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Objectives Fatigue is an aspect of psoriatic arthritis (PsA), which is important to patients. The objective was to evaluate magnitude of fatigue in PsA patients and to assess factors that might explain high levels of fatigue. Methods This was an ancillary analysis of a cross-sectional study in 13 countries of unselected PsA patients who fulfilled the CASPAR criteria. Patient-perceived importance of fatigue was assessed through a priority exercise. Levels of fatigue were assessed by a numeric rating scale (range 0–10). Factors potentially associated with fatigue > 5/10: i.e., demographic variables (age, gender, disease duration, education level) and disease related characteristics including joint counts, C-reactive protein, skin psoriasis, axial involvement, enthesitis, dactylitis, structural damage, were assessed by univariate, multivariate logistic and multiple linear regression. Results In all, 246 patients were analysed: mean ± standard deviation age 51.2 ± 13.0 years, mean disease duration 9.9 ± 10.1 years, mean DAS28 3.5 ± 1.3. Fatigue was ranked second in patient-perceived importance, after pain. Magnitude of fatigue was high: mean fatigue 5.0 ± 3.0. Fatigue > 5/10 was well explained (variance explained 73%) by skin psoriasis (odds ratio 4.67 [95% confidence interval 1.05; 20.72]), tender joints (1.30 [1.01; 1.68]) and lower education level (1.09 [1.02; 1.23]). In the multiple linear regression model, fatigue was explained by skin psoriasis, tender joints, enthesitis, female gender, education level. Conclusions Fatigue is a priority for PsA patients. Fatigue levels were high in these patients and fatigue > 5/10 was mainly associated with disease-related factors but also patient-related variables, indicating that the etiology of fatigue in PsA is multifactorial.

Objective Patient global assessment is a key outcome measure in psoriatic arthritis. To explore the meaning of patient global assessment in psoriatic arthritis by examining associations to domains of health assessed by the Psoriatic arthritis impact of disease score. Methods Post-hoc analysis of a multicentre cross-sectional study of patients with psoriatic arthritis. Data collection included patient global assessment, specific joint and skin global patient assessments, Psoriatic arthritis impact of disease questions covering physical (including joints and skin), psychological and social impact, and other comparator outcomes. Univariate analyses (Pearson correlation) and multivariate linear regression were performed to explain patient global assessment and the specific joint and skin global patient assessments. Results Among 223 patients (mean age: 51.0 [standard deviation, ±13.3] years; mean disease duration: 9.9 [±10.1] years; mean swollen joint count: 4.1 [±5.1]; 84.3% with current psoriasis [mainly of less than 5% body surface area]), 50.2% were females. Mean patient global assessment was 4.8 (±2.7), mean joint and skin patient assessments were respectively 5.6 (±2.5) and 4.1 (±3.0). Intraclass correlation between patient global assessment and joint or skin patient assessment was respectively 0.71 (95% confidence interval, 0.64–0.77) and 0.52 (95% confidence interval, 0.42–0.60). In multivariate analyses, patient global assessment was explained (R2 of model: 0.754) by coping (β = 0.287); pain (β = 0.240); work and/or leisure activities (β = 0.141); and anxiety (β = 0.109). Conclusions Patient global assessment in psoriatic arthritis was explained mainly by physical, but also psychological aspects of the disease.

Patients with spondyloarthritis (SpA) constitute a heterogeneous group of rheumatic diseases with a common genetic background such as positive HLA-B27 and specific clinical characteristics such as inflammation and ankylosis of the axial skeleton and peripheral manifestations (arthritis or enthesitis). A close entity is psoriatic arthritis (PsA), a disease where peripheral manifestations and skin psoriasis are the predominant features. The disease course is highly variable and often characterized for axial SpA by inflammatory lesions, which may develop to new bone formation, and in PsA by peripheral arthritis, which may lead to joint erosions. Both diseases are associated with pain, functional disability, restricted mobility, fatigue, and decreased health-related quality of life (HRQoL).

In dieser Ubersicht werden Daten zur Morbiditat und Mortalitat bei Patienten mit Spondyloarthritiden (SpA) prasentiert. Die Gruppe der SpA ist heterogen; die wichtigsten Vertreter sind die ankylosierende Spondylitis (AS) und die Psoriasisarthritis (PsA). Die Morbiditat bei Patienten mit SpA wird im Wesentlichen durch eingeschrankte Funktionsfahigkeit und durch strukturelle Lasionen hervorgerufen. Der Krankheitsverlauf wird bei der AS masgeblich durch Komorbiditaten wie kardiovaskulare Erkrankungen und Wirbelkorperfrakturen beeinflusst, bei der PsA hauptsachlich durch die Mitbeteiligung peripherer Gelenke. Die Mortalitat der Gesamtgruppe der SpA ist nicht beeinflusst; genaue Daten hierzu fehlen jedoch. Bei ungefahr einem Drittel der AS-Patienten kommt es jedoch zu einem schwerwiegenden Verlauf. Bei diesen Patienten wird eine um das 1,5-fach gesteigerte Mortalitat angegeben.

Objectives. The impact of disease on functioning is the essential information for clinicians when reporting on health problems of individuals. The International Classification of Functioning, Disability and Health (ICF) is a comprehensive and universally accepted model to classify and describe functioning, disability and health in a systematic way. The objective of this article is to outline the development and validation of a health index for patients with AS based on the ICF as a use case. Methods. The project is a combined effort of the Assessment of SpondyloArthritis International Society, the ICF Research Branch of the World Health Organization (WHO) Collaboration Centre of the Family of International Classifications and the WHO. There are five steps in the development and validation of the health index for patients with AS: (i) development of an item pool; (ii) identification of candidate items; (iii) item selection; (iv) item reduction; and (v) creation of a final version. Consensus about items that have to be part will be reached in a final consensus conference. Results. During a meeting in February 2009, we coordinated the development process of the health index for patients with AS. The results of this investigation will be the health index for patients with AS. Conclusion. The goal of developing a health index for patients with AS based on the ICF is very much in line with the broader goal of the WHO to define health indices to ensure the comparability of them within the framework of the ICF.

Adult-onset Still’s disease (AOSD) is a rare systemic autoinflammatory disease, the treatment of which is still not well defined. Biological disease modifying antirheumatic drugs (bDMARDs), including interleukin (IL)-1 and IL-6 antagonists are used empirically in patients refractory to conventional DMARDs.1 This 12-week open-label clinical trial with Tadekinig (recombinant IL-18 binding protein, IL-18BP) showed promising results.2 Herein, we report two patients with AOSD treated successfully with Tadekinig during several months. Case 1 . A 50-year-old patient was diagnosed with AOSD in August 2014 when presenting with arthritis, recurrent fever episodes, sore throat and skin rash. C reactive protein (CRP, 22.9 mg/dL) and ferritin (3568 ng/mL) levels were markedly elevated. Since the initial treatment with prednisolone starting with 100 mg/day and oral methotrexate (MTX) 15 mg/week was insufficient, anakinra was started with 100 mg sc/day and MTX dose was augmented to 25 mg sc/week. High disease activity persisted and prednisolone tapering below 15 mg/day was impossible. As a side effect …

Background Imaging has an essential role in the new spondyloarthritis (SpA) classification criteria for axial but not for peripheral manifestations. We evaluated the impact of imaging findings for identification and treatment decisions in patients with peripheral spondyloarthritis (pSpA) and controls (non-SpA). Methods Patients with pSpA (Assessment of SpA international Society criteria, n=30) and non-SpA (n=30), aged

The evidence-based recommendations on the management of ankylosing spondylitis (AS) have enjoyed a high level of acceptance and circulation in Germany, as well as in other European countries. To make patient participation in the decision-making process regarding their disease easier, as well as to strengthen the physician-patient relationship, the ASAS and EULAR have set up an initiative to formulate a patient-friendly version of the recommendations, initially in English. In order that this lay version can also be used in German-speaking countries, a group predominantly comprising patients was formed to ensure that the German translation of this version has the broadest possible basis. In cooperation with the German (DVMB), Austrian (OVMB) and Swiss Morbus Bechterew Associations (SVMB), as well as the German Rheumatology League, patients from Germany, Austria and Switzerland with appropriate English skills were invited to a meeting in 2008. The aim of the translation was to leave the content unchanged while finding a level of speech easily understandable to the lay person. The translated text was considered as accepted when a minimum of 12 patients (>80%) gave their approval on the wording of the translation of individual recommendations in an open vote. The rheumatologist given the function of moderator was not entitled to vote. The level of approval for each recommendation was determined (0: no approval to 10: full approval). The 14 patients were able to translate the English patient version into German. Choice of words and style of speech were discussed intensively. Acceptance of the translation of the 10 recommendations was generally high. The content was clearly accepted with an approval rate of 8.4+/-1.6. This was the first time that patients, in cooperation with rheumatologists, have translated an international patient version on AS management into German under controlled conditions. The translation text was approved by the majority in terms of both form and content. Acceptance and circulation of the German patient version should be evaluated in the near future.

The aim was to investigate the importance of aspects of health for patients with axial SpA (axSpA) and to explore differences across different subgroups.A Best Worst Scaling exercise was conducted in patients with axSpA from 20 countries (10 patients per country) worldwide. Using the 17 items of the Assessment of SpondyloArthritis international Society Health Index, a set of 17 choice tasks was generated. Patients had to indicate in each choice task the most and least important out of four varying items. The hierarchical Bayes method was used to estimate the relative importance score for each item (summing to 100). Subgroup comparisons were performed for relevant demographic (gender, age, work status, geographical area and education) and disease characteristics (SpA phenotype, disease duration and disease activity) using one-way analysis of variance or the Mann-Whitney U-test.The experiment was completed by 199 patients with axSpA [117 (58.8%) men, mean (sd) age 42.3 (13.6) years, mean (sd) disease duration 11.1 (11.2) years, 130 (65.3%) AS]. The highest relative importance was assigned to pain (14.2; 95% CI: 13.8, 14.6), sleep (10.3; 95% CI: 9.6, 11.0), being exhausted (9.6; 95% CI: 9.0, 10.3), standing (9.25; 95% CI: 8.5, 10.0) and motivation to do anything that requires physical effort (8.7; 95% CI: 8.1, 9.3). The lowest relative importance was assigned to sexual relationships, toileting, contact with people, driving and washing hair. Differences between subgroups were small or in aspects with lower importance.A clear gradient was seen in the importance of the different aspects of health that impact functioning of patients with axSpA. Differences between subgroups were small or non-existent. These findings help to align clinical care to patients' needs.? The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

BackgroundIncreased risk of some comorbidities has been reported in spondyloarthritis (SpA). Recommendations for detection/management of some of these comorbidities have been proposed, and it is known that a gap exists between these and their implementation in practice.ObjectiveTo evaluate (1) the prevalence of comorbidities and risk factors in different countries worldwide, (2) the gap between available recommendations and daily practice for management of these comorbidities and (3) the prevalence of previously unknown risk factors detected as a result of the present initiative.MethodsCross-sectional international study with 22 participating countries (from four continents), including 3984 patients with SpA according to the rheumatologist.Statistical analysisThe prevalence of comorbidities (cardiovascular, infection, cancer, osteoporosis and gastrointestinal) and risk factors; percentage of patients optimally monitored for comorbidities according to available recommendations and percentage of patients for whom a risk factor was detected due to this study.ResultsThe most frequent comorbidities were osteoporosis (13%) and gastroduodenal ulcer (11%). The most frequent risk factors were hypertension (34%), smoking (29%) and hypercholesterolaemia (27%). Substantial intercountry variability was observed for screening of comorbidities (eg, for LDL cholesterol measurement: from 8% (Taiwan) to 98% (Germany)). Systematic evaluation (eg, blood pressure (BP), cholesterol) during this study unveiled previously unknown risk factors (eg, elevated BP (14%)), emphasising the suboptimal monitoring of comorbidities.ConclusionsA high prevalence of comorbidities in SpA has been shown. Rigorous application of systematic evaluation of comorbidities may permit earlier detection, which may ultimately result in an improved outcome of patients with SpA.

The topic under discussion is of strong relevance to the field of spondyloarthritis (SpA) because, in addition to established biological, there are new promising compounds. The reason for the review is to put all available data together to allow for an overview on recent developments and to especially inform readers about emerging drugs, biologics and small molecules in the field of SpA.This review on new therapies in axial and peripheral SpA comprising psoriatic arthritis (PsA) shows, that, in addition to the established anti-TNF agents infliximab, etanercept, adalimumab, golimumab, certolizumab and the first biosimilar approved in the EU, there are at least two emerging biologics in the field of SpA: ustekinumab, a compound targeting IL12/IL-23 via the p40 subunit of both cytokines works for psoriasis and PsA and probably also for Crohn's disease, and the anti-IL-17 antibody secukinumab which has also been shown to work in psoriasis, both compounds seem to also work in ankylosing spondylitis. In addition, the potential of two small molecules, apremilast a phoshodiesterase4 inhibitor and tofacitinib, a januskinase inhibitor is discussed.Since, in contrast to rheumatoid arthritis, the therapeutic array in SpA is currently limited to TNF-blockers, and since there is still an unmet need because some patients do not respond to anti-TNF therapy at all or they loose response, new agents with a different mechanism of action are eagerly awaited.

Despite a large number of approved therapies demonstrating efficacy in the treatment of rheumatic diseases, only 60-85 % of patients with the indications for rheumatoid arthritis are adequately treated in Germany. Additionally, approved therapies for other immune-mediated diseases are often entirely lacking, indicating the great medical need for the development of new innovative therapies in this specialized field. The development of new drugs is expensive due to the high costs of conducting clinical trials in all phases of development up to obtaining approval; therefore, pharmaceutical companies are looking for ways to save costs in the particular developmental stages. Although the classical regions for drug development (i.e. western Europe, the USA and Japan) offer both a high level of data quality and a good infrastructure to conduct clinical trials due to high standards of education and quality, clinical trials are expensive in these regions. Beside high costs, the comparatively low recruitment rates in these regions are one of the main reasons for the shifting of drug developmental stages from classical regions to eastern European, Latin American and Asian countries, which provide services for drug development and high recruitment rates for comparatively less money. However, there are many strong arguments for the participation of regions in western Europe, especially German sites in clinical trials. In this article these arguments are discussed and possible solutions and strategies for conducting and compensation of study centers in Germany for clinical trials in the field of rheumatology are provided.

The characteristic features of spondyloarthritis are inflammation in the axial skeleton (sacroiliitis, spondylitis) and inflammation in peripheral joints (arthritis) and entheses (enthesitis). According to the leading clinical symptom SpA is today differentiated in the either predominant axial or the peripheral form. The axial SpA are further subdivided in ankylosing spondylitis and non-radiographic axial SpA. This subset is characterized by the absence of structural changes on conventional x-rays. In this review we describe the clinical symptoms, the diagnosis and therapy of patients with axial SpA.

Knowledge on the long-term effects of anti-TNF therapy in patients with ankylosing spondylitis (AS) is still limited. Our objective was to study the long-term efficacy and safety of anti-TNF therapy in AS.After having completed the first part of the EASIC trial a total of 71 patients were enrolled into this 96-week extension study. Patients were treated with the same dosages and dosing intervals of infliximab as in the EASIC core study. Efficacy was assessed by using standardised assessment tools such as BASDAI, BASFI, BASMI, patient global assessment, CRP levels and the proportion of patients without any sign of enthesitis or arthritis. Long-term safety was assessed by documenting adverse events (AE), serious adverse events (SAE) and reasons for dropping out.Of the 71 patients included, 64 (90.1%) completed the trial , and 7 discontinued: one was lost to follow-up, 3 withdrew informed consent and in 3 patients therapy was stopped for different reasons: secondary loss of response, recurrent infections and basal cell carcinoma of the skin. The completers showed rather stable low scores of BASDAI (mean 2.4, median 2.52), BASFI (mean 3.1, median 2.76) and BASMI (mean 3.2, median 3) as well as patients global assessment and CRP. The vast majority of patients did not have enthesitis or arthritis. A total of 476 AE were observed, 13 of which were SAE. The majority of these were infections and most of them affected the respiratory tract. Two malignancies occurred: one basal cell carcinoma and one malignant melanoma. These were the only SAE judged to be possibly related to the study drug.Anti-TNF treatment with infliximab is efficacious over long periods of time in patients with AS. The observation of two skin related malignancies, including one melanoma, during the whole study period of 7 years is in line with reports from previous large AS data sets.

Objective.The Assessment of Spondyloarthritis international Society (ASAS) classification criteria for axial spondyloarthritis (axSpA) have added nonradiographic axSpA (nr-axSpA) to the classic ankylosing spondylitis (AS) as defined by the modified New York criteria. However, some confusion remains about differences between classification and diagnosis of axSpA. Our objective was to analyze differences between classification and diagnostic criteria by discussing each feature of the classification criteria based on real cases.Methods.The clinical features of the ASAS classification criteria were evaluated in relation to their significance for an expert diagnosis of axSpA. Twenty cases referred to our tertiary center outpatient clinic were selected because of an incorrect diagnosis of axSpA: 10 cases in which axSpA had been excluded initially because the classification criteria were not fulfilled, and 10 patients who had been previously diagnosed with axSpA because the classification criteria were fulfilled. Upon reevaluation, the former were diagnosed with axSpA while the latter had other diseases.Results.All items that are part of the classification criteria show some variability related to their relevance for a diagnosis of axSpA. There are clinical features suggestive of axSpA that are not part of the classification criteria. Misinterpretation of imaging procedures contributed to false-positive results. Rarely, other diseases may mimic axSpA.Conclusion.Because the sensitivity and specificity of the axSpA classification criteria have been around 80% in clinical trials, some false-positive and false-negative cases were expected. It is hoped that their detailed description and discussion will help to increase the understanding of diagnosing axSpA in relation to the ASAS classification criteria.

Objective To study the relationship of spinal inflammation and fatty degeneration (FD) as detected by MRI and new bone formation seen on conventional radiographs (CRs) in ankylosing spondylitis (AS). Methods CRs at baseline, 2 years and 5 years and spinal MRIs at baseline and 2 years of 73 AS patients treated with infliximab in European AS Infliximab Cohort were available. Relative risks (RR) were calculated with a general linear model after adjustment for within-patient variation. Results In a total of 1466 vertebral edges (VEs) without baseline syndesmophytes, 61 syndesmophytes developed at 5 years, the majority of which (57.4%) had no corresponding detectable MRI lesions at baseline. VEs with both inflammation and FD at baseline had the highest risk (RR 3.3, p=0.009) for syndesmophyte formation at 5 years, followed by VEs that developed new FD or did not resolve FD at 2 years (RR=2.3, p=0.034), while inflammation at baseline with no FD at 2 years had the lowest risk for syndesmophyte formation at 5 years (RR=0.8). Of the VEs with inflammation at baseline, >70% resolved completely, 28.8% turned into FD after 2 years, but only 1 syndesmophyte developed within 5 years. Conclusions Parallel occurrence of inflammation and FD at baseline and development of FD without prior inflammation after 2 years were significantly associated with syndesmophyte formation after 5 years of anti-tumour necrosis factor (TNF) therapy. However, the sequence ‘inflammation–FD–new bone formation’ was rarely observed, an argument against the TNF-brake hypothesis. Whether an early suppression of inflammation leads to a decrease of the risk for new bone formation remains to be demonstrated.

In den letzten Jahren hat sich das Verstandnis genetischer Grundlagen und pathophysiologischer Zusammenhange der Spondyloarthritiden (SpA), insbesondere der ankylosierenden Spondylitis, erweitert. Auf dem 6. Internationalen Spondyloarthritis-Kongress in Gent (2. bis 4. Oktober 2008) wurden jetzt die neuesten Entwicklungen auf dem Gebiet der SpA prasentiert.

Remission or low disease activity is achievable in patients with axial spondyloarthritis (SpA), and remission has been defined as one of the main targets in treating patients with axial SpA. However, it is unclear what actions should be taken once remission has occurred. Very little data are available concerning the effect of TNF inhibitors (TNFi) dosage adjustment or on withdrawal strategies in patients with axial SpA and/or in patients with ankylosing spondylitis (AS). Most issues relating to withdrawal of treatment in patients who are in remission cannot be addressed with traditional randomised placebo-controlled trials (RCT). Facing these challenges, there is a need for conducting trials with an innovative trial design to reflect real-life practice. Possible strategies upon remission include continuation, dose reduction or withdrawal of the effective therapy. Future scenarios should recognise heterogeneity in patients with axial SpA, which makes it questionable whether different trial designs will be applicable for the whole group of axial SpA. Several questions should be addressed before conducting a trial to study remission in patients with axial SpA: definition of remission (clinical and/or imaging remission), duration of remission as a defining inclusion criterion, predictors of remission, definition of subgroups (e.g. TNFi naïve patients or patients who will most likely remain in remission), when to restart and finally dose-adjustment after restart of the therapy.

Treatment of patients suffering from active ankylosing spondylitis (AS) with TNFα blockers, has been shown to result in clinically significant improvement of signs and symptoms of the disease. Long-term extension studies with these agents have shown sustained clinical efficacy for up to 10 years in patients who continued treatment. However, only a few studies have examined whether reduction of dosage of discontinuation of anti-TNF therapy is possible. In daily clinical practice, prolongation of treatment intervals is frequently tried in patients who are in clinical remission for longer periods of time, but no data on the success of that are available. Discontinuation of treatment is usually needed in patients who want to become pregnant, and in patients with severe infections. This review summarises what is known on the topic of discontinuation of biologic treatment in patients with AS.

NTRODUCTION:The Assessments of SpondyloArthritis international society Health Index (ASAS HI) measures functioning and health in patients with spondyloarthritis (SpA) across 17 aspects of health and 9 environmental factors (EF). The objective was to translate and adapt the original English version of the ASAS HI, including the EF Item Set, cross-culturally into 15 languages.METHODS:Translation and cross-cultural adaptation has been carried out following the forward-backward procedure. In the cognitive debriefing, 10 patients/country across a broad spectrum of sociodemographic background, were included.RESULTS:The ASAS HI and the EF Item Set were translated into Arabic, Chinese, Croatian, Dutch, French, German, Greek, Hungarian, Italian, Korean, Portuguese, Russian, Spanish, Thai and Turkish. Some difficulties were experienced with translation of the contextual factors indicating that these concepts may be more culturally-dependent. A total of 215 patients with axial SpA across 23 countries (62.3% men, mean (SD) age 42.4 (13.9) years) participated in the field test. Cognitive debriefing showed that items of the ASAS HI and EF Item Set are clear, relevant and comprehensive. All versions were accepted with minor modifications with respect to item wording and response option. The wording of three items had to be adapted to improve clarity. As a result of cognitive debriefing, a new response option 'not applicable' was added to two items of the ASAS HI to improve appropriateness.DISCUSSION:This study showed that the items of the ASAS HI including the EFs were readily adaptable throughout all countries, indicating that the concepts covered were comprehensive, clear and meaningful in different cultures.

Background The impact of psoriatic arthritis (PsA) is wide-reaching and covers various aspects of life, e.g., physical, psychological and social. This impact could be categorised using a universally accepted, standardized reference system: the International Classification of Functioning, Disability and Health (ICF). Objectives The objective was to assess how the impact of PsA from the patient9s perspective mapped to the ICF. Methods Data sources: Publications with dimensions of health important for PsA patients were identified through a systematic literature review using the following terms: (“psoriatic arthritis”) AND (“quality of life” OR “impact”). Only studies related to impact from the patient9s perspective, i.e., studies using qualitative methodology (e.g., focus groups, individual interviews) or instruments that were patient derived (patients included in the development task force, development based on qualitative methods) were included. Data extraction and interpretation: Domains of health important for patients were identified. Meaningful concepts were extracted from the publications and linked to the ICF categories, according to the updated linking rules [1] by 2 persons. The number of concepts linked to each ICF category and to each ICF level was calculated. The number of concepts not linkable was also calculated. Descriptive statistics were used. Results Eleven studies (13 articles) were included in the analysis, corresponding to 2893 patients (of whom 623 assessed qualitatively); two studies did not precisely define the population involved in their qualitative phases. Eight studies were exclusively on PsA and the other 5 included also patients with only psoriasis; only 5 studies were qualitative per se . Twenty-five domains of health were cited, of which Ability to work/volunteer and Social participation were most cited (both by 10 studies). In total 258 concepts were identified, of which 217 (84.1%) could be linked to 136 different ICF categories; 41 concepts (15.9%), mostly personal factors, namely coping with the disease (21 concepts; 51.21%) could not be linked. The most represented ICF component was Activities and Participation (42.6%) rather than Body functions (29.4%) or Body structures (10.3%). Ten studies (90.9%) reported impairments in Ability to work/volunteer and Social participation; 7 (63.6%) reported Leisure activities, Family and intimacy, Pain, Skin problems and Body image. Conclusions PsA widely impacts all aspects of patients9 lives, in particular regarding activities and participation, reflecting the functional limitations, but also the psycho-social and societal burden of PsA. The ICF is a useful approach for the systematic classification of disease impact. References Cieza A, Geyh S, Chatterji S et al. ICF linking rules: an update based on lessons learned. J Rehabil Med 2005;37:212–8. Acknowledgement Dr. Gudu9s work was supported by a scientific training bursary of the European League Against Rheumatism. Disclosure of Interest None declared

Background The ASAS Health Index (ASAS HI) was developed to measure functioning and health in patients with spondyloarthritis (SpA) aiming to better define the impact of disease in these patients. The 17 questions of the questionnaire (range 0–17, with a lower score indicating a better health status) have now been translated into 18 languages worldwide. Face validity and feasibility (time of completion) have already been assessed in a field test.1 Objectives To test construct validity, discrimination across relevant health states, reliability and responsiveness of the original English version and the 16 translations of the ASAS HI in 23 countries Methods A convenient sample of SpA patients fullfilling the ASAS classification criteria for either axial (axSpA) or peripheral SpA (pSpA) were included into the study from 33 centers of 23 countries worldwide. Data were collected by the local rheumatologist. Construct validity against other health outcomes was evaluated by Spearman correlation. Discrimination across patient reported health states was decribed. Test-retest reliability was assessed by intraclass correlation coefficient (ICC) in patients without treatment changes (stable disease state, interval 4–7 days). In those patients who required a therapeutic change because of high disease activity, responsiveness was tested (standardized response mean (SRM)) after 2–24 weeks depending on the type of medication. Results 1548 patients were included: 64.9% male, mean (SD) age 42.0 (13.4) years, mean (SD) BASDAI 4.1 (2.5)). There were 1299 patients with axSpA (375 nr-axSpA and 924 AS patients) and 256 patients with pSpA. The total score of the ASAS HI was 6.7 ± 4.3 (mean ± SD). Floor or ceiling effects were limited (0.8 and 6.9%, respectively). Convergent validity ranged as hypthesized with Spearman correlations from low (age: 0.10) to good (BASDAI: 0.70). ASAS HI scores showed a high internal consistency with a Cronbachs-α of 0.93. The ASAS HI discriminated well between patients with different stages of disease activity and function irrespective of the tool applied (ASDAS, BASDAI and BASFI) (table). The groups with greater disease activity and more impaired functioning had higher mean ASAS HI scores (indicating impaired functioning) than those with lower disease activity. Reliability (tested in 578 patients) was good (ICC: 0.87 (95%CI 0.84 to 0.89), p Conclusions The ASAS HI is a valid, reliable and responsive measure of disease severity in people affetcte by SpA. It should be used in clinical trials to evaluate the impact of SpA and its treatment on overall functioning and health. References Ann Rheum Dis 2014; 73 (suppl II): 463 Disclosure of Interest None declared

Background Pain, physical function (PF) and quality of life (QoL) are important aspects of the lived experience of those with chronic disease1. Objectives A EULAR funded study to adapt the Osteoarthritis Quality of Life Scale (OAQoL) into five languages (German, Hungarian, Italian, Spanish, Turkish) gave the opportunity to explore the relationships between these key attributes in osteoarthritis (OA). Methods A Path Model was employed, within a Structural Equation Framework, utilising Rasch-transformed latent estimates as single indicator latent variables. Measures included lower & upper limb joint count (Manikin), pain on function (WOMAC), PF (HAQ) and QoL (OAQoL). The hypothesis was that the impact of pain upon QoL would be partially mediated by PF and this relationship will be invariant by age, gender and country. Results 677 patients with OA were recruited across 5 countries, approximately 20% from each. 76% were female, 33% aged 60 and under. 65% were married, 22% in work. Duration differed significantly across countries, with 10.1% of those in Turkey with duration of 15 years or more, compared with 32.5% of those in Spain. Joint count also varied significantly, e.g. 33.8% of those recruited in Spain reported no lower limb involvement compared with just 1.5% in Hungary. Path model fit was acceptable (χ2 7.52 (df 4) p=0.111; RMSEA 0.036; TLI 0.992, CFI 0.997) (Figure). All path weights were consistent with the basic hypothesis and 43% of the impact of pain upon QoL was mediated through PF (Sobel-Goodman Z 10.93; p 0.01) by age, gender, duration and, to a large extent, by country. In the latter there were slight variations in the magnitude of paths weights between pain and PF. The effect appeared much stronger in Italy and Turkey than elsewhere. Overall, the model appeared robust across countries (Model fit χ2 26.85 (df 20) p=0.14; RMSEA 0.05; TLI 0.985, CFI 0.993). Country-specific adjusted R2 for explained variance in QoL ranged between 0.59–0.71. Conclusions Pain, PF and the consequent reduction in perceived QoL are at the centre of the lived experience of those with OA. The relationship between these three variables, including the mediating role of PF, was found to be consistent across age, gender and, with slight variations, country. This “standard model” for OA opens up the opportunity to further explore potential psychological mediating factors which may improve QoL as well as moderating factors such as different types of intervention. References Parker L, et al. The burden of common chronic disease on health-related quality of life in an elderly community-dwelling population in the UK. Fam Pract 2014;31:557–63. Disclosure of Interest None declared

The threshold for disease activity required to start antitumour necrosis factor (TNF) therapy has been arbitrarily set in patients with axial spondyloarthritis (axSpA) at Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4. How this relates to spinal inflammation is unknown.To systematically compare the clinical, laboratory and imaging data of patients with axSpA with respect to their BASDAI level.A total of 100 consecutive patients with axSpA who had never been treated with TNF blockers were included. Laboratory parameters, spinal MRI and x-rays were quantified. Data were stratified according to BASDAI ≥ 4.44 patients were diagnosed as non-radiographic axSpA (nraxSpA) and 56 patients as ankylosing spondylitis (AS): median age 40.3 ± 10.4 years; 57% male, mean disease duration since diagnosis 6.4 ± 8.4 years, 88% HLA-B27+, mean modified Stokes Ankylosing Spondylitis Spinal Score 8.3 ± 16.4. 60% of patients had spinal inflammation by MRI. The stratification based on BASDAI ≥ 4 disclosed significant differences in most clinical parameters but not for inflammation: patients with nraxSpA and BASDAI4 versus ≥ 4 had 0.9 ± 1.4 and 0.5 ± 0.6 inflammatory lesions/patient, respectively (p=0.6), while patients with AS had 3.6 ± 3.7 and 2.7 ± 3.0 inflammatory lesions/patient, respectively (p=0.4).The burden of inflammation is quite comparable in patients with axSpA-regardless of disease activity. These data clearly challenge the concept of the recommended cut-off point of BASDAI ≥ 4.

Purpose of review Axial spondyloarthritis (SpA) - including ankylosing spondylitis (AS) - is a frequent chronic inflammatory disease that affects mainly the axial skeleton. There is evidence that NSAIDs and tumor necrosis factor (TNF) α blockers are efficacious, but not all patients achieve remission or a major clinical response. A variety of new drug classes have been investigated during the last years for the treatment of patients with AS in whom TNF blockers have failed or are contraindicated. Recent findings Data for abatacept, anakinra, apremilast, bisphosphonates, rituximab, secukinumab, sulfasalazine, thalidomide and tocilizumab were found. All studies had problems with design and methodology. Summary Although some trends for efficacy were seen, there is at present insufficient evidence to support a recommendation for any of these compounds. So far, none of these new drugs has been shown to reach response rates compared to TNF-blockers.

HISTORY AND ADMISSION FINDINGS One year after an Echinococcus granulosa cyst had been resected in a 37-year-old woman she presented for follow-up. She was without symptoms and physical examination was unremarkable. INVESTIGATIONS Sonography and computed tomography showed renewed growth of the cyst (6.5 cm diameter) in the VIth liver segment. The Echinococcus antibody titre was increased to 1:20 (normal 1:5). DIAGNOSIS, TREATMENT AND COURSE An echinococcal cyst was again diagnosed and a pericystectomy with intrahepatic drainage performed. A bile leak developed postoperatively through an open bile duct at the operative site. This duct was selectively visualized by endoscopic retrograde choleangiography and its distal part embolized with 1.5 ml Histoacryl: there was no further bile leak. No relevant clinical side effects occurred. CONCLUSION Selective embolization is a possible alternative to currently employed procedures for stopping bile leaks.

Objective To investigate whether patients with ankylosing spondylitis (AS) adapt to their disease, using the ‘then-test’. Methods Data from patients participating in the AS Study for Evaluation of Recombinant Infliximab Therapy (ASSERT) and continuing in the European AS Infliximab Cohort (EASIC) were used. At 5 assessments in EASIC, patients were asked to rerate their global well-being before the start of infliximab in ASSERT. The patients evaluated their past situation by using a ‘then-test’ (‘retrospective patient global’). Initial and retrospective patient global were compared using a paired t test, and mixed linear models investigated whether the retrospective score of well-being was stable at all follow-up assessments in EASIC. Linear regression analysis explored whether treatment response was associated with the difference between the initial and retrospective score (‘gap’) while adjusting for possible confounders. Results 86 patients (mean age 39.8 years (SD=10.4), mean disease duration 10.8 years (SD=8.5)) contributed to the current analyses. At the time of starting infliximab, patients judged their global at 7.0 (SD=1.6), and with the ‘then-test’ at 7.2 (SD=2.3) (p=0.45). Time elapsed did not influence the ‘then-test’ (p=0.13). Multivariably, the gap was irrespective of treatment response, but associated with initial patient global (p

Background Both patients with axial spondyloarthritis (axSpA) and patients with fibromyalgia (FM) are suffering from pain. The new ASAS classification criteria for axSpA have been recently challenged by arguing that FM patients could easily fulfill the clinical arm of the criteria, which could lead to overdiagnosis of axSpA and wrong treatment decisions. Objectives To study similarities and differences between axSpA and FM using different sets of classification criteria and to assess the severity of wide-spread pain in both diseases. Methods In this prospective study, patients were consecutively included if they were diagnosed with axSpA, or FM by a rheumatologist. Patients with rheumatoid arthritis (RA) were also included as an inflammatory control group. Patients on anti-TNF treatment were not included. Established classification and outcome parameters as well as standardized instruments were used in all patients. MRIs were performed in all axSpA and 20 FM patients. All axSpA and FM patients had radiographs. The Mann-Whitney-U test was used for statistical comparisons between groups. Results A total of 214 patients was included: 93 with FM (7.5% HLA B27+), 91 with axSpA (79.1% HLA-B27+) and 30 with RA (53.3% seropositive). The mean age was 50.7±9.1, 43.0±12 and 58.4±11.9 years, respectively, and the mean symptom duration was comparable between groups: 6.6±6.9, 6.4±7.8 and 6.2±11.3, respectively. Expectedly, the gender ratio differed: FM and RA patients were mostly female (93.4% and 76.7%, respectively), as compared to axSpA patients (28.3%). The ASAS classification criteria were not fulfilled by any FM patient. In contrast, the 1990 and 2010 FM criteria were fulfilled by 98.3% and 100% of patients with FM, but also by 14.3% and 34.1% of axSpA (no differences between AS and nr-axSpA) and 30% and 46.7% of RA patients, respectively. The Fibromyalgia impact questionnaire (FIQ) values were 69.5±13.0, 45.4±19.3 (p Conclusions Importantly, no FM patients fulfilled ASAS classification criteria. Only a small proportion of patients with axSpA fulfilled any of the FM classification criteria. There was less overlap between patients with FM, axSpA and RA using the 1990 criteria as compared to the more sophisticated 2010 FM criteria. FM patients reported higher pain scores and more functional deficits. Some patients with widespread pain may have underlying axSpA - this differential diagnosis needs to be taken into account when dealing with the diagnosis of FM in daily practice. Disclosure of Interest None declared

Background In patients with tender and swollen finger joints, the differential diagnosis between rheumatoid arthritis (RA) and osteoarthritis (OA) of the hands can be initially difficult. In a previous pilot study we have shown that the positive response to a 3-day-course of 20 mg prednisolone (the “pred-test”) differentiates between RA and OA of the hands. An subjective percentage of improvement of 40% was found to discriminate best. Objectives To study the diagnostic value of the pred-test in patients with possible RA. Methods Consecutive patients with hand pain referred because of suspected RA (n=100) were included in the study. Clinical examination by one experienced rheumatologist, laboratory tests, and magnetic resonance imaging (MRI) were regularly performed. All patients received 1g paracetamol/day for 5 days. On days 3-5 a morning dose of 20 mg of prednisolone was added. Hand pain was quantified on a numerical rating scale (NRS 0–10) and the subjective percentage of improvement recorded. The predefined cut-off of 40% improvement was applied to differentiate between responders and non-responders. Diagnoses were made by the expert who was unaware of the treatment result. Patients were reexamined at week 12 to confirm the diagnosis. Results There were 95 patients with complete data (Tab.1). RA was diagnosed in about half of the patients. RA patients had more swollen joints, higher CRP levels and a comparable HAQ (Tab.1). The pred test was positive in 42.1% of the patients (40/95). The median percentage of improvement after 3 days of 20 mg of prednisolone was higher in RA than in OA: 50% (IQR 30%>60%) vs. 20% (IQR 10%>30%), p Conclusions This is the first evaluation of the widely used pred-test that has ever been performed. We found that this test has a moderate sensitivity and good specificity. We propose that rheumatologists use this test in uncertain clinical situations to be able to better differentiate between inflammatory arthritis and osteoarthritis. Finally, we hope that a negative test result will prevent patients to receive unnecessary glucocorticoid treatment, while a positive test will help to identify patients with inflammatory arthritis who can then receive proper treatment. Disclosure of Interest None declared

Helicobacter pylori infection of the gastric mucosa may influence gastro-oesophageal reflux disease (GORD). The protein of cytotoxin associated gene A (CagA) is assumed to be a virulence factor of H. pylori. CagA positive strains may induce severe gastroduodenal peptic ulcer disease. The aim of this study was to evaluate the association between H. pylori strains expressing CagA and GORD.Nine hundred and thirty patients were examined by endoscopy. Antral and corpus biopsies for the urease test and serum samples for the detection of IgG antibodies to CagA were taken. Serum samples were assayed by using the western blot technique.The results from 811 patients were analysed statistically. This study population consisted of 264 H. pylori infected patients (264/811, 32%). The H. pylori prevalence was 33% (89/266) in patients with reflux oesophagitis and did not differ from those patients without oesophagitis (175/545, 32%). In contrast, patients with Barrett's oesophagus showed a significantly lower prevalence of H. pylori infection than the other three groups (8/35, 23%). There was no significant influence of CagA, as one of the H. pylori virulence factors, on GORD. Antibodies against CagA were slightly, but insignificantly, more frequent in patients with oesophagitis (55/89, 62%) than in patients without oesophagitis (94/175, 54%).In a large cohort of GORD patients no significant difference in the prevalence of H. pylori in patients with and without GORD was found. In addition, there is no correlation between patients carrying CagA positive strains and development of reflux oesophagitis. However, in the case of histopathologically proven Barrett's oesophagus the prevalence of H. pylori was significantly lower. The influence of CagA positive strains on oesophageal mucosa is discussed.

Background The ASAS Health Index (ASAS HI) is a disease-specific questionnaire aiming at measurement of health in patients with spondyloarthritis (SpA) which has been developed by Assessment of SpondyloArthritis international Society (ASAS). The 17 items of the ASAS HI address aspects of pain, emotional functions, sleep, sexual functions, mobility, self-care and community life based on the International Classification of Functioning, Disability and Health (ICF). These items can serve as the starting point to develop a disease-specific utility instrument that will enable to calculate disease specific quality adjusted life-years. To construct such utility instrument, the development steps require that the number of items should be reduced to a more manageable number of items. This selection should be based on items, which are most essential to patient9s health and on items which are most preferred by patients. It is not know which aspects of health matter most to patients with SpA and also the knowledge about patient9s preferences is limited. Objectives To understand the relative importance of the different items of the ASAS HI for functioning and health of patients with SpA. Methods A best-worse experiment was conducted using a questionnaire in patients with SpA from 20 countries worldwide. Patients answered 17 choice tasks that were constructed using the Sawtooth software. In each task, patients were asked to choose the most important item and the least important from a set of four items about their functioning and health. The estimated hierarchical Bayes method was used to generate the mean relative importance score for each item. Results 206 patients (59.7% male, mean (SD) age 42.4 (13.9) years, mean (SD) BASDAI 3.8 (2.3)) with SpA completed the experiment. The five most important items are pain, sleep, standing, exhausting, and motivation to do anything that requires physical effort (table 1). Eight items address concepts which are less important for the patients: toileting, sexual relations, driving, contact with people, walking outdoors, concentration, washing hair, and be able to overcome difficulties. Four items addresses concepts, which showed intermediate results addressing concepts of running, frustration, traveling, and financial changes. Subgroup analysis regarding subgroups of SpA and European versus Non-European countries showed robust results among subgroups. Conclusions This study provides information on the relative importance for patients with SpA of the items of the ASAS HI that will be used for the development of a utility value for patienst with SpA. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.2883

Background The ASAS Health Index (ASAS HI) is a unidimensional questionnaire measuring health and impairment in functioning in patients with spondyloarthritis (SpA). The ASAS HI is accompanied by a multidimensional item set aiming at measuring environmental factors (EF Item Set). These two disease-specific questionnaires are the first questionnaires which have been developed based on the International classification of functioning, disability and health (ICF). The ASAS HI contains 17 dichotomous items addressing categories of pain, emotional functions, sleep, sexual functions, mobility, self care, and community life and the EF Item Set contains 9 dichotomous items addressing categories of support/relationships, attitudes and health services. Objectives To translate and adapt the ASAS HI and the EF Item Set cross-culturally into 15 languages and to field test the new versions in patients with axial SpA (axSpA). Methods Translation and cross-cultural adaptation was done in 20 countries according to published recommendations (forward-backward procedure) in 5 steps: translation, synthesis of translation, back translation, expert committee review and field-testing. The field test was conducted with patients with axSpA to test its applicability in patients with all forms of SpA. We paid attention to include patients across a broad spectrum of socio-demographic background (age, gender, education). Results The ASAS HI and EF Item Set was translated into Arabic, Chinese, Croatian, Dutch/Flemish, French, German, Greek, Hungarian, Italian, Korean, Portuguese, Russian, Spanish (Colombia, Mexico, Spain), Thai, and Turkish. 206 patients (approximately 10 patients/country, 59.7% male, mean (SD) age 42.4 (13.9) years, mean (SD) BASDAI 3.8 (2.3)) with axSpA did field testing in 23 countries (19 non-English speaking countries, 4 English-speaking countries). 65% of the patients were diagnosed with AS, 35% with non-radiographic axSpA and 33% of the total sample size suffered from peripheral involvement. Interviews showed the English questionnaire and the translations to be clear, relevant and comprehensive. All versions were accepted with minor modifications. The total sum of the ASAS HI (range 0-17, with a lower score indicating a better health status) was 7.1±4.4 (mean ± SD). Completion times for ASAS HI and for EF Item Set were respectively, 2.6±1.6 and 2.1±1.5 (mean ± SD) minutes. Conclusions The ASAS HI and the EF Item Set were successfully translated into 15 languages. This study showed the ASAS HI items to be readily adaptable throughout countries, indicating the concepts covered may be meaningful in many cultures. In the other hand, more difficulties were experienced with the contextual factors indicating these concepts may be more culture-dependent. The field test suggested that the English and the non-English versions have high face and content validity. By investigating patients with axSpA with and without peripheral manifestations it could be shown that the ASAS HI and the EF Item Set are valid to be applied in patients with all forms of SpA. Further validation is underway to test the psychometric properties of this new disease-specific questionnaire. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.1809

Background Fatigue is an important aspect of disease for people suffering from psoriatic arthritis (PsA) (ref 1). However, little is known about the factors explaining fatigue in PsA. The causes of fatigue in inflammatory rheumatic diseases such as PsA, spondyloarthritis or rheumatoid arthritis are unclear; fatigue is diversely reported as being related either to patient characteristics, e.g., demographic, psychological and social factors, or to disease characteristics, e.g. disease activity. Objectives To evaluate the magnitude of fatigue in PsA and to assess if fatigue appears more strongly associated with patient- or with disease-related characteristics. Methods Patients: international cross-sectional study of unselected patients with a definite diagnosis of PsA according to the CASPAR criteria, in 13 countries [1]. Magnitude of fatigue was assessed by a numeric rating scale (range 0-10). Factors associated with high fatigue (>5/10) were assessed by multivariate logistic regression. The factors tested for association were patient related characteristics including demographic variables (age, gender, disease duration and country, education level); disease-related characteristics including articular activity (number of tender joints and number of swollen joints), skin activity (current psoriasis of more than 5% body surface); other activity (axial involvement, enthesitis, dactylitis, extra-articular involvement) and structural damage. Other patient reported outcomes including quality of life were not analysed since usually highly associated to fatigue. Results Data from 246 patients were analysed: mean age 51.2±13.0 yrs; N=119 (48.8%) males. Most had long-standing disease. Mean (±SD) fatigue was 5.0 (±3.0); 44.7% of patients had a fatigue level above 5 out of 10. High fatigue was well explained (AUC of the model, 0.73) by the following elements in multivariate analysis: higher skin activity (odds ratio, OR=4.7 [1.1; 20.7]), higher tender joint count (OR=1.1 [1.0; 1.1]) and lower education level (OR=0.9 [0.8; 1.0]). Conclusions Fatigue levels were high in this population of patients with PsA. High fatigue was explained mainly by disease activity rather than patient-related variables, indicating fatigue may be closely related to the disease process in PsA. Further studies are needed. References Gossec et al. PsAID study, EULAR 2013. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.2309

Background Patients classified as axial spondyloarthritis (axSpA) may have ankylosing spondylitis (AS) or non-radiographic axSpA (nr-axSpA). Treatment recommendations for AS consider non-steroidal anti-inflammatory drugs (NSAIDs) as first-line therapy. After an unsatisfactory response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) within 4 weeks (wk), anti-TNF agents are to be considered. However, it is unknown whether patients with nr-axSpA and AS respond similarly well to NSAIDs. Methods Consecutive patients (pts) with axSpA (n=50 with nr-axSpA and n=50 with AS) were included in a prospective study if their BASDAI level was ≥4, if they had not yet received the maximally approved dose of NSAIDs and if they had not been treated with anti-TNF agents to date. After inclusion the maximal dose of NSAIDs was administered over 1wk and the dose was then adapted in case of BASDAI Results nr-axSpA pts were more often female than AS pts (52% vs. 70%), were younger (mean age 37.6±11 vs. 41.9±12.3 years), and had a shorter symptom duration (7.3±9.1 vs. 14.6±11.837.6±11 years) but were similarly often HLA-B27+ (74% vs. 80%), all p=n.s. Significant differences between the groups were found in mean CRP levels (0.6±0.9 vs. 1.2±1.1) and mean MRI scores (3.1±3.0 vs. 6.7±5.4) in nr-axSpA vs. AS pts, respectively, both p 2.1 in 76% and 74% and a positive MRI occurred in 70% and 78% of pts with nr-axSpA and AS, respectively. After wk1 and wk4, both groups showed similarly increased rates in the NSAID-index and also similar responses to NSAIDs, with significant improvement from BL in all assessments with the exception of CRP levels and MRI-a scores, where almost no changes were observed. At wks 1 and 4, an ASAS20% response was found in 40% (21% with nr-axSpA and 19% with AS) and in 52% of pts (23% nr-axSpA and 29% AS), while ASAS partial remission was found in 10% (4% nr-axSpA and 6% AS) and in 16% of pts (7% nr-axSpA and 9% AS), respectively. However, 49% and 44% of all pts still had a BASDAI ≥4 at wks 1 and 4, and similar results were found for an ASDAS-CRP cut-off of ≥2.1, with 37% and 33% achieving this at wks 1 and 4 (no differences between nr-axSpA and AS). Conclusions Patients with nr-axSpA and AS show similar response rates to NSAID treatment. Although there was some improvement of ASAS response rates, 40-50% of pts with axSpA still showed BASDAI levels >4 after 4wk of intensive NSAID therapy and were, thus, eligible for anti-TNF therapy. Bone marrow edema on MRI and CRP levels were not influenced by continuous NSAID treatment. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.6085

Background Measures for disease activity (BASDAI, ASDAS) are routinely used in patients (pts) with axial spondyloarthritis (axSpA). The ASDAS, a composite score that includes clinical measures and CRP, has high discriminatory capacity for assessment of disease activity. Clinical trial data showed that the ASDAS has a better sensitivity to change than the BASDAI in pts treated with TNF-blockers. However, there are no data on the comparison of ASDAS and BASDAI in axSpA pts treated with NSAIDs, which are recommended as first choice prior to a possible initiation of TNF-blockers. Objectives We compared the performance of BASDAI and ASDAS in assessing and predicting clinical response to intensive NSAID treatment in axSpA pts with high disease activity. Methods Consecutive pts with nr-axSpA and AS (n=50 each group) were included in a prospective study if their BASDAI level was ≥4, if they had not yet received the maximally approved dose of NSAIDs and if they had not been treated with anti-TNF agents to date. After inclusion the maximal dose of NSAIDs was administered over one week (wk) and the dose was then reduced in case of BASDAI Results Baseline characteristics of AS and nr-axSpA patients were similar. Prior to treatment, an ASDAS >2.1 was found in 74% and 76% of pts with AS and nr-axSpA, respectively. There was a significant decrease in both, ASDAS (BL: 2.5±0.6, 1wk: 1.9±0.8, 4wk: 1.6±0.8) and BASDAI (BL: 5.8±1.3 1wk: 4.1±2.1 4wk: 2.1±3.1). At wks 1 and 4, a BASDAI Conclusions BASDAI and ASDAS showed a similar magnitude of response on NSAID treatment in both AS and nr-axSpA. Of interest, the discriminative power of the ASDAS was much clearer in patients classified as nr-axSpA and especially in those who could be considered as candidates for anti-TNF treatment. These data challenge the concept of only using the BASDAI cut-off ≥4 for such treatment decisions. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.6086

Background The impact of ankylosing spondylitis (AS) on a patient’s life can be considerable. The International Classification of Functioning, Disability and Health (ICF) is a model to systematically classify and describe functioning, disability, and health in human beings. However no ICF-based patient-reported outcome measure has been developed. Objectives To develop a measure to assess health in patients with AS, the ASAS (Assessments of SpondyloArthritis international Society (ASAS)) Health Index, based on the Comprehensive ICF Core Set for AS. Methods Development has beenperformed in five phases: Ia Preparatory: Development of an item pool representing the categories of the Comprehensive ICF Core Set for AS, Ib Patient meeting: Patient preference and weighting of the items per ICF category, II 1st postal patient survey: Item reduction (within and across ICF categories), III Expert consultation: Agreement on item reduction, IV 2nd postal survey: Validation of the draft version and further item reduction, V consensus meeting: Agreement on a final version. Results Phase I: The item pool contained 251 items in 44 categories by linking existing items from over 60 questionnaires to the comprehensive ICF core set for AS. Phase II was performed based on data collected along an international cross sectional study among 1915 AS patients (mean age 51.2±3.6, 53% male, BASDAI 5.5±2.4) in 4 continents. For 82 items of the functioning part a unidimensional scale, fit to the Rasch model and absence of Differential Item Function (DIF) could be confirmed. Phase III: An expert committee selected 50 functioning items using predefined selection criteria. Phase IV: An international cross sectional study with 628 AS patients (mean age 48.5±14.2, 51.6% male, BASDAI 5.6±2.3) was conducted in 4 continents. Misfit was identified in 4 items and DIF in 15 items. More than 50% of the items showed a residual correlation between each other above a value of 0.2 in the initial round. Phase 5: Based on results of the analyses in step 4, the consensus members agreed on 17 final items. In the 17 items fit to the model, no residual correlation and absence of constant DIF could be confirmed with a Person-Separation Index of 0.82. The item location has been shown to be 0.00 ± 1.84 with a fit residual of 0.06 ± 1.24 and the person location has been shown to be 0.01 ± 1.80 with a fit residual of -0.30 ± 0.67. The chi-square probability was 0.73. Conclusions The ASAS HI measure contains 17 dichotomous items addressing categories of pain, emotional functions, sleep, sexual functions, mobility, self-care, community life and employment. In covering much of the ICF Core Set for AS, these items represent a whole range of abilities of patients with AS. The questionnaire will be translated and further tested for sensitivity to change. ASAS HI can be used in clinical trials and clinical practiceas a new composite index that captures relevant information on the health status of the patients. Disclosure of Interest None Declared

Background Spondyloarthritides (SpA) are characterized by inflammatory and structural changes in the axial skeleton and in peripheral joints and entheses. Imaging has an essential role in the new classification criteria for axial SpA (axSpA) but not for peripheral manifestations. This is largely due to limited knowledge about the value of imaging to detect peripheral arthritis and enthesitis in SpA and whether it differentiates SpA from other conditions (non-SpA). Objectives To evaluate the significance of imaging procedures and their influence on treatment decision in patients with peripheral involvement of the lower limbs in SpA vs. non-SpA. Methods The main inclusion criterion was a painful heel or knee as reported by the patients, independent of the current treatment, and age Results The groups were similar in mean age (37.2±6.8 years), CRP (0.6±0.9mg/dl), NRS-pain (6.1±2.1) but symptom duration (SpA: 17.2±27.5 vs. non-SpA: 4.4±4.3 months) and HLA-B27 (67% in axSpA vs. 13% in non-SpA) differed (both n Pathologic findings were discovered most frequently using MRI of the heel (85.3% of patients), while x-rays were regarded pathologic in only 16.7% of patients (p Based on the clinical evaluation only, a change in treatment was suggested in 47% and 57% of patients with axSpA and non-SpA, respectively. Imaging (only US and MRI) contributed to a change of medication in an additional 13% of patients with axSpA but not in non-SpA patients. Conclusions In symptomatic patients with peripheral involvement of the knee or the heel, only erosions in the Achilles tendon area as assessed by US and thickness of the patellar tendon as assessed by MRI helped to differentiate SpA from non-SpA patients, while active enthesitis did not. Imaging of peripheral sites helped to make treatment decisions in patients with axSpA. Disclosure of Interest None Declared

Background The main symptom of patients with axial spondyloarthritis (axSpA), chronic inflammatory back pain, has been traditionally evaluated from a biomedical perspective but coping strategies may also have an important role in patients’ adjustment to back pain. Objectives To examine differences in coping strategies in patients with axSpA in a 6-month longitudinal study. Methods A total of 100 consecutive patients diagnosed with axSpA according to the ASAS classification criteria including patients with ankylosing spondylitis (AS, n=56) and non-radiographic axSpA (nr-axSpA, n=44) completed clinical and psychological assessments at baseline and after 6 months. At baseline, the patients were informed about their disease in a similar way by the same physician. The vast majority of patients (>90%) was treated with NSAIDs. Standardized clinical assessment tools evaluated pain (numerical rating scale), disease activity (BASDAI), physical functioning (BASFI), coping strategy (Trier scale for coping), quality of life (QoL) (ASQoL), health status (SF-36) and patient acceptable symptom state (PASS). Results A total of 92 patients completed the follow-up examination. The majority of patients (55.6%) did not report to have a preferred coping strategy. The other patients indicated to prefer the following strategies at baseline: spiritual resources (12%), rumination (10.8%), information seeking (9.7%), withdrawal from society (3.3%), social embedding (2.2%) and fight back (2.2%). At baseline, only 38% of patients rated their disease status as acceptable (PASS+). Most patients who preferred rumination rated their disease status as not acceptable (PASS -) (88.9%). Almost no PASS+ patient reported to prefer rumination (2.9%). At follow-up, the proportion of PASS+ patients had not changed much, and most patients had not changed their coping strategy. However, PASS+ patients reported use of the strategy social embedding more often after 6 months (25.7%) as compared to baseline (11.4%), and this strategy was also more often used by the PASS+ as compared to PASS- patients: 25.7% vs 7%, respectively (p Conclusions Most patients with axSpA did not prefer one coping strategy. Our findings suggest that negative emotion focused coping styles (e.g. rumination) were associated with non-acceptance of the current health status. Whereas, active coping styles (e.g. social embedding) seem to have a rather positive influence on disease acceptance. However, the PASS concept and use of coping styles need to be further analysed and evaluated. Our findings suggest to study the potential benefit of standardized active interventions aimed at improvement and change of coping strategies. Disclosure of Interest None Declared