Body Mass Index and Disease Activity in Chronic Inflammatory Rheumatic Diseases: Results of the Cardiovascular in Rheumatology (Carma) Project.

OBJECTIVE: Since obesity has been associated with a higher inflammatory burden and worse response to therapy in patients with chronic inflammatory rheumatic diseases (CIRD), we aimed to confirm the potential association between body mass index (BMI) and disease activity in a large series of patients with CIRDs included in the Spanish CARdiovascular in rheuMAtology (CARMA) registry. METHODS: Baseline data analysis of patients included from the CARMA project, a 10-year prospective study of patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) attending outpatient rheumatology clinics from 67 Spanish hospitals. Obesity was defined when BMI (kg/m2) was >30 according to the WHO criteria. Scores used to evaluate disease activity were Disease Activity Score of 28 joints (DAS28) in RA, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in AS, and modified DAS for PsA. RESULTS: Data from 2234 patients (775 RA, 738 AS, and 721 PsA) were assessed. The mean ± SD BMI at the baseline visit were: 26.9 ± 4.8 in RA, 27.4 ± 4.4 in AS, and 28.2 ± 4.7 in PsA. A positive association between BMI and disease activity in patients with RA (ß = 0.029; 95%CI (0.01- 0.05); p = 0.007) and PsA (ß = 0.036; 95%CI (0.015-0.058); p = 0.001) but not in those with AS (ß = 0.001; 95%CI (-0.03-0.03); p = 0.926) was found. Disease activity was associated with female sex and rheumatoid factor in RA and with Psoriasis Area Severity Index and enthesitis in PsA. CONCLUSIONS: BMI is associated with disease activity in RA and PsA, but not in AS. Given that obesity is a potentially modifiable factor, adequate control of body weight can improve the outcome of patients with CIRD and, therefore, weight control should be included in the management strategy of these patients.

Digestive involvement in primary Sjögren's syndrome: analysis from the Sjögrenser registry.

OBJECTIVES: Digestive involvement (DI) has been reported in 10-30% of primary Sjögren's syndrome (pSS) patients, and few studies have systematically analysed the prevalence of DI in pSS patients. The aim of this study was to describe DI prevalence in pSS patients from the Sjögrenser Study, and to analyse its clinical associations. METHODS: All patients included in the Sjögrenser study, a Spanish multicentre randomised cohort, containing demographic, clinical and histologic data, have been analysed retrospectively. Patients were classified according to the presence of DI (oesophageal, gastric, intestinal, hepatic and pancreatic), and we have performed DI clinical associations, descriptive statistics, Student t or χ2 test, and uni and multivariate logistic regression. RESULTS: From 437 included patients, 95% were women, with a median age of 58 years, 71 (16.2%) presented DI: 21 (29.5%) chronic atrophic gastritis, 12 (16.9%) oesophageal motility dysfunction, 3 (4.2%) lymphocytic colitis, 18 (25.3%) primary biliary cholangitis, 15 (21.1%) autoimmune hepatitis, 7 (9.8%) pancreatic involvement and 5 (7%) coeliac disease. Half of them developed DI at the same time or after pSS diagnosis. Patients with DI were significantly older at pSS diagnosis (p=0.032), more frequently women (p=0.009), presented more autoimmune hypothyroidism and C3 hypocomplementaemia (p=0.040), and were treated more frequently with glucocorticoids, immunosuppressant and biologic therapies. Patients with pancreatic involvement presented more central nervous system and renal involvement, Raynaud's phenomenon, lymphoma and C3/C4 hypocomplementaemia. CONCLUSIONS: DI is frequent in Sjögrenser patients, mainly in the form of autoimmune disorders, and seem to be associated with a more severe phenotype. Our results suggest that DI should be evaluated in pSS patients, especially those with more severe disease.

Prevalence and factors associated with osteoporosis and fragility fractures in patients with primary Sjögren syndrome.

This study aimed at determining socio-demographic and clinical factors of primary Sjögren syndrome (pSS) associated with osteoporosis (OP) and fragility fracture. SJOGRENSER is a cross-sectional study of patients with pSS, classified according to American European consensus criteria developed in 33 Spanish rheumatology departments. Epidemiological, clinical, serological and treatment data were collected and a descriptive analysis was conducted. Bivariate and multivariate analyses were performed using a binomial logistic regression to study the factors associated with OP and fragility fracture in pSS. 437 patients were included (95% women, with a median age of 58.6 years). 300 women were menopausal (76.4%). Prevalence of OP was 18.5% [in men (N = 21) this measured 19%]. A total of 37 fragility fractures were recorded. In the multivariate analysis, there was an association between OP and age: in the 51-64 age range (menopausal women), the OR measured 9.993 (95% CI 2301-43,399, p = 0.002); In the age > 64 years group, OR was 20.610 (4.679-90.774, p < 0.001); between OP and disease duration, OR was 1.046 (1.008-1085, p = 0.017); past treatment with corticosteroids, OR 2.548 (1.271-5.105, p = 0.008). Similarly, an association was found between fragility fractures and age: in the 51-64 age group, OR measured 5.068 (1.117-22,995, p = 0.035), age > 64 years, OR was 7.674 (1.675-35,151, p < 0.009); disease duration, OR 1.049 (CI 1.003-1097, p < 0.036) and the ESSDAI index, OR 1.080 (1.029-1134, p = 0.002). Patients with pSS can develop osteoporosis and fragility fractures over the course of the disease. Age, corticosteroids treatment and disease duration were associated with the development of OP. Disease duration and ESSDAI were associated with the development of fractures in patients with pSS.

Biologic therapy in severe and refractory peripheral ulcerative keratitis (PUK). Multicenter study of 34 patients.

PURPOSE: We assessed the efficacy and safety of biologic therapy in severe and refractory Peripheral Ulcerative Keratitis (PUK). DESIGN: Open-label multicenter study of biologic-treated patients with severe PUK refractory to conventional immunosuppressive drugs. SUBJECTS: We studied 34 patients (44 affected eyes) (24 women/10 men; mean age, 55.26±17.4 years). PUK was associated with a well-defined condition in 29 of them (rheumatoid arthritis [n = 20], psoriatic arthritis [n = 2], inflammatory bowel disease [n = 2], Behçet disease [n = 1], granulomatosis with polyangiitis [n = 1], microscopic polyangiitis [n = 1], systemic lupus erythematosus [n = 1] and axial spondyloarthritis [n = 1]). Besides topical and oral systemic glucocorticoids, patients had received: methylprednisolone pulses [n = 9], and conventional immunosuppressive drugs, mainly methotrexate [n = 18], and leflunomide [n = 7]. Eleven patients had required ocular surgery prior to biologic therapy. METHODS: Following biologic therapy, baseline main outcomes were compared with those found at 1st week, 1st and 6th months and 1st year. MAIN OUTCOME MEASURES: Efficacy and safety of biologic therapy. Efficacy was analyzed by the assessment of corneal inflammation (corneal thinning, central keratolysis and ocular perforation); other causes of ocular surface inflammation (scleritis, episcleritis); intraocular inflammation (uveitis); visual acuity and glucocorticoid sparing effect. RESULTS: The first biologic agents used were anti-TNFα drugs (n = 25); adalimumab (n = 16), infliximab (n = 8), etanercept (n = 1), and non-TNFα agents (n = 9); rituximab (n = 7), tocilizumab (n = 1) belimumab (n = 1) and abatacept (n = 1). During the follow-up, switching to a second biologic agent was required in 12 of the 25 (48%) patients treated with anti-TNFα drugs. However, no switching was required in those undergoing biologic therapy different from anti-TNFα agents. The main outcome variables showed a rapid and maintained improvement after a mean follow-up of 23.7 ± 20 months. Major adverse effects were tachyphylaxis, relapsing respiratory infections, supraventricular tachycardia, pulmonary tuberculosis and death, one each. CONCLUSIONS: Biologic therapy is effective and relatively safe in patients with severe and refractory PUK. Non-anti-TNFα agents appear to be effective in these patients.

Association of apolipoprotein B/apolipoprotein A1 ratio and cardiovascular events in rheumatoid arthritis: results of the CARMA study.

OBJECTIVES: To assess the plasma apolipoprotein B/apolipoprotein A1 ratio and its potential association with cardiovascular events (CVE) in patients with rheumatoid arthritis (RA). METHODS: A baseline analysis was made of the CARdiovascular in rheuMAtology Project (CARMA), a 10-year prospective study evaluating the presence of at least one CVE in 775 Spanish patients with RA. Of them, 29 had already experienced CVE prior to the inclusion in the study. We assessed the association between the elevation of the apoB/apoA1 ratio with the presence of CVE according to a logistic regression model for possible confounding factors. We also analysed the main parameters of activity of RA and parameters related to lipid metabolism. RA patients were classified according to treatment: patients treated with disease-modifying anti-rheumatic drugs without biologics and those undergoing biologic therapy (anti-TNF-α, anti-IL-6 receptor, and other biologic agents). RESULTS: The apoB/apoA1 ratio of patients who had experienced CVE was higher than that of patients without previous CVE (0.65 vs. 0.60). However, the difference between both subgroups did not reach statistical significance (p=0.197). It was also the case after the multivariate analysis [OR: 1.48 (95% CI: 0.15-14.4); p=0.735]. RA patients from the group with CVE were more commonly receiving lipid-lowering treatment with statins than those without CVE history (41.4% vs. 20%, p=0.005). High HAQ and high atherogenic index were significantly associated with the presence of CVE. There was no statistical association between the type of biologic therapy used in RA and the presence of CVE. CONCLUSIONS: No association between ApoB/apoA1 ratio and CVE was found at the baseline visit of patients with RA from the CARMA study.

Incidence of first cardiovascular event in Spanish patients with inflammatory rheumatic diseases: prospective data from the CARMA project.

OBJECTIVES: To determine the incidence and risk factors of first cardiovascular event (CVE) in patients with chronic inflammatory rheumatic diseases (CIRD). METHODS: Analysis of data after 2.5 years of follow-up from the prospective study CARMA project, that includes patients with CIRD [rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)] and matched individuals without CIRD from 67 hospitals in Spain. CVE cumulative incidence per 1000 patients was calculated after 2.5 years from the start of the project. Weibull proportional hazard model was used to calculate hazard ratio (HR) and 95% confidence interval (95% CI) of the risk factors. RESULTS: 2595 (89.1%) patients completed the 2.5 years of follow-up visit. Cumulative incidence of CVE in patients with CIRD was 15.30 cases per 1000 patients (95% CI: 12.93-17.67), being higher in the subgroup with AS; 22.03 (95% CI: 11.01-33.04). Patients with AS (HR: 4.11; 95% CI: 1.07-15.79), those with older age (HR: 1.09; 95% CI: 1.05-1.13), systolic hypertension (HR: 1.02; 95% CI: 1.00-1.04) and long duration of the disease (HR: 1.07; 95% CI: 1.03-1.12) were at higher risk of first CVE during the 2.5 years of follow-up. In contrast, female gender was a protective factor (HR: 0.43; 95% CI: 0.18-1.00). CONCLUSIONS: Among CIRD patients prospectively followed-up at rheumatology outpatient clinics, those with AS show higher risk of first CVE. Besides cardiovascular risk factors, such as hypertension, being a man and older as well as having a long disease duration increase the risk of CVE in patients with CIRD.

Comorbidities in Patients With Primary Sjögren's Syndrome and Systemic Lupus Erythematosus: A Comparative Registries-Based Study.

OBJECTIVE: To compare the prevalence of the main comorbidities in 2 large cohorts of patients with primary Sjögren's syndrome (SS) and systemic lupus erythematosus (SLE), with a focus on cardiovascular (CV) diseases. METHODS: This was a cross-sectional multicenter study where the prevalence of more relevant comorbidities in 2 cohorts was compared. Patients under followup from SJOGRENSER (Spanish Rheumatology Society Registry of Primary SS) and RELESSER (Spanish Rheumatology Society Registry of SLE), and who fulfilled the 2002 American-European Consensus Group and 1997 American College of Rheumatology classification criteria, respectively, were included. A binomial logistic regression analysis was carried out to explore potential differences, making general adjustments for age, sex, and disease duration and specific adjustments for each variable, including CV risk factors and treatments, when appropriate. RESULTS: A total of 437 primary SS patients (95% female) and 2,926 SLE patients (89% female) were included. The mean age was 58.6 years (interquartile range [IQR] 50.0-69.9 years) for primary SS patients and 45.1 years (IQR 36.4-56.3 years) for SLE patients (P < 0.001), and disease duration was 10.4 years (IQR 6.0-16.7 years) and 13.0 years (IQR 7.45-19.76 years), respectively (P < 0.001). Smoking, dyslipidemia, and arterial hypertension were associated less frequently with primary SS (odds ratio [OR] 0.36 [95% confidence interval (95% CI) 0.28-0.48], 0.74 [95% CI 0.58-0.94], and 0.50 [95% CI 0.38-0.66], respectively) as were life-threatening CV events (i.e., stroke or myocardial infarction; OR 0.57 [95% CI 0.35-0.92]). Conversely, lymphoma was associated more frequently with primary SS (OR 4.41 [95% CI 1.35-14.43]). The prevalence of severe infection was lower in primary SS than in SLE (10.1% versus 16.9%; OR 0.54 [95% CI 0.39-0.76]; P < 0.001). CONCLUSION: Primary SS patients have a consistently less serious CV comorbidity burden and a lower prevalence of severe infection than those with SLE. In contrast, their risk of lymphoma is greater.

Adherence to biologic therapies and associated factors in rheumatoid arthritis, spondyloarthritis and psoriatic arthritis: a systematic literature review.

OBJECTIVES: To analyse the evidence on adherence to biologic therapies in rheumatoid arthris (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA). METHODS: Systematic review of studies retrieved by a sensitive search strategy in MEDLINE database (1961 through March 2012). To be selected, studies had to include patients with RA, SpA, or PsA, treatment with intravenous or subcutaneous biologic therapies, and had to report on measures of adherence. By design, only randomised controlled trials (RCT) or high quality cohort studies with a control group were selected. RESULTS: A total of 24 studies were included, of which 12 reported results from national or local biologic registers, 9 were retrospective studies, 2 prospective studies, and only one was an RCT. Patients included were mostly women with diagnosis of RA or SpA and, less frequently, PsA. There was a great variability in the definition of adherence, measurement methods, and associated factors analysed. In general, adherence to etanercept was superior to that of other biologics, by the measures utilised. The main predictive factors - age, sex, comorbidity, baseline clinical condition, previous or concomitant use of DMARDs, anti-TNF in monotherapy or in combination with MTX - produced diverse, even divergent results across studies. CONCLUSIONS: There is a wide variability related to the adherence concept and its measurement, reflecting the complexity of the phenomenon. In order to draw more consistent conclusions about the relative value of predictive factors on adherence and persistence of biological therapy, larger controlled studies with better selection of variables and analysis of interactions are needed.

Variability in the prescription of non-biologic disease-modifying antirheumatic drugs for the treatment of spondyloarthritis in Spain.

OBJECTIVE: To describe the variability in the prescription of non-biologic disease-modifying antirheumatic drugs (nbDMARDs) for the treatment of spondyloarthritis (SpA) in Spain and to explore which factors relating to the disease, patient, physician, and/or center contribute to these variations. METHODS: A retrospective medical record review was performed using a probabilistic sample of 1168 patients with SpA from 45 centers distributed in 15/19 regions in Spain. The sociodemographic and clinical features and the use of drugs were recorded following a standardized protocol. Logistic regression, with nbDMARDs prescriptions as the dependent variable, was used for bivariable analysis. A multilevel logistic regression model was used to study variability. RESULTS: The probability of receiving an nbDMARD was higher in female patients [OR = 1.548; 95% confidence interval (CI): 1.208-1.984], in those with elevated C-reactive protein (OR = 1.039; 95% CI: 1.012-1.066) and erythrocyte sedimentation rate (OR = 1.012; 95% CI: 1.003-1.021), in those with a higher number of affected peripheral joints (OR = 12.921; 95% CI: 2.911-57.347), and in patients with extra-articular manifestations like dactylitis (OR = 2.997; 95% CI: 1.868-4.809), psoriasis (OR = 2.601; 95% CI: 1.870-3.617), and enthesitis (OR = 1.717; 95% CI: 1.224-2.410). There was a marked variability in the prescription of nbDMARDs for SpA patients, depending on the center (14.3%; variance 0.549; standard error 0.161; median odds ratio 2.366; p < 0.001). After adjusting for patient and center variables, this variability fell to 3.8%. CONCLUSION: A number of factors affecting variability in clinical practice, and which are independent of disease characteristics, are associated with the probability of SpA patients receiving nbDMARDs in Spain.

Ojo rojo como manifestación primaria de vasculitis sistémica / Red eye as the primary manifestation of Wegener’s granulomatosis

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¿Se derivan adecuadamente las espondiloartropatías desde primaria a especializada? / Are spondyloarthropathies adequately referred from primary care to specialized care?

Objetivo. Evaluar el grado de acuerdo entre los médicos de atención primaria (MAP) y los reumatólogos en la valoración de los criterios de derivación en pacientes con sospecha de espondiloartritis (EspA) precoz. Material y métodos. Se derivaron los pacientes con sospecha de EspA precoz, a través de la plataforma electrónica, por MAP siguiendo unos criterios de derivación predeterminados a Unidades de EspA precoz, donde fueron de nuevo evaluados por reumatólogos y confirmados los diagnósticos. Se ha analizado la concordancia de los criterios de derivación predeterminados entre MAP y reumatólogos mediante el índice kappa (k) en aquellos pacientes con diagnóstico de EspA precoz. Resultados. Analizamos 802 pacientes, de los que el 8,31% fueron mal derivados. El grado de acuerdo en relación con criterios de derivación predeterminados fue pobre para la lumbalgia inflamatoria (k=0,16; intervalo de confianza del 95% [IC 95%] 0,09-0,23), sacroilitis radiológica (k=0,31; IC 95% 0,211-0,428), raquialgia o artralgia (k=0,21; IC 95% 0,14-0,29); moderado para el criterio de artritis asimétrica (k=0,51; IC 95% 0,43-0,59), HLA B27 positivo (k=0,59; IC 95% 0,52-0,67) e historia familiar (k=0,50; IC 95% 0,415-0,604). Los grados de acuerdo fueron buenos o muy buenos para la presencia de uveítis anterior (k=0,81; IC 95% 0,68-0,93), enfermedad inflamatoria intestinal (k=0,87; IC 95% 0,79-0,96) y psoriasis (k=0,73; IC 95% 0,65-0,81). Conclusiones. El grado de acuerdo entre MAP y reumatólogos respecto a la valoración de los criterios preestablecidos para derivación de EspA precoz es variable. La concordancia es baja para criterios de derivación clave para el diagnóstico de pacientes con EspA. Facilitar programas de formación y entrenamiento para MAP resulta fundamental para identificar a pacientes con EspA precoz (AU)

Objective: To evaluate the degree of agreement between primary care physicians and rheumatologists when evaluating the referral criteria in patients with suspected early spondyloarthropathy (Spa). Material and methods: Patients with suspected early Spa (according to predefined clinical referral criteria) were sent by primary care physicians to early Spa units (where a rheumatologist evaluated the same criteria and confirmed the diagnosis) through an on-line platform. We assessed the agreement between primary care physicians and rheumatologists regarding the predefined clinical refererral criteria among patients with definitive Spa using the kappa index (k). Results: Eight hundred and two patients were analysed, 8.31% of whom were incorrectly referred to the rheumatologist. The degree of agreement regarding the predefined clinical referral criteria was poor for inflammatory back pain (k = 0.16; 95% confidence interval [95% CI] 0.09-0.23), radiographic sacroiliitis (k = 0.31; 95% CI 0.211-0.428), back or joint pain (k = 0.21; 95% CI 0.14-0.29); mild for asymmetric arthritis (k = 0.51; 95% CI 0.43-0.59), positive HLA B27 (k = 0.59; 95% CI 0.52-0.67) and family history (k = 0.50; 95% CI 0.415-0.604); and it was good or very good for anterior uveitis (k = 0.81; 95% CI 0.68-0.93), inflammatory bowel disease (k = 0.87; 95% CI 0.79-0.96) and psoriasis (k = 0.73; 95% CI 0.65-0.81),. Conclusions: The degree of agreement between primary care physicians and rheumatologists regarding the predefined clinical referral criteria was variable. Agreement was very poor for variables like inflammatory back pain, which are crucial for the diagnosis of Spa. Training programs for primary care physicians are important in order for them to correctly identify early Spa patients (AU)

Are spondyloarthropathies adequately referred from primary care to specialized care?

OBJECTIVE: To evaluate the degree of agreement between primary care physicians and rheumatologists when evaluating the referral criteria in patients with suspected early spondyloarthropathy (Spa). MATERIAL AND METHODS: Patients with suspected early Spa (according to predefined clinical referral criteria) were sent by primary care physicians to early Spa units (where a rheumatologist evaluated the same criteria and confirmed the diagnosis) through an on-line platform. We assessed the agreement between primary care physicians and rheumatologists regarding the predefined clinical referral criteria among patients with definitive Spa using the kappa index (k). RESULTS: Eight hundred and two patients were analysed, 8.31% of whom were incorrectly referred to the rheumatologist. The degree of agreement regarding the predefined clinical referral criteria was poor for inflammatory back pain (k=0,16; 95% confidence interval [95% CI] 0,09-0,23), radiographic sacroiliitis (k=0,31; 95% CI 0,211-0,428), back or joint pain (k=0,21; 95% CI 0,14-0,29); mild for asymmetric arthritis (k=0,51; 95% CI 0,43-0,59), positive HLA B27 (k=0,59; 95% CI 0,52-0,67) and family history (k=0,50; 95% CI 0,415-0,604); and it was good or very good for anterior uveitis (k=0,81; 95% CI 0,68-0,93), inflammatory bowel disease (k=0,87; 95% CI 0,79-0,96) and psoriasis (k=0,73; 95% CI 0,65-0,81),. CONCLUSIONS: The degree of agreement between primary care physicians and rheumatologists regarding the predefined clinical referral criteria was variable. Agreement was very poor for variables like inflammatory back pain, which are crucial for the diagnosis of Spa. Training programs for primary care physicians are important in order for them to correctly identify early Spa patients.

Fibromyalgia Health Assessment Questionnaire, evaluación de la sensibilidad al cambio

Objetivo. Analizar la sensibilidad al cambio del cuestionario Fibromyalgia Health Assessment Questionnaire (FHAQ) en un grupo de pacientes con fibromialgia (FM). Métodos. Estudio observacional, prospectivo longitudinal, incluido en el Proyecto ICAF (Índice combinado de afectación en pacientes con fibromialgia), realizado en 15 centros españoles. Se estudió de forma consecutiva a 232 pacientes con FM con una edad media de 47 años, el 98,3% mujeres, que se evaluaron en una visita basal y 3 meses después de que se les instaurara un tratamiento según práctica médica habitual. El análisis estadístico incluyó: comparación de medias, respuesta media estandarizada (RME), medida basal estándar (DE), coeficiente de correlación intraclase (R), error estándar de medida (EEM), diferencia mínima detectable (DMD) y proporción de cambio real. Resultados. La diferencia de puntuación media del FHAQ en la visita basal y a los 3 meses fue de 0,098 (IC del 95%, 0,034-0,16) con una p<0,003. Sin embargo, la RME fue de 0,21 (cambio pequeño); DE=0,57, R=0,81, EEM=0,25, DMD=0,69. La proporción de cambio real fue del 17% (39 pacientes). No obstante, el sentido del cambio fue positivo en 28 casos (menor puntuación a los 3 meses) y negativo en los otros 11 (mayor puntuación a los 3 meses). Conclusiones. La puntuación a los 3 meses fue significativamente mejor que la basal, pero con los resultados de este estudio no se puede considerar que el FHAQ sea suficientemente sensible al cambio como para recomendar su uso en estudios longitudinales. El hecho, conocido, de que muchos pacientes pueden empeorar con el tratamiento empleado ha ido en detrimento de la valoración psicométrica del FHAQ (AU)

Objective. To analyze the sensitivity to change of the Fibromyalgia Health Assessment Questionnaire (FHAQ) in a group of patients with fibromyalgia (FM). Methods. Observational, prospective and longitudinal study related to the project ICAF was taken part in 15 Spanish centers. 232 patients were included and diagnosed of FM: 98.3% were women, the mean age was 47years old, they were analyzed at a basal visit and 3months visit, afterwards an appropriated treatment was prescribed. The statistical analysis was performed including: mean comparison, mean standardized response (RME), basal standard media (DE), intraclass correlation coefficient (R), standard error of the mean (EEM), minimal detectable difference (DMD) and percentage change in real. Results. The difference in mean comparison of the FHAQ in the baseline visit and the 3monts visit was of 0,098 (IC 95%: 0,034-0,16), with a P<.003. Nevertheless the RME was 0.21, a slightly change, the DE=0.57, R=0.81, EEM=0.25, and the DMD=0.69. The percentage change in real was 17% (39 patients). But the sense of the change was positive in 28cases (less punctuation in the 3monts visit) and negative in other 11cases (higher punctuation in the 3monts visit). Conclusions. The punctuation in the 3months visit was significant better than the basal, but the results of this study do not let it to consider that the FHAQ have enough change susceptibility to recommend it in longitudinal studies. The well knowing fact, some patients can become worse with the treatment prescribed would be to the detriment of the FHAQ psychometric value (AU)

Fibromyalgia Health Assessment Questionnaire: sensitivity to change.

OBJECTIVE: To analyze the responsiveness of the Fibromyalgia Health Assessment Questionnaire (FHAQ) in a group of patients with fibromyalgia (FM). METHODS: Observational, prospective and longitudinal study related to the project ICAF was taken part in 15 Spanish centers. 232 patients were included and diagnosed of FM: 98.3% were women, the mean age was 47 years old, they were analyzed at a basal visit and 3 months visit, afterwards an appropriated treatment was prescribed. The statistical analysis was performed including: mean comparison, mean standardized response (RME), basal standard media (DE), intraclass correlation coefficient (R), standard error of the mean (EEM), minimal detectable difference (DMD) and percentage change in real. RESULTS: The difference in mean comparison of the FHAQ in the baseline visit and the 3 months visit was of 0.098 (95% CI: 0.034­0.16), with a P<.003. Nevertheless the RME was 0.21, a slightly change, the DE=0.57, R=0.81, EEM=0.25, and the DMD=0.69. The percentage change in real was 17% (39 patients). But the sense of the change was positive in 28 cases (less punctuation in the 3 months visit) and negative in other 11 cases (higher punctuation in the 3 months visit). CONCLUSIONS: The punctuation in the 3 months visit was significant better than the basal, but the results of this study do not let it to consider that the FHAQ have enough change susceptibility to recommend it in longitudinal studies. The well knowing fact, some patients can become worse with the treatment prescribed would be to the detriment of the FHAQ psychometric value.

Disminución del tiempo hasta el primer tratamiento con fármacos modificadores de la enfermedad en pacientes con artritis reumatoide / Reduction in time until first treatment with disease modifying treatment in patients with rheumatoid arthritis

Objetivo: Analizar el cambio en el tiempo hasta el primer tratamiento con fármacos modificadores de la enfermedad (FAME) desde el inicio de los síntomas en pacientes diagnosticados de artritis reumatoide (AR) a lo largo de dos décadas en España. Pacientes y método: Revisión de historias clínicas de 865 pacientes diagnosticados de AR atendidos en centros de atención especializada del Sistema Nacional de Salud en España. La variable principal fue el tiempo desde el inicio de los síntomas de la AR hasta la fecha del inicio del primer tratamiento con algún FAME. Las diferencias por año desde el inicio de los síntomas o agrupaciones de 5 años se compararon mediante la prueba de la 2 , la t de Student y el análisis de la variancia. Resultados: Las características clínicas y sociodemográficas se correspondieron con las típicas de una muestra de corte transversal de pacientes diagnosticados de AR. La mediana del tiempo desde el inicio de los síntomas y el primer tratamiento con FAME fue de 14 (6-36) meses para el conjunto de la muestra. Se observó, sin embargo, una reducción significativa del tiempo hasta el primer FAME en las últimas dos décadas (–4,59 ± 0,2 meses por año entre 1980 y 2000; p < 0,0001). Esta disminución se debió principalmente a una reducción en el tiempo hasta la primera visita con un especialista desde el inicio de los síntomas, con una reducción comparativamente menor en el tiempo entre la primera visita y la primera prescripción del FAME. Conclusiones: Entre los años 1980 y 2000 se ha producido en España una disminución muy significativa en el tiempo que tardan los pacientes con AR en recibir su primer FAME, motivada principalmente por una reducción en el tiempo de acceso al especialista que prescribe estos tratamientos (AU)

Objective: To analyze changes in the lag time to first disease modifying antirheumatic drug (DMARD) prescription since onset of symptoms of rheumatoid arthritis (RA) over the last 2 decades in Spain. Patients and method: Review of medical records of 865 patients diagnosed with RA living in Spain and attended in specialty care settings of the National Health System. The principal variable was the lag time between the onset of symptoms of RA and the date of first DMARD therapy prescription. Analyses were performed by year and five-year periods and differences between groups were assessed by 2 test, Student t test and analysis of variance. Results: Sociodemographic and clinical characteristics corresponded to a typical cross-sectional population of patients diagnosed with RA. The median lag time between symptom onset and first DMARD therapy was 14 months (6-36) for the whole group. However, a significant shortening of time to first DMARD was observed over the last two decades (–4.59 ± 0.2 months by year; P< 001). Shortening of time to first DMARD was mainly due to a shortening of time to first visit with specialists since onset of symptoms with a smaller decrease in time from first visit to first prescription of a DMARD agent. Conclusions: A significant shortening in the lag time to first DMARD therapy was observed over the last 2 decades in Spain, being a significant reduction in the time to first visit with a specialists its major cause (AU)