Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR

Autor: Julio C. B. Moraes, Javier Eduardo Rosa, Manoel Barros Bertolo, Ivanio Alves Pereira, Inês Guimarães da Silveira, Ingrid Petkovic, Claiton Viegas Brenol, Osvaldo Luis Cerda, Alejandro Benitez, Paulo Louzada-Jr, Roberto Acayaba de Toledo, Miguel Angel Descalzo, Ana Quinteros, Andrea Smichowski, Enrique R. Soriano, Izaias Pereira da Costa, Bárbara Stadler Kahlow, Maria de Fátima Lobato C da Sauma, Pablo Finucci Curi, Amelia Granel, Marìa Gimena Gómez, Rogério de Melo Costa Pinto, Eduardo Mussano, Manuel Buhl, Mónica Vázquez Díaz, Alejandro Brigante, Sílvia Papasidero, Verónica Saurit, Ida Elena Exeni, Maria Celina de la Vega, Reginaldo Botelho Teodoro, André Luiz Shinji Hayata, Aline Ranzolin, Georges Basile Christopoulos, Ângela Luzia Branco P Duarte, Geraldo da Rocha Castelar Pinheiro, Washington A. Bianchi, Valeria Valim, Maria Alicia Lazaro, José Roberto Silva Miranda, David C. Titton, Marcelo de Medeiros Pinheiro, Vander Fernandes, Ana María Cappuccio, G Casado, Hellen Mary da Silveira Carvalho, Roberto Ranza, Mônica Valéria Siqueira Santana de Vechi, Adriana Maria Kakehasi, Pablo Astesana, Carolina Sánchez Andia, Juan J. Gomez-Reino, Edson Velozo, Ieda Maria Magalhães Laurindo, Gláucio Ricardo Werner de Castro
Rok vydání: 2019
Předmět:
Zdroj: Clinical rheumatology. 38(8)
ISSN: 1434-9949
Popis: 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.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.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.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.
Databáze: OpenAIRE
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