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Find video protocols related to scientific articles indexed in Pubmed.
Characteristics associated with the presence and development of extra-articular manifestations in ankylosing spondylitis: 12-year results from OASIS.
Rheumatology (Oxford)
PUBLISHED: 09-20-2014
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The aim of this study was to identify characteristics associated with the presence and development of extra-articular manifestations (EAMs) in a prevalence cohort of patients with AS.
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Non-steroidal anti-inflammatory drugs for acute gout.
Cochrane Database Syst Rev
PUBLISHED: 09-17-2014
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Gout is an inflammatory arthritis that is characterised by the deposition of monosodium urate crystals in synovial fluid and other tissues. The natural history of articular gout is generally characterised by three periods: asymptomatic hyperuricaemia, episodes of acute gout and chronic gouty arthritis. Non-steroidal anti-inflammatory drugs (NSAIDs) including selective cyclo-oxygenase-2 (COX-2) inhibitors (COXIBs) are commonly used to treat acute gout. Published guidelines recommend their use to treat acute attacks, using maximum recommended doses for a short time.
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Optimisation of rheumatic disease assessments in clinical trials, clinical care, and long-term databases.
Clin. Exp. Rheumatol.
PUBLISHED: 09-15-2014
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The assessment of disease in rheumatological diseases is rather complicated, because it may involve different contexts (clinical practice, clinical trials, observational studies, registries, etc.) as well as different domains (disease activity, physical function, radiographic damage, quality of life, etc.). Furthermore, available tools can be comprehensive but also rather condense, may be patient-oriented or rather physician-oriented, and so on. In this article all these levels that may matter in case of a choice of disease assessment tool are discussed, arriving at a conclusion that choosing the appropriate tool for the assessment of disease is not 'cookbook medicine'.
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Comparison of tests for lumbar flexion and hip function in patients with axial spondyloarthritis and in normal individuals.
Arthritis Care Res (Hoboken)
PUBLISHED: 09-03-2014
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Objectives: To compare the 15cm- with the 10cm-Schober's test, and the intermalleolar distance (IMD) with the internal hip rotation (IHR). Methods: A cross-sectional study was conducted among both normal individuals and patients with axial spondyloarthritis (axSpA).The spinal and hip mobility tests were assessed in all subjects. Agreement between the different tests was assessed with correlation coefficients, Bland and Altman agreement, and by cumulative-probability-plots. The component scores for lumbar flexion in the Bath Ankylosing Spondylitis Metrology Index (BASMI) with use of either the 10cm-Schober's test or the 15cm-Schober's test were compared. Results: A total of 393 normal individuals (51% males; mean age 44 years) and 90 patients with axSpA (53% males; mean age 49 years) were included. A strong correlation was found between the 10cm- and 15cm-Schober's test, both in normal individuals (r = 0.89) and in patients (r = 0.93). The 10cm-Schober's test was systematically lower than the 15cm-test with an average difference of 1.5cm (SD 0.8) in patients, resulting in a higher total BASMI score of 0.4 (SD 0.2) points. The correlation between IMD and IRH was weak, both in normal individuals (r = 0.29) and in patients (r = 0.40). Conclusion: The 10cm- and 15cm-Schober's tests are highly correlated but, as expected, the 10cm-method is systematically lower than the 15cm-method. Therefore, these measures cannot be interchangeably used in the BASMI. The IMD and IHR are not correlated, indicating that they measure different aspects of hip mobility. Therefore, the IHR cannot be used as a substitute for the IMD. © 2014 American College of Rheumatology.
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Treatment of gout patients with impairment of renal function: a systematic literature review.
J Rheumatol Suppl
PUBLISHED: 09-03-2014
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To assess the efficacy and safety of gout-specific medications in gout patients with a comorbidity and/or comedication.
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Cardiovascular risk factors and comorbidities in patients with hyperuricemia and/or gout: a systematic review of the literature.
J Rheumatol Suppl
PUBLISHED: 09-03-2014
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To review the available literature on the likelihood of having cardiovascular (CV) risk factors and on developing CV comorbidities in patients with gout and/or asymptomatic hyperuricemia as an evidence base for generating multinational clinical practice recommendations in the 3e (Evidence, Expertise, Exchange) Initiative in Rheumatology.
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The METEOR initiative: the way forward for optimal, worldwide data integration to improve care for RA patients.
Clin. Exp. Rheumatol.
PUBLISHED: 09-02-2014
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The METEOR (Measurement of Efficacy of Treatment in the 'Era of Outcome' in Rheumatology) initiative aims at improving care for RA patients by assisting rheumatologists in strict monitoring and tight control of disease activity. The state of the art of the METEOR initiative, the technical organisation of the database and future perspectives are described.
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Serum 14-3-3? is a Novel Marker that Complements Current Serological Measurements to Enhance Detection of Patients with Rheumatoid Arthritis.
J. Rheumatol.
PUBLISHED: 08-15-2014
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Serum 14-3-3? is a novel joint-derived proinflammatory mediator implicated in the pathogenesis of rheumatoid arthritis (RA). In our study, we assessed the diagnostic utility of 14-3-3? and its association with standard clinical and serological measures.
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Can we improve the performance and reporting of investigator-initiated clinical trials? Rheumatoid arthritis as an example.
Ann. Rheum. Dis.
PUBLISHED: 08-11-2014
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Investigator-initiated trials, some of which have been referred to as comparative effectiveness trials, pragmatic trials, or strategy trials, are sometimes considered to be of greater clinical importance than industry-driven trials, because they address important but unresolved clinical questions that differ from the questions asked in industry-driven trials. Regulatory authorities have provided methodological guidance for industry-driven trials for the approval of new treatments, but such guidance is less clear for investigator-initiated trials. The European League Against Rheumatism (EULAR) task force for the update of the recommendations for the management of rheumatoid arthritis has critically looked at the methodological quality and conduct of many investigator-initiated trials, and has identified a number of concerns. In this Viewpoint paper, we highlight commonly encountered issues that are discussed using examples of well-known investigator-initiated trials. These issues cover three themes: (1) design choice (superiority vs non-inferiority designs); (2) statistical power and (3) convenience reporting. Since we acknowledge the importance of investigator-initiated research, we also propose a shortlist of points-to-consider when designing, performing and reporting investigator-initiated trials.
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Relationship between types of radiographic damage and disability in patients with rheumatoid arthritis in the EURIDISS cohort: a longitudinal study.
Rheumatology (Oxford)
PUBLISHED: 07-28-2014
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The aim of this study was to assess if any of the different types of radiographic damage [true joint space narrowing (JSN), (sub)luxation and erosions] are preferentially related to disability in patients with RA.
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How to calculate the ASDAS if the conventional CRP is below the limit of detection or if using high sensitivity CRP? - An analysis in the DESIR cohort.
PUBLISHED: 07-01-2014
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Background: The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite measure of disease activity in axial spondyloarthritis. Objectives: Our aims were to investigate the most appropriate ASDAS-C-reactive protein (ASDAS-CRP) calculation method when the conventional CRP (cCRP) is below the limit of detection, to study the arithmetic influence of low CRP values obtained by high sensitivity CRP (hsCRP) in ASDAS-CRP results and to test agreement between different ASDAS formulae. Methods: Patients with axial spondyloarthritis and cCRP below the limit of detection (5mg/L, n=257) were selected. ASDAS-cCRP was calculated using eleven imputation strategies for the cCRP (range 0-5, at 0.5 intervals). ASDAS-hsCRP and ASDAS-ESR were also calculated. Agreement between ASDAS formulae was tested. Results: ASDAS-CRP calculated with the cCRP imputation values of 1.5 and 2.0mg/L and ASDAS-erythrocyte sedimentation rate (ESR) had better agreement with ASDAS-hsCRP than other imputed formulae. Disagreement was mainly in lower disease activity states (inactive/moderate disease activity). When the CRP value is <2mg/L, the CRP component of the ASDAS-CRP formula can take very low values that may result in inappropriately low ASDAS-CRP values. Conclusion: When the cCRP is below the limit of detection or when the hsCRP is <2mg/L, the constant value of 2mg/L should be used to calculate ASDAS-CRP. There is good agreement between ASDAS-hsCRP and ASDAS-ESR; however, formulae are not interchangeable. © 2014 American College of Rheumatology.
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How well are the ASAS/OMERACT Core Outcome Sets for Ankylosing Spondylitis implemented in randomized clinical trials? A systematic literature review.
Clin. Rheumatol.
PUBLISHED: 06-10-2014
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This study aims to investigate how well the Assessment of SpondyloArthritis international Society (ASAS)/Outcome Measures in Rheumatology Clinical Trials (OMERACT) core set and response criteria for ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions. A systematic literature search was performed up to June 2013 looking for RCTs in patients with axial spondyloarthritis (SpA) (AS and non-radiographic axial SpA). The assessed domains and instruments belonging to the core sets for disease-controlling anti-rheumatic therapy (DC-ART) and symptom-modifying anti-rheumatic drugs (SMARDs) were extracted. Results were reported separately for those trials published until 2 years after the publication of the core set (1 April 2001; 'control trials') and those trials published at least 2 years after the publication date ('implementation trials'). One hundred twenty-three articles from 99 RCTs were included in the analysis, comparing 48 'control trials' and 51 'implementation trials'. Regarding DC-ART core set, the following domains were significantly more frequently assessed in the 'implementation group' in comparison to the 'control group': 'physical function' (100 vs 41.7 %; p???0.001), 'peripheral joints/entheses' (100 vs 33.3 %; p???0.001) and 'fatigue' (100 vs 0 %; p???0.001). Three instruments were significantly more used in the 'implementation group': Bath Ankylosing Spondylitis Functional Index (BASFI) (100 vs 8.3 %; p?=???0.001), CRP (92.3 vs 58.3 %; p?=?0.01) and Bath Ankylosing Spondylitis Metrology Index (BASMI) (53.8 vs 0 %; p?=?0.001). Regarding SMARD core set domains, physical function (92 vs 23 %; p???0.001) and fatigue (84 vs 17 %; p???0.001), as well as the instruments BASFI (88 vs 14 %; p???0.001) and BASMI (52 vs 0 %; p???0.001), increased significantly in the 'implementation group'. Twenty per cent of trials from the 'implementation group' but none from the 'control group' included all domains of the core set. In conclusion, this study provides evidence for the implementation of the ASAS/OMERACT core set in RCTs of both DC-ART and SMARD. This applies to the use of the domains and, to a lesser extent, to the specific instruments.
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Analysis of integrated radiographic data from two long-term, open-label extension studies of adalimumab for the treatment of rheumatoid arthritis.
Arthritis Care Res (Hoboken)
PUBLISHED: 06-04-2014
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Objective: A longitudinal integration approach evaluated all radiographic scores assessed over 10 years, rather than only completer data, from 2 studies of adalimumab (ADA) for rheumatoid arthritis (RA). Methods: DE019 (methotrexate [MTX]-inadequate responders, long-standing RA) and PREMIER (MTX-naïve, early RA) had, respectively, 1- or 2-year double-blind periods followed by 9- or 8-year open-label extensions (OLEs). Patients received ADA±MTX in both OLEs. Radiographic progression was assessed using change from baseline in modified total Sharp score (?mTSS). A mixed effect model was used post hoc to evaluate repeated measurements of different data campaigns and estimate ?mTSS through up to 10 years of treatment based on original randomization groups (placebo [PBO]+MTX or standard dose ADA+MTX). Results: Data from patients with baseline and ?1 post-baseline x-ray were included (DE019, n=327; PREMIER, n=452). Integrated and 10-year-completer ?mTSS progression curves differed slightly. In DE019, for patients originally assigned PBO+MTX, accrued ?mTSS at Year 10 was 6.6 units (integrated model) and 6.2 units (completers); for patients originally assigned ADA+MTX, accrued ?mTSS was 0.9 units by integrated analysis and 0.7 units in completers. In PREMIER, for patients originally assigned PBO+MTX, accrued ?mTSS at Year 10 was 11.2 units (integrated analysis) and 11.0 units (completers); for patients originally assigned ADA+MTX, accrued ?mTSS was 5.1 units (integrated analysis) and 4.0 units (completers). A higher radiographic progression rate was observed in patients who received delayed versus immediate ADA+MTX treatment. Conclusions: Longitudinal integrated analysis provided robust estimates of radiographic progression that only slightly differed from completers-only scores, and confirmed the effects. © 2014 American College of Rheumatology.
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Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology.
Ann. Rheum. Dis.
PUBLISHED: 05-16-2014
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Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports.
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Higher disease activity leads to more structural damage in the spine in ankylosing spondylitis: 12-year longitudinal data from the OASIS cohort.
Ann. Rheum. Dis.
PUBLISHED: 05-07-2014
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To analyse the long-term relationship between disease activity and radiographic damage in the spine in patients with ankylosing spondylitis (AS).
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Bone marrow edema on magnetic resonance imaging (MRI) of the sacroiliac joints is associated with development of fatty lesions on MRI over a 1-year interval in patients with early inflammatory low back pain: a 2-year followup study.
J. Rheumatol.
PUBLISHED: 04-15-2014
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To assess whether bone marrow edema (BME) detected on magnetic resonance imaging (MRI) of the sacroiliac joints (MRI-SIJ) is associated with development of structural changes on both MRI and pelvic radiographs in patients with early inflammatory back pain (IBP).
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Updating the OMERACT filter: implications of filter 2.0 to select outcome instruments through assessment of "truth": content, face, and construct validity.
J. Rheumatol.
PUBLISHED: 04-01-2014
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The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter requires that criteria be met to demonstrate that the outcome instrument meets the criteria for content, face, and construct validity.
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Updating the OMERACT filter: discrimination and feasibility.
J. Rheumatol.
PUBLISHED: 04-01-2014
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The "Discrimination" part of the OMERACT Filter asks whether a measure discriminates between situations that are of interest. "Feasibility" in the OMERACT Filter encompasses the practical considerations of using an instrument, including its ease of use, time to complete, monetary costs, and interpretability of the question(s) included in the instrument. Both the Discrimination and Reliability parts of the filter have been helpful but were agreed on primarily by consensus of OMERACT participants rather than through explicit evidence-based guidelines. In Filter 2.0 we wanted to improve this definition and provide specific guidance and advice to participants.
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Effects of cardiovascular comorbidities on work participation in rheumatic diseases: a prospective cohort study among working individuals.
Arthritis Care Res (Hoboken)
PUBLISHED: 03-29-2014
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To determine the risk of sick leave and work disability in relation to rheumatic diseases and cardiovascular comorbidities among working individuals.
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Reference intervals of spinal mobility measures in normal individuals: the mobility study.
Ann. Rheum. Dis.
PUBLISHED: 03-26-2014
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To establish reference intervals (RIs) for spinal mobility measures as recommended for patients with axial spondyloarthritis, and to determine the effect of age, height and gender on spinal mobility, in normal individuals.
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14-3-3? is a novel mediator associated with the pathogenesis of rheumatoid arthritis and joint damage.
Arthritis Res. Ther.
PUBLISHED: 03-25-2014
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The aim of this study was to investigate whether 14-3-3?, a specific isoform of a family of proteins regulating processes such as cellular signalling, activates cell-signalling pathways and induces factors known to contribute to the pathophysiology of rheumatoid arthritis (RA). We also investigated whether 14-3-3? is associated with more severe disease in both early and established RA.
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Updating the OMERACT filter: core areas as a basis for defining core outcome sets.
J. Rheumatol.
PUBLISHED: 03-15-2014
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The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter presupposes an explicit framework for identifying the relevant core outcomes that are universal to all studies of the effects of intervention effects. There is no published outline for instrument choice or development that is aimed at measuring outcome, was derived from broad consensus over its underlying philosophy, or includes a structured and documented critique. Therefore, a new proposal for defining core areas of measurement ("Filter 2.0 Core Areas of Measurement") was presented at OMERACT 11 to explore areas of consensus and to consider whether already endorsed core outcome sets fit into this newly proposed framework.
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Updating the OMERACT filter: implications for patient-reported outcomes.
J. Rheumatol.
PUBLISHED: 03-01-2014
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At a previous Outcome Measures in Rheumatology (OMERACT) meeting, participants reflected on the underlying methods of patient-reported outcome (PRO) instrument development. The participants requested proposals for more explicit instrument development protocols that would contribute to an enhanced version of the "Truth" statement in the OMERACT Filter, a widely used guide for outcome validation. In the present OMERACT session, we explored to what extent these new Filter 2.0 proposals were practicable, feasible, and already being applied.
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Updating the OMERACT filter: implications for imaging and soluble biomarkers.
J. Rheumatol.
PUBLISHED: 03-01-2014
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The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment.
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How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0.
J. Rheumatol.
PUBLISHED: 03-01-2014
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The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed "OMERACT Filter 2.0."
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Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.
J Clin Epidemiol
PUBLISHED: 02-28-2014
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Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process.
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Transgenerational occurrence of allergic disease and autoimmunity: general practice-based epidemiological research.
Prim Care Respir J
PUBLISHED: 01-23-2014
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Corresponding with the T helper cell type 1/T helper cell type 2 hypothesis, autoimmune and allergic diseases are considered pathologically distinct and mutually exclusive conditions. Co-occurrence of autoimmune disorders and allergy within patients, however, has been reported. Transgenerational co-occurrence of autoimmune and allergic disease has been less often described and may differ from the intra-patient results.
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Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis.
Ann. Rheum. Dis.
PUBLISHED: 01-08-2014
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To update the evidence for the safety of synthetic disease-modifying antirheumatic drugs (sDMARDs), glucocorticoids (GC) and biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform the European League Against Rheumatism (EULAR) recommendations for the management of RA.
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Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis.
Ann. Rheum. Dis.
PUBLISHED: 01-07-2014
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To update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARD) in patients with rheumatoid arthritis (RA) to inform the European League Against Rheumatism(EULAR) Task Force treatment recommendations.
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Efficacy of conventional synthetic disease-modifying antirheumatic drugs, glucocorticoids and tofacitinib: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis.
Ann. Rheum. Dis.
PUBLISHED: 01-06-2014
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To update a previous systematic review assessing the efficacy of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in rheumatoid arthritis (RA).
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Intra articular injection with corticosteroids in patients with recent onset rheumatoid arthritis: subanalyses from the BeSt study.
Clin. Rheumatol.
PUBLISHED: 01-03-2014
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To investigate the association between intra-articular (IA) large joint corticosteroid injections and clinical outcomes in patients with recent onset rheumatoid arthritis (RA). We compared pain (visual analog scale (VAS)), the Disease Activity Score (44 joints) (DAS), and swollen and tender joint counts before and after IA injection. Using linear mixed models (LMM), the DAS and the Health Assessment Questionnaire (HAQ) score over time were compared in IA injected versus noninjected patients. In year 1, 93 joints were injected in 44 patients treated with initial methotrexate monotherapy and 16 in patients treated with initial combination therapy (p?
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Longterm Effect of Delaying Combination Therapy with Tumor Necrosis Factor Inhibitor in Patients with Aggressive Early Rheumatoid Arthritis: 10-year Efficacy and Safety of Adalimumab from the Randomized Controlled PREMIER Trial with Open-label Extension.
J. Rheumatol.
PUBLISHED: 11-15-2013
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To evaluate the longterm safety of adalimumab administered with or without methotrexate (MTX) and compare the efficacy of combination therapy initialization to adalimumab or MTX monotherapy initialization during the open-label extension (OLE) of the PREMIER trial (ClinicalTrials.gov Identifier:NCT00195663).
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EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update.
Ann. Rheum. Dis.
PUBLISHED: 10-25-2013
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In this article, the 2010 European League against Rheumatism (EULAR) recommendations for the management of rheumatoid arthritis (RA) with synthetic and biological disease-modifying antirheumatic drugs (sDMARDs and bDMARDs, respectively) have been updated. The 2013 update has been developed by an international task force, which based its decisions mostly on evidence from three systematic literature reviews (one each on sDMARDs, including glucocorticoids, bDMARDs and safety aspects of DMARD therapy); treatment strategies were also covered by the searches. The evidence presented was discussed and summarised by the experts in the course of a consensus finding and voting process. Levels of evidence and grades of recommendations were derived and levels of agreement (strengths of recommendations) were determined. Fourteen recommendations were developed (instead of 15 in 2010). Some of the 2010 recommendations were deleted, and others were amended or split. The recommendations cover general aspects, such as attainment of remission or low disease activity using a treat-to-target approach, and the need for shared decision-making between rheumatologists and patients. The more specific items relate to starting DMARD therapy using a conventional sDMARD (csDMARD) strategy in combination with glucocorticoids, followed by the addition of a bDMARD or another csDMARD strategy (after stratification by presence or absence of adverse risk factors) if the treatment target is not reached within 6 months (or improvement not seen at 3 months). Tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, biosimilars), abatacept, tocilizumab and, under certain circumstances, rituximab are essentially considered to have similar efficacy and safety. If the first bDMARD strategy fails, any other bDMARD may be used. The recommendations also address tofacitinib as a targeted sDMARD (tsDMARD), which is recommended, where licensed, after use of at least one bDMARD. Biosimilars are also addressed. These recommendations are intended to inform rheumatologists, patients, national rheumatology societies and other stakeholders about EULARs most recent consensus on the management of RA with sDMARDs, glucocorticoids and bDMARDs. They are based on evidence and expert opinion and intended to improve outcome in patients with RA.
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Proposal for a new nomenclature of disease-modifying antirheumatic drugs.
Ann. Rheum. Dis.
PUBLISHED: 09-26-2013
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In light of the recent emergence of new therapeutics for rheumatoid arthritis, such as kinase inhibitors and biosimilars, a new nomenclature for disease-modifying antirheumatic drugs (DMARDs), which are currently often classified as synthetic (or chemical) DMARDs (sDMARDS) and biological DMARDs (bDMARDs), may be needed. We propose to divide the latter into biological original and biosimilar DMARDs (boDMARDs and bsDMARDs, respectively, such as abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab, but also emerging ones like clazakizumab, ixekizumab, sarilumab, secukinumab or sirukumab) and the former into conventional synthetic and targeted synthetic DMARDs (csDMARDs and tsDMARDs, respectively). tsDMARDs would then constitute only those that were specifically developed to target a particular molecular structure (such as tofacitinib, fostamatinib, baricitinib or apremilast, or agents not focused primarily on rheumatic diseases, such as imatinib or ibrutinib), while csDMARDs would comprise the traditional drugs (such as methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold salts and others). The proposed nomenclature may provide means to group and distinguish the different types of DMARDs in clinical studies and review articles.
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Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial.
Lancet
PUBLISHED: 09-13-2013
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Ankylosing spondylitis is a chronic immune-mediated inflammatory disease characterised by spinal inflammation, progressive spinal rigidity, and peripheral arthritis. Interleukin 17 (IL-17) is thought to be a key inflammatory cytokine in the development of ankylosing spondylitis, the prototypical form of spondyloarthritis. We assessed the efficacy and safety of the anti-IL-17A monoclonal antibody secukinumab in treating patients with active ankylosing spondylitis.
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Evolution of radiographic damage in ankylosing spondylitis: a 12 year prospective follow-up of the OASIS study.
Ann. Rheum. Dis.
PUBLISHED: 08-20-2013
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To describe the evolution of radiographic abnormalities of the spine in patients with ankylosing spondylitis (AS).
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Increase in bone density in patients with spondyloarthritis during anti-tumor necrosis factor therapy: 6-year followup study.
J. Rheumatol.
PUBLISHED: 08-15-2013
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To assess the effects on bone mineral density (BMD) of prolonged anti-tumor necrosis factor (anti-TNF) therapy in patients with spondyloarthritis (SpA); to compare the BMD changes to those observed in SpA patients not treated with anti-TNF; and to identify the predictors of these changes.
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Assessment of global disease activity in RA patients monitored in the METEOR database: the patients versus the rheumatologists opinion.
Clin. Rheumatol.
PUBLISHED: 08-13-2013
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The objectives of this study were to compare the patients (PtGDA) and physicians (PhGDA) assessment of global disease activity and to identify factors that might influence these differences as well as factors that may influence the patients and the physicians scores separately. Anonymous data were used from 2,117 Dutch patients included in the Measurement of efficacy of Treatment in the Era of Rheumatology database. PtGDA and PhGDA were scored independently on a 100-mm visual analog scale (VAS) with 0 and 100 as extremes. The agreement, intraclass correlation coefficients (ICC), was calculated and a Bland-Altman plot was created to visualize the differences between PtGDA and PhGDA. Linear mixed model analysis was used to model PtGDA and PhGDA. Logistic repeated measurements were used to model the difference in PtGDA and PhGDA (PtGDA?>?PhGDA versus PtGDA???PhGDA). Gender patient, gender physician, age, swollen joint count (SJC), tender joint count, VAS pain, disease duration, and erythrocyte sedimentation rate (ESR) were considered as possible determinants in both models. Mean (standard deviation) age was 57 (15)?years and 67 % of the patients were female. Agreement between PtGDA and PhGDA was moderate (ICC, 0.57). Patients scored on average 11 units higher (worse) than rheumatologists (95 % limits of agreement, -25.2 to 47.6). Patients perception of pain (VAS) was positively associated with a PtGDA being higher than PhGDA. Similarly, ESR and swollen joint counts were positively associated with a PtGDA being lower or equal to the PhGDA. Patients rate global disease activity consistently higher than their rheumatologists. Patients base their judgment primarily on the level of pain, physicians on the level of SJC and ESR.
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Long-term safety and efficacy of certolizumab pegol in combination with methotrexate in the treatment of rheumatoid arthritis: 5-year results from the RAPID 1 trial and open-label extension.
Ann. Rheum. Dis.
PUBLISHED: 08-05-2013
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To examine the safety and efficacy of 5-year administration of certolizumab pegol (CZP)+methotrexate (MTX) in patients with active rheumatoid arthritis (RA).
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Multinational evidence-based recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion of a broad panel of rheumatologists in the 3e initiative.
Ann. Rheum. Dis.
PUBLISHED: 07-18-2013
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We aimed to develop evidence-based multinational recommendations for the diagnosis and management of gout. Using a formal voting process, a panel of 78 international rheumatologists developed 10 key clinical questions pertinent to the diagnosis and management of gout. Each question was investigated with a systematic literature review. Medline, Embase, Cochrane CENTRAL and abstracts from 2010-2011 European League Against Rheumatism and American College of Rheumatology meetings were searched in each review. Relevant studies were independently reviewed by two individuals for data extraction and synthesis and risk of bias assessment. Using this evidence, rheumatologists from 14 countries (Europe, South America and Australasia) developed national recommendations. After rounds of discussion and voting, multinational recommendations were formulated. Each recommendation was graded according to the level of evidence. Agreement and potential impact on clinical practice were assessed. Combining evidence and clinical expertise, 10 recommendations were produced. One recommendation referred to the diagnosis of gout, two referred to cardiovascular and renal comorbidities, six focused on different aspects of the management of gout (including drug treatment and monitoring), and the last recommendation referred to the management of asymptomatic hyperuricaemia. The level of agreement with the recommendations ranged from 8.1 to 9.2 (mean 8.7) on a 1-10 scale, with 10 representing full agreement. Ten recommendations on the diagnosis and management of gout were established. They are evidence-based and supported by a large panel of rheumatologists from 14 countries, enhancing their utility in clinical practice.
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Prevalence of self-reported spondyloarthritis features in a cohort of patients with inflammatory bowel disease.
Can. J. Gastroenterol.
PUBLISHED: 04-26-2013
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Musculoskeletal symptoms belonging to the spectrum of seronegative spondyloarthritis (SpA) are the most common extraintestinal manifestations in patients with inflammatory bowel disease (IBD) and may lead to important disease burden. Patients with suspected SpA should be referred to a rheumatologist for further evaluation.
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From inhibition of radiographic progression to maintaining structural integrity: a methodological framework for radiographic progression in rheumatoid arthritis and psoriatic arthritis clinical trials.
Ann. Rheum. Dis.
PUBLISHED: 04-25-2013
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Usually, a clinical trial in rheumatoid arthritis and psoriatic arthritis aiming to demonstrate that a new antirheumatic drug treatment can inhibit progression of structural damage has a superiority design: The new treatment is compared to placebo or to another active treatment. Currently, many new drug treatments have shown to be able to completely suppress progression (progression rates close to zero). For largely unknown reasons, during the last 10 years, radiographic progression rates in clinical trials have gradually decreased, so that progression rates in the comparator groups are often too low to demonstrate meaningful inhibition, and thus superiority of the new treatment. We here propose an alternative framework to demonstrate that new treatments have the ability to preserve structural integrity rather than to inhibit radiographic progression. Anno 2013, preserving structural integrity is conceptually more realistic than inhibiting radiographic progression.
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Predictors for health improvement in patients with fibromyalgia: a 2-year follow-up study.
Clin. Rheumatol.
PUBLISHED: 03-13-2013
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Fibromyalgia (FM) has a high impact on all aspects of health. The effect from interventions is usually small and characterized by uncertainty. Better insight in predictors for improved health is essential. The present study aimed to understand predictors for patient global impression of change and changes in overall health. Data from a longitudinal cohort of recently diagnosed FM patients (n?=?203) were used. Within this cohort, patients were pre-randomized to either a multidisciplinary (n?=?108) or an, aerobic exercise (n?=?47) program, or usual care (n?=?48). Only a limited number of patients started with the programs (n?=?86) or participated fully, i.e., attended >70 % of the scheduled sessions (n?=?68). Patients completed questionnaires covering all components of the International Classification of Functioning, Disability and Health (ICF) bio-psycho-social model of health, which was used as a framework to structure potential predictors. Principal component analysis was used to reduce the number of potential predictors. Regression analyses were used to explore associations with the outcome variables. Principal component analysis yielded five factors representing areas that covered different ICF components and chapters. "Being employed" and "full participation in a program" were independently associated with a better global impression of change. A longer duration of FM-related symptoms and more limitations in physical areas of body functions were independently associated with a worse impression of overall health. Higher levels of perceived limitations in physical and mental activities were associated with "starting to participate in a program" and with "full participation in a program." Recently diagnosed FM patients that report fewer physical limitations may experience more improvement in health if they are at work and have a positive attitude towards participating in an offered health-care intervention. These findings give support to an active rather than to a care-avoiding attitude of health-care workers in their contacts to these patients.
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EULAR definition of erosive disease in light of the 2010 ACR/EULAR rheumatoid arthritis classification criteria.
Ann. Rheum. Dis.
PUBLISHED: 02-02-2013
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The aim of this report was to propose a definition for erosive disease in the context of inflammatory arthritis in light of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) criteria for use in clinical practice and studies. A EULAR task force was formed including 16 rheumatologists and one rheumatology fellow. The process was both evidence based and consensus based, and included, between March 2010 and April 2012, analyses of data from two cohorts, two face-to-face meetings, one online voting and one teleconference. The Leiden Early Arthritis Cohort and the French ESPOIR cohort were used for the evidence-based part. The outcome measures, which were initiation of methotrexate therapy, or any disease-modifying antirheumatic drug therapy within the first year of disease and arthritis persistency over 5 years, were studied with the aim to give the best definition of erosive disease. A decision was made to select a definition with a high specificity and focus on patients who did not otherwise fulfil the 2010 ACR/EULAR RA criteria (<6 points). By a unanimous vote the following definition was selected: erosive disease for use in the 2010 ACR/EULAR RA classification criteria is defined when an erosion (defined as a cortical break) is seen in at least three separate joints at any of the following sites: the proximal interphalangeal, the metacarpophalangeal, the wrist (counted as one joint) and the metatarsophalangeal joints on radiographs of both hands and feet. A highly specific definition for erosive disease has thus been formulated.
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Rate of adjudication of radiological progression in rheumatoid arthritis randomized controlled trials depending on preset limits of agreement: a pooled analysis from 15 randomized trials.
Rheumatology (Oxford)
PUBLISHED: 01-16-2013
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The aim of this study is to provide data on the adjudication rate for a predetermined threshold of difference in change score between two readers in randomized controlled trials (RCTs).
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Scoring radiographic progression in ankylosing spondylitis: should we use the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) or the Radiographic Ankylosing Spondylitis Spinal Score (RASSS)?
Arthritis Res. Ther.
PUBLISHED: 01-04-2013
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ABSTRACT: INTRODUCTION: Radiographic damage is one of the core outcomes in axial SpA and is usually assessed with the modified Stoke Ankylosing Spondylitis (AS) Spine Score (mSASSS). Alternatively, the Radiographic AS Spinal Score (RASSS) is proposed, which includes the lower thoracic vertebrae, under the hypothesis that most progression occurs in these segments. We aimed to compare the mSASSS and RASSS with regard to performance. METHODS: Two-yearly spinal radiographs from patients followed in the Outcome in AS International Study (OASIS) were used (scored independently by two readers). A total of 195 patients had at least one radiograph (12-year follow-up) to be included. We assessed the accessibility of vertebral corners (VCs) for scoring, as well as status and 2-year progression scores of both scoring methods. To assess the potential additional value of including the thoracic segment in the score, the relative contribution (in %) to the 2-year total RASSS progression of each spinal segment (cervical, thoracic and lumbar) was determined, and compared to the expected contribution, under the assumption that a balanced segmental progression would occur, proportional to the number of sites per segment. RESULTS: The mSASSS could be scored in a total of 809 radiographs and the RASSS in 78% of these. In 58% of the latter, the score was based on one to two available thoracic VCs scores, and the remaining two to three were imputed because they were missing. There were 520 two-year mSASSS intervals available, and in 63% of them RASSS progression could be assessed. The mean (SD) 2-year interval progression score (330 intervals) was 2.0 (3.6) for the mSASSS and 2.4 (4.4) for the RASSS, yielding a similar effect size (mSASSS 0.57 and RASSS 0.55). Exclusive progression of the thoracic segment occurred in only 5% of the cases. There was no significant difference between the observed (14%) and expected (16%) contribution to progression of the thoracic segment (P = 0.70). CONCLUSIONS: The determination of RASSS for radiographic damage of the spine is frequently impossible or strongly influenced by non-contributory imputation. In comparison to the mSASSS, the contribution of thoracic VCs in the RASSS method is negligible, and does not justify the additional scoring efforts.
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Biologicals and switch in rheumatoid arthritis throughout time - are we being more aggressive?
Acta Reumatol Port
PUBLISHED: 11-26-2011
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To investigate the switches performed in patients with rheumatoid arthritis under biological therapy and specifically comparing the switches from earlier days with more recent switches.
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[The recognition of patients with spondyloarthritis. New classification criteria].
Ned Tijdschr Geneeskd
PUBLISHED: 11-17-2011
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Spondyloarthritis (SpA) is an umbrella term for a group of rheumatic diseases characterised by inflammation of the sacroiliac (SI) joints and vertebral column; today, differentiation is made between axial SpA and peripheral SpA. Ankylosing spondylitis (Bechterews disease) is the most typical form of axial SpA whereby sacroiliitis can be found on X-rays of the SI joints. Axial SpA can, however, also be present without radiographic evidence of sacroiliitis. A range of SpA-related symptoms can also manifest themselves outside the musculoskeletal system, for example, uveitis, psoriasis and inflammatory intestinal diseases. Tumour necrosis factor (TNF)-? inhibitors play an important role in the treatment of SpA. New classification criteria have recently been established in which MRI of the SI joints and the presence of the HLA-B27 tissue antigen are key. Axial and peripheral SpA should be recognized early in order to be able to successfully treat these conditions.
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[The multidisciplinary practice guideline "The responsible use of biologicals"].
Ned Tijdschr Geneeskd
PUBLISHED: 11-17-2011
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A multidisciplinary working group has developed a practice guideline containing various recommendations on the responsible and efficient use of biologicals. These biologicals include both soluble immune-receptor proteins and monoclonal antibodies that are aimed at immune mediators, receptors or cells. They are produced by biotechnology. Biologicals are used to treat patients with immune-mediated inflammatory disorders (IMIDs) such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, juvenile idiopathic arthritis (JIA), psoriasis, ulcerative colitis, Crohns disease, uveitis and sarcoidosis. This article summarises the most important recommendations contained in the practice guideline. The practice guideline is intended for members of the medical profession in addition to patients, who are considering, or are already, using biologicals.
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EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis.
Ann. Rheum. Dis.
PUBLISHED: 10-28-2011
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The authors aim to develop European League Against Rheumatism recommendations for the role of the nurse in the management of patients with chronic inflammatory arthritis, to identify a research agenda and to determine an educational agenda.
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Development of new syndesmophytes and bridges in ankylosing spondylitis and their predictors: a longitudinal study.
Ann. Rheum. Dis.
PUBLISHED: 10-11-2011
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Structural damage of the spine in ankylosing spondylitis (AS) is associated with worse physical function and impaired spinal mobility. Knowledge about predictors of new syndesmophyte formation is limited.
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Combination therapy for pain management in inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, other spondyloarthritis).
Cochrane Database Syst Rev
PUBLISHED: 10-07-2011
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Despite optimal therapy with disease-modifying antirheumatic drugs, many people with inflammatory arthritis (IA) continue to have persistent pain that may require additional therapy.
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MRI inflammation at the vertebral unit only marginally predicts new syndesmophyte formation: a multilevel analysis in patients with ankylosing spondylitis.
Ann. Rheum. Dis.
PUBLISHED: 10-06-2011
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To investigate the relationship between MRI inflammation at the vertebral unit and the formation and growth of syndesmophytes at the same vertebral unit.
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OMERACT magnetic resonance imaging initiative on structural and inflammatory lesions in ankylosing spondylitis--report of a special interest group at OMERACT 10 on sacroiliac joint and spine lesions.
J. Rheumatol.
PUBLISHED: 09-03-2011
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The ASAS/OMERACT MRI group recently described and defined magnetic resonance imaging (MRI) findings in sacroiliac joints (SIJ) that are essential for the diagnosis of sacroiliitis in patients with axial spondyloarthritis, including ankylosing spondylitis (AS). At the Outcome Measures in Rheumatology Clinical Trials (OMERACT) 2010 meeting, a special interest group (SIG) was formed to design a research agenda for the definition and description of structural lesions in the SIJ and the spine in patients with established AS. During the SIG, a summary of the previous work of the group was presented to all participants, containing: (1) a description of the current definitions of structural SIJ changes; (2) available scoring methods for SIJ changes; (3) data from a previous pilot MRI exercise on chronic SIJ changes performed by members of the group; and (4) a proposal for a research agenda for OMERACT 11. The group agreed on the projects scientific merits and the need to evaluate all available scoring methods and to have clear definitions for all possible abnormalities that can be seen on MRI, prior to the start of the exercise. It was also agreed that the exercise should include scoring of both structural and inflammatory lesions, due to lack of agreement about the best scoring method for assessing both types of lesions in AS. Participants agreed that longitudinal MRI over a certain period are needed to learn about the time sequence of pathologic changes and to understand the course of the disease. Finally, participants asked the group to add the development of a scoring method for structural changes in the spine in a subsequent exercise. Further to these objectives, all experts who agreed to contribute in the exercise will collaborate to achieve consensus on definitions and to organize training in the different scoring systems prior to the start of the project, with the aim to finalize the multiple reader exercise by the end of 2011, in time for OMERACT 11.
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Damage and progression on radiographs in individual joints: data from pivotal randomized controlled trials.
J. Rheumatol.
PUBLISHED: 09-03-2011
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Radiographic progression is usually assessed by Sharp-based methods (van der Heijde-modified Sharp score and the Genant-modified Sharp score). The aim of this study was to evaluate, in a range of randomized controlled trials (RCT), the presence of erosions and joint space narrowing (JSN) in all individual joints, as well as progression in these joints, and to determine if any redundancy exists due to infrequently involved joints.
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OMERACT 10 Sharp Symposium: important findings in examination of imaging methods for measurement of joint damage in rheumatoid arthritis.
J. Rheumatol.
PUBLISHED: 09-03-2011
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The Sharp Symposium was held at the Outcome Measures in Rheumatology Clinical Trials 2010 meeting (OMERACT 10) in honor of the late John Sharp, consummate rheumatologist and researcher. The symposium focused on the status of current scoring methods in radiography, magnetic resonance imaging (MRI), and ultrasound (US) in rheumatoid arthritis (RA), as well as on the use of soluble and tissue biomarkers in RA, with the aim of updating recommendations regarding methods for enhanced detection, monitoring, and prediction of joint damage in clinical trials.
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A stratified model for health outcomes in ankylosing spondylitis.
Ann. Rheum. Dis.
PUBLISHED: 07-25-2011
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To investigate the relationships between several health outcomes in ankylosing spondylitis (AS).
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Endorsement of definitions of disease activity states and improvement scores for the Ankylosing Spondylitis Disease Activity Score: results from OMERACT 10.
J. Rheumatol.
PUBLISHED: 07-05-2011
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The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite index to assess disease activity in ankylosing spondylitis (AS). Criteria for disease activity states and improvement scores are important for use in clinical practice, observational studies, and clinical trials, and have been proposed by the Assessment of SpondyloArthritis international Society (ASAS). At OMERACT 10, our aim was to obtain endorsement from OMERACT for the ASDAS disease activity states and response criteria proposed by the ASAS membership. This article summarizes the associated discussions, the scientific basis of the validation process, and the results from the voting sessions, and identifies areas for research using the ASDAS. OMERACT participants agreed with the selection of cutoff values, which now have the combined endorsement of ASAS and OMERACT and are ready to be used in clinical practice and in research settings.
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2010 Update of the international ASAS recommendations for the use of anti-TNF agents in patients with axial spondyloarthritis.
Ann. Rheum. Dis.
PUBLISHED: 05-05-2011
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This paper presents the second update of the Assessment in SpondyloArthritis international Society (ASAS) consensus statement on the use of anti-tumour necrosis factor (anti-TNF) agents in patients with axial spondyloarthritis (SpA). A major change from the previous recommendations is that patients fulfilling the ASAS axial SpA criteria, which also include patients fulfilling the modified New York criteria for ankylosing spondylitis, can be treated with anti-TNF agents. This makes an earlier start in the disease process possible. A second major change is the mandatory pretreatment before anti-TNF agents can be started. All patients should have tried a minimum of two non-steroidal anti-inflammatory drugs for a minimum of 4 weeks in total. This is significantly shorter than the previous requirement of 3 months. As previously, patients with axial symptoms require no further pretreatment. Patients with symptomatic peripheral symptoms should normally have had an adequate therapeutic trial of a disease-modifying antirheumatic drug, preferably sulfasalazine. Sulfasalazine is no longer mandatory in this group of patients. Finally, efficacy should be evaluated after at least 12 weeks. The remaining recommendations stayed largely unchanged.
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Specialized rheumatology nurse substitutes for rheumatologists in the diagnostic process of fibromyalgia: a cost-consequence analysis and a randomized controlled trial.
J. Rheumatol.
PUBLISHED: 04-01-2011
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To perform a cost-consequence analysis of the substitution of specialized rheumatology nurses (SRN) for rheumatologists (RMT) in the diagnostic process of fibromyalgia (FM), using both a healthcare and societal perspective and a 9-month period.
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Diagnostic and prognostic value of synovial biopsy in adult undifferentiated peripheral inflammatory arthritis: a systematic review.
J Rheumatol Suppl
PUBLISHED: 03-03-2011
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Our aim was to systematically review the literature on the diagnostic and prognostic value of synovial biopsy in undifferentiated peripheral inflammatory arthritis (UPIA) as an evidence base for generating clinical practice recommendations. The results lead to multinational recommendations in the 3e Initiative in Rheumatology.
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Diagnostic and predictive value of acute-phase reactants in adult undifferentiated peripheral inflammatory arthritis: a systematic review.
J Rheumatol Suppl
PUBLISHED: 03-03-2011
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To review the available literature on the diagnostic and predictive value of acute-phase reactants in adult undifferentiated peripheral inflammatory arthritis (UPIA) as an evidence base for generating multinational clinical practice recommendations in the 3e Initiative in Rheumatology.
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JoVE Visualize is a tool created to match the last 5 years of PubMed publications to methods in JoVE's video library.

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In developing our video relationships, we compare around 5 million PubMed articles to our library of over 4,500 methods videos. In some cases the language used in the PubMed abstracts makes matching that content to a JoVE video difficult. In other cases, there happens not to be any content in our video library that is relevant to the topic of a given abstract. In these cases, our algorithms are trying their best to display videos with relevant content, which can sometimes result in matched videos with only a slight relation.