Background Anti-tumor necrosis factor (TNF) therapies have been shown to be highly effective in the treatment of pediatric rheumatic patients. The experience from long term follow up of adult patients treated with anti TNF drugs have identified the occurrence of infections and immune mediated reactions possibly related with the use of these therapies.
Objectives This study was undertaken to evaluate the long-term safety of anti-TNF agents in pediatric rheumatic patients, followed up in a single center.
Methods Patients were followed up using Reuma.pt, an electronic medical chart coupled with a database developed by the Portuguese Society of Rheumatology. This evaluation was based on all pediatric rheumatic patients followed up in the Rheumatology Department of Hospital de Santa Maria, Lisbon, who started an anti TNF drug before the age of 18 years.
Results Twenty-four patients treated with anti-TNF agents were analyzed. Fifteen were female (62.5%) and 9 were male (37.5%). Mean age was 16.3±5.7 years old, mean disease duration was 9.6±6.0 years, the mean duration of biological therapy was 42.7±34.6 months. In a total of 24 patients, 14 were under treatment with etanercept (ETN), 8 with infliximab (IFX) and 2 with adalimumab (ADA). Seventy-one percent of the patients were under treatment for more than 2 years. From the 24 patients, 22 had Juvenile Idiopathic Arthritis, 1 Polyarteritis nodosa and 1 Idiopathic uveitis. Twenty-eight possibly related adverse events (AE) were registered, of which 2 were severe (bronchospasm and tuberculosis) and led to the switch to another TNF antagonist in one case and to stopping definitely biological therapy in another case. Twenty four AE were registered in patients treated with IFX, (82,1%) mild-moderate and 1 (3,6%) severe AE. Three (10,7%) mild-moderate and none severe AE in patients treated with ETN and 1 (3,6%) severe and none mild-moderate in patients on ADA. Fifty six percent of the mild-moderate AE were due to infections (urinary and upper respiratory systems), 13% due to elevated liver enzymes, 13% due to cytopenia and the remaining 18% due to diverse causes (cough, tachycardia, and hypotension).No malignancies, lymphomas, demyelinating disorders or deaths were reported.
Conclusions These data confirms an acceptable safety profile for the use of anti-TNF agents in pediatric rheumatic patients.
Disclosure of Interest None Declared