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Title: | Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR |
Authors: | RANZA, Roberto; VEGA, Maria Celina de la; LAURINDO, Ieda Maria Magalhaes; GOMEZ, Maria Gimena; TITTON, David Cezar; KAKEHASI, Adriana Maria; BRIGANTE, Alejandro; BENITEZ, Alejandro; RANZOLIN, Aline; GRANEL, Amelia; CAPPUCCIO, Ana Maria; QUINTEROS, Ana; HAYATA, Andre Luiz Shinji; SMICHOWSKI, Andrea; DUARTE, Angela Luzia Branco P.; KAHLOW, Barbara Stadler; ANDIA, Carolina Sanchez; BRENOL, Claiton Viegas; VELOZO, Edson; MUSSANO, Eduardo; SORIANO, Enrique R.; CHRISTOPOULOS, Georges Basile; PINHEIRO, Geraldo da Rocha Castelar; CASTRO, Glaucio Ricardo Werner de; CASADO, Gustavo; CARVALHO, Hellen Mary da Silveira; EXENI, Ida Elena; SILVEIRA, Ines Guimaraes da; PETKOVIC, Ingrid; PEREIRA, Ivanio Alves; COSTA, Izaias Pereira da; ROSA, Javier Eduardo; MIRANDA, Jose Roberto Silva; MORAES, Julio Cesar Bertacini de; BERTOLO, Manoel Barros; BUHL, Manuel; LAZARO, Maria Alicia; SAUMA, Maria de Fatima Lobato C. da; PINHEIRO, Marcelo de Medeiros; DIAZ, Monica; VECHI, Monica Valeria Siqueira Santana de; CERDA, Osvaldo Luis; ASTESANA, Pablo; CURI, Pablo Finucci; LOUZADA- JR., Paulo; TEODORO, Reginaldo Botelho; TOLEDO, Roberto Acayaba; PAPASIDERO, Silvia; VALIM, Valeria; FERNANDES, Vander; SAURIT, Veronica; BIANCHI, Washington Alves; PINTO, Rogerio de Melo Costa; DESCALZO, Miguel Angel; GOMEZ-REINO, Juan Jesus |
Citation: | CLINICAL RHEUMATOLOGY, v.38, n.8, p.2129-2139, 2019 |
Abstract: | ObjectiveMost reports on serious infections (SI) in rheumatoid arthritis (RA) patients treated with biological disease-modifying antirheumatic drugs (bDMARDs) are from the USA and Western Europe. Data from other regions are largely missing. We report data from South American countries with different backgrounds and health-care systems but similar registries.MethodsWe merged 2010-2016 data from two registries, BIOBADABRASIL (Brazil) and BIOBADASAR (Argentina), which share the same protocol, online platform and data monitoring process. Patients with active RA were included when they began the first bDMARD or a conventional synthetic DMARD (csDMARD, control group). The SI incidence rate (IR) per 1000 patient/years and adjusted IR ratio (aIRR) were estimated for bDMARDs and csDMARDs.ResultsData were analysed for 3717 RA patients with an exposure of 13,380 patient/years. The 2591 patients treated with bDMARDs (64% tumour necrosis factor-alpha inhibitors (TNFi)) had a follow-up of 9300years, and the 1126 treated with csDMARDs had an exposure of 4081 patient/years. The SI IR was 30.54 (CI 27.18-34.30) for all bDMARDs and 5.15 (CI 3.36-7.89) for csDMARDs. The aIRR between the two groups was 2.03 ([1.05, 3.9] p=0.034) for the first 6months of treatment but subsequently increased to 8.26 ([4.32, 15.76] p<0.001). The SI IR for bDMARDs decreased over time in both registries, dropping from 36.59 (28.41-47.12) in 2012 to 7.27 (4.79-11.05) in 2016.ConclusionWhile SI remains a major concern in South American patients with RA treated with bDMARDs, a favourable trend toward a reduction was observed in the last years. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - HC/ICHC Artigos e Materiais de Revistas Científicas - LIM/17 |
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