• Hermine I Brunner, Nicolino Ruperto, Zbigniew Zuber, Caroline Keane, Olivier Harari, Andrew Kenwright, Peng Lu, Ruben Cuttica, Vladimir Keltsev, Ricardo M Xavier, Inmaculada Calvo, Irina Nikishina, Nadina Rubio-Pérez, Ekaterina Alexeeva, Vyacheslav Chasnyk, Gerd Horneff, Violetta Opoka-Winiarska, Pierre Quartier, Clovis A Silva, Earl Silverman, Alberto Spindler, Eileen Baildam, M Luz Gámir, Alan Martin, Christoph Rietschel, Daniel Siri, Elzbieta Smolewska, Daniel Lovell, Alberto Martini, Fabrizio De Benedetti, Paediatric Rheumatology International Trials Organisation PRINTO, and Pediatric Rheumatology Collaborative Study Group (PRCSG).
• Division of Rheumatology, Department of Pediatrics, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA.
• Ann. Rheum. Dis. 2015 Jun 1; 74 (6): 1110-7.

ObjectiveTo evaluate the interleukin-6 receptor inhibitor tocilizumab for the treatment of patients with polyarticular-course juvenile idiopathic arthritis (pcJIA).MethodsThis three-part, randomised, placebo-controlled, double-blind withdrawal study (NCT00988221) included patients who had active pcJIA for ≥6 months and inadequate responses to methotrexate. During part 1, patients received open-label tocilizumab every 4 weeks (8 or 10 mg/kg for body weight (BW) <30 kg; 8 mg/kg for BW ≥30 kg). At week 16, patients with ≥JIA-American College of Rheumatology (ACR) 30 improvement entered the 24-week, double-blind part 2 after randomisation 1:1 to placebo or tocilizumab (stratified by methotrexate and steroid background therapy) for evaluation of the primary end point: JIA flare, compared with week 16. Patients flaring or completing part 2 received open-label tocilizumab.ResultsIn part 1, 188 patients received tocilizumab (<30 kg: 10 mg/kg (n=35) or 8 mg/kg (n=34); ≥30 kg: n=119). In part 2, 163 patients received tocilizumab (n=82) or placebo (n=81). JIA flare occurred in 48.1% of patients on placebo versus 25.6% continuing tocilizumab (difference in means adjusted for stratification: -0.21; 95% CI -0.35 to -0.08; p=0.0024). At the end of part 2, 64.6% and 45.1% of patients receiving tocilizumab had JIA-ACR70 and JIA-ACR90 responses, respectively. Rates/100 patient-years (PY) of adverse events (AEs) and serious AEs (SAEs) were 480 and 12.5, respectively; infections were the most common SAE (4.9/100 PY).ConclusionsTocilizumab treatment results in significant improvement, maintained over time, of pcJIA signs and symptoms and has a safety profile consistent with that for adults with rheumatoid arthritis.Trial Registration NumberNCT00988221.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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