Safety of biologic and synthetic targeted therapies in patients with immune-mediated diseases: data from the BIOBADAGUAY registry

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.