Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis : results from a phase 3, randomised, double-blind withdrawal trial
dc.contributor.author | Brunner, Hermine I. | pt_BR |
dc.contributor.author | Ruperto, Nicolino | pt_BR |
dc.contributor.author | Zuber, Zbigniew | pt_BR |
dc.contributor.author | Keane, Caroline | pt_BR |
dc.contributor.author | Harari, Olivier | pt_BR |
dc.contributor.author | Kenwright, Andrew | pt_BR |
dc.contributor.author | Lu, Peng | pt_BR |
dc.contributor.author | Cuttica, Ruben | pt_BR |
dc.contributor.author | Keltsev, Vladimir | pt_BR |
dc.contributor.author | Xavier, Ricardo Machado | pt_BR |
dc.contributor.author | Calvo, Inmaculada | pt_BR |
dc.contributor.author | Nikishina, Irina | pt_BR |
dc.contributor.author | Pérez, Nadina Eugenia Rubio | pt_BR |
dc.contributor.author | Alexeeva, Ekaterina | pt_BR |
dc.contributor.author | Chasnyk, Vyacheslav | pt_BR |
dc.contributor.author | Horneff, Gerd | pt_BR |
dc.contributor.author | Opoka-Winiarska, Violetta | pt_BR |
dc.contributor.author | Quartier-dit-Maire, Pierre | pt_BR |
dc.contributor.author | Silva, Clovis Artur Almeida da | pt_BR |
dc.contributor.author | Silverman, Earl | pt_BR |
dc.contributor.author | Spindler, Alberto | pt_BR |
dc.contributor.author | Baildam, Eileen | pt_BR |
dc.contributor.author | Gámir, María Luz | pt_BR |
dc.contributor.author | Martin, Alan D. | pt_BR |
dc.contributor.author | Rietschel, Christoph | pt_BR |
dc.contributor.author | Siri, Daniel | pt_BR |
dc.contributor.author | Smolewska, Elzbieta | pt_BR |
dc.contributor.author | Lovell, Daniel | pt_BR |
dc.contributor.author | Martini, Alberto | pt_BR |
dc.contributor.author | De Benedetti, Fabrizio | pt_BR |
dc.date.accessioned | 2015-12-23T02:40:36Z | pt_BR |
dc.date.issued | 2015 | pt_BR |
dc.identifier.issn | 0003-4967 | pt_BR |
dc.identifier.uri | http://hdl.handle.net/10183/131289 | pt_BR |
dc.description.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. | en |
dc.format.mimetype | application/pdf | |
dc.language.iso | eng | pt_BR |
dc.relation.ispartof | Annals of the rheumatic diseases. London. Vol. 74, no. 6 (Jun. 2015), p. 1110-1117 | pt_BR |
dc.rights | Open Access | en |
dc.subject | Artrite | pt_BR |
dc.subject | Imunossupressores | pt_BR |
dc.subject | Método duplo-cego | pt_BR |
dc.title | Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis : results from a phase 3, randomised, double-blind withdrawal trial | pt_BR |
dc.type | Artigo de periódico | pt_BR |
dc.identifier.nrb | 000977540 | pt_BR |
dc.type.origin | Estrangeiro | pt_BR |
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