THU0574 Long term pharmacovigilance of biologics for juvenile idiopathic arthritis: the biker-registry

Abstract

Background: Long-term surveillance of biologics drugs is particularly important in paediatric patients (pts) Objectives: To evaluate long-term rates of serious adverse events (AE) and AEs of special interest (AESI) in clinical practice in pts with juvenile idiopathic arthritis (JIA) Methods: Safety data from pts registered in the BIKER registry were analysed. Rates of 25 AESI were analysed from first dose through 70 days after last dose and compared by Wald test Results: A total of 3975 courses of biologics with a total exposure of 7592 PY were identified with Etanercept (5376PY) followed by Adalimumab (1334PY), Tocilizumab (435PY), Abatacept (109PY), Infliximab (99PY), Anakinra (96 PY), Canakinumab (71PY) and Golimumab (67PY). Differences in JIA category distribution and concomitant treatment were noted. A total of 3586 AE (47.2/100PY), 461 (6.1) SAE and 629 (8.3) AESI were reported. The most common AESI were uveitis (194 (2.6)) followed by medically important infections (155 (2.0)), cytopenias (62 (0.8)), hepatic events 39 (0.5), anaphylaxis (28 (0.4))), other autoimmunopathies (25 (0.3)), chronic inflammatory bowel disease (23 (0.3)), depression (17 (0.2)), macrophage activation syndrome (12 (0.2)), malignancies (8 (0.1)) and pregnancies (8 (0.1)). There were marked differences in the rate of AESI with different biologics. Uveitis were most common in TNF-antibody treated cohorts, infections upon GOL, TOC, ANA, cytopenias upon TOC, CAN, hepatic events upon TOC, anaphylaxis upon INF, TOC, CED upon ETA, INF (table 1). One case of latent TB but no further opportunistic infections were reported. There was a single death due to sepsis. [KM1]Vorn 2481 [KM2]Vorn 67? Conclusions: Surveillance of pharmacotherapy as provided by BIKER is an import approach especially for long term treatment of children. Overall, tolerance is acceptable. Differences between several biologics were noted and should be considered in daily patient care.