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Long-term treatment of systemic juvenile idiopathic arthritis with tocilizumab: results of an open-label extension study in Japan
  1. Shumpei Yokota1,
  2. Tomoyuki Imagawa1,
  3. Masaaki Mori2,
  4. Takako Miyamae1,
  5. Syuji Takei3,
  6. Naomi Iwata4,
  7. Hiroaki Umebayashi5,
  8. Takuji Murata6,
  9. Mari Miyoshi7,
  10. Minako Tomiita8,
  11. Norihiro Nishimoto9,
  12. Tadamitsu Kishimoto10
  1. 1Department of Paediatrics, Yokohama City University School of Medicine, Yokohama, Japan
  2. 2Department of Paediatrics, Yokohama City University Medical Center, Yokohama, Japan
  3. 3School of Health Science, Kagoshima University, Kagoshima, Japan
  4. 4Aichi Children's Health and Medical Centre, Aichi, Japan
  5. 5Miyagi Children's Hospital, Miyagi, Japan
  6. 6Department of Paediatrics, Osaka Medical College, Osaka, Japan
  7. 7Kobe Children's Hospital, Kobe, Japan
  8. 8Department of Paediatrics, Graduate School of Medicine, Chiba University, Chiba, Japan
  9. 9Laboratory of Immune Regulation, Wakayama Medical University, Osaka, Japan
  10. 10Immunology Frontier Research Center, Osaka University, Osaka, Japan
  1. Correspondence to Professor Shumpei Yokota, Department of Paediatrics, Yokohama City University School of Medicine, 3–9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236–0004, Japan; syokota{at}med.yokohama-cu.ac.jp

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Systemic-onset juvenile idiopathic arthritis (sJIA) is a chronic childhood disease associated with many complications.1–5 Treatments comprise non-steroidal anti-inflammatory drugs, corticosteroids, disease-modifying antirheumatic drugs and biologics,6–9 including tocilizumab, an interleukin-6 receptor monoclonal antibody.10

Results of a randomised, placebo-controlled, phase III trial of tocilizumab in sJIA patients at eight Japanese hospitals, as well as the first 48 weeks of an open-label extension, have been published.3 Protocols and amendments for this extension phase were approved by the Japanese Ministry of Health, Labor and Welfare and the institutional review board at each centre. Of 56 patients initially enrolled, six withdrew during the open-label, lead-in phase (anti-tocilizumab antibodies, three; anaphylactoid reaction, one; gastrointestinal haemorrhage, one; non-efficacy, one). During the double-blind phase, one patient from each treatment arm withdrew because of adverse events (AEs) but re-entered the open-label extension after the resolution of AEs. In total, 50 patients responding to tocilizumab and needing further treatment entered the open-label extension; two patients subsequently withdrew within the first year because of AEs. Herein, the long-term efficacy and safety of treatment through 144 weeks are presented. …

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