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

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 differen...

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Bibliographic Details
Published in:Clinical rheumatology 2019-08, Vol.38 (8), p.2129-2139
Main Authors: Ranza, Roberto, de la Vega, Maria Celina, Laurindo, Ieda Maria Magalhães, Gómez, Marìa Gimena, Titton, David Cezar, Kakehasi, Adriana Maria, Brigante, Alejandro, Benitez, Alejandro, Ranzolin, Aline, Granel, Amelia, Cappuccio, Ana María, Quinteros, Ana, Hayata, André Luiz Shinji, Smichowski, Andrea, Duarte, Ângela Luzia Branco P., Kahlow, Barbara Stadler, Andia, Carolina Sánchez, Brenol, Claiton Viegas, Velozo, Edson, Mussano, Eduardo, Soriano, Enrique R., Christopoulos, Georges Basile, da Rocha Castelar Pinheiro, Geraldo, de Castro, Gláucio Ricardo Werner, Casado, Gustavo, da Silveira Carvalho, Hellen Mary, Exeni, Ida Elena, da Silveira, Inês Guimarães, Petkovic, Ingrid, Pereira, Ivanio Alves, da Costa, Izaias Pereira, Rosa, Javier Eduardo, Miranda, José Roberto Silva, de Moraes, Julio Cesar Bertacini, Bertolo, Manoel Barros, Buhl, Manuel, Lázaro, Maria Alícia, da Sauma, Maria de Fátima Lobato C., de Medeiros Pinheiro, Marcelo, Díaz, Monica, de Vechi, Mônica Valéria Siqueira Santana, Cerda, Osvaldo Luis, Astesana, Pablo, Curi, Pablo Finucci, Louzada-Jr, Paulo, Teodoro, Reginaldo Botelho, Toledo, Roberto Acayaba, Papasidero, Sílvia, Valim, Valeria, Fernandes, Vander, Saurit, Veronica, Bianchi, Washington Alves, de Melo Costa Pinto, Rogério, Descalzo, Miguel Angel, Gomez-Reino, Juan Jesus
Format: Article
Language:English
Subjects:
Adult
Aged
Antirheumatic Agents - adverse effects
Arthritis, Rheumatoid - complications
Arthritis, Rheumatoid - epidemiology
Arthritis, Rheumatoid - therapy
Biological Products - adverse effects
Brazil
Data processing
Female
Humans
Incidence
Infections
Infections - epidemiology
Infections - etiology
Infectious Disease Medicine - trends
Male
Medicine
Medicine & Public Health
Middle Aged
Original Article
Patients
Registries
Rheumatoid arthritis
Rheumatology
Risk Factors
South America - epidemiology
Tumor necrosis factor
Tumor Necrosis Factor-alpha - antagonists & inhibitors
Tumors
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Summary: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  
ISSN:0770-3198
1434-9949
DOI:10.1007/s10067-019-04516-2