Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas - BiobadaBrasil).
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Yonekura Claudia Leiko, Oliveira Rene Donizeti Ribeiro, Titton David C, Ranza Roberto, Ranzolin Aline, Hayata André L, Duarte Ângela, Silveira Inês G, Carvalho Hellen M da S de, Moraes Júlio C Bertacini de, Abreu Mirhelen Mendes de, Valim Valéria, Bianchi Washington, Brenol Claiton Viegas, Pereira Ivanio A, Costa Izaias, Macieira José C, Miranda José R S, Guedes-Barbosa Luiz S, Bertolo Manoel B, Sauma Maria Fátima Lobato da C, Silva Marília B G, Freire Marlene, Scheinberg Morton A, Toledo Roberto A, Oliveira Sheila K F, Fernandes Vander, Pinheiro Marcelo M, Castro Glaucio, Vieira Walber Pinto, Baaklini Cesar Emile, Ruffino-Netto Antonio, Pinheiro Geraldo da Rocha Castelar, Laurindo Ieda Maria Magalhães, Louzada-Junior Paulo
Аннотация
PATIENTS AND METHODS: This 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 1552 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.
RESULTS: The 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 1.01/1000 patient-years in the controls and 2.87 patient-years among anti-TNF users (adalimumab=4.43/1000 patient-years; etanercept=1.92/1000 patient-years and infliximab=1.82/1000 patient-years). No cases of tuberculosis occurred in the other biologics group. The mean drug exposure time until the occurrence of tuberculosis was 27(11) months for the anti-TNF group.
CONCLUSIONS: The 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.