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Extended report
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
  1. Shumpei Yokota1,2,
  2. Yasuhiko Itoh1,3,
  3. Tomohiro Morio1,4,
  4. Hideki Origasa1,5,
  5. Naokata Sumitomo1,6,
  6. Minako Tomobe7,
  7. Kunihiko Tanaka7,
  8. Seiji Minota1,8
  1. 1Chugai Tocilizumab JIA Safety Evaluation Comittee, Kanagawa, Japan
  2. 2Yokohama City University School of Medicine, Kanagawa, Japan
  3. 3Department of Pediatrics, Nippon Medical School, Tokyo, Japan
  4. 4Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University, Tokyo, Japan
  5. 5Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Japan
  6. 6Saitama International Medical Center, Saitama, Japan
  7. 7Chugai Pharmaceutical Co Ltd., Tokyo, Japan
  8. 8Jichi Medical School, Tochigi, Japan
  1. Correspondence to Professor Shumpei Yokota, Department of Pediatrics, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-000, Japan; yokotashumpei{at}gmail.com

Abstract

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.

  • Juvenile Idiopathic Arthritis
  • DMARDs (biologic)
  • Treatment

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