PMID- 26644233 OWN - NLM STAT- MEDLINE DCOM- 20170601 LR - 20220410 IS - 1468-2060 (Electronic) IS - 0003-4967 (Print) IS - 0003-4967 (Linking) VI - 75 IP - 9 DP - 2016 Sep TI - Tocilizumab in systemic juvenile idiopathic arthritis in a real-world clinical setting: results from 1 year of postmarketing surveillance follow-up of 417 patients in Japan. PG - 1654-60 LID - 10.1136/annrheumdis-2015-207818 [doi] AB - OBJECTIVES: To evaluate the safety and effectiveness of tocilizumab (TCZ) in patients with systemic juvenile idiopathic arthritis (sJIA) in real-world clinical settings in Japan. METHODS: Paediatric patients with sJIA initiating TCZ between April 2008 and February 2012 and those previously enrolled in clinical trials who initiated TCZ before April 2008 were enrolled in a Japanese registry surveillance programme. Safety and effectiveness parameters were collected for 52 weeks. RESULTS: Of 417 patients enrolled, mean age was 11.2 years and 48.0% were female. TCZ exposure was 407.0 patient-years (PYs). Baseline corticosteroid use was higher than in clinical trials. Rates of total adverse events (AEs) and serious AEs (SAEs) were 224.3/100 PYs and 54.5/100 PYs, respectively, with SAEs higher than previously reported. The most frequent AEs and SAEs were infections and infestations (69.8/100 PYs and 18.2/100 PYs, respectively). 74 serious infections occurred in 55 patients (18.2/100 PYs); higher than previously reported. 26 macrophage activation syndrome events were reported in 24 patients (6.4/100 PYs). Fever and rash symptoms improved from baseline to week 52 (54.6% to 5.6% and 43.0% to 5.6%, respectively). At 4 weeks, 8 weeks and 52 weeks, 90.5%, 96.2% and 99.0% of patients achieved normal C reactive protein levels (<0.3 mg/dL), respectively. CONCLUSIONS: These first real-world data demonstrated that TCZ was well tolerated, with acceptable safety and effectiveness in patients with sJIA. Higher incidences of SAEs and serious infections may be due to differences, such as corticosteroid use and concomitant diseases, between patient populations enrolled in previously reported clinical trials and this study. CI - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ FAU - Yokota, Shumpei AU - Yokota S AD - Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Yokohama City University School of Medicine, Kanagawa, Japan. FAU - Itoh, Yasuhiko AU - Itoh Y AD - Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Department of Pediatrics, Nippon Medical School, Tokyo, Japan. FAU - Morio, Tomohiro AU - Morio T AD - Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University, Tokyo, Japan. FAU - Origasa, Hideki AU - Origasa H AD - Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Japan. FAU - Sumitomo, Naokata AU - Sumitomo N AD - Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Saitama International Medical Center, Saitama, Japan. FAU - Tomobe, Minako AU - Tomobe M AD - Chugai Pharmaceutical Co Ltd., Tokyo, Japan. FAU - Tanaka, Kunihiko AU - Tanaka K AD - Chugai Pharmaceutical Co Ltd., Tokyo, Japan. FAU - Minota, Seiji AU - Minota S AD - Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Jichi Medical School, Tochigi, Japan. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20151207 PL - England TA - Ann Rheum Dis JT - Annals of the rheumatic diseases JID - 0372355 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - I031V2H011 (tocilizumab) SB - IM MH - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use MH - Antirheumatic Agents/adverse effects/*therapeutic use MH - Arthritis, Juvenile/*drug therapy MH - Child MH - Female MH - Follow-Up Studies MH - Humans MH - Japan MH - Male MH - *Product Surveillance, Postmarketing MH - Registries MH - Time Factors MH - Treatment Outcome PMC - PMC5013079 OTO - NOTNLM OT - DMARDs (biologic) OT - Juvenile Idiopathic Arthritis OT - Treatment EDAT- 2015/12/09 06:00 MHDA- 2017/06/02 06:00 PMCR- 2016/09/07 CRDT- 2015/12/09 06:00 PHST- 2015/04/20 00:00 [received] PHST- 2015/10/03 00:00 [accepted] PHST- 2015/12/09 06:00 [entrez] PHST- 2015/12/09 06:00 [pubmed] PHST- 2017/06/02 06:00 [medline] PHST- 2016/09/07 00:00 [pmc-release] AID - annrheumdis-2015-207818 [pii] AID - 10.1136/annrheumdis-2015-207818 [doi] PST - ppublish SO - Ann Rheum Dis. 2016 Sep;75(9):1654-60. doi: 10.1136/annrheumdis-2015-207818. Epub 2015 Dec 7.