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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. …
Contributors Conception and design, acquisition of data or analysis and interpretation of data: SY, TI, MM (Masaaki Mori), TM (Takako Miyamae), ST, NI, HU, TM (Takuji Murata), MM (Mari Miyoshi), MT, NN, TK. Drafting the article or revising it critically for important intellectual content: SY. Final approval of the version to be published: SY, TI, MM (Masaaki Mori), TM (Takako Miyamae), ST, NI, HU, TM (Takuji Murata), MM (Mari Miyoshi), MT, NN, TK.
Competing interests None.
Ethics approval Protocols and amendments were approved by the Japanese Ministry of Health, Labour, and Welfare and the institutional review board of each centre. The parent or guardian of every child gave written informed consent, and the child gave assent when appropriate.
Funding This study was sponsored by Chugai Pharmaceuticals Co, Ltd. Editorial support was provided by Genentech Inc, a member of the Roche group.
Provenance and peer review Not commissioned; externally peer reviewed.
Clinical Trial Registry Numbers: NCT00144599 and NCT00144612.
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