ArticleClinical rheumatology2019
Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR.
Article in Clinical rheumatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 21 citations in OpenAlex.
- Real-World Safety and Efficacy of Targeted Therapies in Rheumatoid Arthritis: A 5-Year, 5130-Case Follow-Up from FIRST Registry.Rheumatology and therapy · 2025Article
- Frequency of severe infections in rheumatic disease patients receiving bDMARDs post-kidney transplantation: a multicenter study.Clinical rheumatology · 2025Article
- Longitudinal risk of serious infections in patients with inflammatory arthritis on immunomodulating therapy compared to controls.Rheumatology advances in practice · 2025Article
- Predictors of serious infections in rheumatoid arthritis-a prospective Brazilian cohort.Advances in rheumatology (London, England) · 2024Observational
- Rheumatoid arthritis study of the Egyptian College of Rheumatology (ECR): nationwide presentation and worldwide stance.Rheumatology international · 2023Article
- Performance of the RABBIT infection risk score in an Argentinian rheumatoid arthritis cohort.Clinical rheumatology · 2021Article
- Adverse Events in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Receiving Long-Term Biological Agents in a Real-Life Setting.Frontiers in pharmacology · 2019Article
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Authors and funding
56 authors at 20 institutions in 2 countries.
Funding
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-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.
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.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.
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