Seguridad de terapias biológicas y sintéticas dirigidas en pacientes con enfermedades inmunomediadas: datos del registro BIOBADAGUAY

IF 1.2 Q4 RHEUMATOLOGY

Reumatologia Clinica Pub Date : 2025-02-01 DOI:10.1016/j.reuma.2024.09.008

Paloma de Abreu , Sonia Cabrera , Darwin Cordovilla , Lourdes Román , Cristina Brunengo , Patricia Melgarejo , Macarena Soto , Vannia Valinotti , Angelica Amarilla , Belem Acevedo , Alexis Pineda , Evelyn Leiva , Paola Pusineri , Sandra Consani , Mariela Zarza , Clyde Parodi , Zoilo Morel , Roger Rolón , Paola Jara , Raquel Aranda , Gabriela Ávila

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引用次数: 0

Abstract

Objective

To analyze the safety of biologic (DMARDs-b) and synthetic targeted therapies (DMARDs-sd) in the BIOBADAGUAY registry (Paraguayan-Uruguayan registry of adverse events (AEs) in patients with inflammatory rheumatic diseases).

Methods

BIOBADAGUAY is a registry to prospectively evaluate the efficacy and safety of FAME-b and FAME-sd. The full methodology is available at https://biobadaguay.ser.es. Variables associated with the safety of the therapies were used for the present study. The incidence of AA 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

1104 patients (73.3% female) with 1366 AA, predominantly mild (87.2%), were analyzed. The overall incidence of AEs was 251.75 per 1000 patient-years. Infections were the most frequent (55.0%), with an incidence of 138.4 per 1000 patient-years. Rheumatoid arthritis and corticosteroid use were associated with more global AEs, while anti-TNF was associated with less AEs.

Conclusions

This study from the BIOBADAGUAY registry has provided valuable data on the safety of DMARD-b, sd in a cohort of patients with inflammatory rheumatic diseases. The incidence of predominantly mild AEs, with infections as the most frequent adverse event, underscores the need for rigorous and constant monitoring in this population.

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来源期刊

Reumatologia Clinica RHEUMATOLOGY-

CiteScore

2.40

自引率

6.70%

发文量

105

审稿时长

54 days

期刊介绍： Una gran revista para cubrir eficazmente las necesidades de conocimientos en una patología de etiología, expresividad clínica y tratamiento tan amplios. Además es La Publicación Oficial de la Sociedad Española de Reumatología y del Colegio Mexicano de Reumatología y está incluida en los más prestigiosos índices de referencia en medicina.