Background Biological therapy is a major therapeutic tool to prevent clinical and radiological progression of rheumatoid arthritis (RA). On the other hand, adverse effects of these medications are a problem in clinical practice.
Objectives The aim of this study was to describe and compare the most frequent adverse events with the use of biologic therapy in patients with RA in a real-life ambulatory setting.
Methods A descriptive study was done by nursing service. A review of adverse event reports presented in pharmacovigilance committee was completed monthly during last 36 months in a specialized in RA center in Colombia. Descriptive epidemiology was used, percentages and averages were calculated.
Results 570 patients were using biological therapy in a cohort of 2214 RA patients last 36 months. Were 490 women (85.9%) and 80 (14.0%) men. Mean age 60.7 years old. In 163 (28.5% of all) patients were reported adverse events (AE); AE were categorized according WHO classification in mild, moderate and severe; between them 59 (36.2%) were mild, 97 (59.5%) were moderate and 7 (4.2%) were severe. From 163 AE reported, 86 (52.7%) were systemic and 77 (47.2%) dermatologic reactions. Regarding therapeutic approach in 63 patients (38.6%) biologic was temporarily suspended, in 57 (34.9%) was permanently withdrawn and patients switched to another biological, and 43 (26.3%) patients were followed for drug and reactions surveillance. Concerning to type of biologic in 120 patients (73.6%) AE were with anti-TNF therapies.
Conclusions AE using biologics documented in patients of a specialized RA center are similar to those reported in literature; Biological therapy is considered a safe and recommended treatment for management of RA. AE were more common with anti-TNFs therapies.
Disclosure of Interest None declared