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.
Highlights
Infections are the most frequent and concerning serious adverse events related to rheumatoid arthritis (RA) treatment with biological disease-modifying antirheumatic drugs [1]
Data were obtained and analysed for 3717 RA patients and 4986 treatments covering a total of 13,380 patient years
Among biological disease-modifying antirheumatic drugs (bDMARDs), follow-up times were longer for tumour necrosis factor-α inhibitors (TNFi) than for non-TNFi
Summary
Infections are the most frequent and concerning serious adverse events related to rheumatoid arthritis (RA) treatment with biological disease-modifying antirheumatic drugs (bDMARDs) [1]. In 2009, the BIOBADAMERICA registry project, open to all South and Central America countries, was established. It focused on safety monitoring of bDMARDs in rheumatic diseases and shared the same platform used by the previously established BIOBADASER registry [3]. The Brazilian (BIOBADABRASIL) and Argentinian (BIOBADASAR) registries are owned and sponsored by the Brazilian Society of Rheumatology (SBR) and the Argentinian Society of Rheumatology (SAR), respectively. This grants independence, availability to all interested investigators, clear methodological guidelines and consistent training programs [4, 5]. The purpose of this study was to present data on serious infections (SI) and the trends over time in patients with RA treated with bDMARDs in two South American countries based on data collected in analogous registries
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