title: 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.
abstract: To evaluate the safety and effectiveness of tocilizumab (TCZ) in patients with systemic juvenile idiopathic arthritis (sJIA) in real-world clinical settings in Japan.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Yokohama City University School of Medicine, Kanagawa, Japan.
authors.forename: Shumpei
authors.initials: S
authors.lastname: Yokota
authors.affiliation: Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Department of Pediatrics, Nippon Medical School, Tokyo, Japan.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Itoh
authors.affiliation: Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Morio
authors.affiliation: Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Origasa
authors.affiliation: Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Saitama International Medical Center, Saitama, Japan.
authors.forename: Naokata
authors.initials: N
authors.lastname: Sumitomo
authors.affiliation: Chugai Pharmaceutical Co Ltd., Tokyo, Japan.
authors.forename: Minako
authors.initials: M
authors.lastname: Tomobe
authors.affiliation: Chugai Pharmaceutical Co Ltd., Tokyo, Japan.
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Tanaka
authors.affiliation: Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan Jichi Medical School, Tochigi, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Minota
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008297:Male; D011358:Product Surveillance, Postmarketing; D012042:Registries; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; C502936:tocilizumab
keywords: DMARDs (biologic); Juvenile Idiopathic Arthritis; Treatment