Adverse events involving biological medicines used in the treatment of rheumatoid arthritis reported in the Brazilian reporting system
DOI:
https://doi.org/10.15448/1980-6108.2025.1.47283Keywords:
arthritis, rheumatoid, biological therapy, drug-related side effects and adverse reactions, adverse drug reaction reporting systems, pharmacovigilanceAbstract
Objectives: To describe suspected adverse drug events (ADEs) involving biological disease-modifying anti-rheumatic drugs (bDMARDs) used in the treatment of rheumatoid arthritis (RA) reported in VigiMed, the Brazilian reporting system.
Methods: Descriptive study of reports carried out in the VigiMed system, between 1st January 2019 and 31st March 2023, involving people aged 19 or over, using bDMARDs.
Results: 3,037 suspected ADEs involving bDMARDs were reported during the referred period, with the greater part of reports presenting at least one serious reaction/event. The Reporting Odds Ratio (ROR=3.10; 95%IC 2.81-3.42) demonstrated that reports involving at least one serious reaction/event were most frequent for this class than for other products. The majority of suspected ADEs involved female (n=1,979; 65.2%) and adult (n=2,404; 79.2%) patients. The bDMARD most frequently involved in suspected ADEs was infliximab (75.4%), and in only 431 (12.5%) of the reports the identifiability and traceability of the bDMARDs involved in the suspected ADEs were ensured. A total of 9,069 reactions/events involving bDMARDs were reported and a predominance of these were related to general disorders and administration site conditions (15.3%).
Conclusion: The results of this study highlight possible safety issues involving bDMARDs, that should be considered when decision-making in pharmacotherapy in RA. This is especially relevant since biological medicines have substantial differences in the safety profile as compared with small molecules. Furthermore, by analysing the reports registered in the VigiMed system, it is possible to identify which initiatives should be adopted to educate and engage notifiers to improve the quality of report.
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Copyright (c) 2025 Cristiane de Paula Rezende, Juliana de Oliveira Gomes Ramos , Paulo Vitor Rozario da Silva, Priscilla Brunelli Pujatti, Lídia Freitas Fontes, Djenane Ramalho-de-Oliveira, Mariana Martins Gonzaga do Nascimento
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