Safety of biological therapies in a cohort of paraguayan patients
Abstract
Objectives: to analyze the safety of biologic therapies (FAME-b) in the Paraguayan patient cohort of the BIOBADAGUAY registry (Paraguayan-Uruguayan registry of adverse events (AE) in patients with inflammatory rheumatic diseases.
Methods: BIOBADAGUAY is a registry to prospectively evaluate the efficacy and safety of b-DMARDs. The complete methodology is available at https://biobadaguay.ser.es. Variables associated with the safety of therapies were used for the present study. The incidence of EA was calculated as incidence rate (IR) per 1000 patient-years, with 95% confidence intervals (CI) and Poisson regression for the incidence rate ratio (IRR).
Results: We analyzed 696 patients (71.3% women) with 1077 predominantly mild AE (88.6%). The overall incidence was 323.8 per 1000 patient-years. Infections were the most frequent AA (55.3%). Anti-TNF treatment was associated with a lower incidence of EA, while second and subsequent lines of treatment were associated with more AE.
Conclusions: This study has provided valuable data on the safety of FAME-b in a cohort of Paraguayan patients with inflammatory rheumatic diseases. Most of AEs were mild and infectious processes were the most frequent AE. It is important to continue with these registries to contribute to a rigorous and permanent control of this patient population.
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Copyright (c) 2025 Paloma de Abreu, Sonia Cabrera Villalba, Lourdes Román, Patricia Melgarejo Paniagua, Vannia Valinotti Cabrera, Angélica Amarilla Ortiz, Alexis Pineda, Paola Pusineri, Mariela Zarza Torres, Raquel Aranda, Clyde Parodi, Evelyn Leiva Ríos, Laura Martínez, Paola Jara Gómez, Zoilo Morel Ayala, Roger Rolón Campuzano, Magali Zanotti Cavazzoni, Cynthia Vega Balbuena, Pedro Babak, Gabriela Ávila Pedretti
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