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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

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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

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Título Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis : results from a phase 3, randomised, double-blind withdrawal trial
Autor Brunner, Hermine I.
Ruperto, Nicolino
Zuber, Zbigniew
Keane, Caroline
Harari, Olivier
Kenwright, Andrew
Lu, Peng
Cuttica, Ruben
Keltsev, Vladimir
Xavier, Ricardo Machado
Calvo, Inmaculada
Nikishina, Irina
Pérez, Nadina Eugenia Rubio
Alexeeva, Ekaterina
Chasnyk, Vyacheslav
Horneff, Gerd
Opoka-Winiarska, Violetta
Quartier-dit-Maire, Pierre
Silva, Clovis Artur Almeida da
Silverman, Earl
Spindler, Alberto
Baildam, Eileen
Gámir, María Luz
Martin, Alan D.
Rietschel, Christoph
Siri, Daniel
Smolewska, Elzbieta
Lovell, Daniel
Martini, Alberto
De Benedetti, Fabrizio
Abstract Objective 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, placebocontrolled, 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 JIAACR90 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.
Contido em Annals of the rheumatic diseases. London. Vol. 74, no. 6 (Jun. 2015), p. 1110-1117
Assunto Artrite
Imunossupressores
Método duplo-cego
Origem Estrangeiro
Tipo Artigo de periódico
URI http://hdl.handle.net/10183/131289
Arquivos Descrição Formato
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