RESUMEN
OBJECTIVE: To investigate the performance of the Michigan Hand Outcomes Questionnaire (MHQ) in hand osteoarthritis (OA) by evaluating truth, discrimination and feasibility. DESIGN: Symptomatic hand OA patients from the Hand Osteoarthritis in Secondary Care (HOSTAS) cohort completed questionnaires (demographics, MHQ, Australian/Canadian Hand Osteoarthritis Index [AUSCAN], Functional Index for Hand Osteoarthritis [FIHOA] and visual analogue scale [VAS] pain) at baseline (n = 383), 1- and 2-year follow-up (n = 312, n = 293). Anchor questions at follow-up assessed whether pain/function levels were (un)acceptable and had changed compared to baseline. Correlations between MHQ and other pain/function questionnaires were calculated. Validity of unique MHQ domains (work performance, aesthetics, satisfaction), discrimination across disease stages, and responsiveness were assessed by categorizing patients by external anchors (employment, joint deformities, erosions, and anchor questions). Between-group differences were assessed with linear regression, probability plots and comparison of medians. RESULTS: MHQ pain and function subscales correlated moderately-to-good with other instruments (rs 0.63-0.81). Work performance scores were worse in patients with reduced working capacity than in employed patients. Aesthetics scores were worse in patients with more deformities. Patients with unacceptable complaints had worse satisfaction scores. All pain/function instruments discriminated between patients with acceptable vs unacceptable pain/function, while only MHQ activities of daily living (ADL), FIHOA, and MHQ aesthetics could discriminate between erosive and non-erosive disease. MHQ and AUSCAN were most responsive. CONCLUSIONS: MHQ has several unique aspects and advantages justifying its use in hand OA, including the unique assessment of work performance, aesthetics, and satisfaction. However, MHQ, AUSCAN and FIHOA appear to measure different aspects of pain and function.
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Articulaciones de la Mano/fisiopatología , Osteoartritis/rehabilitación , Actividades Cotidianas , Anciano , Evaluación de la Discapacidad , Empleo , Femenino , Estudios de Seguimiento , Fuerza de la Mano/fisiología , Humanos , Masculino , Persona de Mediana Edad , Osteoartritis/complicaciones , Osteoartritis/fisiopatología , Evaluación de Resultado en la Atención de Salud/métodos , Dolor/etiología , Dimensión del Dolor/métodos , Índice de Severidad de la Enfermedad , Encuestas y CuestionariosRESUMEN
OBJECTIVES: Concerns have been raised about overdiagnosis of axial spondyloarthritis (axSpA). We investigated whether patients with chronic back pain (CBP) of short duration and multiple SpA features are always diagnosed with axSpA by the rheumatologist, and to what extent fulfilment of the Assessment of SpondyloArthritis International Society (ASAS) axSpA criteria is associated with an axSpA diagnosis. METHODS: Baseline data from 500 patients from the SPondyloArthritis Caught Early cohort which includes patients with CBP (≥3â months, ≤2â years, onset <45â years) were analysed. All patients underwent full diagnostic workup including MRI of the sacroiliac joints (MRI-SI) and radiograph of sacroiliac joints (X-SI). For each patient, the total number of SpA features excluding sacroiliac imaging and human leucocyte antigen B27 (HLA-B27) status was calculated. RESULTS: Before sacroiliac imaging and HLA-B27 testing, 32% of patients had ≤1 SpA feature, 29% had 2 SpA features, 16% had 3 SpA features and 24% had ≥4 SpA features. A diagnosis of axSpA was made in 250 (50%) of the patients: 24% with ≤1 SpA feature, 43% with 2 SpA features, 62% with 3 SpA features and 85% with ≥4 SpA features. Of the 230 patients with a positive ASAS classification 40 (17.4%) did not have a diagnosis of axSpA. HLA-B27 positivity (OR 5.6; 95% CI 3.7 to 8.3) and any (MRI-SI and/or X-SI) positive imaging (OR 34.3; 95% CI 17.3 to 67.7) were strong determinants of an axSpA diagnosis. CONCLUSIONS: In this cohort of patients with CBP, neither the presence of numerous SpA features nor fulfilment of the ASAS classification criteria did automatically lead to a diagnosis axSpA. Positive imaging was considered particularly important in making a diagnosis of axSpA.
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Dolor de Espalda/etiología , Dolor Crónico/etiología , Antígeno HLA-B27/sangre , Imagen por Resonancia Magnética , Espondiloartropatías/diagnóstico , Adulto , Algoritmos , Diagnóstico Precoz , Humanos , Masculino , Radiografía , Articulación Sacroiliaca/diagnóstico por imagen , Espondiloartropatías/sangre , Espondiloartropatías/complicaciones , Adulto JovenRESUMEN
OBJECTIVES: To assess the efficacy and safety of certolizumab pegol (CZP)+dose-optimised methotrexate (MTX) versus placebo (PBO)+dose-optimised MTX in inducing and sustaining clinical remission in DMARD-naïve patients with moderate-to-severe, active, progressive rheumatoid arthritis (RA), with poor prognostic factors over 52â weeks. METHODS: DMARD-naïve patients with ≤1â year of active RA were randomised (3:1) in a double-blind manner to CZP (400â mg Weeks 0, 2, 4, then 200â mg Q2W to Week 52)+MTX or PBO+MTX (the mean optimised-MTX dose=21 and 22â mg/week, respectively). Sustained remission (sREM) and sustained low disease activity (sLDA; DAS28(ESR)<2.6 and DAS28(ESR)≤3.2, respectively, at both Weeks 40 and 52) were the primary and secondary endpoints. RESULTS: Patients were randomised to CZP+MTX (n=660) and PBO+MTX (n=219). At Week 52, significantly more patients assigned to CZP+MTX compared with PBO+MTX achieved sREM (28.9% vs 15.0%, p<0.001) and sLDA (43.8% vs 28.6%, p<0.001). Inhibition of radiographic progression and improvements in physical functioning were significantly greater for CZP+MTX versus PBO+MTX (van der Heijde modified total Sharp score (mTSS) mean absolute change from baseline (CFB): 0.2 vs 1.8, p<0.001, rate of mTSS non-progressors: 70.3% vs 49.7%, p<0.001; least squares (LS) mean CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI): -1.00 vs -0.82, p<0.001). Incidence of adverse events (AEs) and serious AEs was similar between treatment groups. Infection was the most frequent AE, with higher incidence for CZP+MTX (71.8/100 patient-years (PY)) versus PBO+MTX (52.7/100â PY); the rate of serious infection was similar between CZP+MTX (3.3/100â PY) and PBO+MTX (3.7/100â PY). CONCLUSIONS: CZP+dose-optimised MTX treatment of DMARD-naïve early RA resulted in significantly more patients achieving sREM and sLDA, improved physical function and inhibited structural damage compared with PBO+dose-optimised MTX. TRIAL REGISTRATION NUMBER: NCT01519791.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Certolizumab Pegol/uso terapéutico , Metotrexato/uso terapéutico , Adulto , Antirreumáticos/administración & dosificación , Antirreumáticos/efectos adversos , Artritis Reumatoide/diagnóstico por imagen , Certolizumab Pegol/efectos adversos , Método Doble Ciego , Quimioterapia Combinada/efectos adversos , Femenino , Humanos , Infecciones/inducido químicamente , Masculino , Metotrexato/administración & dosificación , Metotrexato/efectos adversos , Persona de Mediana Edad , Pronóstico , Radiografía , Inducción de RemisiónRESUMEN
PURPOSE: Patients with inflammatory bowel disease (IBD) often experience severe impairment in different life domains. Psychological factors, such as illness perceptions and coping, may play a role in the adjustment to IBD as indicated by mental and physical health, activity, and work impairment. The present study aimed at examining the assumption of the Common Sense Model (CSM) that coping mediates the relationship between illness perceptions and adjustment in patients with IBD. METHOD: In a cross-sectional design, 211 IBD patients (73 % Crohn's disease, 40 % male, mean age 42.9 ± 12.9 years) attending an outpatient clinic completed questionnaires assessing illness perceptions (IPQ-R), coping (CORS), mental and physical health (SF-36), as well as activity and work impairment (WPAI). Multiple mediation analyses were applied that allow estimating the total and direct effects of all illness perception dimensions and the indirect effects through all coping strategies on the illness outcomes simultaneously. RESULTS: The analyses yielded significant direct effects of perceptions regarding the cyclical course, the chronic course, the severity of the consequences, the comprehensibility, and the emotional impact of IBD on study outcomes. Additionally, significant indirect effects were found for the perceptions regarding the severity of the consequences, the possibility of personal control, and the comprehensibility of IBD on mental and physical health as well as activity impairment through the use of one specific coping strategy, i.e., reduction of activity. CONCLUSION: The results provide evidence for the assumptions of the CSM and suggest the importance of addressing illness perceptions and activity stimulation in quality health care for IBD patients.
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Adaptación Psicológica , Enfermedad de Crohn/psicología , Enfermedades Inflamatorias del Intestino/psicología , Adulto , Estudios Transversales , Emociones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Percepción , Calidad de Vida , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To determine in a cohort of young patients with suspected axial spondyloarthritis (axSpA), the prevalence of lumbosacral transitional vertebra (LSTV), its association with local bone marrow edema (BME) and lumbar spine degeneration, and the potential relationship with MRI findings and clinical signs of axSpA. MATERIALS AND METHODS: Baseline imaging studies and clinical information of patients from the SPondyloArthritis Caught Early-cohort (back pain ≥3 months, ≤2 years, onset <45 years) were used. Two independent readers assessed all patients for LSTV on radiography, and BME-like and degenerative changes on MRI. Patients with and without LSTV were compared with regard to the prevalence of MRI findings and the results of clinical assessment using Chi-squared test or t test. RESULTS: Of 273 patients (35.1% male, mean age 30.0), 68 (25%) patients showed an LSTV, without statistical significant difference between patients with and without axSpA (p = 0.327). Local sacral BME was present in 9 out of 68 (13%) patients with LSTV and absent in patients without LSTV (p < 0.001). Visual analogue scale (VAS) pain score and spinal mobility assessments were comparable. CONCLUSIONS: LSTV is of low clinical relevance in the early diagnosis of axSpA. There is no difference between patients with and without LSTV regarding the prevalence of axSpA, pain and spinal mobility, and a BME-like pattern at the pseudoarticulation does not reach the SI joints.
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Dolor de Espalda/complicaciones , Vértebras Lumbares/anomalías , Vértebras Lumbares/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Espondiloartritis/complicaciones , Espondiloartritis/diagnóstico por imagen , Adolescente , Adulto , Estudios de Cohortes , Diagnóstico Diferencial , Diagnóstico Precoz , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Reproducibilidad de los Resultados , Adulto JovenRESUMEN
BACKGROUND: Since 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. METHODS: A 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. RESULTS: The 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. CONCLUSIONS: These 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.
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Algoritmos , Antirreumáticos/uso terapéutico , Artritis Psoriásica/tratamiento farmacológico , Glucocorticoides/uso terapéutico , Antiinflamatorios no Esteroideos/uso terapéutico , Manejo de la Enfermedad , Europa (Continente) , Humanos , Reumatología , Sociedades MédicasRESUMEN
OBJECTIVE: To compare the prevalence of synovitis, pain and radiographic progression in non-erosive and erosive hand osteoarthritis (HOA), and to explore whether the different rate of disease progression is explained by different levels of synovitis and structural damage. DESIGN: We included 31 and 34 participants with non-erosive and erosive HOA at baseline, respectively. Using Generalized Estimating Equations, we explored whether participants with erosive HOA had more synovitis (by MRI, ultrasound and clinical examination) independent of the degree of structural damage. Similarly, we explored whether pain at baseline and radiographic progression after 5 years were higher in erosive HOA, independent of the levels of synovitis and structural damage. All analyses were adjusted for age and sex. RESULTS: Power Doppler activity was found mainly in erosive HOA. Participants with erosive HOA demonstrated more moderate-to-severe synovitis, assessed by MRI (OR = 1.73, 95% CI 1.11-2.70), grey-scale ultrasound (OR = 2.02, 95% CI 1.25-3.26) and clinical examination (OR = 1.80, 95% CI 1.44-2.25). The associations became non-significant when adjusting for more structural damage. The higher frequency of joint tenderness in erosive HOA was at least partly explained more structural damage and inflammation. Radiographic progression (OR = 2.53, 95% CI 1.73-3.69) was more common in erosive HOA independent of radiographic HOA severity and synovitis (here: adjusted for grey-scale synovitis by ultrasound). CONCLUSION: Erosive HOA is characterized by higher frequency and more severe synovitis, pain and radiographic progression compared to non-erosive HOA. The higher rate of disease progression was independent of baseline synovitis and structural damage.
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Articulaciones de la Mano/diagnóstico por imagen , Osteoartritis/diagnóstico por imagen , Sinovitis/diagnóstico por imagen , Anciano , Progresión de la Enfermedad , Femenino , Humanos , Estudios Longitudinales , Imagen por Resonancia Magnética/métodos , Masculino , Persona de Mediana Edad , Osteoartritis/complicaciones , Dolor/etiología , Fenotipo , Radiografía/métodos , Índice de Severidad de la Enfermedad , Sinovitis/etiología , Ultrasonografía Doppler/métodosRESUMEN
OBJECTIVE: To evaluate the signal intensity (SI) of the intervertebral discs of the cervical spine on magnetic resonance (MR) fluid sensitive sequences, and correlate this to secondary signs of degeneration on MR and radiographs as well as to age. MATERIAL AND METHODS: A total of 265 patients aged ≥16 with back pain (≥3-months, <2-year, onset <45-years) from the SPondyloArthritis Caught Early (SPACE) cohort were included. Sagittal 1.5 T MR images and lateral radiographs of the cervical spine were independently evaluated by two readers for: SI of the intervertebral discs using a grading system based of Pfirrmann (grade 1 normal/bright SI; 2 inhomogeneous/bright SI; 3 inhomogeneous/mildly decreased SI; 4 inhomogeneous/markedly decreased SI; 5 signal void), disc herniation and Modic changes (MRI) and disc space narrowing, osteophytes and sclerosis (radiograph). Readers were blinded for clinical information. Descriptive statistics were used for characteristics and prevalence of findings, and regression analysis was used for age and grades. RESULTS: Of 265 patients (36% male, mean age 30), 221 (83%) patients had 1 to 6 discs (median 4) with decreased SI. Of 1,590 discs, 737 (46%) were grade 1; 711 (45%) grade 2; 133 (8%) grade 3; 8 (1%) grade 4 and 1 (0%) grade 5. Secondary signs of degeneration were rare and seen predominantly in C5-C7 and appear to be related to signal loss grade 3 and 4. CONCLUSION: Low signal intensity of intervertebral discs in absence of secondary degenerative signs in the cervical spine on fluid sensitive MR images might be pre-existing and part of the natural course.
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Envejecimiento/patología , Degeneración del Disco Intervertebral/diagnóstico por imagen , Degeneración del Disco Intervertebral/patología , Disco Intervertebral/diagnóstico por imagen , Disco Intervertebral/patología , Imagen por Resonancia Magnética/métodos , Adolescente , Adulto , Vértebra Cervical Axis/diagnóstico por imagen , Vértebra Cervical Axis/patología , Líquido Cefalorraquídeo/citología , Líquido Cefalorraquídeo/diagnóstico por imagen , Femenino , Humanos , Aumento de la Imagen/métodos , Interpretación de Imagen Asistida por Computador/métodos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Relación Señal-Ruido , Adulto JovenRESUMEN
This study investigates the association of CRP (C-reactive protein) single-nucleotide polymorphisms (SNPs) with plasma CRP levels and radiographic severity in African Americans with early and established rheumatoid arthritis (RA). Using a cross-sectional case-only design, CRP SNPs were genotyped in two independent sets of African Americans with RA: Consortium for the Longitudinal Evaluation of African Americans with RA (CLEAR 1) and CLEAR 2. Radiographic data and CRP measurements were available for 294 individuals from CLEAR 1 (median (interquartile range (IQR) 25-75) disease duration of 1 (0.6-1.6) year) and in 407 persons from CLEAR 2 (median (IQR 25-75) disease duration of 8.9 (3.5-17.7) years). In CLEAR 1, in adjusted models, the minor allele of rs2808630 was associated with total radiographic score (incident rate ratio 0.37 (95% confidence interval (CI) 0.19-0.74), P-value=0.0051). In CLEAR 2, the minor allele of rs3093062 was associated with increased plasma CRP levels (P-value=0.002). For each rs3093062 minor allele, the plasma CRP increased by 1.51 (95% CI 1.15-1.95) mg dl(-1) when all the other covariates remained constant. These findings have important implications for assessment of the risk of joint damage in African Americans with RA.
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Artritis Reumatoide/etnología , Artritis Reumatoide/genética , Negro o Afroamericano/genética , Proteína C-Reactiva/genética , Adulto , Anciano , Alelos , Artritis Reumatoide/diagnóstico por imagen , Estudios Transversales , Femenino , Estudios de Asociación Genética , Predisposición Genética a la Enfermedad/etiología , Variación Genética , Humanos , Masculino , Persona de Mediana Edad , Polimorfismo de Nucleótido Simple , RadiografíaRESUMEN
OBJECTIVES: To evaluate the effect of certolizumab pegol (CZP) on productivity outside and within the home, and on participation in family, social and leisure activities in adult patients with psoriatic arthritis (PsA). METHODS: RAPID-PsA (NCT01087788) is a phase 3, double-blind, placebo-controlled trial. 409 patients with active PsA were randomised 1:1:1 to placebo, CZP 200â mg every 2â weeks (Q2W) or CZP 400â mg every 4â weeks (Q4W). The arthritis-specific Work Productivity Survey (WPS) assessed the impact of PsA on paid work and household productivity, and participation in social activities during the preceding month. WPS responses were compared between treatment arms using a non-parametric bootstrap-t method. RESULTS: At baseline, 56.6%, 60.1% and 61.5% of placebo, CZP 200â mg Q2W and CZP 400â mg Q4W patients were employed. By week 24, employed CZP patients reported an average of 1.0-1.8 and 3.0-3.9 fewer days of absenteeism and presenteeism, respectively, per month compared with 1.0 and 0.3 fewer days for placebo patients (p<0.05). Within the home, by week 24, CZP patients reported an average of 3.0-3.5 household work days gained per month versus 1.0â day for placebo (p<0.05). CZP patients also reported fewer days with reduced household productivity or days lost for participation in family, social and leisure activities. Improvements with CZP were seen as early as week 4 and continued to week 24. CONCLUSIONS: CZP treatment significantly improved productivity at paid work and within the home, and resulted in greater participation in social activities for PsA patients. TRIAL REGISTRATION NUMBER: NCT01087788.
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Actividades Cotidianas , Anticuerpos Monoclonales Humanizados/uso terapéutico , Artritis Psoriásica/tratamiento farmacológico , Eficiencia , Empleo , Fragmentos Fab de Inmunoglobulinas/uso terapéutico , Inmunosupresores/uso terapéutico , Polietilenglicoles/uso terapéutico , Trabajo , Adulto , Certolizumab Pegol , Método Doble Ciego , Femenino , Humanos , Actividades Recreativas , Masculino , Persona de Mediana Edad , Ausencia por Enfermedad , Participación Social , Resultado del TratamientoRESUMEN
BACKGROUND: MRI is increasingly used to measure inflammation in rheumatoid arthritis (RA) research, but the correlation to clinical assessment is unexplored. This study determined the association and concordance between inflammation of small joints measured with MRI and physical examination. METHODS: 179 patients with early arthritis underwent a 68 tender joint count and 66 swollen joint count and 1.5T MRI of MCP (2-5), wrist and MTP (1-5) joints at the most painful side. Two readers scored synovitis and bone marrow oedema (BME) according to the OMERACT RA MRI scoring method and assessed tenosynovitis. The MRI data were first analysed continuously and then dichotomised to analyse the concordance with inflammation at joint examination. RESULTS: 1790 joints of 179 patients were studied. Synovitis and tenosynovitis on MRI were independently associated with clinical swelling, in contrast to BME. In 86% of the swollen MCP joints and in 92% of the swollen wrist joints any inflammation on MRI was present. In 27% of the non-swollen MCP joints and in 66% of the non-swollen wrist joints any MRI inflammation was present. Vice versa, of all MCP, wrist and MTP joints with inflammation on MRI 64%, 61% and 77%, respectively, were not swollen. BME, also in case of severe lesions, occurred frequently in clinically non-swollen joints. Similar results were observed for joint tenderness. CONCLUSIONS: Inflammation on MRI is not only present in clinically swollen but also in non-swollen joints. In particular BME occurred in clinically non-inflamed joints. The relevance of subclinical inflammation for the disease course is a subject for further studies.
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Artritis Reumatoide/diagnóstico , Articulaciones de la Mano/patología , Articulación Metatarsofalángica/patología , Adulto , Anciano , Artritis Reumatoide/complicaciones , Enfermedades de la Médula Ósea/diagnóstico , Enfermedades de la Médula Ósea/etiología , Estudios de Cohortes , Edema/diagnóstico , Edema/etiología , Femenino , Humanos , Inflamación/diagnóstico , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Examen Físico , Sinovitis/diagnóstico , Sinovitis/etiología , Tenosinovitis/diagnóstico , Tenosinovitis/etiologíaRESUMEN
OBJECTIVES: The burden of disease in patients with ankylosing spondylitis (AS) can be considerable. However, no agreement has been reached among expert members of Assessment of SpondyloArthritis International Society (ASAS) to define severity of AS. Based on the International Classification of Functioning, Disability and Health (ICF), a core set of items for AS has been selected to represent the entire spectrum of possible problems in functioning. Based on this, the objective of this study was to develop a tool to quantify health in AS, the ASAS Health Index. METHODS: First, based on a literature search, experts' and patients' opinion, a large item pool covering the categories of the ICF core set was generated. In several steps this item pool was reduced based on reliability, Rasch analysis and consensus building after two cross-sectional surveys to come up with the best fitting items representing most categories of the ICF core set for AS. RESULTS: After the first survey with 1754 patients, the item pool of 251 items was reduced to 82. After selection by an expert committee, 50 items remained which were tested in a second cross-sectional survey. The results were used to reduce the number of items to a final set of 17 items. This selection showed the best reliability and fit to the Rasch model, no residual correlation, and absence of consistent differential item function and a Person Separation Index of 0.82. CONCLUSIONS: In this long sequential study, 17 items which cover most of the ICF core set were identified that showed the best representation of the health status of patients with AS. The ASAS Health Index is a linear composite measure which differs from other measures in the public domain.
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Actividades Cotidianas , Adaptación Psicológica , Indicadores de Salud , Calidad de Vida , Espondilitis Anquilosante/fisiopatología , Adulto , Anciano , Consenso , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Espondilitis Anquilosante/psicología , Encuestas y CuestionariosRESUMEN
A taskforce comprised of an expert group of 21 rheumatologists, radiologists and methodologists from 11 countries developed evidence-based recommendations on the use of imaging in the clinical management of both axial and peripheral spondyloarthritis (SpA). Twelve key questions on the role of imaging in SpA were generated using a process of discussion and consensus. Imaging modalities included conventional radiography, ultrasound, magnetic resonance imaging, computed tomography (CT), positron emission tomography, single photon emission CT, dual-emission x-ray absorptiometry and scintigraphy. Experts applied research evidence obtained from systematic literature reviews using MEDLINE and EMBASE to develop a set of 10 recommendations. The strength of recommendations (SOR) was assessed by taskforce members using a visual analogue scale. A total of 7550 references were identified in the search process, from which 158 studies were included in the systematic review. Ten recommendations were produced using research-based evidence and expert opinion encompassing the role of imaging in making a diagnosis of axial SpA or peripheral SpA, monitoring inflammation and damage, predicting outcome, response to treatment, and detecting spinal fractures and osteoporosis. The SOR for each recommendation was generally very high (range 8.9-9.5). These are the first recommendations which encompass the entire spectrum of SpA and evaluate the full role of all commonly used imaging modalities. We aimed to produce recommendations that are practical and valuable in daily practice for rheumatologists, radiologists and general practitioners.
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Diagnóstico por Imagen/métodos , Espondiloartritis/diagnóstico , Espondiloartritis/terapia , Europa (Continente) , Humanos , Imagen por Resonancia Magnética , Tomografía de Emisión de Positrones , Radiografía , Espondiloartritis/clasificación , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , UltrasonografíaRESUMEN
OBJECTIVES: Few longitudinal studies have studied the association between body mass index (BMI) and hand osteoarthritis (OA). We aimed to explore the association between BMI and progressive hand OA in a longitudinal study of the Oslo hand OA cohort. METHOD: Participants with existing hand OA had hand radiographs and BMI data taken at baseline and 7-year follow-up (n = 103). The radiographs were read according to the Kellgren-Lawrence (KL) scale. First, we examined the association between baseline BMI and incident OA (KL grade ≥ 2) in joints without OA at baseline (adjusted for age and sex) using generalized estimating equation (GEE) analyses. Second, we examined whether changes in BMI from baseline to follow-up were associated with increasing KL sum score from baseline to follow-up using linear regression. We repeated the analyses using changes in number of joints with symptomatic OA and patient-reported pain and physical function as the outcome. RESULTS: The mean (SD) age at baseline was 61.6 (5.6) years and 91 (94%) of the cohort were women. The mean (SD) BMI was 25.7 (4.0) kg/m(2) at baseline and the mean (SD) BMI change was 1.1 (2.0) kg/m(2). There was no relationship between baseline BMI and development of more joints with OA during follow-up. Similarly, there was no association between change in BMI and hand OA progression, increasing hand pain or disability. CONCLUSIONS: In the Oslo hand OA cohort, higher BMI was not related to hand OA progression.
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Índice de Masa Corporal , Progresión de la Enfermedad , Articulaciones de la Mano , Osteoartritis/epidemiología , Osteoartritis/fisiopatología , Anciano , Artralgia/epidemiología , Artralgia/fisiopatología , Estudios de Cohortes , Evaluación de la Discapacidad , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Modelos Lineales , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Noruega/epidemiología , Obesidad/complicaciones , Factores de RiesgoRESUMEN
OBJECTIVES: To describe the distribution and evolution over time of bone marrow oedema (BME) on magnetic resonance imaging of the sacroiliac joint (MRI-SIJ) in patients with recent-onset inflammatory back pain (IBP) suspected for axial spondyloarthritis (axSpA). METHOD: A 2-year follow-up study with annual MRI-SIJ was conducted in patients with IBP of duration ≤ 2 years. Each SIJ was divided into quadrants and MRI scores were analysed on a per-patient and per-SIJ quadrant basis. The presence of BME in each SIJ quadrant was recorded. Fulfilment of the Assessment of SpondyloArthritis international Society (ASAS) criteria for axSpA was assessed at baseline and at follow-up. RESULTS: At baseline, 68 patients (38% male; mean age 34.9 ± 10.3 years) were included. BME was visible at baseline in 24 (35%) patients, all fulfilling the ASAS axSpA criteria. Twenty-three of these 24 patients had a follow-up MRI. Not taking into account the baseline MRI, three (13%) of these 23 patients would no longer fulfil the ASAS criteria during follow-up because of subsiding BME. Forty-four (65%) patients had a negative baseline MRI, of whom 39 had a follow-up MRI available. New BME at follow-up meant that three (8%) of these 39 patients now fulfilled the ASAS criteria. At follow-up, baseline BME lesions subsided completely in 47% of SIJ quadrants (range 33-71%) whereas new BME lesions were detected in 8% of SIJ quadrants (range 2-11%). CONCLUSIONS: BME shows a fluctuating course in patients with early IBP suspected for axSpA. This may have an impact on diagnosis and the overall performance of the ASAS axSpA criteria.
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Dolor de Espalda/patología , Enfermedades de la Médula Ósea/patología , Edema/patología , Articulación Sacroiliaca/patología , Adulto , Dolor de Espalda/diagnóstico , Enfermedades de la Médula Ósea/diagnóstico , Diagnóstico Diferencial , Progresión de la Enfermedad , Edema/diagnóstico , Femenino , Estudios de Seguimiento , Humanos , Estudios Longitudinales , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Espondiloartritis/diagnóstico , Espondiloartritis/patologíaRESUMEN
OBJECTIVES: To evaluate if the mean smallest detectable change (SDC) of multiple time intervals using the Bland & Altman (B&A) levels of agreement (LoA) method is an appropriate surrogate for the generalisability analysis method for estimating the overall SDC of radiological progression in rheumatoid arthritis (RA) trials. Secondly, to compare the SDC based on 95% LoA with the SDC based on 80% LoA, and to investigate the association between SDC and baseline damage and progression. METHODS: Fifteen datasets from randomised controlled trials in RA were scored by 13 experienced readers as pairs according to the modified Sharp/van der Heijde method. The SDC using the 95% and 80% LoA and the generalisability methods was calculated. RESULTS: 21 295 radiographic time points from 7643 patients were included. The mean (range) SDC for the LoA and the generalisability methods was 3.1 (2.3-4.3) and 3.2 (2.3-4.6) units, respectively. The mean ± SD difference between the two methods was -0.13 ± 0.28. The mean SDC including all intervals (n=31) was 3.0 ± 0.7 for 95% LoA and 2.0 ± 0.4 for 80% LoA. No relationship was observed between baseline damage and the SDC, whereas the SDC increased with increasing radiological progression. CONCLUSIONS: The mean of the interval SDCs obtained by the simple LoA method is a valid surrogate for the SDC obtained by complex generalisability methods. The SDC depends on the level of radiographic progression rather than on the level of absolute damage. In addition, the use of an SDC based on 80% rather than on 95% LoA is proposed.
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Artritis Reumatoide/diagnóstico por imagen , Límite de Detección , Análisis de Varianza , Artritis Reumatoide/terapia , Bases de Datos Factuales , Progresión de la Enfermedad , Humanos , Radiografía , Ensayos Clínicos Controlados Aleatorios como Asunto , Reproducibilidad de los Resultados , Resultado del TratamientoRESUMEN
OBJECTIVES: To report the effect of different imputation methodologies on the assessment of radiographic progression in clinical trials. METHODS: The 216-week RAPID-psoriatic arthritis (PsA) (NCT01087788) trial of certolizumab pegol (CZP) in patients with active PsA was double-blind and placebo-controlled until week 24. A primary end point was change from baseline in modified Total Sharp Score(s) (mTSS). Prespecified imputation methodology in patients with fewer than two analysable mTSS used minimum observed baseline score for missing baseline values and maximum observed week 24 score for missing week 24 values. Post hoc analyses used alternative methods of imputation in patients with fewer than two analysable mTSS. mTSS non-progressors were defined as patients with ≤0 (predefined) or ≤0.5 (post hoc) change in mTSS from baseline to week 24. Baseline mTSS and C-reactive protein levels as predictors of radiographic progression were investigated. RESULTS: 409 patients were randomised. Baseline demographics were similar between groups. Prespecified imputation analysis inappropriately overestimated radiographic progression (least squares mean placebo, 28.9; CZP, 18.3; p≥0.05). Multiple post hoc analyses demonstrated that CZP inhibited radiographic progression compared with placebo, particularly in patients with high baseline mTSS and C-reactive protein levels. mTSS non-progression rate was higher in CZP than placebo groups in all analyses. CONCLUSIONS: Inappropriate prespecified imputation methodology resulted in an unrealistic assessment of progression in all arms. Methodologies for imputing missing radiographic data can greatly affect assessment and reporting of mTSS progression.
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Anticuerpos Monoclonales Humanizados/administración & dosificación , Artritis Psoriásica/diagnóstico por imagen , Artritis Psoriásica/tratamiento farmacológico , Monitoreo de Drogas/métodos , Fragmentos Fab de Inmunoglobulinas/administración & dosificación , Inmunosupresores/administración & dosificación , Polietilenglicoles/administración & dosificación , Adulto , Anticuerpos Monoclonales Humanizados/efectos adversos , Certolizumab Pegol , Progresión de la Enfermedad , Método Doble Ciego , Femenino , Humanos , Fragmentos Fab de Inmunoglobulinas/efectos adversos , Inmunosupresores/efectos adversos , Masculino , Persona de Mediana Edad , Placebos , Polietilenglicoles/efectos adversos , Valor Predictivo de las Pruebas , Radiografía , Resultado del TratamientoRESUMEN
OBJECTIVE: To compare the efficacy of etanercept (ETN) and methotrexate (MTX) versus MTX monotherapy for remission induction in patients with early inflammatory arthritis. METHODS: In a 78-week multicentre randomised placebo-controlled superiority trial, 110 DMARD-naïve patients with early clinical synovitis (≥1 tender and swollen joint, and within 3 months of diagnosis) and either rheumatoid factor, anticitrullinated protein antibodies or shared epitope positive were randomised 1:1 to receive MTX+ETN or MTX+placebo (PBO) for 52 weeks. Injections (ETN or PBO) were stopped in all patients at week 52. In those with no tender or swollen joints (NTSJ) for >26 weeks, injections were stopped early. If patients had NTSJ >12 weeks after stopping the injections, MTX was weaned. The primary endpoint was NTSJ at week 52. RESULTS: No statistically significant difference was seen for the primary endpoint (NTSJ at week 52 (32.5% vs 28.1% [adjusted OR 1.32 (0.56 to 3.09), p=0.522]) in the MTX+ETN and MTX+PBO groups, respectively). The secondary endpoints did not differ between groups at week 52 or 78. Exploratory analyses showed a higher proportions of patients with DAS28-CRP<2.6 in the MTX+ETN group at week 2 (38.5% vs 9.2%, adjusted OR 8.87 (2.53 to 31.17), p=0.001) and week 12 (65.1% vs 43.8%, adjusted OR 2.49 (1.12 to 5.54), p=0.026). CONCLUSIONS: In this group of patients with early inflammatory arthritis, almost a third had no tender, swollen joints after 1 year. MTX+ETN was not superior to MTX monotherapy in achieving this outcome. Clinical responses, however, including DAS28-CRP<2.6, were achieved earlier with MTX+ETN combination therapy. TRIAL REGISTRATION NUMBER: The EMPIRE trial is registered on the following trial registries: Eudract-2005-005467-29; ISRCTN 55428162 (http://www.controlled-trials.com/ISRCTN55428162/EMPIRE). The full trial protocol can be obtained from the corresponding author.
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Antirreumáticos/uso terapéutico , Artritis/tratamiento farmacológico , Inmunoglobulina G/uso terapéutico , Metotrexato/uso terapéutico , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Sinovitis/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Artritis/inmunología , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/inmunología , Autoanticuerpos/inmunología , Método Doble Ciego , Quimioterapia Combinada/métodos , Intervención Médica Temprana/métodos , Etanercept , Femenino , Humanos , Quimioterapia de Inducción/métodos , Masculino , Persona de Mediana Edad , Inducción de Remisión/métodos , Factor Reumatoide/inmunología , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: We recently demonstrated that MRI inflammation is prevalent in clinically non-swollen joints of early arthritis patients. In this study, we assessed the relevance of this subclinical inflammation with regard to radiographic progression. METHODS: 1130 joints (unilateral metacarpophalangeal 2-5, wrist and metatarsophalangeal 1-5) of 113 early arthritis patients underwent clinical examination and 1.5â T MRI at baseline, and radiographs at baseline and 1 year. Two readers scored the MRIs for synovitis, bone marrow oedema (BME) and tenosynovitis according to Rheumatoid Arthritis (RA) Magnetic Resonance Imaging (MRI) Scoring System (RAMRIS). Radiographic progression over 1 year was determined using the Sharp-van der Heijde scoring method. RESULTS: On patient level, BME, synovitis and tenosynovitis were associated with radiographic progression, independent of known risk factors (p=0.003, 0.001 and 0.011, respectively). Of all non-swollen joints (n=932), 232 joints (26%) had subclinical inflammation (≥1 MRI-inflammation feature present). These joints were distributed among 91% of patients. Radiographic progression was present in 4% of non-swollen joints with subclinical inflammation compared to 1% of non-swollen joints without subclinical inflammation (relative risks (RR) 3.5, 95% CI 1.3 to 9.6). Similar observations were done for BME (RR5.3, 95% CI 2.0 to 14.0), synovitis (RR3.4, 95% CI 1.2 to 9.3) and tenosynovitis (RR3.0, 95% CI 0.7 to 12.7) separately. CONCLUSIONS: Radiographic progression was infrequent, but joints with subclinical inflammation had an increased risk of radiographic progression within year 1. This demonstrates the relevance of MRI-detected subclinical inflammation.
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Artritis Reumatoide/diagnóstico , Inflamación/diagnóstico , Adulto , Anciano , Artritis Reumatoide/complicaciones , Artritis Reumatoide/diagnóstico por imagen , Enfermedades de la Médula Ósea/diagnóstico , Enfermedades de la Médula Ósea/etiología , Progresión de la Enfermedad , Diagnóstico Precoz , Edema/diagnóstico , Edema/etiología , Femenino , Estudios de Seguimiento , Humanos , Inflamación/etiología , Imagen por Resonancia Magnética/métodos , Masculino , Articulación Metacarpofalángica/diagnóstico por imagen , Articulación Metacarpofalángica/patología , Persona de Mediana Edad , Pronóstico , Radiografía , Índice de Severidad de la Enfermedad , Sinovitis/diagnóstico , Sinovitis/etiología , Tenosinovitis/diagnóstico , Tenosinovitis/etiología , Articulación de la Muñeca/diagnóstico por imagen , Articulación de la Muñeca/patologíaRESUMEN
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.