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Objective To determine (1) the proportion of routine spondyloarthritis (SpA) outpatient visits considered (un)necessary by rheumatologists, (2) characteristics of (un)necessary visits, and (3) whether previsit remote health outcome assessments can identify the necessity of ensuing visits. Methods A random sample of follow-up visits was evaluated at an SpA outpatient clinic. Before visits, patient-reported outcomes and disease activity were collected through an online health registry (SpA-Net). Rheumatologists were asked whether visits were considered necessary and whether therapy was altered. Clinical actions during visits were documented alongside demographic and clinical patient characteristics; these were compared for necessary vs unnecessary visits. Multivariable logistic regressions explored which previsit health outcomes (disease activity, patient-reported physical and mental health) were associated with the perceived necessity of visits. Predictive value was calculated for high disease activity thresholds of Ankylosing Spondylitis Disease Activity Score (ASDAS) and patient global assessment (PtGA). Results Of 114 outpatient visits, 39 (34.2%) were considered unnecessary. These visits involved fewer treatment changes (6 of 39 [15.4%] vs 39 of 75 [52.0%] visits) and clinical actions (9 of 39 [23.1%] vs 47 of 75 [62.7%] visits) compared to visits considered necessary. Previsit ASDAS (OR 4.06, 95% CI 1.80-9.17) and PtGA (OR 1.65, 95% CI 1.25-2.17) were associated with the perceived necessity of visits. Positive predictive value of ASDAS ≥ 2.1 and PtGA ≥ 3.0 were 91.7% and 80.0%, respectively. Conclusion Traditional physician-initiated follow-up for patients with SpA likely results in a suboptimal use of time and resources. Remote disease activity assessments can help identify patients for whom visits might be necessary from a rheumatologist's perspective.

ObjectivesTo disseminate and assess the level of acceptability and applicability of the European Alliance of Associations for Rheumatology (EULAR) recommendations for patient education among professionals in rheumatology across Europe and three Asian countries and identify potential barriers and facilitators to their application.MethodsA parallel convergent mixed-methods design with an inductive approach was used. A web-based survey, available in 20 different languages, was distributed to health professionals by non-probability sampling. The level of agreement and applicability of each recommendation was assessed by (0–10) rating scales. Barriers and facilitators to implementation were assessed using free-text responses. Quantitative data were analysed descriptively and qualitative data by content analysis and presented in 16 categories supported by quotes.ResultsA total of 1159 completed the survey; 852 (73.5%) were women. Most of the professionals were nurses (n=487), rheumatologists (n=320), physiotherapists (n=158). For all recommendations, the level of agreement was high but applicability was lower. The four most common barriers to application were lack of time, lack of training in how to provide patient education, not having enough staff to perform this task and lack of evaluation tools. The most common facilitators were tailoring patient education to individual patients, using group education, linking patient education with diagnosis and treatment and inviting patients to provide feedback on patient education delivery.ConclusionsThis project has disseminated the EULAR recommendations for patient education to health professionals across 23 countries. Potential barriers to their application were identified and some are amenable to change, namely training patient education providers and developing evaluation tools.

ObjectiveTo develop EULAR points-to-consider for therapeutic drug monitoring (TDM) of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases (RMDs).MethodsThe points-to-consider were developed in accordance with EULAR standardised operation procedures by a multidisciplinary task force from eight European countries, based on a systematic literature review and expert consensus. Level of evidence and strength of the points-to-consider were determined, and mean levels of agreement among the task force were calculated using a 10-point rating scale.ResultsSix overarching principles and 13 points-to-consider were formulated. The level of agreement among the task force for the overarching principles and points-to-consider ranged from 8.4 to 9.9.The overarching principles define TDM and its subtypes, and reinforce the underlying pharmacokinetic/pharmacodynamic principles, which are relevant to all biopharmaceutical classes. The points-to-consider highlight the clinical utility of the measurement and interpretation of biopharmaceutical blood concentrations and antidrug antibodies in specific clinical scenarios, including factors that influence these parameters. In general, proactive use of TDM is not recommended but reactive TDM could be considered in certain clinical situations. An important factor limiting wider adoption of TDM is the lack of both high quality trials addressing effectiveness and safety of TDM and robust economic evaluation in patients with RMDs. Future research should focus on providing this evidence, as well as on further understanding of pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals.ConclusionThese points-to-consider are evidence-based and consensus-based statements for the use of TDM of biopharmaceuticals in inflammatory RMDs, addressing the clinical utility of TDM.

Objectives To evaluate the extent to which internationally agreed treat-to-target recommendations were applied in clinical practice in patients with axial spondyloarthritis. Methods Data were used from a web-based patient registry for monitoring SpA in daily practice in the Netherlands. The extent to which treat-to-target was applied was evaluated through four indicators: the proportion of patients (i) with ≥1 Ankylosing Spondylitis Disease Activity Score (ASDAS) assessed during a 1-year period, (ii) having inactive disease/low disease activity (i.e. ASDAS Results In 185 out of 219 patients (84%), disease activity was monitored with ≥1 ASDAS during a 1-year period, of whom 71 (38%) patients had a score below the target (ASDAS Conclusions Treat-to-target was applied to a limited extent in clinical practice in patients with axial spondyloarthritis. Available disease activity scores seemed not to be used for determining the frequency of re-evaluation nor treatment adaptation.

ObjectiveTo investigate concurrent validity and discrimination of the Disease Activity Index for Psoriatic Arthritis (DAPSA) score, Psoriatic Arthritis Disease Activity Score (PASDAS), and Ankylosing Spondylitis Disease Activity Score (ASDAS) in peripheral spondyloarthritis (pSpA) in clinical practice.MethodsData from a Dutch registry for SpA (SpA-Net) were used. Predefined hypotheses on concurrent validity of the composite measures with 15 other outcome measures of disease activity, physical function, and health-related quality of life were tested. Concurrent validity was considered acceptable if ≥ 75% of the hypotheses were confirmed. Discrimination was assessed by stratifying patients in DAPSA, PASDAS, and ASDAS predefined disease activity states and studying mean differences in health outcomes by 1-way ANOVA. Further, the concordance in disease activity states was determined. All analyses were repeated in subgroups with and without psoriasis (PsO).ResultsDAPSA, PASDAS, and ASDAS scores were available for 191, 139, and 279 patients with pSpA, respectively. The concurrent validity and discrimination of all composite measures were acceptable, as the strength of correlations were as hypothesized in ≥ 75% of the studied correlations. With increasing disease activity states, scores in nearly all outcome measures worsened significantly. The DAPSA, PASDAS, and ASDAS classified 22%, 56%, and 48% of the patients, respectively, in the 2 highest disease activity states. Stratified analyses for concomitant PsO revealed no relevant subgroup differences.ConclusionThe performance of DAPSA, PASDAS, and ASDAS in pSpA was acceptable, and independent of concomitant PsO. Due to discrepancy in classification, the validity of existing thresholds for disease activity states warrants further study in pSpA.

Contains fulltext : 287596.pdf (Publisher’s version ) (Open Access) OBJECTIVE: As first-degree relatives (FDRs) of HLA-B27-positive patients with axial spondyloarthritis (SpA) have an increased risk of developing axial SpA, the objectives were 1) to evaluate the presence of highly specific imaging features as well as clinical signs of SpA at baseline and after 1 year of follow-up, and 2) to describe the evolution toward clinical disease within 1 year of follow-up in a cohort of seemingly healthy FDRs of HLA-B27-positive axial SpA patients. METHODS: The Pre-SpA cohort is a 5-year prospective inception cohort of seemingly healthy FDRs of HLA-B27-positive axial SpA patients. Clinical and imaging features were collected and recorded. RESULTS: At baseline, 19% of the FDRs reported inflammatory back pain, 32% current arthralgia, 3% arthritis (ever), 5% enthesitis (ever), and 1% dactylitis (ever), and 3% had an extraarticular manifestation. C-reactive protein level was elevated in 16%, and erythrocyte sedimentation rate was elevated in 7%. On magnetic resonance imaging (MRI) views of sacroiliac joints, 10% had a Spondyloarthritis Research Consortium of Canada score of ≥2, 4% had a score of ≥5, and 4% had deep lesions. In total, 1% fulfilled the modified New York criteria for radiographic sacroiliitis. Clinical, MRI, and acute phase findings were equally distributed between HLA-B27-positive and -negative FDRs. After 1 year of follow-up, clinical parameters did not change on the group level, but 6% of the FDRs were clinically diagnosed with axial SpA, of whom 86% were HLA-B27-positive. CONCLUSION: Features associated with SpA or imaging abnormalities were found in up to 32% of seemingly healthy FDRs, with an equal distribution between HLA-B27-positive and -negative FDRs. Progression to clinical axial SpA within 1 year of follow-up was mainly observed in HLA-B27-positive FDRs.

AIM: To identify all possible definitions of "early SpA" employed in the literature, including "early axial SpA (axSpA)" and "early peripheral SpA (pSpA)". METHODS: A systematic literature review was conducted in Medline, EMBASE and the Cochrane Library for studies that included any mention of "early SpA" or its subtypes. The proportion of studies including a definition was calculated, and the different definitions were assessed. RESULTS: Out of 9651 titles identified, 336 publications reporting data from 183 studies were included. Over time, an increasing number of publications were identified. In total, 114 (62%) studies reported a specific definition: 33% of them based it on symptom duration, 31% on radiographic damage, 28% on disease duration, 5% on both symptom/disease duration and radiographic damage, and 3% on other aspects. Overall, 61 (33%) studies included the term "early axSpA", whereas 60 (33%) included "early ankylosing spondylitis (AS)". Regarding the studies that referred to "early axSpA", the most used definition was symptom/disease duration

Objective To develop an alternative Ankylosing Spondylitis Disease Activity Score (ASDAS) to be used in research settings in axial SpA (axSpA) when Patient Global Assessment (PGA) is unavailable in databases. Methods Longitudinal data from four axSpA cohorts and two randomized controlled trials were combined. Observations were randomly split in a development (N = 1026) and a validation cohort (N = 1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were established in the development cohort. Conversion factors for each substitute were defined by Generalized Estimating Equations, obtaining seven ‘alternative’ formulae. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: (i) truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient and in disease activity states, by weighted kappa); (ii) discrimination [standardized mean difference of ASDAS scores between high/low disease activity states defined by external anchors, e.g. Patient Acceptable Symptom State; agreement (kappa) in the percentage of patients reaching ASDAS improvement criteria according to alternative vs original formulae]; and (iii) feasibility. Results Comparing various options, alternative-ASDAS using BASDAI total as PGA replacement proved to be: truthful (intraclass correlation coefficient = 0.98, kappa = 0.90), discriminative [ASDAS scores between Patient Acceptable Symptom State no/yes: standardized mean difference = 1.37 (original-ASDAS standardized mean difference = 1.43); agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa = 0.93/0.88] and feasible (BASDAI total often available, as questions required for the ASDAS; conversion coefficient ≈ 1). Conclusion Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument.

Objective To summarize evidence on the relationship between early treatment (definition based on symptom/disease duration or radiographic damage) and treatment clinical response in patients with SpA. Methods A systematic literature review was conducted in studies on SpA patients treated with NSAIDs or biological/targeted synthetic DMARDs addressing the impact of symptom/disease duration or presence of radiographic damage on treatment response assessed by any disease activity outcome. For categorical outcomes, relative risk, relative risk ratio and number needed to treat were calculated, and for continuous outcomes, differences in differences, to compare groups stratified based on symptom/disease duration or the presence of radiographic damage. Results From the 8769 articles retrieved, 25 were included and 2 added by hand-search, all in axial SpA (axSpA), most of them with low risk of bias. Twenty-one studies compared groups based on symptom duration (n = 6) or disease duration (n = 15) and seven studies based on absence/presence of radiographic damage (two studies used two comparisons). When early axSpA was defined by symptom duration ( Conclusion Evidence towards better outcomes in early axSpA is very limited and restricted to non-radiographic axSpA and

According to several international recommendations, disease activity should be regularly monitored with validated outcome measures in patients with axial spondyloarthritis (axSpA), and therapy should be adapted accordingly.1-3 Increasingly, healthcare providers are encouraged to also use patient-reported outcomes (PROs) for this purpose, to capture valuable data from the patient's perspective.

Objectives To describe the cumulative incidences of adverse drug reactions (ADRs) associated with disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients from real-world data (RWD), using the DREAM-RA registry, and to compare these with incidence frequencies mentioned in the Summary of Product Characteristics (SmPC). Methods All ADRs in patients with recorded use of adalimumab, etanercept, hydroxychloroquine, leflunomide, oral and subcutaneous methotrexate, and sulfasalazine from a single center participating in the DREAM-RA registry (n = 1,098 patients) that were directly sent to the Netherlands Pharmacovigilance Center Lareb were assessed. Cumulative incidences were calculated, described and compared to the most recently revised SmPCs. Results In total, 14 ADRs (>= 5 case reports) associated with the use of one of the included DMARDs were reported with a higher estimated cumulative incidence compared to the SmPC. For hydroxychloroquine and sulfasalazine, 5 ADRs (>= 5 case reports) mentioned with an 'unknown' incidence in the SmPC were reported as 'common' in this study. Conclusions Although ADR data in the DREAM-RA registry were partly comparable with data in the SmPCs, RWD from this patient registry provided an added value to the currently available information on the incidences of ADRs associated with DMARDs in RA patients as described in SmPCs.

Contains fulltext : 248979.pdf (Publisher’s version ) (Open Access) OBJECTIVES: Research on effectiveness and cost-effectiveness of longstanding exercise therapy in patients with axial SpondyloArthritis (axSpA) or Rheumatoid Arthritis (RA) is scarce, and mainly concerned patients with a relatively favorable health status. We aim to evaluate the effectiveness and cost-effectiveness of longstanding exercise therapy compared to usual care in the subgroup of patients with axSpA or RA and severe limitations in functioning. METHODS: In two separate, parallel randomized controlled trials the effectiveness and cost-effectiveness of longstanding, active exercise therapy (52 weeks) compared with usual care (1:1) will be evaluated. The longstanding, active exercise therapy will focus on improving individual limitations in daily activities and participation and will be given by a trained physical therapist in the vicinity of the participant. For each diagnosis, 215 patients with severe limitations in activities and participation will be included. Assessments are performed at baseline, 12, 26, and 52 weeks. The primary outcome measure of effectiveness is the individual level of functioning (activities and participation), as measured with the Patient-Specific Complaints instrument at 52 weeks. For cost-effectiveness analyses, the EuroQol (EQ-5D-5L) and questionnaires on healthcare use and productivity will be administered. The economic evaluation will be a cost-utility analysis from a societal perspective. After 52 weeks, the patients in the usual care group are offered longstanding, active exercise therapy as well. Follow-up assessments are done at 104, 156, and 208 weeks. CONCLUSION: The results of these studies will provide insights in the effectiveness and cost-effectiveness of longstanding exercise therapy in the subgroup of axSpA and RA patients with severe functional limitations.

ObjectiveWe aimed to describe the nature and frequency of gastrointestinal adverse drug reactions (GI-ADRs) of etanercept (ETN) using patient-reported and healthcare professional (HCP)-registered data and compared this frequency with the GI-ADR frequency of the widely used tumor necrosis factor-α inhibitor adalimumab (ADA).MethodsReported GI-ADRs of ETN for rheumatic diseases were collected from the Dutch Biologic Monitor and DREAM registries. We described the clinical course of GI-ADRs and compared the frequency with ADA in both data sources using Fisher exact test.ResultsOut of 416 patients using ETN for inflammatory rheumatic diseases in the Dutch Biologic Monitor, 25 (6%) patients reported 36 GI-ADRs. In the DREAM registries 11 GI-ADRs were registered for 9 patients (2.3%), out of 399 patients using ETN, with an incidence of 7.1 per 1000 patient-years. Most GI-ADRs consisted of diarrhea, nausea, and abdominal pain. GI-ADRs led to ETN discontinuation in 1 patient (4%) and dose adjustment in 4 (16%) in the Dutch Biologic Monitor. Eight GI-ADRs (73%) led to ETN discontinuation in the DREAM registries. The frequency of GI-ADRs of ETN did not significantly differ from GI-ADRs of ADA in both data sources (Dutch Biologic Monitor: ETN 8.7% vs ADA 5.3%, P = 0.07; DREAM: ETN 2.8% vs ADA 4.7%, P = 0.16).ConclusionMost GI-ADRs associated with ETN concerned gastrointestinal symptoms. These ADRs may lead to dose adjustment or ETN discontinuation. The frequency of ETN-associated GI-ADRs was comparable to the frequency of ADA-associated GI-ADRs. Knowledge about these previously unknown ADRs can facilitate early recognition and improve patient communication.

ObjectivesWe explored the effects of B-cell directed therapy in subjects at risk of developing autoantibodypositive rheumatoid arthritis (RA), who never experienced inflammatory arthritis before, and explored biomarkers predictive of arthritis development.MethodsIndividuals positive for both anti-citrullinated peptide antibodies and rheumatoid factor but without arthritis were included in a randomised, double-blind, placebo-controlled study to receive a single infusion of 1000 mg rituximab or placebo.ResultsEighty-one individuals received treatment and were followed up for a mean of 29.0 (0–54) months, during which 30/81 (37%) individuals developed arthritis. The observed risk of developing arthritis in the placebo-treated group was 40%, which was decreased by 55% (HR 0.45, 95% CI 0.154 to 1.322) in the rituximab-treated group at 12 months. Rituximab treatment caused a delay in arthritis development of 12 months compared with placebo treatment at the point when 25% of the subjects had developed arthritis (pConclusionsA single infusion of 1000 mg rituximab significantly delays the development of arthritis in subjects at risk of developing RA, providing evidence for the pathogenetic role of B cells in the earliest, prearthritis stage of autoantibody positive RA.

ObjectiveTo investigate whether work productivity in patients with spondyloarthritis (SpA) changed following the onset of the COVID-19 pandemic.MethodsData from the Dutch SpA-Net registry were used. Work productivity was assessed with the Work Productivity and Activity Impairment General Health questionnaire. Proportions of patients employed and their overall work impairment (0%–100%) were compared during a 1-year period before (‘pre-pandemic’) and a 1-year period after the onset (‘post-onset’) of the pandemic (March 2020). Generalised estimating equation analysis of all assessments since 2016 explored whether overall work impairment (absenteeism and presenteeism) in employed patients changed with pandemic onset, adjusting for confounders. Similar analyses with disease activity as outcome were used to facilitate interpretation of work productivity results.ResultsData were available during pre-pandemic and post-onset years for 204 patients. Pre-pandemic, 128 (62%) patients were employed. Post-onset, 7 (3.4%) had lost employment, while another 7 (3.4%) originally unemployed gained employment. Overall work impairment was worse following pandemic onset (37.0%) compared with pre-pandemic (27.0%) (pConclusionsWork productivity worsened in patients with SpA after pandemic onset, especially in patients with lower education, while employment losses were limited and disease activity remained stable. Work support should be considered during the COVID-19 pandemic and thereafter for those vulnerable to adverse work outcome.

To describe the delivery of care for patients with rheumatic and musculoskeletal diseases (RMDs) from the perspective of rheumatologists in the Netherlands during the first months of the COVID-19 pandemic. A mixed methods design was used with quantitative and qualitative data from a cross-sectional survey sent to all members of the Dutch Rheumatology Society in May 2020. The survey contained questions on demographics, the current way of care delivery, and also on usage, acceptance, facilitators and barriers of telemedicine. Quantitative data were analyzed descriptively. The answers to the open questions were categorized into themes. Seventy-five respondents completed the survey. During the COVID-19 pandemic, continuity of care was guaranteed through telephone and video consultations by 99% and 9% of the respondents, respectively. More than 80% of the total number of outpatient visits were performed exclusively via telephone with in-person visits only on indication. One-quarter of the respondents used patient reported outcomes to guide telephone consultations. The top three facilitators for telemedicine were less travel time for patients, ease of use of the system and shorter waiting period for patients. The top three barriers were impossibility to perform physical examination, difficulty estimating how the patient is doing and difficulty in reaching patients. During the COVID-19 epidemic, care for patients with RMDs in the Netherlands continued uninterrupted by the aid of telemedicine. On average, respondents were content with current solutions, although some felt insecure mainly because of the inability to perform physical examination and missing nonverbal communication with their patients. Supplementary Information The online version contains supplementary material available at 10.1007/s00296-020-04771-6.

Background Patients with ankylosing spondylitis (AS) are at increased risk of depression. This increased risk has been hypothesized to be solely secondary due to AS-related symptoms, or additionally due to a common inflammatory pathway. From a clinical perspective, it is important to know whether treatment with tumor necrosis factor alpha inhibitors reduces depressive symptoms, while from a pathophysiological point of view, it would be insightful to understand whether such an effect would be a direct result of reduced inflammation, the result of reduced AS-related symptoms, or both. The objective of this study was to evaluate the effect of infliximab on depressive symptoms in patients with AS in a randomized-controlled trial setting. Methods Data were retrieved from a subgroup of patients from the AS Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT). Patients were randomly allocated to infliximab (n = 16) or placebo (n = 7) until week 24, after which all received infliximab until week 54. Associations between treatment group and depressive symptoms, measured with the Center for Epidemiological Studies Depression scale (CES-D, range 0–60 (best-worst)) at baseline and over time, were explored with generalized estimating equations (GEE). Results Mean CES-D score at baseline was 15.5 (SD 9.3) in the infliximab group and 17.3 (SD 5.7) in the placebo group. Twelve patients (52%) had a CES-D score > 16, suggestive for clinical depression. After 24 weeks, mean CES-D had decreased to 9.5 (SD 11.4) in the infliximab group, but was 18.0 (SD 6.9) in the placebo group. GEE revealed larger improvements in depressive symptoms (B = − 6.63, 95%CI − 13.35 to 0.09) and odds of possible depression (OR = 0.02, 95%CI 0.00 to 0.72) in the infliximab group, compared to the placebo group. Both associations largely disappeared when adjusted for self-reported disease activity and/or physical function. Additional adjustment for C-reactive protein (CRP) did not change results. Conclusions Depressive symptoms are common in patients with AS and active disease. Infliximab improves these depressive symptoms in AS when compared to placebo by improving disease symptoms. We did not find an indication for a direct link between CRP-mediated inflammation and depressive symptoms. Trial registration Trial registration (ASSERT): NCT00207701. Registered on September 21, 2005 (retrospectively registered).

Objective To confirm validity of the Self-administered Comorbidity Questionnaire modified for patients with SpA (mSCQ), and assess whether validity improves when adding items on extra-articular manifestations (EAMs), i.e. uveitis, psoriasis, and IBD, and osteoporosis and fractures. Methods Data from the Assessment in SpondyloArthritis international Society COMOrbidities in SPondyloArthritis study were used. Criterion validity of presence of EAMs, osteoporosis and fractures was assessed as agreement (kappa) between patients’ self-reported and physician-confirmed disease. Construct validity of the mSCQ including EAMs, osteoporosis and/or fractures (SpA-SCQ) was assessed by testing hypotheses about correlations with demographics, physical function, work ability, health utility and disease activity, and was compared with construct validity of the rheumatic disease comorbidity index. Results In total, 3984 patients contributed to the analyses. Agreement between patient-reported and physician-reported EAMs was substantial to almost perfect (uveitis ĸ = 0.81, IBD ĸ = 0.73, psoriasis ĸ = 0.86). Agreement for osteoporosis (ĸ = 0.38) and fractures (ĸ = 0.39) was fair. As hypothesized, the mSCQ correlated moderately to weakly with age, physical function, work limitations and health utility, and very weakly with disease activity. In contrast to our hypothesis, adding EAMs, osteoporosis and/or fractures to the mSCQ decreased correlations with several external constructs, especially among patients with peripheral SpA. Correlations with the different constructs were stronger for the both mSCQ and SpA-SCQ (rBASFI = 0.34; rEQ-5D = −0.33) compared with the rheumatic disease comorbidity index (rBASFI = 0.24; rEQ-5D = −0.21). Conclusion The mSCQ is a valid self-report instrument to assess the influence of comorbidities on health outcomes in patients with SpA. Adding EAMs and/or osteoporosis or fractures does not improve validity of the mSCQ.

BACKGROUND & AIMS: Telemedicine can be used to monitor determinants and outcomes of patients with chronic diseases, possibly increasing the quality and value of care. Telemedicine was found to reduce outpatient visits and hospital admissions for patients with inflammatory bowel diseases (IBD). We performed a full economic evaluation of telemedicine interventions in patients with IBD, comparing the cost-utility of telemedicine vs standard care.METHODS: We performed a randomized trial of 909 patients with IBD at 2 academic and 2 non-academic hospitals in The Netherlands. Patients were randomly assigned to groups that received telemedicine (myIBDcoach; n = 465) or standard outpatient care (n = 444) and followed for 12 months. Costs were measured from a societal perspective. Direct healthcare costs were based on actual resource use. Indirect costs comprised self-reported hours sick leave from work, intervention costs (annual license fee of €40 per patient [$45]), and utility costs (assessed using EQ5D). Cost-utility and uncertainty were estimated using the non-parametric bootstrapping method.RESULTS: Telemedicine resulted in lower mean annual costs of €547/patient [$612] (95% CI, €1029-2143 [$1150-2393]; mean costs of €9481 [$10,587] for standard care and €8924 [$9965] for telemedicine) without changing quality adjusted life years. At the Dutch threshold of €80,000 [$89,335] per quality adjusted life year, the intervention had increased incremental cost-effectiveness over standard care in 83% of replications and an incremental net monetary benefit of €707/patient [$790] (95% CI, €1241-2544 [$1386-2841]).CONCLUSIONS: Telemedicine with myIBDcoach is cost saving and has a high probability of being cost effective for patients with IBD. This self-management tool enables continuous registration of quality indicators and (patient-reported) outcomes and might help reorganize IBD care toward value-based healthcare. ClinicalTrials.gov no: NCT02173002.

Psoriatic arthritis (PsA) is a chronic, inflammatory disease. The effects of PsA real-world treatment patterns on patient-reported outcomes in the US and 5 European countries (EU5; France, Germany, Italy, Spain, UK) were evaluated. Respondents from the 2016 National Health and Wellness Survey received advanced therapies (e.g., biologic disease-modifying antirheumatic drugs [DMARDs]), other therapies, (e.g., conventional synthetic DMARDs), or no treatment. Assessments included demographics, disease severity (patient-reported), comorbidities (Charlson Comorbidity Index), health status (Short Form-36 Health Survey), depression (Patient Health Questionnaire-9), work productivity (Work Productivity and Activity Index), and treatment adherence (Morisky Medication Adherence Scale-8). Overall, 1037 respondents from the US and 947 respondents from the EU5 were included. Of these, 21.7% US and 7.3% EU5 respondents received advanced therapies; 16.6% and 28.5%, other therapies; and 61.7% and 64.2%, no treatment, respectively. During treatment with advanced or other therapies, 40.8–54.7% US and 57.7–58.9% EU5 respondents self-reported moderate or severe PsA. Respondents receiving advanced therapies had the highest Charlson Comorbidity Index score (US, 1.25; EU5, 1.42); the lowest scores were with no treatment (0.52 and 0.49, respectively). Employment was lowest with other therapies (US, 47.7%; EU5, 41.1%). Overall work impairment was reported by 57.9% US and 62.6% EU5 respondents receiving advanced therapies. Medication adherence was generally low in the US and medium in the EU5 (Morisky Medication Adherence Scale-8: low, US 40.1–46.7%, EU5, 29.0–35.2%; medium, US 29.3–36.1%, EU5 37.8–49.3%; high, US 23.8–24.0%; EU5, 21.7–27.0%). Advanced and other therapies reduced PsA severity; however, > 40% of respondents reported moderate or severe PsA during treatment. Better management and adherence may reduce unmet need and disease burden. Further work is required to improve PsA diagnosis and time to treatment initiation. Electronic supplementary material The online version of this article (10.1007/s00296-018-4195-x) contains supplementary material, which is available to authorized users.

ObjectivesThe Assessment of SpondyloArthritis International Society (ASAS) aimed to develop a set of quality standards (QS) to help improve the quality of healthcare provided to adult patients affected by axial spondyloarthritis (axSpA) worldwide.MethodsAn ASAS task force developed a set of QS using a stepwise approach. First, key areas for quality improvement were identified, discussed, rated and agreed on. Thereafter, areas were prioritised and statements for the most important key areas were phrased on consensus. Appropriate quality measures were defined to allow quantification of the QS at the community level.ResultsThe ASAS task force, consisting of 20 rheumatologists, two physiotherapists and two patients, selected and proposed 34 potential key areas for quality improvement which were then commented by 140 ASAS members and patients. Within that process three new key areas came up, which led to a re-evaluation of all 37 key areas by 120 ASAS members and patients. Five key areas were identified as most important to determine quality of care: referral including rapid access, rheumatology assessment, treatment, education/self-management and comorbidities. Finally, nine QS were agreed on and endorsed by the whole ASAS membership.ConclusionsASAS successfully developed the first set of QS to help improving healthcare for adult patients with axSpA. Even though it may currently not be realistic to achieve the QS in all healthcare systems, they provide high-quality of care framework for patients with axSpA that should be aimed for.

Background and Aims: Patient-reported outcome measures [PROMs] assessing inflammatory bowel disease [IBD] activity are of interest for monitoring in clinical practice, telemedicine systems, or trials. Different PROMs for follow-up of disease activity are available; however, none was developed with endoscopy as gold standard. The objective of this study was to develop and validate a PROM to predict endoscopic disease activity, following the recommendations of the Food and Drug Administration.Methods: During development, 178 IBD patients undergoing a colonoscopy were asked to fill out 13 clinical questions derived from the literature. During endoscopy, inflammation was assessed with the simplified endoscopic score for Crohn's disease [CD] and the Mayo endoscopic subscore for ulcerative colitis [UC]. Based on correlation with endoscopic inflammation, questions were reduced to a total of six for CD and five for UC. The newly developed Monitor IBD At Home questionnaire [MIAH] was validated in an independent cohort of 135 CD and 131 UC patients. Additionally, diagnostic accuracy of the MIAH combined with a calprotectin home test [CHT] was assessed.Results: The MIAH-CD includes questions on rectal bleeding, mucus, stool frequency, urgency, fatigue, and patient-reported disease activity. The MIAH-UC contains items on rectal bleeding, stool frequency, urgency, abdominal pain, and patient-reported disease activity. Both questionnaires showed to be valid, reliable, and responsive to changes. The MIAH and CHT combined had a sensitivity, specificity, negative predictive value [NPV], and positive predicitive value [PPV] of 96.7%, 66.7%, 94.7%, and 76.3% for CD and of 88.2%, 81.4%, 95.6%, and 60.0% for UC, respectively, compared with endoscopy.Conclusions: The MIAH is the first PROM developed to predict endoscopic inflammation in IBD patients. A combination of this questionnaire and a CHT shows excellent diagnostic accuracy to screen for patients who need further assessment of disease activity, and can be used in daily practice, telemedicine systems, and trials.

Objective. Patients' experience of overall health is often assessed through a single-item global question. Here, we evaluated among patients with AS and population controls whether single-item questions on the constructs health, wellbeing and quality of life (QoL) are interchangeable. Methods. In a mixed quantitative and qualitative approach, all subjects scored the three single-item globals on a numeric rating scale (0-10, best). Next, they indicated for each of the questions which aspects they had been considering when scoring. After forced reflection, globals were scored again. Dissimilarities in scores among constructs, between patients and controls, and before or after reflection were tested using mixed linear models. Themes identified per construct in the qualitative part were linked to the International Classification of Functioning, Disability and Health. The type of themes per construct was compared between patients and controls. Results. Sixty-eight AS patients and 84 controls completed the questionnaire. Patients scored significantly worse on each global than controls (mean 6.1-6.3 vs 7.2-7.6, all P< 0.01). Within groups, however, no significant differences in scores on each construct, or in scores before or after forced reflection were found. Health-related themes were relevant to each construct for patients, but were less relevant for controls when considering well-being and QoL. Emotional functions were relevant to well-being in all participants. Social roles and financial situation were more frequently related to well-being and QoL in controls. Conclusion. While patients and controls identified content-related dissimilarities between the three constructs studied, this was not reflected in different scores of the globals.

ObjectivesTo evaluate construct validity, interpretability, reliability and responsiveness as well as determination of cut-off points for good and poor health within the original English version and the 18 translations of the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI) in 23 countries worldwide in patients with spondyloarthritis (SpA).MethodsA representative sample of patients with SpA fulfilling the ASAS classification criteria for axial (axSpA) or peripheral SpA was used. The construct validity of the ASAS HI was tested using Spearman correlation with several standard health outcomes for axSpA. Test–retest reliability was assessed by intraclass correlation coefficients (ICCs) in patients with stable disease (interval 4–7 days). In patients who required an escalation of therapy because of high disease activity, responsiveness was tested after 2–24weeks using standardised response mean (SRM).ResultsAmong the 1548 patients, 64.9% were men, with a mean (SD) age 42.0 (13.4) years. Construct validity ranged from low (age: 0.10) to high (Bath AnkylosingSpondylitisFunctioning Index: 0.71). Internal consistency was high (Cronbach’s α of 0.93). The reliability among 578 patients was good (ICC=0.87 (95% CI 0.84 to 0.89)). Responsiveness among 246 patients was moderate-large (SRM=−0.44 for non-steroidal anti-inflammatory drugs, −0.69 for conventional synthetic disease-modifying antirheumatic drug and −0.85 for tumour necrosis factor inhibitor). The smallest detectable change was 3.0. Values ≤5.0 have balanced specificity to distinguish good health as opposed to moderate health, and values ≥12.0 are specific to represent poor health as opposed to moderate health.ConclusionsThe ASAS HI proved to be valid, reliable and responsive. It can be used to evaluate the impact of SpA and its treatment on functioning and health. Furthermore, comparison of disease impact between populations is possible.

Small cortical interruptions may be the first sign of an erosion, and more interruptions can be found in patients with rheumatoid arthritis (RA) compared with healthy subjects. First, we compared the number and size of interruptions in patients with RA with healthy subjects using high-resolution peripheral quantitative CT (HR-pQCT). Second, we investigated the association between structural damage and inflammatory markers on conventional radiography (CR) and MRI with interruptions on HR-pQCT. Third, the added value of HR-pQCT over CR and MRI was investigated. The finger joints of 39 patients with RA and 38 healthy subjects were examined through CR, MRI, and HR-pQCT. CRs were scored using the Sharp/Van der Heijde method. MRI images were analyzed for the presence of erosions, bone marrow edema, and synovitis. HR-pQCT images were analyzed for the number, surface area, and volume of interruptions using a semiautomated algorithm. Descriptives were calculated and associations were tested using generalized estimating equations. Significantly more interruptions and both a larger surface area and the volume of interruptions were detected in the metacarpophalangeal joints of patients with RA compared with healthy subjects (median, 2.0, 1.42 mm2 , and 0.48 mm3 versus 1.0, 0.69 mm2 , and 0.23 mm3 , respectively; all p

Background and aim Biologicals are potent drugs for immune mediated inflammatory diseases (IMIDs). After discontinuation or switch of therapy, many patients have unused biological injectors left. We aimed to evaluate potential redistribution of unused injectors to prevent spillage of these costly drugs by assessing 1) the quality of transport and home storage through the proportion of injectors stored within the recommended temperature range (2°C-8°C) and 2) acceptance of redistribution by patients. Methods All golimumab users, irrespective of the indication, at Maastricht University Medical Center were eligible for inclusion. Patients received golimumab in a sealed bag containing a validated temperature sensor, measuring temperature every 5 minutes. Patients were asked to store their medication as usual. Deviations from the recommended range were defined as any duration below 0°C and >30 minutes below 2°C or above 8°C. After 3 months, patients completed a questionnaire on their opinion towards potential redistribution of unused biologicals. Results Fifty patients (42.0% male, mean age 53.2±14.3 years) received 276 injectors. The mean storage time was 30.9±33.1 days. Only 11.6% of the injectors were stored within the recommended temperature range. In addition, 11.2% were stored >30 minutes below 0°C and 33.2% were stored > 1 week above 8°C. Of all patients, 95% would accept redistributed medication when product quality is ensured. conclusions During transport and home-storage, only one in eight biological injectors was stored within the recommended temperature range. This hinders redistribution of unused injectors, but also raises concern regarding drug effectiveness in IMID-patients.

BACKGROUND: Tight and personalised control of inflammatory bowel disease in a traditional setting is challenging because of the disease complexity, high pressure on outpatient clinics, and rising incidence. We compared the effects of self-management with a telemedicine system, which was developed for all subtypes of inflammatory bowel disease, on health-care utilisation and patient-reported quality of care versus standard care.METHODS: We did this pragmatic, randomised trial in two academic and two non-academic hospitals in the Netherlands. Outpatients aged 18-75 years with inflammatory bowel disease and without an ileoanal or ileorectal pouch anastomosis, who had internet access and Dutch proficiency, were randomly assigned (1:1) to care via a telemedicine system (myIBDcoach) that monitors and registers disease activity or standard care and followed up for 12 months. Randomisation was done with a computer-generated sequence and used the minimisation method. Participants, health-care providers, and staff who assessed outcome measures were not masked to treatment allocation. Primary outcomes were the number of outpatient visits and patient-reported quality of care (assessed by visual analogue scale score 0-10). Safety endpoints were the numbers of flares, corticosteroid courses, hospital admissions, emergency visits, and surgeries. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02173002.FINDINGS: Between Sept 9, 2014, and May 18, 2015, 909 patients were randomly assigned to telemedicine (n=465) or standard care (n=444). At 12 months, the mean number of outpatient visits to the gastroenterologist or nurse was significantly lower in the telemedicine group (1·55 [SD 1·50]) than in the standard care group (2·34 [1·64]; difference -0·79 [95% CI -0·98 to -0·59]; pINTERPRETATION: Telemedicine was safe and reduced outpatient visits and hospital admissions compared with standard care. This self-management tool might be useful for reorganising care of inflammatory bowel disease towards personalised and value-based health care.FUNDING: Maastricht University Medical Centre and Ferring.

BackgroundWomen with chronic inflammatory diseases face uncertainty regarding the safety of biologics during breast feeding. CRADLE was the first industry-sponsored study to evaluate certolizumab pegol (CZP) concentrations in human breast milk and estimate average daily infant dose (ADID) of maternal CZP.MethodsCRADLE (NCT02154425) was a pharmacokinetic study of lactating mothers receiving CZP. After ≥3 CZP doses, breast milk samples were collected across one dosing period (14 days for 200 mg every 2 weeks [Q2W]; 28 days for 400 mg every 4 weeks [Q4W]). Optimal analytical methods were developed to determine CZP and polyethylene glycol (PEG) levels in breast milk. ADID and relative infant dose (RID) were estimated. Safety events in mothers and infants were assessed.Results19 CZP-treated mothers were screened; 17 entered the sampling period: 16 on 200 mg Q2W, 1 on 400 mg Q4W. 77/137 (56%) breast milk samples had no measurable CZP. For 4/17 mothers, all samples were below the lower limit of quantification (LLOQ). Estimated ADID was 0–0.0104 mg/kg/day; median RID: 0.15%. PEG was undetectable in 134/137 samples (results could not be determined in three samples). Infants of CZP-exposed mothers had a safety profile consistent with that of unexposed similar-age infants.ConclusionWhen quantifiable, CZP concentrations were Trial registration numberNCT02154425; Results.

To update the European League Against Rheumatism (EULAR) recommendations for the role of the nurse in the management of chronic inflammatory arthritis (CIA) using the most up to date evidence. The EULAR standardised operating procedures were followed. A task force of rheumatologists, health professionals and patients, representing 17 European countries updated the recommendations, based on a systematic literature review and expert consensus. Higher level of evidence and new insights into nursing care for patients with CIA were added to the recommendation. Level of agreement was obtained by email voting. The search identified 2609 records, of which 51 (41 papers, 10 abstracts), mostly on rheumatoid arthritis, were included. Based on consensus, the task force formulated three overarching principles and eight recommendations. One recommendation remained unchanged, six were reworded, two were merged and one was reformulated as an overarching principle. Two additional overarching principles were formulated. The overarching principles emphasise the nurse’s role as part of a healthcare team, describe the importance of providing evidence-based care and endorse shared decision-making in the nursing consultation with the patient. The recommendations cover the contribution of rheumatology nursing in needs-based patient education, satisfaction with care, timely access to care, disease management, efficiency of care, psychosocial support and the promotion of self-management. The level of agreement among task force members was high (mean 9.7, range 9.6-10.0). The updated recommendations encompass three overarching principles and eight evidence-based and expert opinion-based recommendations for the role of the nurse in the management of CIA.

Objectives To test the psychometric properties of the United Kingdom’s Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure (CQRA-PREM) in patients with spondyloarthritis (SpA) and rheumatoid arthritis (RA) and to implement this questionnaire in daily practice in the Netherlands. Methods After a forward-backward translation procedure into Dutch, the CQRA-PREM was tested into two quality registries in daily practice. Face validity was assessed with focus group interviews. Feasibility was evaluated through completion times and interpretability of domain scores through floor and ceiling effects. Internal consistency (Cronbach’s α coefficients) and homogeneity (corrected item-total correlations) were determined. Divergent validity was assessed by Spearman’s rank correlation coefficients (rs) between the average scores of domains and outcome measures. The CQRA-PREM was implemented in daily practice, and the results were used in quality improvement cycles. Results Face validity of the CQRA-PREM was good. The CQRA-PREM was completed by 282 patients with SpA and 376 with RA. Median time to complete the CQRA-PREM was 4.7 min. Ceiling effects were found in three out of seven domains. Internal consistency of nearly all domains was considered good (0.65 ≤ α ≤ 0.95). Thresholds for homogeneity were exceeded within three domains (rp > 0.7), suggesting item redundancy. Divergent validity showed that nearly all domains of the CQRA-PREM were at most weakly correlated with outcomes measures (− 0.3 ≤ rs ≤ 0.3). The CQRA-PREM could identify areas of improvement for providing patient-centered care. Conclusion The CQRA-PREM has acceptable psychometric properties and has shown to be a useful tool in evaluating quality of care from the patients’ perspective in the Netherlands. Trial registration SpA-Net is registered in the Netherlands Trial Registry (NTR6740). Key Points • The Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure (CQRA-PREM) is a valid measure for assessing patient-centeredness of rheumatology care. • The Dutch version of the CQRA-PREM shows acceptable psychometric properties. • The CQRA-PREM shows to be a useful tool in Plan-Do-Check-Act quality improvement cycles in the Netherlands. • The CQRA-PREM can be used for benchmarking and quality improvement of rheumatology services.

BackgroundPatients with spondyloarthritis with radiographic sacroiliitis are traditionally classified according to the modified New York (mNY) criteria as ankylosing spondylitis (AS) and more recently according to the Assessment of SpondyloArthritis international Society (ASAS) criteria as radiographic axial spondyloarthritis (r-axSpA).ObjectiveTo investigate the agreement between the mNY criteria for AS and the ASAS criteria for r-axSpA and reasons for disagreement.MethodsPatients with back pain ≥3 months diagnosed as axSpA with radiographic sacroiliitis (mNY radiographic criterion) were selected from eight cohorts (ASAS, Esperanza, GESPIC, OASIS, Reuma.pt, SCQM, SPACE, UCSF). Subsequently, we calculated the percentage of patients who fulfilled the ASAS r-axSpA criteria within the group of patients who fulfilled the mNY criteria and vice versa in six cohorts with complete information.ResultsOf the 3882 patients fulfilling the mNY criteria, 93% also fulfilled the ASAS r-axSpA criteria. Inversely, of the 3434 patients fulfilling the ASAS r-axSpA criteria, 96% also fulfilled the mNY criteria. The main cause for discrepancy between the two criteria sets was the reported age at onset of back pain.ConclusionAlmost all patients with axSpA with radiographic sacroiliitis fulfil both ASAS and mNY criteria, which supports the interchangeable use of the terms AS and r-axSpA.

Background: Diagnosis in axial spondyloarthritis (axSpA) is challenging and often delayed by several years, resulting in a delay in treatment. Previously we reported presence of spondyloarthritis (SpA) features and imaging abnormalities in first-degree relatives (FDRs) of HLA-B27 axSpA patients, who are at risk of developing axSpA [1]. Follow up of these at risk individuals could help to identify clinical signs, imaging abnormalities or biomarkers that are predictive of development of axSpA. Objectives: To investigate imaging, biologic and/or clinical signs of SpA at baseline and after 1 year follow up, as well as development of clinicallly manifest axSpA after 1 year follow up in at risk individuals. Methods: The Pre-SpA cohort[1] is a prospective inception cohort in which FDRs of HLA-B27 positive axSpA patients are included and followed for 5 years. The main exclusion criteria were: a diagnosis of SpA at baseline and back pain with a previous non-rheumatic diagnosis, such as spinal disc herniation. Clinical and biologic characteristics were collected at baseline and after 1 year. Imaging was performed at baseline including MRI of the sacroiliac joints (SIJ) and X-rays of the cervical and lumbar spine and SIJ. MRIs were scored according to the ASAS definition for a positive MRI by two readers. X-rays were scored according to the modified New York (mNY) criteria for ankylosing spondylitis by two readers. Results: In the current study we report the characteristics of 201 participants at baseline and 123 participants after one year of follow-up. 126(62.7%) participants reported back pain, of which 39(19.4%) fulfilled criteria for inflammatory back pain. Median [IQR] VAS total back pain (0-100mm) was 11 (0-28). Six (2.9%) were previously diagnosed with arthritis by a physician, nine(4.4%) with enthesitis and one(0.5%) with dactylitis. In none of these participants a diagnosis of SpA was made. Seven participants were previously diagnosed with an extra-articular manifestation possibly related to SpA: four with psoriasis and three with anterior uveitis. Three (1.5%) participants fulfilled the mNY criteria for sacroiliitis on radiography. Ten (5%) participants had bone marrow edema on MRI of the SIJ suggestive of SpA. Fifty-six (27.8%) participants would have fulfilled ASAS classification criteria for axSpA if they would have had a clinical diagnosis of axSpA. After one year patient-reported disease activity variables remained stable; median [IQR] VAS total back pain (0-100mm) was still low: 4[0-24]. During one year of follow-up, in total seven participants developed symptoms and were clinically diagnosed with axSpA. Conclusion: Imaging signs and clinical signs of SpA are present in a substantial proportion of seemingly healthy FDRs of HLA-B27 positive AxSpA patients. Twelve (6.0%) participants had imaging suggestive of SpA, but a clinical diagnosis of axSpA was still rare after one year of follow up (5.7%). Future follow-up will increase numbers of individuals diagnosed with axSpA and help us identify early symptoms and signs of SpA in this at risk population. Reference [1] Turina MC, et al., Arthritis Rheumatol. 2016Oct;68(10):2444-55 Acknowledgement: The Pre-SpA cohort is supported by a Dutch Arthritis Society grant Disclosure of Interests: Henriette de Jong: None declared, Janneke de Winter: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Dirkjan van Schaardenburg: None declared, Floris A. van Gaalen: None declared, Astrid van Tubergen: None declared, Angelique Weel: None declared, Robert B.M. Landewe: None declared, Dominique Baeten Employee of: UCB Pharma, Marleen van de Sande Grant/research support from: Research support from Janssen, Novartis, Eli Lily, Consultant for: Received consultation fees from Abbvie and Novartis

Background The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a widely used composite measure of disease activity in axial spondyloarthritis (axSpA). Such a tool is lacking for peripheral SpA (pSpA). However, the ASDAS also assesses peripheral joint symptoms. Previously, trial data have shown that the ASDAS has high sensitivity to change and high discriminatory ability between disease states in pSpA (1). We hypothesized that the ASDAS can be used to measure disease activity in all patients with pSpA in clinical practice. Objectives To investigate the construct validity of the ASDAS in pSpA in comparison with axSpA in clinical practice. Methods Data from a registry for SpA in the Netherlands (SpA-Net) were used. Construct validity of the ASDAS was assessed by testing hypotheses about Spearman correlations with other outcomes measures including individual components of disease activity, physical functioning and health-related quality of life (HRQoL). Construct validity was also assessed by stratifying patients according to ASDAS cut-offs to compare means of different health outcomes across ASDAS states by one-way ANOVA analyses. All analyses were repeated after stratification for the presence/absence of psoriasis in pSpA. Results were compared to the performance of the ASDAS in axSpA. Results In total, 194 patients with pSpA and 222 patients with axSpA were included. Poor to high correlation was found between ASDAS and measures of disease activity (rs0.20 to 0.78), a moderate correlation was found between ASDAS and measures of physical functioning (rs0.61 to 0.64) and a poor to moderate correlation was found between ASDAS and measures of HRQoL in pSpA (rs-0.27 to -0.66) (table 1). With increasing ASDAS states, significantly worse scores were found on (other) measures of disease activity, physical functioning and HRQoL in pSpA (table 2). Stratification for the presence/absence of psoriasis showed similar results (data not shown). All results for pSpA were comparable to axSpA (see for example Table 1). Conclusion The ASDAS demonstrated similar construct validity in all patients with pSpA and axSpA in clinical practice. Therefore, the ASDAS can also be used to measure disease activity in pSpA in daily practice. Reference [1] Turina MC, et al. A psychometric analysis of outcome measures in peripheral spondyloarthritis. ARD 2016;75:1302-7. Disclosure of Interests None declared

Background: There is wide variation in the management of patients with axial spondyloarthritis (axSpA) worldwide with significant unmet needs such as delayed diagnosis. A major goal of the international organization Assessment of SpondyloArthritis international Society (ASAS) is to improve quality of care and health outcomes in axSpA. One way to achieve this is to define quality standards (QS) in order to identify resources and processes which may need to be optimized. Such standards must be specific, measurable, aspirational and achievable in daily care. Objectives: To develop ASAS QS to ultimately improve the quality of care for adults with axSpA. Methods: The ASAS QS group, established in 2015, developed a step-wise approach starting with (I) an overview and open discussions resulting in a proposal for possible key areas for quality improvement. Thereafter, (II) ASAS members and invited patients discussed and commented on a provisional list via a web-based survey with the possibility to propose additional key areas for quality improvement. (III) The complete list was then evaluated by ASAS members and invited patients. (IV) Then, the ASAS QS group prioritized key areas for which quality statements and measures are to be developed, and (V) phrased QS for the most important key areas. Finally (VI), a draft version was commented on, discussed and finally agreed by the ASAS members at the Annual ASAS Meeting 2019. Results: The ASAS QS group, consisting of 20 rheumatologists, 2 physiotherapists and 2 patients, provided 34 potentially key areas for quality improvement which were commented by 140 participants (86 physicians, 42 patients). Within that process 3 new key areas were proposed and all 37 key areas for improvement were again evaluated by 120 participants (86 physicians, 29 patients). Five key areas were identified to be most important to phrase QS: referral, rheumatologic assessment, treatment, education/self-management and comorbidities. Altogether, 9 QS, each accompanied by a rationale and a measure (figure), were endorsed by ASAS. Conclusion: ASAS successfully developed the first QS set for improvement of health care provided for adults with axSpA. All QS are achievable in daily care in an optimized situation and intend to minimize variation in quality of care. It is emphasized that ASAS is well aware that all QS are ideal visions of an optimal care which may currently not be realistic in many countries. Disclouser of Interest: Uta Kiltz Grant/research support from: AbbVie, Chugai, Eli Lilly, Grunenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., Consultant for: AbbVie, Chugai, Eli Lilly, Grunenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., Robert B.M. Landewe: None declared, Desiree van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, Union Chimique Belge, Martin Rudwaleit Consultant for: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Consultant for: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, maxime dougados Grant/research support from: Eli Lilly and Company, Pfizer, AbbVie, and UCB Pharma, Consultant for: Eli Lilly and Company, Pfizer, AbbVie, and UCB Pharma, Nurullah Akkoc: None declared, Annelies Boonen: None declared, Jan Brandt-Juergens: None declared, Philippe Caroon: None declared, Laure Gossec Grant/research support from: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Sanofi, and UCB, Consultant for: AbbVie, Biogen, BMS, Celgene, Janssen, Lilly, MSD, Nordic Pharma, Novartis-Sandoz, Pfizer, Roche, Sanofi, and UCB, Consultant for: L Gossec has received honoraria from Celgene as investigator for this study, Merryn Jongkees: None declared, Pedro Machado Consultant for: Abbvie, BMS, Celgene, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: Abbvie, BMS, Celgene, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Helena Marzo-Ortega Grant/research support from: Janssen, Novartis and Pfizer, Consultant for: AbbVie, Celgene, Janssen, Eli-Lilly, Novartis and UCB, Speakers bureau: AbbVie, Celgene, Janssen, Eli-Lilly, Novartis and UCB, Anna Molto: None declared, Victoria Navarro-Compan: None declared, Karin Niedermann Schneider: None declared, Percival D. Sampaio-Barros: None declared, Gleb Slobodin: None declared, Filip van den Bosch Consultant for: AbbVie, BMS, Galapagos, Janssen, Lilly, Merck, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, BMS, Janssen, Lilly, Merck, Novartis, Pfizer and UCB., Astrid van Tubergen: None declared, Salima van Weely: None declared, Michael Weisman: None declared, Dieter Wiek: None declared, Juergen Braun Shareholder of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Grant/research support from: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Grant/research support from: Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB, Consultant for: Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB, Consultant for: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Speakers bureau: Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB

Background: Numerous biological DMARDs (bDMARDs) are used in RA treatment, however detailed knowledge of patients’ perceptions on drug use and the impact of adverse drug reactions (ADRs) is sparse. Objectives: To gain insight into bDMARD-induced ADRs and their burden from the RA patients’ perspective. Methods: The Dutch Biologic Monitor is an ADR-patient web-based questionnaire used for a prospective, multicentre, event monitoring cohort study including patients using a bDMARD for an immune-mediated inflammatory disease between January 1, 2017 and December 31, 2018. Patients were asked to complete questionnaires bi-monthly about used bDMARDs, indication and bDMARD-induced ADRs. ADRs were coded according to MedDRA terminology and their impact was measured on a 5-point scale, ranging from 1 (no burden) to 5 (very high burden). Per patient, every recurrent unique ADR was included as one ADR. ADRs regarding infections (INF), skin (SK), gastrointestinal (GI) and injection site (INJ) were clustered and analysed for the reported prevalence and burden. Fatigue and headache were separately analysed for prevalence and burden. The prevalence of clustered ADRs between the various bDMARDs was compared using a χ2-test and the average burden was compared using a Mann-Whitney U test. Results: In the Dutch Biologic Monitor 583 consecutive (44.8%) RA patients were included (71.2% female, average age 59 years, SD±12.4) using the originator or a biosimilar of etanercept (ETN, 265), adalimumab (ADA, 196), tocilizumab (41), abatacept (35), certolizumab pegol (23), rituximab (19), infliximab (18), golimumab (15), sarilumab (2), secukinumab (1), anakinra (1). Almost half of the patients (276; 47.3%) reported at least one bDMARD-induced ADR with a total of 703 ADRs in 2,559 completed questionnaires. Patients reported 129 INJ reactions (129 ADRs/583 pts, prevalence of 22.1%, reported by 86 pts) with an average burden of 1.7 (SD±0.8), 57 GI reactions (9.8%, 41 pts) with an average burden of 2.9 (SD±1.1), 102 SK reactions (17.5%, 64 pts) with an average burden of 2.9 (SD±1.1) and 109 INFs (18.7%, 79 pts) with an average burden of 3.3 (SD±1.0). Prevalence of INJ and GI reactions was significantly higher among ETN users than among ADA users (INJ: 76 ADRs/265 ETN users (28.7%) vs 30 ADRs/196 ADA users (15.3%), P=0.007; GI: 30/265 (11.3%) vs 9/196 (4.6%), P=0.01). The prevalence of INFs and SK reactions did not differ. The perceived burden of GI reactions was higher for ETN than for ADA users (3.1 ±1.0 vs 2.0 ±0.7, p=0.006) but did not differ for other clustered ADRs. The number of patients using other bDMARDs was too low for further analysis. Prevalence of bDMARD-induced headache was 1.9% (12 ADRs/583 pts) with an average burden of 3.4 (SD±0.9). Prevalence of bDMARD-induced fatigue was 4.3% (25 ADRs) with an average burden of 2.7 (SD±1.0). Conclusion: Almost half of the RA patients reported bDMARD-induced ADRs. From the patients’ perspective INJ reactions have the highest prevalence with a relatively low burden, whereas INFs and headache are less prevalent but give the highest burden of the analysed ADRs. Further studies are required to obtain more insight into the perceived differences in ADRs between bDMARDs. Disclosure of Interests: Jette van Lint: None declared, Naomi Jessurun: None declared, Sander W. Tas: None declared, Harald Vonkeman: None declared, Bart van den Bemt Grant/research support from: UCB, Pfizer, Abbvie; Speakers bureau: Pfizer, AbbVie, UCB, Biogen, Sandoz, Consultant for: UCB, Novartis and Pfizer, Astrid van Tubergen: None declared, Michael Nurmohamed Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi and UCB, Consultant for: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi and UCB, Eugene van Puijenbroek: None declared

Objective To summarize the prevalence of spondyloarthritis (SpA) and its subtypes in the general population, and to identify demographic and methodologic characteristics that might explain heterogeneity in prevalence estimates. Methods A systematic literature search was performed to identify relevant articles. Risk of bias was assessed and data were extracted. Pooled prevalences were calculated. Potential sources of heterogeneity were explored by subgroup analysis and meta-regression analysis. Results The prevalence of SpA ranged from 0.20% (95% confidence interval [95% CI] 0.00–0.66) in South-East Asia to 1.61% (95% CI 1.27–2.00) in Northern Arctic communities; the prevalence of ankylosing spondylitis (AS) from 0.02% (95% CI 0.00–0.21) in Sub-Saharan Africa to 0.35% (95% CI 0.24–0.48) in Northern Arctic communities; and the prevalence of psoriatic arthritis (PsA) from 0.01% (95% CI 0.00–0.17) in the Middle East to 0.19% (95% CI 0.16–0.32) in Europe. The following characteristics were significantly associated with variation in prevalence of SpA, AS, and/or PsA: proportion of females, mean age of the sample, geographic area and setting (demographic characteristics), year of data collection, case finding, and case ascertainment (methodologic characteristics). For the other SpA subgroups, too few studies were available to conduct a meta-analysis, but prevalence estimates of reactive arthritis (range 0.0–0.2%), SpA related to inflammatory bowel disease (range 0.0–0.1%), and undifferentiated SpA (range 0.0–0.7%) were generally low. Conclusion SpA is a common disease, but with large variation in reported prevalence estimates, which can partly be explained by differences in demographic and methodologic characteristics. Particularly, geographic area as well as case finding account for a substantial part of the heterogeneity.