Keywords
disease-modifying drugs
safety
inflammatory rheumatic diseases
How to Cite
Abstract
Objective: To present the latest data from the Paraguayan–Uruguayan registry of adverse events in patients with inflammatory rheumatic diseases receiving biologic, biosimilar, and targeted synthetic disease-modifying antirheumatic drugs (b/bs/tsDMARDs): BIOBADAGUAY.
Methods: Data were collected from patients enrolled in BIOBADAGUAY up to March 2025. The methodology is available at https://biobadaguay.ser.es/.
Results: A total of 1,289 patients were analyzed, including 1,078 receiving b/bs/tsDMARDs and 211 receiving conventional synthetic DMARDs (csDMARDs) as the control group. Women accounted for 78.7% of the cohort. The mean age at initiation of the first treatment was 44.6 ± 16.7 years. Rheumatoid arthritis (RA) was the most frequent diagnosis (68.7%). A total of 1,633 treatment courses were administered (1,421 b/tsDMARDs and 212 csDMARDs). Overall, 1,893 adverse events (AEs) were recorded, of which 1,615 (88.0%) were mild, 206 (11.2%) were serious, and 15 (0.82%) were fatal. Infections were the most common AEs (55.2%), with the majority being mild (89.7%). In the multivariate analysis according to diagnosis, using RA as the reference category, patients with spondylarthritis (SpA) showed a lower risk of overall AEs. Additionally, second and subsequent treatment lines, hypertension, hypercholesterolemia, concomitant corticosteroid therapy, and leflunomide use were associated with an increased risk of AEs.
Conclusions: The incidence of AEs was predominantly mild, with infections being the most frequently reported events. These findings highlight the need for rigorous and continuous monitoring of patients receiving these therapies.
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Copyright (c) 2026 Paloma de Abreu Trigueros, Sonia Cabrera Villalba, Patricia Melgarejo Paniagua, Teresa Chávez Olazar, Mariela Zarza Torres, Angélica Amarilla Ortiz, Lourdes Román Ruíz-Díaz, Vannia Valinotti Cabrera, Astrid Paats, Alexis Pineda, Evelyn Leiva Ríos, Zoilo Morel Ayala, Pedro Delgadillo Benítez, Roger Rolón Campuzano, Raquel Aranda, Paola Pusineri, Paola Jara Gómez , Laura Martínez, Claudia Coronel, Sany Gómez González, Santiagoç Ferreira Maidana, Cristina Brunengo, Darwin Cordovilla, Clyde Parodi, Mireya Invernizzi, Alicia Quiñonez, Edis Ortigoza Aquino, Silvia Calderoli, Sebastián Alderete, Magui Viviana Ullón Godoy, Carolina Díaz, Sandra Consani, Pilar Garino, Sofia Rostan, Carlos Costa, Yesica de León, Pedro Babak, Cynthia Vega Balbuena, Pamela Velázquez , Gabriela Ávila Pedretti