AB0395 IMMUNE-MEDIATED SKIN LESIONS RELATED TO BIOLOGICAL DISEASE-MODIFYING ANTIRHEUMATIC DRUGS: A 22-YEAR EXPERIENCE OF A TERTIARY CENTER

Abstract

Background: Biological disease-modifying antirheumatic drugs (bDMARDs) have revolutionized the treatment of chronic inflammatory rheumatic diseases. However, the physician and the patient should be aware of possible adverse reactions. Skin is one of the most frequent organs involved in bDMARD adverse reactions and immune-mediated skin lesions (IMSL) have rarely been described before in cohort studies and their incidence is unknown. Objective(s): To explore the cumulative incidence, type of lesions, management and outcomes of IMSL related to bDMARD in a large cohort of patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). Method(s): We conducted a retrospective single-center study including patients with RA, axSpA and PsA followed at a Rheumatology Department from a University Hospital Center between April 2000 and December 2021, treated with at least one bDMARD for at least 6 months. Sociodemographic characteristics, disease duration, age at diagnosis, concomitant immunosuppressive medications, type and duration of the treatment with bDMARD and number of previous bDMARD were collected. For all patients with IMSL, age at onset, disease duration at the time of the IMSL, culprit bDMARD and duration of the treatment, specific management and outcomes were collected. Descriptive statistics for continuous variables were presented with mean and standard deviation and categorical variables were presented with absolute and relative frequencies. Result(s): A total of 441 patients with RA, 386 with axSpA and 162 with PsA were included. The majority were female (63.4%), with a mean age of 54.3 +/- 12.8 years. An important proportion of patients (47.6%, n=471) were taking csDMARDs and the most prescribed bDMARD was adalimumab (21.8 %), followed by etanercept (16.5%). Twenty-seven (2.7%) patients presented IMSL potentially related to the bDMARD. Regarding the patients with IMSL, 55.6% were females, mean age at the onset of IMSL was 48.4 +/- 12.0 years, mean duration of the treatment with bDMARDs was 4.3 +/- 4.5 years and mean duration of the treatment with the culprit bDMARD was 2.3 +/- 2.1 years. The majority of patients had SpA (n= 14), followed by RA (n=10) and PsA (n=3). Adalimumab was the culprit agent in half of the patients (n=14), followed by etanercept (n=4), golimumab (n=3), infliximab (n=3), rituximab (n=2) and tocilizumab (n=1). Four patients (14.8%) needed hospitalization with the purpose of performing a clinical, laboratorial and histological investigation. In most patients, skin lesions resolved completely with topical (n=12) or systemic (n=6) treatment. IMSL led to withdrawal of bDMARD in 18 patients (66.7%). More information about the type of IMSL was described in table 1. Conclusion(s): IMSL related to bDMARDs are unusual events with an estimated cumulative incidence of 2.9%, in our sample. The most frequent IMSL were psoriasis and cutaneous manifestations of DILE and the most frequent culprit bDMARD was adalimumab. The majority of patients didn't need hospitalization and presented complete resolution of IMSL. IMSL led to withdrawal of the bDMARD in 2/3 of patients.