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 dermatologic adverse events with the use of biologic anti-TNF therapy in patients with RA in a real-life ambulatory setting.
Methods A descriptive study was done. A review of dermatological 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). In 77 (46.9% of all AE) patients were reported dermatologic adverse events (AE); AE were categorized according WHO classification in mild, moderate and severe; between them 27 (35.0%) were mild, 47 (61.0%) were moderate and 3 (3.9%) were severe. From 77 events reported, only 6 (7.7%) needed biopsied to clarified what type of dermatologic reaction presented. Regarding therapeutic approach in 36 patients (46.7%) biologics were suspended, in 29 (37.6%) was permanently withdrawn and patients were switched to another biological, and 12 (15.5%) patients were followed for drug and reactions surveillance. From 77 events reported, 22 (28.6%) were acute dermatitis, 26 (33.7%) were dermatologic symptoms due to allergic skin rashes, 8 (10.3%) infection by Herpes zoster, and the other 21 cases (27.2%) were due to other causes. Concerning to type of biologic in 64 patients (83.1%), dermatologic adverse events were with anti-TNF therapies.
Conclusions Dermatological adverse events using biologics founded 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. Dermatologic AE were more mostly common with anti-TNFs therapies.
Disclosure of Interest None declared