Incidência de tuberculose em pacientes com artrite reumatoide em uso de bloqueadores do TNF no Brasil: dados do Registro Brasileiro de Monitoração de Terapias Biológicas BiobadaBrasil

Abstract

ObjectivesTo assess the incidence of tuberculosis and to screen for latent tuberculosis infection among Brazilians with rheumatoid arthritis using biologics in clinical practice. Patients and methodsThis cohort study used data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas–BiobadaBrasil), from 01/2009 to 05/2013, encompassing 1,552 treatments, including 415 with only synthetic disease‐modifying anti‐rheumatic drugs, 942 synthetic DMARDs combined with anti‐tumor necrosis factor (etanercept, infliximab, adalimumab) and 195 synthetic DMARDs combined with other biologics (abatacept, rituximab and tocilizumab). The occurrence of tuberculosis and the drug exposure time were assessed, and screening for tuberculosis was performed. Statistical analysis: Unpaired t‐test and Fisher's two‐tailed test; p<0.05. ResultsThe exposure times were 981 patient‐years in the controls, 1744 patient‐years in the anti‐TNF group (adalimumab=676, infliximab=547 and etanercept=521 patient‐years) and 336 patient‐years in the other biologics group. The incidence rates of tuberculosis were 1.01/1,000 patient‐years in the controls and 2.87 patient‐years among anti‐TNF users (adalimumab=4.43/1,000 patient‐years; etanercept=1.92/1,000 patient‐years and infliximab=1.82/1,000 patient‐years). No cases of tuberculosis occurred in the other biologics group. The mean drug exposure time until the occurrence of TB was 27(11) months for the anti‐TNF group. ConclusionsThe incidence of tuberculosis was higher among users of synthetic DMARDs and anti‐TNF than among users of synthetic DMARDs and synthetic DMARDs and non‐anti‐TNF biologics and also occurred later, suggesting infection during treatment and no screening failure