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Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial.

AbstractOBJECTIVE:
To evaluate the interleukin-6 receptor inhibitor tocilizumab for the treatment of patients with polyarticular-course juvenile idiopathic arthritis (pcJIA).
METHODS:
This 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.
RESULTS:
In 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).
CONCLUSIONS:
Tocilizumab 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 NUMBER:
NCT00988221.
AuthorsHermine 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, Pediatric Rheumatology Collaborative Study Group (PRCSG)
JournalAnnals of the rheumatic diseases (Ann Rheum Dis) Vol. 74 Issue 6 Pg. 1110-7 (Jun 2015) ISSN: 1468-2060 [Electronic] England
PMID24834925 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightPublished 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.
Chemical References
  • Adrenal Cortex Hormones
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • Receptors, Interleukin-6
  • tocilizumab
  • Methotrexate
Topics
  • Adolescent
  • Adrenal Cortex Hormones (therapeutic use)
  • Antibodies, Monoclonal, Humanized (therapeutic use)
  • Antirheumatic Agents (therapeutic use)
  • Arthritis, Juvenile (drug therapy)
  • Bronchitis (chemically induced)
  • Cellulitis (chemically induced)
  • Child
  • Child, Preschool
  • Disease Progression
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Maintenance Chemotherapy (methods)
  • Male
  • Methotrexate (therapeutic use)
  • Pneumonia (chemically induced)
  • Receptors, Interleukin-6 (antagonists & inhibitors)
  • Remission Induction (methods)
  • Treatment Outcome

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