PMID- 25504896 OWN - NLM STAT- MEDLINE DCOM- 20150915 LR - 20151119 IS - 1462-0332 (Electronic) IS - 1462-0324 (Linking) VI - 54 IP - 7 DP - 2015 Jul TI - Occurrence of adverse events in patients with JIA receiving biologic agents: long-term follow-up in a real-life setting. PG - 1170-6 LID - 10.1093/rheumatology/keu457 [doi] AB - OBJECTIVE: The aim of this study was to carry out a safety evaluation of biologic agents in patients with JIA and associated uveitis. METHODS: In three tertiary centres in Finland, all adverse events (AEs) in 348 consecutive patients were collected. AEs were classified according to the Common Terminology Criteria for AEs. RESULTS: A total of 1516 patient-years (py) were included: 710 on etanercept, 591 on infliximab, 188 on adalimumab, 8 on rituximab, 5 on anakinra, 6 on tocilizumab, 6 on abatacept and 1 on golimumab. The median follow-up of an individual patient was 51 months (range 1-155). The most common of the 2902 AEs (191/100 py) observed were mild infections, infusion or injection site reactions and alanine aminotransferase elevations. At least one AE occurred in 319 (92%) patients and 121 (35%) had at least one serious AE (SAE). The rate of SAEs was 11.4/100 py on etanercept, 11.8 on infliximab, 10.1 on adalimumab, 15.7 on abatacept, 31.2 on tocilizumab and 87.5 on rituximab, higher than with most anti-TNF agents (P = 0.005). No cases of malignant neoplasms or tuberculosis were detected. New-onset uveitis occurred in 9 patients, psoriasis or psoriasiform lesions in 13 and IBD in 6. CONCLUSION: Mild and moderate AEs in patients with JIA treated with biologics were more frequent than previously reported. SAEs were observed in one-third of the patients, but SAEs seldom led to drug discontinuation. CI - (c) The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com. FAU - Tarkiainen, Maarit AU - Tarkiainen M AD - Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland maarit.tarkiainen@helsinki.fi. FAU - Tynjala, Pirjo AU - Tynjala P AD - Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland. FAU - Vahasalo, Paula AU - Vahasalo P AD - Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland. FAU - Lahdenne, Pekka AU - Lahdenne P AD - Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20141210 PL - England TA - Rheumatology (Oxford) JT - Rheumatology (Oxford, England) JID - 100883501 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Biological Factors) RN - 0 (Immunoglobulin G) RN - 0 (Receptors, Tumor Necrosis Factor) RN - 0 (Tumor Necrosis Factor-alpha) RN - B72HH48FLU (Infliximab) RN - EC 2.6.1.2 (Alanine Transaminase) RN - FYS6T7F842 (Adalimumab) RN - OP401G7OJC (Etanercept) SB - IM MH - Adalimumab MH - Adolescent MH - Alanine Transaminase/blood MH - Antibodies, Monoclonal/adverse effects/therapeutic use MH - Antibodies, Monoclonal, Humanized/adverse effects/therapeutic use MH - Arthritis, Juvenile/blood/complications/*drug therapy MH - Biological Factors/*adverse effects/*therapeutic use MH - Child MH - Child, Preschool MH - Etanercept MH - Female MH - Follow-Up Studies MH - Headache/chemically induced/epidemiology MH - Humans MH - Immunoglobulin G/adverse effects/therapeutic use MH - Incidence MH - Infant MH - Infliximab MH - Longitudinal Studies MH - Male MH - Opportunistic Infections/chemically induced/*epidemiology MH - Patient Compliance MH - Psoriasis/chemically induced/*epidemiology MH - Receptors, Tumor Necrosis Factor/therapeutic use MH - Retrospective Studies MH - Tumor Necrosis Factor-alpha/antagonists & inhibitors MH - Uveitis/chemically induced/*epidemiology MH - Young Adult OTO - NOTNLM OT - adverse drug event OT - anti-TNF OT - anti-rheumatic agent OT - biologic therapy OT - disease-modifying anti-rheumatic drug OT - juvenile idiopathic arthritis EDAT- 2014/12/17 06:00 MHDA- 2015/09/16 06:00 CRDT- 2014/12/16 06:00 PHST- 2014/02/27 00:00 [received] PHST- 2014/12/16 06:00 [entrez] PHST- 2014/12/17 06:00 [pubmed] PHST- 2015/09/16 06:00 [medline] AID - keu457 [pii] AID - 10.1093/rheumatology/keu457 [doi] PST - ppublish SO - Rheumatology (Oxford). 2015 Jul;54(7):1170-6. doi: 10.1093/rheumatology/keu457. Epub 2014 Dec 10.