RESUMEN
OBJECTIVES: To evaluate prevalence of dose escalation among RA patients in normal clinical practice treated with etanercept, adalimumab or infliximab and to estimate its economic impact. METHODS: A retrospective observational study of 739 patients with RA receiving continuous treatment with etanercept (n=319), adalimumab (n=313) or infliximab (n=107) for 18 months. Dose escalation, intensification of concomitant DMARDs and risk of dose escalation were evaluated, as well as costs. RESULTS: Significantly more patients prescribed adalimumab (10%, p<0.001) or infliximab (35%, p<0.001) experienced dose escalation compared with patients treated with etanercept (3%). DMARD or steroid dose adjustment, when added as criteria of escalation, occurred more often among patients treated with adalimumab (28%; p=0.022) or infliximab (47%; p<0.001) than those prescribed etanercept (19%). Independent of confounding covariates, hazard of dose escalation was significantly higher for either infliximab (28.1-fold) or adalimumab (4.9-fold) relative to etanercept. Escalation among subjects treated with either infliximab or adalimumab incurred statistically significant increases in total cost of care compared with non-escalators whereas such differences observed for subjects treated with etanercept were not significant. CONCLUSIONS: Patients receiving monoclonal antibody therapies, adalimumab or infliximab, had significantly higher rates of dose escalation than patients receiving the soluble TNF receptor, etanercept, and related costs were higher.
Asunto(s)
Anticuerpos Monoclonales/administración & dosificación , Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Inmunoglobulina G/administración & dosificación , Receptores del Factor de Necrosis Tumoral/administración & dosificación , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adalimumab , Anticuerpos Monoclonales Humanizados , Antirreumáticos/administración & dosificación , Artritis Reumatoide/fisiopatología , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Cálculo de Dosificación de Drogas , Etanercept , Femenino , Estado de Salud , Humanos , Infliximab , Masculino , Persona de Mediana Edad , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: The efficacy of treatments for generalized anxiety disorder has usually been measured in terms of response or remission of symptoms. These endpoints, however, may not adequately capture the transient periods of symptom abatement and relapse characteristic of chronic psychiatric disorders. Here, we evaluate the measurement of treatment effectiveness in terms of the number of symptom-free days (SFDs). RESEARCH DESIGN AND METHODS: A pooled analysis was performed of data from five manufacturer-initiated trials of venlafaxine extended-release (XR) in patients with generalized anxiety disorder without co-morbid major depressive disorder. The trials were randomized, double-blind, placebo-controlled and of 8 weeks duration (total intent-to-treat population 1295 venlafaxine XR, 544 placebo). Two of the studies had extensions up to 6 months (intent-to-treat population 514 venlafaxine XR, 253 placebo). The patients were >or= 18 years of age with a Hamilton Rating Scale for Anxiety (HAM-A) score of >or= 18. MAIN OUTCOME MEASURES: SFDs were estimated using weekly scores on the HAM-A. Values of 7 and 0 SFDs, respectively, were assigned to each week the patient had a HAM-A score of