Replication of PTPRC as genetic biomarker of response to TNF inhibitors in patients with rheumatoid arthritis.

Genetic biomarkers could be useful for orienting treatment of patients with rheumatoid arthritis (RA), but none has been convincingly validated yet. Putative biomarkers include 14 single nucleotide polymorphisms that have shown association with response to TNF inhibitors (TNFi) in candidate gene studies and that we assayed here in 755 RA patients. Three of them, in the PTPRC, IL10 and CHUK genes, were significantly associated with response to TNFi. The most significant result was obtained with rs10919563 in PTPRC, which is a confirmed RA susceptibility locus. Its RA risk allele was associated with improved response (B=0.33, P=0.006). This is the second independent replication of this biomarker (P=9.08 × 10(-8) in the combined 3003 RA patients). In this way, PTPRC has become the most replicated genetic biomarker of response to TNFi. In addition, the positive but weaker replication of IL10 and CHUK should stimulate further validation studies.

A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project.

OBJECTIVE: AMELIA (OsteoArthritis Modifying Effects of Long-term Intra-articular Adant) was designed to compare against placebo the efficacy and safety of repeated injections of hyaluronic acid (HA) and its effect on disease progression over 40 months. METHODS: A multicentre, randomised, patient and evaluator-blinded, controlled study in 306 patients fulfilling American College of Rheumatology criteria for knee osteoarthritis, radiological grades II-III (Kellgren-Lawrence) and joint space width ≥ 2 mm. Patients received four cycles of five intra-articular HA or placebo injections with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles. Osteoarthritis Research Society International (OARSI) 2004 responder criteria were used to assess efficacy. The consumption of rescue medication was a secondary outcome. Adverse events were recorded for safety purposes. RESULTS: At the 40-month visit significantly more patients responded to HA compared with placebo (OARSI 2004, p=0.004). The number of responders to HA increased through the study, whereas those to placebo did not change. Significant differences were also found in favour of HA for each individual component of the OARSI 2004. No safety problems were recorded. CONCLUSIONS: The results of AMELIA offer pioneer evidence that repeated cycles of intra-articular injections of HA not only improve knee osteoarthritis symptoms during the in-between cycle period but also exert a marked carry-over effect for at least 1 year after the last cycle. In this respect, it is not possible to establish if this carry-over effect reflects true osteoarthritis remission or just a modification of the disease's natural course. ClinicalTrials.gov number, NCT00669032.

Dose escalation of the anti-TNF-alpha agents in patients with rheumatoid arthritis. A systematic review.

OBJECTIVE: To estimate the proportion of rheumatoid arthritis (RA) patients on anti-tumour necrosis factor (anti-TNF) who require dose escalation. METHODS: Systematic review of the scientific literature. Infliximab, etanercept and adalimumab studies in RA were considered. Primary outcome was the proportion of patients requiring dose escalation. American College Rheumatology (ACR) and Disease activity score (DAS) responses post-escalation were assessed when available. RESULTS: From 1801 references, 16 studies with 8510 patients were included. Of all the infliximab patients, 53.7% underwent dose escalation. Fourty-four per cent of the infliximab patients experienced dose increase and 8.3%, frequency increase. The ACR20 response to dose escalation ranged from 27 to 36% and DAS28 improved from 5.2 to 4.5 in one study and from 4.1 to 3.7 in another. Of the etanercept patients, 17.5% experienced a dose increase but changes on the mean dose were not statistically significant. CONCLUSIONS: Dose escalation is common in patients treated with infliximab, and less frequent with etanercept. In a proportion of patients, the dose escalation seems effective. The design and evidence level of the available studies limit the strength of the conclusions.

Adaptación transcultural y validación de una versión en español de un instrumento específico para medir calidad de vida relacionada con la salud en pacientes con espondilitis anquilosante: el ASQoL / Cross-cultural adaptation and validation of a Spanish version of a specific instrument to measure health-related quality of life in patients with ankylosing spondylitis

Objetivo: Adaptación transcultural y validación de la versión en español del Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL). Pacientes y métodos: Estudio transversal con prueba testretest. Se incluyeron pacientes con espondilitis anquilosante (EA). Se realizó adaptación transcultural de la versión original del ASQoL mediante traducción y retrotraducción. Se estudiaron validez de constructo, consistencia interna, reproducibilidad y factibilidad. El análisis estadístico se realizó con el coeficiente de correlación de Spearman, la pruebas U de Mann- Whitney y Kruskal-Wallis, el coeficiente alfa de Cronbach y el estadístico kappa. Resultados: Se incluyeron 54 pacientes, 37 (68,5%) varones, con edad (promedio ± DE) 40,5 ± 10,5 años. El ASQoL tuvo una puntuación de 6,8 ± 4,7 (mediana, 7; intervalo, 0-17) y presentó correlaciones altas con los componentes globales físico (rho = 0,79) y mental (0,69) del SF-36 y con los dominios de dolor (0,82), vitalidad (0,75) y rol físico (0,68), así como con la mayoría de variables representativas de la EA. Las puntuaciones del ASQoL fueron significativamente diferentes entre los pacientes con distintos niveles de respuesta en el perfil de salud del EuroQol. El ASQoL tuvo un coeficiente alfa de Cronbach de 0,86. La prueba test-retest se realizó en 10 pacientes con un intervalo de 24 h y tuvo una kappa entre 1 (12 preguntas) y 0,57 (1 pregunta) con rho de 0,98 para las puntuaciones globales. El tiempo empleado osciló entre 2 y 5 min. Conclusiones: La versión en español del ASQoL es válida, fiable y factible de aplicar en nuestro medio para medir la calidad de vida de los pacientes con EA(AU)

Objective: To make a cross-cultural adaptation and validation of a version in Spanish of the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) for assessing the health-related quality of life (HRQL) of patients with Ankylosing Spondylitis (AS). Patients and methods: A cross-sectional study with test-retest. AS patients (modified New York criteria) were included. Cross-cultural adaptation was done. Construct validity was assessed comparing the ASQoL scores with the SF-36 and EuroQol scores and diseaserelated variables. Internal consistency and reliability (test-retest) were assessed. Feasibility was assessed by the time spent to complete the questionnaire and the number of items without answer. Spearman correlation coefficient, Mann-Whitney U test, and Kruskal-Wallis test were used in the statistical analysis. Cronbach´alpha coefficient and statistic kappa were used for assessing internal consistency and reliability. Results: Fifty-four patients, 37 males (68.5%), with age (mean±SD) 40.5 ± 10.5 years, were included. The ASQoL global score was 6.8 ± 4.7 (median, 7; range, 0-17). The ASQoL scores had high correlations with physical (rho = 0.79) and mental (0.69) SF-36 components, the SF-36 domains pain (0.82), vitality (0.75), and role-physical (0.68), and the most of the disease-related variables. The ASQoL scores were significantly different between patients with different response levels in the health profile of the EuroQol. The Cronbach´alpha coefficient was 0.86. The reliability had kappa = 1 in 12 items and rho = 0.98. The time spent to complete the ASQoL was from 2 to 5 minutes and there only was a missing answer in one patient. Conclusion: The Spanish ASQoL is valid, reliable, and feasible instrument for assessing the HRQL of the AS patients(AU)

[Cross-cultural adaptation and validation of a Spanish version of a specific instrument to measure health-related quality of life in patients with ankylosing spondylitis]. / Adaptación transcultural y validación de una versión en español de un instrumento específico para medir calidad de vida relacionada con la salud en pacientes con espondilitis anquilosante: el ASQoL.

OBJECTIVE: To make a cross-cultural adaptation and validation of a version in Spanish of the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) for assessing the health-related quality of life (HRQL) of patients with Ankylosing Spondylitis (AS). PATIENTS AND METHODS: A cross-sectional study with test-retest. AS patients (modified New York criteria) were included. Cross-cultural adaptation was done. Construct validity was assessed comparing the ASQoL scores with the SF-36 and EuroQol scores and diseaserelated variables. Internal consistency and reliability (test-retest) were assessed. Feasibility was assessed by the time spent to complete the questionnaire and the number of items without answer. Spearman correlation coefficient, Mann-Whitney U test, and Kruskal-Wallis test were used in the statistical analysis. Cronbach́alpha coefficient and statistic kappa were used for assessing internal consistency and reliability. RESULTS: Fifty-four patients, 37 males (68.5%), with age (mean±SD) 40.5±10.5 years, were included. The ASQoL global score was 6.8±4.7 (median, 7; range, 0-17). The ASQoL scores had high correlations with physical (rho = 0.79) and mental (0.69) SF-36 components, the SF-36 domains pain (0.82), vitality (0.75), and role-physical (0.68), and the most of the disease-related variables. The ASQoL scores were significantly different between patients with different response levels in the health profile of the EuroQol. The Cronbach́alpha coefficient was 0.86. The reliability had kappa = 1 in 12 items and rho = 0.98. The time spent to complete the ASQoL was from 2 to 5 minutes and there only was a missing answer in one patient. CONCLUSION: The Spanish ASQoL is valid, reliable, and feasible instrument for assessing the HRQL of the AS patients.

Análisis de costes en una cohorte de enfermos con artritis reumatoide atendidos en área especializada de reumatología en España / Cost analysis in a cohort of rheumatoid arthritis patients managed in rheumatology units in Spain

Objetivo: Conocer los costes generados durante un año por pacientes con artritis reumatoide (AR) atendidos en unidades de reumatología de hospitales públicos españoles. Métodos: Estudio observacional, multicéntrico, longitudinal y prospectivo, de un año de duración, realizado en unidades de reumatología de hospitales públicos españoles seleccionados de forma probabilística. Los pacientes con AR se seleccionaron aleatoriamente en cada hospital. Se realizaron 4 visitas (basal y cada 4 meses). Se registró la utilización de recursos y costes mediante diarios y entrevistas estructuradas. Resultados: Se incluyó a 301 pacientes y completaron 190 (83% mujeres), con edad (media ± DE) de 59 ± 13 años y duración de la enfermedad de 10 ± 10 años. El coste mediano anual por paciente fue de 3.845 euros (318- 36.783). El coste global anual estimado para la AR atendida en unidades de reumatología de hospitales públicos españoles es de 590.110.000 euros. De los costes globales, el 74% correspondió a costes directos y el 26% a costes indirectos. El 81% del coste directo fue por gasto médico y, de éste, el 56%, por fármacos y el 11%, por hospitalización, el 21% correspondió a visitas médicas y el 12%, a pruebas de laboratorio y complementarias. El principal componente del coste indirecto fue la invalidez, que supuso el 66% del total. Conclusión: El coste directo de la AR fue sustancialmente mayor que el indirecto. El coste por medicamentos fue el principal componente del coste. El coste anual por paciente tuvo un rango muy amplio debido a la gran variabilidad en la utilización de recursos(AU)

Objective: To assess the annual costs of rheumatoid arthritis (RA) patients attended at rheumatology units in Spanish public hospitals. Methods: A longitudinal, prospective, multicenter, observational, 1-year study was performed in the rheumatology units of randomly selected Spanish public hospitals. Randomly selected RA patients were included. The patients made four visits (at baseline and every 4 months). Resource use and costs were collected from patient diaries and structured questionnaires. Results: A total of 301 patients were included and 190 (83% women) completed the study. The mean (± SD) age was 59 ± 13 years and the mean disease duration was 10 ± 10 years. The median annual cost per patient was 3,845 euros (318-36,783). The estimated total annual cost of the Spanish RA population managed in the rheumatology units of public hospitals was 590,110,000 euros. Of total costs, 74% were direct costs and 26% were indirect costs. Medical costs represented 81% of direct costs. The main components of medical costs were drugs (56%), medical visits (21%), complementary tests (12%), and hospitalizations (11%). Permanent work disability represented 66% of indirect costs. Conclusions: Direct costs were substantially higher than indirect costs. The main components of medical costs were drugs. There was high variability in resource use with a wide range of annual costs per patient(AU)

Adalimumab for treating rheumatoid arthritis.

BACKGROUND: Adalimumab is a fully human anti-TNFalpha monoclonal antibody. Published studies indicate that its use in patients with RA can be effective and safe. OBJECTIVES: The aim of this review was to assess the efficacy and safety of adalimumab in the treatment of RA. SEARCH STRATEGY: Electronic databases were searched up to August, 2004: MEDLINE, CINAHL, EBM Reviews (CDSR, ACP Journal Club, DARE and CENTRAL) and Health STAR. Conference proceedings were hand searched and pharmaceutical companies were contacted to obtain additional unpublished data from published trials. Adalimumab was searched as a text word as it is not currently indexed. The search was not limited by language, year of publication or type of publication. SELECTION CRITERIA: All randomised controlled trials (RCTs) or controlled clinical trials (CCTs) comparing adalimumab alone or in combination with DMARDs to placebo or other DMARDs. DATA COLLECTION AND ANALYSIS: Two reviewers independently collected the data in a standardized form and assessed the methodological quality of the trial using validated criteria. Outcome measures included ACR and EULAR responses, DAS 28 and components of ACR response and radiographic data. Safety data were also included. Continuous data were reported as weighted mean difference (WMD) with 95% confidence interval (95%CI), absolute benefit (AB) and relative difference (RD). Dichotomous outcomes were reported as relative risk (RR) with 95% CI, absolute risk difference (ARD) or risk difference (RDiff) with 95%CI and number needed to treat (NNT) or to harm (NNH). When significant heterogeneity was not found, data were pooled. MAIN RESULTS: Six studies with 2381 patients were included in this review. Two comparisons were done: A. adalimumab subcutaneously (sc) + methotrexate (or DMARDs) versus placebo sc + methotrexate (or DMARDs). B. adalimumab sc in monotherapy versus placebo sc. In the comparison A, with adalimumab 40 mg every other week (e.o.w.), the RR to achieve an ACR 20 response at 24 weeks ranged in the included studies from 1.52 to 4.63, and the NNT ranged from 1.9 to 5.4. The RR (95%CI) to achieve an ACR 50 response was 4.63 (3.04-7.05), and the NNT was 3.0 (95%CI 2.0-6.0). The RR (95%CI) to achieve an ACR 70 response was 5.14 (3.14-8.41) and the number needed to treat was 7.0 (95%CI 5.0-13.0). At 52 weeks, the RRs (95%CI) to achieve an ACR 20, 50, and 70 response were 2.46 (1.87-3.22), 4.37 (2.77-6.91), and 5.15 (2.60-10.22), with NNTs of 2.9, 3.1, and 5.3, respectively. At 52 weeks, adalimumab 40 mg e.o.w. and 20 mg every week (e.w.) significantly slowed the radiological progression including Sharp modified index, erosion score, and joint space score (only with 40 mg e.o.w.). In the comparison B, with adalimumab 40 mg e.o w. , the RRs to achieve an ACR 20, 50, and 70 response at 24/26 weeks were 1.91 (1.17-3.10), 2.84 (1.58-5.12), and 7.33 (2.25-33.90) with NNTs of 5.0 (95%CI 3.0-9.0), 7.0 (4.0-20.0), and 9.0 (3.0-38.0), respectively. In most of the analysed studies and comparisons, there were not significant differences in safety outcomes between adalimumab and control groups. The development of positive antinuclear antibodies was significantly more frequent in adalimumab patients than in placebo patients. Serious infections were significantly more frequent in adalimumab patients in only one study (Keystone 2004) with a RR (95%CI) of 7.64(1.02-57.18) and a NNH of 30.2. AUTHORS' CONCLUSIONS: On the basis of the studies reviewed here, adalimumab in combination with methotrexate is efficacious and safe in the treatment of the rheumatoid arthritis. Adalimumab 40 mg sc e.o.w. and 20 mg e.w. slows the radiographic progression at 52 weeks. Adalimumab in combination with DMARDs other than methotrexate is also efficacious and safe, even though data from one only study are available and the number of patients in each group is low. Adalimumab in monotherapy is efficacious and safe in the treatment of the rheumatoid arthritis but the effect size is lower than with combined therapy.

[Resource utilization in a cohort of rheumatoid arthritis patients attended in rheumatology units in Spain]. / Utilización de recursos en una cohorte de pacientes con artritis reumatoide atendidos en área especializada de reumatología en España.

OBJECTIVE: To determine resource use over a 1-year period in patients with rheumatoid arthritis (RA) attended in rheumatology units in hospitals within the Spanish public health system. PATIENTS AND METHODS: An observational, longitudinal, prospective, multicenter, 1-year study was performed in randomly selected rheumatology units in hospitals of the Spanish public health system. Patients with RA were randomly selected in each hospital. Four visits (at baseline and every 4 months) were conducted by a rheumatologist not routinely involved in the care of the patient. Demographic and disease-related variables were collected. Patient diaries and systematic interviews were used to gather data on resource use. RESULTS: A total of 301 patients were included and 190 (83% females) completed the study. The mean age was 59 ± 13 years and the mean disease duration was 10 ± 10 years. The resources most heavily used were medical. All of the patients made medical visits with a median of four visits to rheumatologists (1-13). Ninetynine percent of the patients took at least one drug. The most frequent drugs were paracetamol (41%), deflaza-cort (32%), and methotrexate (24%). Laboratory tests were performed in all patients, and x-rays were performed in 59%. Sixty-one patients (32%) were hospitalized; 75% of these patients were non-surgical. The most frequently used non-medical direct resources were meals and home visits by non-medical staff (39%). Thirtyone patients (16%) had some type of work disability. CONCLUSIONS: AR is associated with substantial utilization of medical and non-medical resources related to the disease and work disability.

[Cost analysis in a cohort of rheumatoid arthritis patients managed in rheumatology units in Spain]. / Análisis de costes en una cohorte de enfermos con artritis reumatoide atendidos en área especializada de reumatología en España.

OBJECTIVE: To assess the annual costs of rheumatoid arthritis (RA) patients attended at rheumatology units in Spanish public hospitals. METHODS: A longitudinal, prospective, multicenter, observational, 1-year study was performed in the rheumatology units of randomly selected Spanish public hospitals. Randomly selected RA patients were included. The patients made four visits (at baseline and every 4 months). Resource use and costs were collected from patient diaries and structured questionnaires. RESULTS: A total of 301 patients were included and 190 (83% women) completed the study. The mean (± SD) age was 59±13 years and the mean disease duration was 10±10 years. The median annual cost per patient was 3,845 euros (318-36,783). The estimated total annual cost of the Spanish RA population managed in the rheumatology units of public hospitals was 590,110,000 euros. Of total costs, 74% were direct costs and 26% were indirect costs. Medical costs represented 81% of direct costs. The main components of medical costs were drugs (56%), medical visits (21%), complementary tests (12%), and hospitalizations (11%). Permanent work disability represented 66% of indirect costs. CONCLUSIONS: Direct costs were substantially higher than indirect costs. The main components of medical costs were drugs. There was high variability in resource use with a wide range of annual costs per patient.

[Rofecoxib versus non-steroidal anti-inflammatory drugs in arthrosis treatment: cost-effectiveness analysis for Spain]. / Rofecoxib frente a antiinflamatorios no esteroideos en el tratamiento de la artrosis: análisis coste-efectividad para España.

OBJECTIVE: Analyze the efficiency of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) versus rofecoxib prescription for arthrosis treatment in Spain through a theoretical model of cost-effectiveness. METHODOLOGY: A theoretical model of decision that evaluates the efficiency of the use of non-selective NSAIDs and rofecoxib in the treatment of patients > 65 years with arthrosis who were nonrespondent to the administration of acetaminophen 4 g/day. The analysis focuses on the estimate of the impact derived from the gastrointestinal (GI) adverse effects. Two alternative analysis contexts are considered: "customary clinical practice" and "rational use of GI drugs" with possible preventive use of gastroprotective (GP) drugs in both groups. The time horizon is 1 year. Direct expenses are estimated from the Spanish Health System perspective. The effectiveness parameter used is the number of severe GI complications prevented. RESULTS: Under the assumptions of the first context, with a 55% estimated combinated prescription of non-selective GP with NSAID, and 6% with rofecoxib, the percentage of cost compensation of rofecoxib is 72%. Under the assumptions of the second context, the cost of rofecoxib is totally compensated when the percentage of combinated prescription of GP with NSAIDs is 59%. CONCLUSION: The use of rofecoxib can be a cost-effective alternative with regard to the traditional non-selective NSAID in the arthrosis treatment, especially in context of higher preventive use of CI drugs.

Rofecoxib frente a antiinflamatorios no esteroideos en el tratamiento de la artrosis: análisis coste-efectividad para España / Rofecoxib versus non-steroidal anti-inflammatory drugs in arthrosis treatment: cost-effectiveness analysis for Spain

Objetivo. Analizar la eficiencia de la prescripción de antiinflamatorios no esteroideos (AINE) no selectivos frente a rofecoxib para tratamiento de la artrosis en España en un modelo teórico de coste-efectividad. Metodología. Modelo de decisión teórico que evalúa la eficiencia del uso de AINE no selectivos y rofecoxib en el tratamiento de pacientes artrósicos mayores de 65 años que no responden al tratamiento con paracetamol 4 g/día. El análisis se centra en la estimación del impacto derivado de los efectos adversos gastrointestinales (GI). Se consideran dos escenarios de análisis alternativos: "práctica clínica habitual" y "uso racional de fármacos GI" con posible uso preventivo de fármacos gastroprotectores (GP) en ambas ramas. El horizonte temporal es de un año. Se estiman costes directos desde la perspectiva del Sistema Sanitario español. La medida de efectividad considerada es el número de complicaciones GI graves (PUH) evitadas. Resultados. Bajo los supuestos del primer escenario, con una coprescripción estimada de GP con AINE no selectivos de un 55 por ciento y de un 6 por ciento con rofecoxib, el porcentaje de compensación de coste de rofecoxib es de un 72 por ciento. Bajo los supuestos del segundo escenario el coste de rofecoxib se ve totalmente compensado cuando el porcentaje de coprescripción de gastroprotección con AINE es del 59 por ciento. Conclusión. El uso de rofecoxib puede ser una alternativa coste-efectiva a los AINE no selectivos tradicionales en el tratamiento de la artrosis, especialmente en contextos de un elevado uso preventivo de fármacos GI (AU)

La versión española del BASDAI es fiable y se correlaciona con la actividad de la enfermedad en pacientes con espondilitis anquilosante / The Spanish version of the BASDAI is reliable and correlates with disease activity in patients with ankylosing spondylitis

Objetivo: Estudiar la fiabilidad, validez de constructo y factibilidad de una versión en español del Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) para medir la actividad de la enfermedad en pacientes con espondilitis anquilosante (EA).Métodos: Estudio transversal. Se incluyeron pacientes con EA (criterios de Nueva York modificados). El mismo reumatólogo evaluó a todos los pacientes. Se registraron variables demográficas y relacionadas con la EA, incluyendo valoraciones globales del médico y el paciente, valoración del dolor por el paciente, BASDAI, BASFI (Bath Ankylosing Spondylitis Functional Index), BASMI (Bath Ankylosing Spondylitis Metrology Index) y cuestionarios de calidad de vida SF-36 y EuroQol. El BASDAI fue adaptado al español. Se estudiaron la fiabilidad (consistencia interna y reproducibilidad test-retest), validez de constructo y factibilidad (tiempo empleado y comprensión).Resultados: Se incluyeron 92 pacientes, 69 varones (75 por ciento), con edad (X +/- DE [media +/- desviación estándar]) de 40,7 +/- 9,1 años y duración de la enfermedad (X +/- DE) de 11 +/- 7,8 años. La puntuación del BASDAI mostró correlación estadísticamente significativa con r de Pearson mayores de 0,6 con a valoración del dolor por el paciente (VGP), valoración del dolor por el paciente y medido por el SF-36, función física medida por el BASFI y por el SF-36, calidad de vida medida por el SF-36 y Euro Qol y vitalidad medida por el SF-36. VGP, valoración del dolor por el paciente, BASFI y vitalidad mantuvieron asociación independiente con el BASDAI, en el modelo de regresión y explicaron el 73 por ciento de las variaciones en su puntuación. El coeficiente alfa de Cronbach fue de 0,87 y la prueba test-retest tuvo una rho de Spearman de 0,92, p<0,0001. El tiempo promedio fue de 60 segundos y la comprensión buena. Conclusiones: La versión en español del BASDAI mostró fiabilidad, validez de constructo y factibilidad, por lo que puede ser utilizada para medir la actividad de la enfermedad en pacientes españoles con EA (AU)

Costes calidad de vida-artritis reumatoide. Estudio económico y de la calidad de vida de los pacientes con artritis reumatoide en España. Resultados preliminares / The costs and quality of life in rheumatoid arthritis study in Spain. Preliminary results

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Calidad de vida de los pacientes con osteoporosis. Validación de la versión en español de un instrumento específico: el OPTQoL / Quality of life in patients with osteoporosis. Validation of the Spanish version of the Osteoporosis-Targeted Quality of Life Questionnaire

Objetivo: Estudiar la validez y confiabilidad de una versión española del Osteoporosis-Targeted Quality of Life Questionnaire (OPTQoL), un instrumento específico para medir calidad de vida relacionada con la salud (CVRS) en pacientes con osteoporosis (OP).Pacientes y métodos: Estudio transversal. Se incluyó a las pacientes con OP primaria (posmenopáusica o senil) definida por densidad mineral ósea (DMO) en columna lumbar o cuello femoral con T-score < -2,5 desviaciones estándar (DE). Se registraron variables demográficas y de enfermedad y se aplicaron los instrumentos OPTQoL (de 0 a 10, mejor a peor CVRS), SF-36 (de 0 a 10, mejor a peor CVRS), EuroQoL-pefil de salud (de 0 a 2, mejor a peor CVRS) y EuroQol-escala visual (de 0 a 10, mejor a peor estado de salud). Se estudió validez de constructo del OPTQoL (análisis de correlación y regresión con SF-36 y otras variables), capacidad discriminativa entre pacientes con y sin fractura vertebral (prueba de la U de Mann-Whitney), coherencia interna ( de Cronbach), reproducibilidad (prueba test-retest), tiempo empleado y comprensión. Para los análisis de correlación se utilizaron el doble producto momento de Pearson y el coeficiente de correlación de Spearman (test-retest). Se consideró significativo un valor de p < 0,05, sin ajuste para comparaciones múltiples. Resultados: 45 pacientes (43 mujeres) con edad (media ñ DE), 66,3 ñ 6,8 años; tiempo desde la menopausia (mujeres), 20,1 ñ 8,5 años, y T-score en columna lumbar, -3,42 ñ 0,9 DE; 20 (44 por ciento) con fracturas vertebrales. OPTQoL global, 7 ñ 2,1; correlación con SF-36 global, r = 0,69, p < 0,0001. OPTQoL- función física, 6,7 ñ 2,5; correlación con SF-36 función física, r = 0,74, p < 0,0001. OPTQoL adaptaciones, 7,1 ñ 2,1; correlación con SF-36escala física global, r = 0,66, p < 0,0001. OPTQoL miedos, 7,1 ñ 2,1. OPTQoL en pacientes con fracturas, mediana 8,2 frente a 6,3 en pacientes sin fractura, p = 0,0068. Coherencia interna y reproducibilidad test-retest: OPTQoL función física: alfa, 0,84 y rho, 0,95; adaptaciones, 0,85 y 0,98; miedos, 0,82 y 0,96. Tiempo: 5-10 min. Comprensión: buena. Conclusiones: La versión española del OPTQoL es válida, confiable y factible para medir CVRS en pacientes con OP. El deterioro de CVRS en la muestra de pacientes estudiada es importante (AU)

[IgM, IgG and IgA rheumatoid factors in rheumatoid arthritis]. / Factores reumatoides IgM, IgG e IgA en la artritis reumatoide.

The IgM, IgG and IgA rheumatoid factors (RF) were studied by ELISA in the serum of 122 patients with rheumatoid arthritis (RA) associating the Waaler-Rose test results, with the clinical and radiological aspects of the disease. 75 patients (61%) had RF IgM positive according to the Waaler-Rose test while the ELISA showed positive in 104 (85%). The RF (IgG was positive in 64 cases (52%) and RF IgA in 82 (67%). The levels of RF IgA were correlated to RF IgM levels, determined by the Waaler-Rose test (p < 0.01) and ELISA (p < 0.001), while RF IgG levels were not correlated to RF IgM or IgA. There was a significant correlation between RF IgA titles and Lansbury's index (p < 0.01), and between RF IgG and sedimentation rate (p < 0.01). In patients with extraarticular disease high levels of RF have been observed, especially RF IgM and IgA. We concluded that the ELISA technique is the preferred method to measure the RF.