Adverse events during anti-TNF therapy in 269 patients with juvenile idiopathic arthritis

Abstract

Background: Patients with juvenile idiopathic arthritis (JIA), non-responsive to disease-modifying anti-rheumatic drugs (DMARDs), are treated with anti-tumour necrosis factor (TNF) agents. The aim of this study was to evaluate the occurrence of adverse events (AEs) in these refractory patients. Methods: In three tertiary centres, patient charts were reviewed, and for each anti-TNF drug the severity and type of AEs were specified. Of 292 patients, 97% were on concomitant DMARDs at anti-TNF onset. Their mean age was 5.4 years (SD 3.8) at disease onset and 10.5 years (SD 3.9) at anti-TNF onset. Results: The total drug exposure was 781 years; etanercept exposure was 403 years, infliximab 337, and adalimumab 41. Of altogether 1418 AEs, 66 (5%) were considered serious (Table 1). A total of 627 (44%) infections occurred, of which 313 (50%) were upper respiratory tract infections. Dermatological problems were documented in 69 (24%) patients, and hypersensitivity reactions (including infusion and injection site reactions) in 70. Three patients developed an inflammatory bowel disease during anti-TNF treatment and one had colitis ulcerosa at arthritis onset. Neither malignancies nor tuberculosis appeared, although one patient had a mycobacterium avium pneumonia during adalimumab treatment. Conclusions: Infections were the most common AEs in patients with JIA receiving anti-TNF therapy, but the rate of serious infections seemed to below. Table 1. Adverse events (AEs) and serious adverse events (SAEs) per patientyear during anti-TNF therapy. Etanercept Infliximab Adalimumab All AEs 1.70 1.87 2.52 1.81 SAEs 0.09 0.08 0.05 0.08 All infections 0.79 0.81 0.82 0.80 Upper respiratory 0.41 0.40 0.34 0.40 Serious infections 0.03 0.02 0.02 0.03 Hypersensitivity reactions 0.04 0.29 0.19 0.14.