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Estudio primario

No clasificado

Riesgo de herpes zoster en pacientes con artritis reumatoide tratados con agentes anti-TNF-alfa.

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Revista JAMA : the journal of the American Medical Association
Año 2009
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Este artículo está incluido en 6 Revisiones sistemáticas Revisiones sistemáticas (6 referencias) 3 Síntesis amplias Síntesis amplias (3 referencias)

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CONTEXTO: El riesgo de infección bacteriana se incrementa en pacientes tratados con fármacos que inhiben el factor de necrosis tumoral alfa (TNF-alfa). Poco se sabe sobre la reactivación de infecciones virales latentes durante el tratamiento con inhibidores de TNF-alfa. OBJETIVO: Investigar si los inhibidores de TNF-alfa en conjunto como una clase, o por separado, ya sea como anticuerpos monoclonales anti-TNF-alfa (adalimumab, infliximab) o una proteína de fusión (etanercept), están relacionados con las tasas más altas de herpes zoster en pacientes con reumatoide artritis. Diseño, lugar y pacientes: Los pacientes fueron incluidos en los productos biológicos alemanes registrarse CONEJO, una cohorte prospectiva, entre mayo de 2001 y diciembre de 2006 en el inicio del tratamiento con infliximab, etanercept, adalimumab, anakinra o, o cuando cambiaron modificadores de la enfermedad convencional fármacos antirreumáticos (DMARD). El tratamiento, el estado clínico y los eventos adversos fueron evaluados por los reumatólogos en puntos fijos durante el seguimiento. Principales medidas de resultado: cociente de riesgo (CR) de los episodios de herpes zoster después de un tratamiento anti-TNF-alfa. Objetivos del estudio fueron para detectar una diferencia clínicamente significativa (HR, 2,0) entre los inhibidores de TNF-alfa como una clase en comparación con DMARD y detectar un HR de al menos 2,5 para cada uno de 2 tipos de inhibidores de TNF-alfa, los anticuerpos monoclonales o la proteína de fusión, en comparación con DMARDs convencionales. RESULTADOS: Entre 5040 pacientes tratados con inhibidores de TNF-alfa o FAME convencionales, 86 episodios de herpes zoster se produjeron en 82 pacientes. Treinta y nueve ocurrencias podrían atribuirse al tratamiento con anticuerpos anti-TNF-alfa, 23 a etanercept, y 24 a FARME convencionales. La tasa bruta de incidencia por cada 1.000 pacientes-año fue de 11,1 (intervalo de confianza del 95% [IC]: 7,9 a 15,1) para los anticuerpos monoclonales, 8,9 (IC del 95%, 5,6-13,3) para etanercept y 5,6 (IC del 95%, 3,6 -8.3) para FARME convencionales. Ajustado por edad, la severidad de la artritis reumatoide, y el uso de glucocorticoides, se observó un aumento significativo del riesgo para el tratamiento con los anticuerpos monoclonales (HR, 1,82 [IC del 95%, 01.05 a 03.15]), aunque este riesgo fue menor que el umbral de significación clínica . No se encontraron asociaciones significativas para el uso de etanercept (HR, [IC 95%, 0,73-2,55] 1,36) o para el tratamiento anti-TNF-alfa (HR, 1,63 [IC 95%, 0,97-2,74]) como clase. CONCLUSIÓN: El tratamiento con anticuerpos anti-TNF-alfa monoclonales pueden estar asociados con un mayor riesgo de herpes zóster, pero esto requiere un mayor estudio.

Estudio primario

No clasificado

Anti-tumor necrosis factor alpha therapy and the risk of serious bacterial infections in elderly patients with rheumatoid arthritis.

Revista Arthritis and rheumatism
Año 2007
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Este artículo está incluido en 3 Síntesis amplias Síntesis amplias (3 referencias) 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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OBJECTIVE: To assess the association between the initiation of anti-tumor necrosis factor alpha (anti-TNFalpha) therapy and the risk of serious bacterial infections in routine care. METHODS: This was a cohort study of patients with rheumatoid arthritis (RA) in whom specific disease-modifying antirheumatic drugs (DMARDs) were initiated. Patients were Medicare beneficiaries ages 65 years and older (mean age 76.5 years) who were concurrently enrolled in the Pharmaceutical Assistance Contract for the Elderly provided by the state of Pennsylvania. A total of 15,597 RA patients in whom a DMARD was initiated between January 1, 1995 and December 31, 2003 were identified using linked data on all prescription drug dispensings, physician services, and hospitalizations. Initiation of anti-TNFalpha therapy, cytotoxic agents other than methotrexate (MTX), noncytotoxic agents, and glucocorticoids was compared with initiation of MTX. The main outcome measure was serious bacterial infections that required hospitalization. RESULTS: The incidence of serious bacterial infections was, on average, 2.2 per 100 patient-years in this population (95% confidence interval [95% CI] 2.0-2.4). Glucocorticoid use doubled the rate of serious bacterial infections as compared with MTX use, independent of previous DMARD use (rate ratio [RR] 2.1 [95% CI 1.5-3.1]), with a clear dose-response relationship for dosages >5 mg/day (for < or = 5 mg/day, RR 1.34; for 6-9 mg/day, RR 1.53; for 10-19 mg/day, RR 2.97; and for > or = 20 mg/day, RR 5.48 [P for trend < 0.0001]). Adjusted models showed no increase in the rate of serious infections among initiators of anti-TNFalpha therapy (RR 1.0 [95% CI 0.6-1.7]) or other DMARDs as compared with initiators of MTX. CONCLUSION: In a large cohort of patients with RA, we found no increase in serious bacterial infections among users of anti-TNFalpha therapy compared with users of MTX. Glucocorticoid use was associated with a dose-dependent increase in such infections.

Estudio primario

No clasificado

Incidence of adverse effects during long-term, low-dose glucocorticoid treatment of rheumatoid arthritis.

Revista Arthritis Rheum
Año 2007

Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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Hilo de publicación

ReAct (Research in Active Rheumatoid Arthritis)

Este hilo de publicación incluye 3 referencias

Estudio primario

No clasificado

Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor alpha antagonists.

Revista Arthritis and rheumatism
Año 2007
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Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias) 4 Síntesis amplias Síntesis amplias (4 referencias)

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OBJECTIVE: To evaluate the risk of serious bacterial infections associated with tumor necrosis factor alpha (TNFalpha) antagonists among rheumatoid arthritis (RA) patients. METHODS: A retrospective cohort study of US RA patients enrolled in a large health care organization identified patients who received either TNFalpha antagonists or methotrexate (MTX). Administrative data were used to identify hospitalizations with possible bacterial infections; corresponding medical records were abstracted and reviewed by infectious disease specialists for evidence of definite infections. Proportional hazards models evaluated time-dependent infection risks associated with TNFalpha antagonists. RESULTS: Hospital medical records with claims-identified suspected bacterial infections were abstracted (n=187) among RA patients who received TNFalpha antagonists (n=2,393; observation time 3,894 person-years) or MTX (n=2,933; 4,846 person-years). Over a median followup time of 17 months, the rate of hospitalization with a confirmed bacterial infection was 2.7% among the patients treated with TNFalpha antagonists compared with 2.0% among the patients treated with MTX only. The multivariable-adjusted hazard ratio (HR) of infection among the patients who received TNFalpha antagonists was 1.9 (95% confidence interval [95% CI] 1.3-2.8) compared with patients who received MTX only. The incidence of infections was highest within 6 months after initiating TNFalpha antagonist therapy (2.9 versus 1.4 infections per 100 person-years; multivariable-adjusted HR 4.2, 95% CI 2.0-8.8). CONCLUSION: The multivariable-adjusted risk of hospitalization with a physician-confirmed definite bacterial infection was approximately 2-fold higher overall and 4-fold higher in the first 6 months among patients receiving TNFalpha antagonists versus those receiving MTX alone. RA patients were at increased risk of serious infections, irrespective of the method used to define an infectious outcome. Patients and physicians should vigilantly monitor for signs of infection when using TNFalpha antagonists, particularly shortly after treatment initiation.

Estudio primario

No clasificado

The risk of herpes zoster in patients with rheumatoid arthritis in the United States and the United Kingdom.

Revista Arthritis and rheumatism
Año 2007
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Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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OBJECTIVE: To determine whether the incidence of herpes zoster is elevated in patients with rheumatoid arthritis (RA) and whether herpes zoster is associated with use of disease-modifying antirheumatic drugs (DMARDs) in patients with RA. METHODS: Two retrospective cohort studies were conducted using data from a US integrated managed care database (PharMetrics claims database) from 1998-2002 and the UK General Practice Research Database (GPRD) between 1990-2001. Rates of herpes zoster among patients with RA and randomly sampled non-RA patients were compared. A nested case-control analysis was performed within each RA cohort to examine the effect of current treatment on herpes zoster risk. RESULTS: A total of 122,272 patients with RA from the PharMetrics database and 38,621 from the GPRD were included. The adjusted hazard ratios of herpes zoster for patients with RA compared with non-RA patients were 1.91 (95% confidence interval [95% CI] 1.80-2.03) in the PharMetrics database and 1.65 (95% CI 1.57-1.75) in the GPRD. In the PharMetrics database, current use of biologic DMARDs alone was associated with herpes zoster (odds ratio [OR] 1.54, 95% CI 1.04-2.29), as was current use of traditional DMARDs alone (OR 1.37, 95% CI 1.18-1.59). In the GPRD, current use of traditional DMARDs was associated with herpes zoster (OR 1.27, 95% CI 1.10-1.48). In both data sources, use of oral corticosteroids was associated with herpes zoster regardless of concomitant therapies. CONCLUSION: Data from 2 large databases suggested that patients with RA are at increased risk of herpes zoster. Among patients with RA, DMARDs and/or use of oral corticosteroids appeared to be associated with herpes zoster.

Estudio primario

No clasificado

Lack of increase in postoperative complications with low-dose methotrexate therapy in patients with rheumatoid arthritis undergoing elective orthopedic surgery.

Revista Modern rheumatology
Año 2006
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Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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To determine the potential contribution of intermittent low-dose methotrexate (MTX) treatment (2-8 mg/week) to postoperative complications, we studied 122 patients with rheumatoid arthritis (RA) who had 201 surgical procedures. The patients with treatment with MTX were allocated to two groups: those who continued MTX (group A, 77 procedures) and those who discontinued MTX more than 1 week (group B, 21 procedures). The patients who had no treatment with MTX were allocated to group C (103 procedures). The incidence of postoperative infection, poor wound healing, and flare-up of RA was compared between the three groups. Postoperative infection occurred in 3.9%, 4.8%, and 3.9% in groups A, B, and C, respectively. Poor wound healing was experienced in 1.3%, 9.5%, and 7.8% in groups A, B, and C, respectively. At 4 weeks postoperatively, 3.9%, 14.3%, and 6.8% of flares were seen in groups A, B, and C, respectively. No significant difference was found in the patients with or without perioperative use of MTX. From these results, it is unlikely that continuation of intermittent low-dose MTX treatment increases the risk of postoperative complications in patients with RA. Continued treatment with MTX during perioperative period could suppress disease flares, especially in severe RA patients.

Estudio primario

No clasificado

Treatment for rheumatoid arthritis and the risk of hospitalization for pneumonia: associations with prednisone, disease-modifying antirheumatic drugs, and anti-tumor necrosis factor therapy.

Autores Wolfe F , Caplan L , Michaud K
Revista Arthritis and rheumatism
Año 2006
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Este artículo está incluido en 4 Síntesis amplias Síntesis amplias (4 referencias) 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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OBJECTIVE: Pneumonia is a major cause of mortality and morbidity in rheumatoid arthritis (RA). This study was undertaken to determine the rate and predictors of hospitalization for pneumonia and the extent to which specific RA treatments increase pneumonia risk. METHODS: RA patients (n = 16,788) were assessed semiannually for 3.5 years. Pneumonia was confirmed by medical records or detailed patient interview. Covariates included RA severity measures, diabetes, pulmonary disease, and myocardial infarction. Cox proportional hazards regression was used to determine the multivariable risk associated with RA treatments. RESULTS: After adjustment for covariates, prednisone use increased the risk of pneumonia hospitalization (hazard ratio [HR] 1.7 [95% confidence interval 1.5-2.0]), including a dose-related increase in risk (< or = 5 mg/day HR 1.4 [95% confidence interval 1.1-1.6], > 5-10 mg/day HR 2.1 [95% confidence interval 1.7-2.7], > 10 mg/day HR 2.3 [95% confidence interval 1.6-3.2]). Leflunomide also increased the risk (HR 1.2 [95% confidence interval 1.0-1.5]). HRs for etanercept (0.8 [95% confidence interval 0.6-110]) and sulfasalazine (0.7 [95% confidence interval 0.5-1.0]) did not reflect an increased risk of pneumonia. HRs for infliximab, adalimumab, and methotrexate were not significantly different from zero. CONCLUSION: There is a dose-related relationship between prednisone use and pneumonia risk in RA. No increase in risk was found for anti-tumor necrosis factor therapy or methotrexate. These data call into question the belief that low-dose prednisone is safe. Because corticosteroid use is common in RA, the results of this study suggest that prednisone exposure may have important public health consequences.

Estudio primario

No clasificado

Infections in patients with rheumatoid arthritis treated with biologic agents.

Revista Arthritis and rheumatism
Año 2005
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Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias) 3 Síntesis amplias Síntesis amplias (3 referencias)

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OBJECTIVE: To estimate the incidence rates of serious and nonserious infections in patients with rheumatoid arthritis (RA) who start treatment with a biologic agent, and to compare these rates with those in patients with RA who receive conventional treatment. METHODS: Patients enrolled in the German biologics register between May 2001 and September 2003 were included. Treating rheumatologists assessed adverse events and serious adverse events. All adverse events and serious adverse events experienced within 12 months after study entry were analyzed. Propensity score methods were applied to estimate which part of a rate increase was likely to be attributable to differences in patient characteristics. RESULTS: Data were available for 512 patients receiving etanercept, 346 patients receiving infliximab, 70 patients receiving anakinra, and 601 control patients treated with disease-modifying antirheumatic drugs. The total number of adverse events per 100 patient-years was 22.6 (95% confidence interval [95% CI] 18.7-27.2) among patients receiving etanercept, 28.3 (95% CI 23.1-34.7) among patients receiving infliximab, and 6.8 (95% CI 5.0-9.4) among controls (P < 0.0001). Significant differences in the rate of serious adverse events were also observed. For patients receiving etanercept, those receiving infliximab, and controls, the total numbers of serious adverse events per 100 patient-years were 6.4 (95% CI 4.5-9.1), 6.2 (95% CI 4.0-9.5), and 2.3 (95% CI 1.3-3.9), respectively (P = 0.0016). After adjusting for differences in the case patient mix, the relative risks of serious adverse events were 2.2 (95% CI 0.9-5.4) for patients receiving etanercept and 2.1 (95% CI 0.8-5.5) for patients receiving infliximab, compared with controls. CONCLUSION: Patients treated with biologic agents have a higher a priori risk of infection. However, our data suggest that this risk is increased by treatment with tumor necrosis factor inhibitors.

Estudio primario

No clasificado

Dosis bajas de terapia de prednisona en pacientes con artritis reumatoide activa precoz: eficacia clínica, las propiedades modificadoras de la enfermedad y los efectos secundarios: un estudio aleatorizado, doble ciego, ensayo clínico controlado con placebo.

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Revista Annals of internal medicine
Año 2002
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Este artículo está incluido en 9 Revisiones sistemáticas Revisiones sistemáticas (9 referencias) 1 Síntesis amplia Síntesis amplias (1 referencia)

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ANTECEDENTES: glucocorticoides orales combinados con la enfermedad de fármacos antirreumáticos modificadores de daño radiológico son beneficiosos y retardar articular en la artritis reumatoide. OBJETIVO: Para investigar la eficacia clínica, las propiedades modificadoras de la enfermedad y los efectos secundarios de los glucocorticoides a dosis bajas como monoterapia para pacientes no tratados previamente con los principios de la artritis reumatoide activa. DISEÑO: 2 años, aleatorizado, doble ciego, ensayo clínico controlado con placebo. AJUSTE: 2 consultorios de reumatología ambulatoria. PACIENTES: 81 pacientes con artritis reumatoide activa precoz que no habían sido tratados con la enfermedad de fármacos antirreumáticos modificadores. INTERVENCIÓN: 41 pacientes fueron asignados a 10 mg de prednisona oral por día, y 40 fueron asignados a placebo. No esteroides antiinflamatorios se les permitió en ambos grupos. Después de 6 meses, la sulfasalazina (2 g / día) podría ser prescritos como medicación de rescate. MEDIDAS: Las variables clínicas se evaluaron al inicio y cada 3 meses, los estudios radiológicos se realizaron cada 6 meses. Los efectos adversos fueron documentados cada 3 meses. RESULTADOS: En los primeros 6 meses, el grupo de prednisona mostraron una mejoría clínica más que en el grupo placebo. Este efecto no se observó después de 6 meses, salvo en la fuerza de agarre y la puntuación de 28 conjuntos de ternura. El uso de terapias adicionales fue significativamente menos frecuente en el grupo de prednisona, sobre todo en los primeros 6 meses. Más del 65% de los que completaron el estudio no tomaban sulfasalazina. Después de 6 meses, los resultados radiológicos mostraron progresión significativamente menor en el grupo de prednisona que en el grupo placebo. No se observaron efectos adversos clínicamente relevantes se observaron, a excepción de una mayor incidencia de fracturas osteoporóticas en el grupo de prednisona. CONCLUSIONES: La prednisona, 10 mg / día, proporciona un beneficio clínico, especialmente en los primeros 6 meses, y de forma sustancial inhibe la progresión del daño radiológico articular en pacientes con artritis reumatoide activa precoz y sin tratamiento previo con enfermedad de fármacos antirreumáticos modificadores. Debido a sus limitados efectos modificadores de la enfermedad, los glucocorticoides se debe combinar con modificadores de la enfermedad fármacos antirreumáticos en pacientes con artritis reumatoide.