Published in:
Open Access
01-08-2019 | Rheumatoid Arthritis | Original Article
Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR
Authors:
Roberto Ranza, Maria Celina de la Vega, Ieda Maria Magalhães Laurindo, Marìa Gimena Gómez, David Cezar Titton, Adriana Maria Kakehasi, Alejandro Brigante, Alejandro Benitez, Aline Ranzolin, Amelia Granel, Ana María Cappuccio, Ana Quinteros, André Luiz Shinji Hayata, Andrea Smichowski, Ângela Luzia Branco P. Duarte, Barbara Stadler Kahlow, Carolina Sánchez Andia, Claiton Viegas Brenol, Edson Velozo, Eduardo Mussano, Enrique R. Soriano, Georges Basile Christopoulos, Geraldo da Rocha Castelar Pinheiro, Gláucio Ricardo Werner de Castro, Gustavo Casado, Hellen Mary da Silveira Carvalho, Ida Elena Exeni, Inês Guimarães da Silveira, Ingrid Petkovic, Ivanio Alves Pereira, Izaias Pereira da Costa, Javier Eduardo Rosa, José Roberto Silva Miranda, Julio Cesar Bertacini de Moraes, Manoel Barros Bertolo, Manuel Buhl, Maria Alícia Lázaro, Maria de Fátima Lobato C. da Sauma, Marcelo de Medeiros Pinheiro, Monica Díaz, Mônica Valéria Siqueira Santana de Vechi, Osvaldo Luis Cerda, Pablo Astesana, Pablo Finucci Curi, Paulo Louzada-Jr, Reginaldo Botelho Teodoro, Roberto Acayaba Toledo, Sílvia Papasidero, Valeria Valim, Vander Fernandes, Veronica Saurit, Washington Alves Bianchi, Rogério de Melo Costa Pinto, Miguel Angel Descalzo, Juan Jesus Gomez-Reino, on behalf of the BIOBADABRASIL study group, Sociedade Brasileira de Reumatologia and of the BIOBADASAR study group, Sociedad Argentina de Reumatologia
Published in:
Clinical Rheumatology
|
Issue 8/2019
Login to get access
Abstract
Objective
Most 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.
Methods
We 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.
Results
Data were analysed for 3717 RA patients with an exposure of 13,380 patient/years. The 2591 patients treated with bDMARDs (64% tumour necrosis factor-α inhibitors (TNFi)) had a follow-up of 9300 years, 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 6 months 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.
Conclusion
While 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.
Key Points • New comprehensive data on biologic drugs safety from international collaboration in South America. • First proposal for national registries data merging in South America. • Serious infections remain a major concern in RA patients treated with biologics. • A significant reduction of serious infections in RA patients exposed to biologics was observed over a 7 years period. |