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
; 74(6): 1110-7, 2015 Jun.
Article
en En
| MEDLINE
| ID: mdl-24834925
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 ≥6â months and inadequate responses to methotrexate. During part 1, patients received open-label tocilizumab every 4â weeks (8 or 10â mg/kg for body weight (BW) <30â kg; 8â mg/kg for BW ≥30â kg). At week 16, patients with ≥JIA-American College of Rheumatology (ACR) 30 improvement entered the 24-week, double-blind part 2 after randomisation 11 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 (<30â kg 10â mg/kg (n=35) or 8â mg/kg (n=34); ≥30â 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.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Artritis Juvenil
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Antirreumáticos
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Receptores de Interleucina-6
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Anticuerpos Monoclonales Humanizados
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Quimioterapia de Mantención
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Child
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Child, preschool
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Female
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Humans
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Male
Idioma:
En
Revista:
Ann Rheum Dis
Año:
2015
Tipo del documento:
Article
País de afiliación:
Estados Unidos