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 Regarding therapeutic approach in 36 patients (46.7%) biologics were suspended, in 29 (37.6%) was permanently withdrawn and patients were switched to another biological, and 12 (15.5%) patients were followed for drug and reactions surveillance.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
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.