Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR.
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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, BIOBADABRASIL study group, Sociedade Brasileira de Reumatologia and of the BIOBADASAR study group, Sociedad Argentina de Reumatologia, de Melo Costa Pinto Rogério, Descalzo Miguel Angel, Gomez-Reino Juan Jesus
Аннотация
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.