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A Phase II Study to Evaluate Dosing and Preliminary Safety and Efficacy of Canakinumab in Systemic Juvenile Idiopathic Arthritis With Active Systemic Features

Ruperto, Nicolino and Quartier, Pierre and Wulffraat, Nico and Woo, Patricia and Ravelli, Angelo and Mouy, Richard and Bader-Meunier, Brigitte and Vastert, Sebastiaan J and Noseda, Emanuele and D'Ambrosio, Daniele and Lecot, Jean and Chakraborty, Abhijit and Martini, Alberto and Chioato, Andrea (2012) A Phase II Study to Evaluate Dosing and Preliminary Safety and Efficacy of Canakinumab in Systemic Juvenile Idiopathic Arthritis With Active Systemic Features. Arthritis & Rheumatism, 64 (2). pp. 557-567. ISSN 0004-3591

Abstract

Objectives: To assess dosing, preliminary safety, and efficacy of canakinumab, a fully human anti-interleukin-1β (IL-1β) antibody, in children with systemic juvenile idiopathic arthritis (sJIA) and active systemic features.
Methods: In this open-label, dose-escalation, phase II study, children with sJIA who were ≥ 4 years of age, with fever, and receiving ≤ 0.4 mg/kg/d of corticosteroids, were administered a single subcutaneous (sc) dose of canakinumab, 0.5–9 mg/kg and were re-dosed upon relapse. Response was assessed according to adapted American College of Rheumatology (ACR) pediatric criteria.
Results: 23 Children (aged 4–19 years) with active disease were enrolled; 1 patient was excluded and 3 re-enrolled patients were included twice in the efficacy analysis. By day 15 of the first treatment cycle, 15/25 (60%) of patients achieved an adapted ACR ped 50 with 4 of them achieving inactive disease status. Response was sustained over time with 11/13 patients able to maintain response throughout the study. 8/11 Responders receiving steroids at baseline decreased their steroid dose from 0.38 to 0.13mg/kg/day over the first 5 months, with 4 patients able to discontinue. At a dose of canakinumab 4 mg/kg sc every 4 weeks, the median percentage of patients predicted to relapse within 4 weeks was estimated to be 6% (95% confidence interval, 1% to 21%). Therapy was generally well tolerated and few patients experienced injection-site reactions.
Conclusions: Canakinumab has a promising preliminary safety and efficacy profile in this limited cohort. This trial warrants further studies in a larger population of children with sJIA.

Item Type: Article
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Additional Information: author can archive post-print (ie final draft post-refereeing); On personal web site or secure external website at authors institution; Publisher's version/PDF cannot be used
Keywords: canakinumab, SJIA, IL-1B
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Date Deposited: 13 Oct 2015 13:15
Last Modified: 13 Oct 2015 13:15
URI: https://oak.novartis.com/id/eprint/5700

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