Portal de investigación
Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Brunner HI
- Ruperto N
- Zuber Z
- Keane C
- Harari O
- Kenwright A
- Lu P
- Cuttica R
- Keltsev V
- Xavier RM
- Nikishina I
- Rubio-Pérez N
- Alexeeva E
- Chasnyk V
- Horneff G
- Opoka-Winiarska V
- Quartier P
- Silva CA
- Silverman E
- Spindler A
- Baildam E
- Gámir ML
- Martin A
- Rietschel C
- Siri D
- Smolewska E
- Lovell D
- Martini A
- De Benedetti F
- Paediatric Rheumatology International Trials Organisation PRINTO
- Pediatric Rheumatology Collaborative Study Group (PRCSG)
Grupos
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, placebo-controlled, double-blind withdrawal study (NCT00988221) included patients who had active pcJIA for 6months and inadequate responses to methotrexate. During part 1, patients received open-label tocilizumab every 4weeks (8 or 10mg/kg for body weight (BW) <30kg; 8mg/kg for BW 30kg). 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 (<30kg: 10mg/kg (n=35) or 8mg/kg (n=34); 30kg: 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.
Datos de la publicación
- ISSN/ISSNe:
- 0003-4967, 1468-2060
- Tipo:
- Article
- Páginas:
- 1110-1117
- PubMed:
- 24834925
- Factor de Impacto:
- 5,909 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
ANNALS OF THE RHEUMATIC DISEASES ELSEVIER
Citas Recibidas en Web of Science: 226
Documentos
- No hay documentos
Filiaciones
Keywords
- DMARDs (biologic); Juvenile Idiopathic Arthritis; Treatment
Campos de Estudio
Cita
Brunner HI,Ruperto N,Zuber Z,Keane C,Harari O,Kenwright A,Lu P,Cuttica R,Keltsev V,Xavier RM,CALVO I,Nikishina I,Rubio N,Alexeeva E,Chasnyk V,Horneff G,Opoka V,Quartier P,Silva CA,Silverman E,Spindler A,Baildam E,Gámir ML,Martin A,Rietschel C,Siri D,Smolewska E,Lovell D,Martini A,De Benedetti F,Paediatric Rheumatology International Trials Organisation P,Pediatric Rheumatology Collaborative Study Group (PRCSG). Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial. Ann. Rheum. Dis. 2015. 74. (6):p. 1110-1117. IF:12,384. (1).