Cost-minimization analysis of individually tailored or fixed-scheduled rituximab maintenance therapy for antineutrophil-cytoplasm antibody associated vasculitides.

OBJECTIVE: Patients included in MAINRITSAN2 trial received either an individually tailored or a fixed-schedule therapy with rituximab as  maintenance treatment of antineutrophil cytoplasm antibody associated  vasculitides. The aim of this study was to compare the real-world costs  of both arms. METHOD: We performed a cost-minimization analysis over an 18-month time period, estimating direct costs -drug acquisition,  preparation, administration and monitoring costs- from the health  system perspective. We conducted a number of additional sensitivity  analyses with different assumptions for unit costs, with further scenarios including the interquartile range of the tailored-infusion group results,  different number of monitoring visits for fixed-schedule regimen and  different number of reported severe adverse events. A cost- effectiveness analysis was conducted as a sensitivity analysis using the  absolute difference in the relapse rate and its confidence interval. RESULTS: The individually tailored maintenance therapy with rituximab was shown to be a cost-saving treatment compared to the  fixed-schedule therapy (6,049 euros vs. 7,850 euros). Savings resulted  primarily from  lower drug acquisition costs (2,861 vs. 4,768 euros) and lower preparation and administration costs (892 vs. 1,486 euros), due to the lower number of infusions per patient in the tailored-infusion  regimen. The tailoredinfusion regimen presented higher monitoring  costs (2,296 vs. 1,596 euros). This result was replicated in all  assumptions considered in the sensitivity analysis of cost-minimization  approach. CONCLUSIONS: From the perspective of the health system, the  tailoredtherapy regimen seems to be the preferable option in terms of  direct costs. Further studies assessing all the effects and costs  associated to vasculitides maintenance treatment with rituximab are  needed to support clinical management and healthcare planning.

Objetivo: Los pacientes incluidos en el ensayo MAINRITSAN2 recibieron una pauta individualizada o un esquema fijo de rituximab  como tratamiento de mantenimiento para la vasculitis asociada con  anticuerpos contra el citoplasma de los neutrófilos. El objetivo de este  estudio es comparar los costes reales de ambos esquemas de  tratamiento.Método: Se llevó a cabo un análisis de minimización de costes sobre un periodo de 18 meses, estimando los costes directos ­adquisición del fármaco, preparación, administración y costes de monitorización­  desde la perspectiva del sistema de salud. Se realizaron varios análisis  de sensibilidad con diferentes supuestos para los costes unitarios,  añadiendo escenarios que incluían el rango intercuartílico de los  resultados en el grupo de la pauta individualizada, diferente número de  visitas de control para el grupo que seguía el esquema fijo y distinto  número de eventos adversos registrados. Se realizó un análisis de  coste-efectividad como parte del análisis de sensibilidad usando la  diferencia absoluta en la tasa de recaída y su intervalo de confianza.Resultados: El esquema de tratamiento con la pauta individualizada demostró una reducción del coste en comparación con el  esquema de dosis fijas (6.049 versus 7.850 euros). El ahorro se debió  principalmente a un menor coste en la adquisición del fármaco (2.861  versus 4.768 euros) dexchlorphey a menos costes de preparación y  administración (892 versus 1.486 euros), debido al menor número de  infusiones por paciente en el brazo del esquema individualizado. Este  esquema individualizado presentó mayores costes de monitorización  (2.296 versus 1.596 euros). Este resultado se repitió en todos los  supuestos considerados en el análisis de sensibilidad desde el enfoque  de minimización de costes.Conclusiones: Desde la perspectiva del sistema de salud, la pauta individualizada parece ser la opción preferible en términos de  costes directos. No obstante, son necesarios más estudios que evalúen  todos los efectos y costes asociados al tratamiento de mantenimiento  con rituximab de la vasculitis por anticuerpo anticitoplasma de neutrófilo para respaldar el manejo clínico y la asistencia sanitaria.

Minimización de costes del mantenimiento con rituximab a intervalos fijos o individualizados en vasculitis por anticuerpos contra el citoplasma de los neutrófilos / Cost-minimization analysis of individually tailored or fixed-scheduled rituximab maintenance therapy for antineutrophil-cytoplasm antibody associated vasculitides

OBJETIVO: Los pacientes incluidos en el ensayo MAINRITSAN2 recibieronuna pauta individualizada o un esquema fijo de rituximab como tratamiento de mantenimiento para la vasculitis asociada con anticuerpos contra el citoplasma de los neutrófilos. El objetivo de este estudio es comparar los costes reales de ambos esquemas de tratamiento. MÉTODO: Se llevó a cabo un análisis de minimización de costes sobre un periodo de 18 meses, estimando los costes directos -adquisición del fármaco, preparación, administración y costes de monitorización- desde la perspectiva del sistema de salud. Se realizaron varios análisis de sensibilidad con diferentes supuestos para los costes unitarios, añadiendo escenarios que incluían el rango intercuartílico de los resultados en el grupo de la pauta individualizada, diferente número de visitas de control para el grupo que seguía el esquema fijo y distinto número de eventos adversos registrados. Se realizó un análisis de coste-efectividad como parte del análisis de sensibilidad usan-do la diferencia absoluta en la tasa de recaída y su intervalo de confianza. RESULTADOS: El esquema de tratamiento con la pauta individualizada demostró una reducción del coste en comparación con el esquema de dosis fijas (6.049 versus 7.850 euros). El ahorro se debió principalmente a un menor coste en la adquisición del fármaco (2.861 versus 4.768 euros) y a menos costes de preparación y administración (892 versus 1.486 euros), debido al menor número de infusiones por paciente en el brazo del esquema individualizado. Este esquema individualizado presentó mayo-res costes de monitorización (2.296 versus 1.596 euros). Este resultado se repitió en todos los supuestos considerados en el análisis de sensibilidad desde el enfoque de minimización de costes. CONCLUSIONES: Desde la perspectiva del sistema de salud, la pauta individualizada parece ser la opción preferible en términos de costes directos. No obstante, son necesarios más estudios que evalúen todos los efectos y costes asociados al tratamiento de mantenimiento con rituximab de la vasculitis por anticuerpo anticitoplasma de neutrófilo para respaldar el manejo clínico y la asistencia sanitaria

OBJECTIVE: Patients included in MAINRITSAN2 trial received either an individually tailored or a fixed-schedule therapy with rituximab as maintenance treatment of antineutrophil cytoplasm antibody associated vasculi-tides. The aim of this study was to compare the real-world costs of both arms. METHOD: We performed a cost-minimization analysis over an 18-month time period, estimating direct costs-drug acquisition, preparation, administration and monitoring costs- from the health system perspective. We conducted a number of additional sensitivity analyses with different assumptions for unit costs, with further scenarios including the interquartile range of the tailored-infusion group results, different number of monitoring visits for fixed-schedule regimen and different number of reported severe adverse events. A cost-effectiveness analysis was conducted as a sensitivity analysis using the absolute difference in the relapse rate and its confidence interval. RESULTS: The individually tailored maintenance therapy with rituximab was shown to be a cost-saving treatment compared to the fixed-schedule therapy (6,049 euros vs. 7,850 euros). Savings resulted primarily from ower drug acquisition costs (2,861 vs. 4,768 euros) and lower prepara-tion and administration costs (892 vs. 1,486 euros), due to the lower number of infusions per patient in the tailored-infusion regimen. The tailored-infusion regimen presented higher monitoring costs (2,296 vs. 1,596 euros). This result was replicated in all assumptions considered in the sensitivity analysis of cost-minimization approach. CONCLUSIONS: From the perspective of the health system, the tailored-therapy regimen seems to be the preferable option in terms of direct costs. Further studies assessing all the effects and costs associated to vasculitides maintenance treatment with rituximab are needed to support clinical ma-nagement and healthcare planning

Venous thrombosis and relapses in patients with Behçet's disease. Descriptive analysis from Spanish network of Behçet's disease (REGEB cohort).

OBJECTIVES: To describe the characteristics of patients with Behçet's disease (BD) who presented with venous thrombosis. In addition, we identified the factors associated with this venous involvement and those related with recurrent venous thrombosis. METHODS: Up to January 2015, 544 BD patients from 20 Spanish hospitals had been included in the REGEB (REGistro de la Enfermedad de Behçet as Spanish nomenclature). We selected those patients who presented venous thrombosis. Descriptive analysis was performed and factors related with venous thrombosis were identified. RESULTS: Overall, 99 (18.2%) BD patients had vascular thrombosis, 91 (16.7%) of them (16.7%) involving venous vessels and 18 (19.7%) suffered from venous thrombotic relapse. Lower limbs were the most common location of deep venous thrombosis present in up to 60% of patients. In 12 (13.2%) patients, venous thrombosis affected two vascular territories simultaneously and in 6 (6.6%) the venous and arterial involvement coincided in time. Overall, at the diagnosis of venous thrombosis, 97.6% of patients presented concomitantly other clinical symptoms attributable to BD. In logistic regression multivariate analysis factors associated to venous thrombosis were male sex (Odds ratio [OR] 4.3, 95% confidence interval [CI] 2.5-7.7), erythema nodosum (OR 2.4, 95%CI 1.4-4.1), fever (OR 2.0, 95%CI 1.1-3.8), and central nervous system (CNS) involvement (OR 2.5, 95%CI 1.3-4.8). Considering relapses, CNS involvement was an independent risk factor according logistic regression. However, Cox multivariate analysis did not confirm this finding. CONCLUSIONS: We identified factors related with venous involvement in patients included in the REGEB cohort.

[Cyclooxygenase-2 polymorphisms and bronchoalveolar lavage cellularity of sarcoidosis]. / El polimorfismo COX2.8473t>C del gen de la ciclooxigenasa-2 está asociado al cociente CD4/CD8 del lavado broncoalveolar en la sarcoidosis.

OBJECTIVES: Recent studies have found cyclooxygenase-2 (COX-2) and its polymorphisms to be associated with sarcoidosis, being it significantly decreased in alveolar macrophages, with no information on the relationship between these polymorphisms and the rest of cells in bronchoalveolar layage (BAL). The present study aimed to investigate the potential association between COX-2 gene polymorphisms and the BAL cell profile including the CD4/CD8 ratio. MATERIAL AND METHODS: This observational cross-sectional study involved six hospitals in Spain. Patients diagnosed with sarcoidosis with a BAL performed were included. The following variables were recorded: age, gender, initial diagnostic methods, serum angiotensin-converting enzyme levels, pulmonary function tests, radiological stage, and the cellularity and CD4/CD8 ratio from BAL. Genotyping of four COX-2 polymorphisms (COX2.5909T>G, COX2.8473T>C, COX2.926G>C, and COX2.3050G>C) was undertaken on DNA extracted from peripheral blood lymphocytes using fluorescent hybridization probes. The relationship between the polymorphisms and the cellularity was done by means of a multiple linear regression, adjusting for gender. RESULTS: A total of 51 sarcoid patients (23 males, mean age: 45 +/- 15 years) were studied. CD4/CD8 ratio was significantly higher among homozygote allele C carriers of the polymorphism COX2.8473T>C (CC 11.2 +/- 5.5 vs. CT+TT 4.4 +/- 3.5; p = 0.022; beta = 7.43; 95% CI 1.38 - 13.48). Although several differences were observed in other cell groups, they did not reach the statistical significance level. CONCLUSIONS: In patients diagnosed with sarcoidosis, there seems to be a relationship between COX2.8473 polymorphism and CD4/CD8 ratio from BAL.