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The extra-spinal manifestations in axial spondyloarthritis can be categorised in 2 mains sub-groups: the extra-spinal rheumatological manifestations on one hand and the extra rheumatological manifestations in the other hand.The extra spinal manifestations comprise synovitis, dactylitis and enthesitis and extra rheumatological manifestations comprise mainly skin psoriasis, uveitis and inflammatory bowel disease.In terms of diagnostic approach in case of a patient presenting with axial symptoms, the probability to detect any extra-spinal manifestations in the past-history of the patients and/or concomitantly to the axial symptoms is very high (>75% at the baseline visit of the DESIR cohort including patients with recent onset axial symptoms suggestive of spondyloarthritis). These manifestations (based on data from different databases: for example the DESIR cohort and the ASAS-COMOSPA cross-sectional study) will be describedThe long term follow-up of patients presenting with axial spondyloarthritis emphasises the possibility to observe these extra-spinal manifestations overtime (incident cases).These data are strong arguments toJustify the inclusion of these extra–spinal manifestations in the set of classification criteria of axial spondyloarthritisJustify specific investigations (mainly interview and physical exam ) of the patients at the time of the diagnosisJustify a systematic monitoring of these different extra–spinal manifestations during the entire course of the diseaseDisclosure of InterestNone declared

The field of spondyloarthritis (SpA) has experienced major progress in the last decade, especially with regard to new treatments, earlier diagnosis, imaging technology and a better definition of outcome parameters for clinical trials. In the present work, the Assessment in SpondyloArthritis international Society (ASAS) provides a comprehensive handbook on the most relevant aspects for the assessments of spondyloarthritis, covering classification criteria, MRI and x rays for sacroiliac joints and the spine, a complete set of all measurements relevant for clinical trials and international recommendations for the management of SpA. The handbook focuses at this time on axial SpA, with ankylosing spondylitis (AS) being the prototype disease, for which recent progress has been faster than in peripheral SpA. The target audience includes rheumatologists, trial methodologists and any doctor and/or medical student interested in SpA. The focus of this handbook is on practicality, with many examples of MRI and x ray images, which will help to standardise not only patient care but also the design of clinical studies.

Objective: To validate and refine two sets of candidate criteria for classification/ diagnosis of axial spondyloarthritis (SpA). Methods: All ASAS members were invited to include consecutively new patients with chronic (≥3 months) back pain of unknown origin that began before 45 years of age. The candidate criteria were first tested in the entire cohort of 649 patients from 25 centres, and then refined in a random selection of 40% of cases and thereafter validated in the remaining 60%. Results: Upon diagnostic work up, axial SpA was diagnosed in 60.2% of the cohort. Of these, 70% did not fulfil modified New York criteria, and, therefore, were classified as having \"non-radiographic\" axial SpA. Refinement of the candidate criteria resulted in new ASAS classification criteria which are defined as: presence of sacroiliitis by radiography or by MRI plus at least 1 SpA feature (\"imaging arm\"), or presence of HLA-B27 plus at least 2 SpA features (\"clinical arm\"). Sensitivity and specificity of the entire set of the new criteria were 82.9% and 84.4%, and for the imaging arm alone 66.2% and 97.3%, respectively. The specificity of the new criteria was much better than that of the ESSG criteria modified for MRI (sensitivity 85.1%, specificity 65.1%) and slightly better than that of the modified Amor criteria (sensitivity 82.9, specificity 77.5%). Conclusion: The new ASAS classification criteria for axial SpA can reliably classify patients for clinical studies, and may help rheumatologists in clinical practice in diagnosing axial SpA in those with chronic back pain.

Objectives To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPID-axSpA (NCT01087762), an ongoing Phase 3 trial in patients with axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA). Methods Patients with active axSpA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). In total 325 patients were randomised. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society 20) response at week 12. Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Metrology Index (BASMI) linear. Results Baseline disease activity was similar between AS and nr-axSpA. At week 12, ASAS20 response rates were significantly higher in CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo (57.7 and 63.6 vs 38.3, p≤0.004). At week 24, combined CZP arms showed significant (p<0.001) differences in change from baseline versus placebo in BASFI (−2.28 vs −0.40), BASDAI (−3.05 vs −1.05), and BASMI (−0.52 vs −0.07). Improvements were observed as early as week 1. Similar improvements were reported with CZP versus placebo in both AS and nr-axSpA subpopulations. Adverse events were reported in 70.4% vs 62.6%, and serious adverse events in 4.7% vs 4.7% of All CZP versus placebo groups. No deaths or malignancies were reported. Conclusions CZP rapidly reduced the signs and symptoms of axSpA, with no new safety signals observed compared to the safety profile of CZP in RA. Similar improvements were observed across CZP dosing regimens, and in AS and nr-axSpA patients.

Background:Uveitis is reported to be the most common extra-articular manifestation in spondyloarthritis (SpA); however, its prevalence and characteristics are not well established.Objective:To perform a systematic literature review in order to examine these topics.Methods:A systematic literature analysis was conducted in the Medline database up to October 2006 and in the abstracts of rheumatology scientific meetings for the years 2004, 2005 and 2006. A hand search of references was also performed. Articles were analysed if they reported the prevalence or characteristics of uveitis in SpA. Data abstraction was standardised. Statistical analysis was mainly descriptive.Results:Among the 957 articles selected by the search, 126 articles (29 877 patients) allowed a calculation of the prevalence of uveitis in SpA; 36 articles (1989 patients) described its characteristics. The mean (SD) prevalence of uveitis was 32.7 (0.5)%; it varied with the type of SpA—for example, 33.2 (0.8)% for ankylosing spondylitis versus 25.1 (2.3)% for psoriatic arthritis. This prevalence increased with mean disease duration and was higher in HLA-B27-positive patients with an odds ratio of 4.2. Uveitis was acute in 88.7 (2.5)%, anterior in 90.5 (2.0)%, unilateral in 87.3 (2.8)%. Recurrence occurred in 50.6 (2.6)% and a reduction of visual acuity was observed in 8.3 (3.8)%.Conclusion:The prevalence of uveitis varies with disease duration and according to the type of SpA. Reduction of visual acuity is not exceptional. Because of recent promising data about the effects of anti-tumour necrosis factor therapy on uveitis flares in SpA, it was important to determine this baseline prevalence.

Background:Tumour necrosis factor α blockers in rheumatoid arthritis are known to increase the risk of serious infections defined as life-threatening, requiring hospitalisation or intravenous antibiotics. Recently, new biological agents have become available. Their safety is an important issue.Purpose:To assess if biological agents, ie rituximab, abatacept and anakinra increase the risk of serious infections in patients with rheumatoid arthritis in published randomised controlled trials.Data source:A systematic review of the literature using PUBMED, EMBASE, Cochrane library and abstracts databases (American College of Rheumatology and European League Against Rheumatism annual meetings) was performed up to October 2007. This search was completed with data from the Food and Drug Administration, the European Agency for the Evaluation of Medicinal Products and manufacturers.Data extraction:Three fixed-effect meta-analyses were performed to compare serious infection rates between each biological agent and placebo. Pooled odds ratios (ORs) were calculated, using the Mantel–Haenszel method with a continuity correction.Data synthesis:Twelve randomised controlled trials with data concerning serious infections were analysed (three for rituximab, five for abatacept and four for anakinra). They included 745 patients, 1960 patients, 2062 patients and 2112 patients treated by rituximab, abatacept, anakinra and placebo respectively. The overall pooled ORs did not reveal a statistically significant increased risk of serious infection for abatacept and rituximab; this risk was increased for high doses of anakinra (⩾100 mg daily) versus low dose and placebo (ORs = 9.63 (95% CI, 1.31 to 70.91) and 3.40 (95% CI, 1.11 to 10.46) respectively).Conclusions:These meta-analyses did not reveal a significant increase in the risk of serious infections during rituximab or abatacept treatments in patients with rheumatoid arthritis; however, high doses of anakinra may increase this risk, especially when patients have comorbidity factors. Large studies must be performed to confirm this safety profile in daily practice.

Objective:To validate and compare the definition of the Disease Activity Score 28 based on C-reactive protein (DAS28 (CRP)) to the definition based on erythrocyte sedimentation rate (ESR).Methods:Data were analysed from two randomised, double-blind, placebo-controlled trials of abatacept of 6-month and 12-month duration in patients with rheumatoid arthritis. European League Against Rheumatism (EULAR) response criteria and the proportion of patients in remission (DAS28 <2.6) based on the two DAS28 definitions were examined. Trends in radiographic progression (erosion score, joint space narrowing score and total score) and physical function (Health Assessment Questionnaire Disability Index (HAQ-DI)) across the EULAR responder states (none, moderate and good) were analysed.Results:There was general agreement in determining the EULAR responder state using both DAS28 definitions (κ = 0.80, 95% CI 0.76 to 0.83). Overall, there was 82.4% agreement on the EULAR response criteria; when disagreements occurred, the DAS28 (CRP) yielded a better EULAR response more often then DAS28 (ESR) (12.6% vs 4.9%, respectively). There was also agreement in determining remission: κ = 0.69 (95% CI 0.60 to 0.78). Radiographic progression decreased in patients treated with abatacept across EULAR states (from none to moderate to good) based on both definitions. For patients treated with placebo, the trend was not as pronounced, with radiographic scores higher for moderate vs non-responders. For physical function, similar trends were observed across the EULAR states for both DAS28 definitions.Conclusions:The DAS28 (CRP) has been validated against radiographic progression and physical function. While the DAS28 (CRP) yielded a better EULAR response more often than the DAS28 (ESR), the validation profile was similar to the DAS28 (ESR), indicating that both measures are useful for assessing disease activity in patients with rheumatoid arthritis.

Patients with rheumatoid arthritis (RA) and other inflammatory joint disorders (IJD) have increased cardiovascular disease (CVD) risk compared with the general population. In 2009, the European League Against Rheumatism (EULAR) taskforce recommended screening, identification of CVD risk factors and CVD risk management largely based on expert opinion. In view of substantial new evidence, an update was conducted with the aim of producing CVD risk management recommendations for patients with IJD that now incorporates an increasing evidence base. A multidisciplinary steering committee (representing 13 European countries) comprised 26 members including patient representatives, rheumatologists, cardiologists, internists, epidemiologists, a health professional and fellows. Systematic literature searches were performed and evidence was categorised according to standard guidelines. The evidence was discussed and summarised by the experts in the course of a consensus finding and voting process. Three overarching principles were defined. First, there is a higher risk for CVD in patients with RA, and this may also apply to ankylosing spondylitis and psoriatic arthritis. Second, the rheumatologist is responsible for CVD risk management in patients with IJD. Third, the use of non-steroidal anti-inflammatory drugs and corticosteroids should be in accordance with treatment-specific recommendations from EULAR and Assessment of Spondyloarthritis International Society. Ten recommendations were defined, of which one is new and six were changed compared with the 2009 recommendations. Each designated an appropriate evidence support level. The present update extends on the evidence that CVD risk in the whole spectrum of IJD is increased. This underscores the need for CVD risk management in these patients. These recommendations are defined to provide assistance in CVD risk management in IJD, based on expert opinion and scientific evidence.

BackgroundComorbidities are increasingly important when considering the management of patients with chronic inflammatory rheumatic diseases. Such importance is not only due to the aging of our patients but also the recognized increased risk of some comorbidities such as cardiovascular diseases because of the disease itself or its treatment.ObjectivesTo propose a standardized way of reporting and detecting commonly observed comorbidities in chronic inflammatory rheumatic diseases.MethodsUnder the umbrella of EULAR, a task force was composed of rheumatologists, fellows, epidemiologists, health professionals and patients. Such task force had to define clearly the main objectives of this initiative including the target population, the selection of comorbidities to be adressed. the method to report and/or to detect and/or to prevent such comorbidities. The methodology used both a systematic literature research and a consensual approach.ResultsThe task force concluded the following:–The target population is defined by patients suffering from chronic inflammatory rheumatic diseases such as rheumatoid arthritis, spondyloarthritis including psoriatic arthritis, connective tissue disorders such as systemic lupus erythematosus, microcristalline polyarticular disease; the potential inclusion of polyarthrosis was discussed.–The context is defined by the fact that the proposals would be used in daily practice by rheumatologists but also by health professionals such as nurses. A potential future proposal to be used by the patients (e.g. self-administered comorbidity questionnaire) was discussed.–The selected comorbidities are cardiovascular diseases, malignancies, infections, osteoporosis, gastrointestinal diseases and depression.–For each comorbidity, the following items were proposed: How to report a specific comorbidity? (e.g. breast cancer), how to detect a specific comorbidity? (e.g. mammography for breast cancer), how to prevent such comorbidity?(e.g. hypertension for cardiovascular disease).–The final proposals are presented in a such a way that they will be easily implemented in daily practice.ConclusionSuch initiative should facilitate the standardization and therefore should improve the management of comorbidities in patients suffering from chronic inflammatory rheumatic diseases.Disclosure of InterestNone declared

BackgroundSince the publication of the European League Against Rheumatism recommendations for the pharmacological treatment of psoriatic arthritis (PsA) in 2012, new evidence and new therapeutic agents have emerged. The objective was to update these recommendations.MethodsA systematic literature review was performed regarding pharmacological treatment in PsA. Subsequently, recommendations were formulated based on the evidence and the expert opinion of the 34 Task Force members. Levels of evidence and strengths of recommendations were allocated.ResultsThe updated recommendations comprise 5 overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The first bDMARD would usually be a tumour necrosis factor (TNF) inhibitor. bDMARDs targeting interleukin (IL)12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used.ConclusionsThese recommendations provide stakeholders with an updated consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes in PsA, based on a combination of evidence and expert opinion.