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FRI0112 Dermatologic Adverse Events in a Cohort of Patients with Rheumatoid Arthritis Using Biological Therapy in a Real-Life Setting
  1. F. Salas1,
  2. G. Fuquen2,
  3. J. Castro2,
  4. G. Saavedra3,
  5. D. Gomez4,
  6. J. Bello-Gualtero4,
  7. P. Santos-Moreno4
  1. 1Pharmacy
  2. 2Nursing
  3. 3Epidemiology
  4. 4Rheumatology, Biomab, Center For Rheumatoid Arthritis, Bogota, Bogota, Colombia


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 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 45 months in a specialized in RA center in Colombia. Descriptive epidemiology was used, percentages and averages were calculated.

Results 680 patients were using biological therapy in a cohort of 2905 RA patients last 45 months; 579 women (85.2%) and 101 (14.8%) men. Mean age 60.3 years old. In 153 (22.5% of all patients who received biologics) patients were reported dermatologic adverse events (AE); AE were categorized according WHO classification in mild, moderate and severe; between them 53 (34.6%) were mild, 88 (57.5%) were moderate and 12 (7.8%) were severe. From 153 events reported, only 3 (1.9%) needed a biopsy to clarify what type of dermatologic reaction presented. Regarding therapeutic approach in 54 patients (35.2%) biologics were temporally suspended, in 21 (13.7%) was permanently withdrawn, 27 patients (17.6%) were switched to another biological, and 51 (33.3%) patients were followed for drug and reactions surveillance. From 153 events reported, 11 (7.1%) were acute dermatitis, 51 (33.3%) were dermatologic symptoms due to allergic skin rashes, 20 (13.1%) infection by Herpes zoster, 24 (15.6%) were dermatologic symptoms due to infection causes and the other 47 cases (30.7%) were due to other causes. Concerning to type of biologic, in 124 patients (81.0%) dermatologic adverse events were with anti-TNF therapies.

Conclusions Dermatological adverse events using biologics are observed in a fifth of patients from a specialized RA center and 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 subcutaneous therapies.

Disclosure of Interest None declared

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