (€18767), €10 380 (€15 608) and €17 408 (€21 828) for strategy A, B and C (P = 0.012, B vs C). Direct as well as indirect costs were higher with iMM (strategy C) compared with iTDT (strategy B). Higher direct costs were due to ∼40% more biologic usage over time. Higher indirect costs, on the other hand, were caused by more long-term sickness and reduction in contract hours. iTDT was >95% cost-effective across all willingness-to-pay thresholds compared with iMM.CONCLUSION:iTDT was more cost-effective and had better worker productivity compared with iMM.

OBJECTIVE:In this study we aimed to evaluate the effect of lowering the cut point of the 2010 criteria to identify more patients with RA among early inflammatory arthritis patients.METHODS:We included early arthritis patients from the Rotterdam Early Arthritis Cohort with at least one joint with clinical synovitis and symptoms for <1 year, with no other explanation for their symptoms. The demographic and clinical characteristics of each patient were recorded at baseline. Patients were classified as case or non-case at the 1-year follow-up by the definition used in the development of the 2010 criteria (MTX initiation). To assess the diagnostic performance of the 2010 criteria, the sensitivity and specificity at each cut point were determined.RESULTS:We included 557 patients in our analysis. At the 1-year follow-up, 253 patients (45%) were classified as case (MTX use). In the group of patients who scored 0-5 points (n = 328), 98 patients (30%) were classified as case (MTX use). The sensitivity and specificity of the 2010 criteria using the cut point of 6 were 61% and 76%, respectively. With the cut point of 5, the sensitivity would increase to 76% and the specificity would decrease to 68%.CONCLUSION:By lowering the cut point of the 2010 criteria from 6 to 5 points, we were able to identify 15% more RA patients at the cost of 8% more false-positive patients.