A Martini

DJ Lovell

G Horneff

H Brunner

H Ozdogan

K Lheritier

L McCann

L Rutkowska-Sak

L Tseng

M Erguven

MA Ferrandiz

N Ruperto

NM Wulffraat

null null

P Quartier

R Brik

R Preiss

T Constantin

T Kallinich

Y Berkun

English

PubMed

Crossref

Pediatric Rheumatology

Efficacy and safety of canakinumab, a long acting fully human anti-Interleukin-1β antibody, in systemic juvenile idiopathic arthritis with active systemic features: results from a phase III study

McCann L

Ozdogan H

Rutkowska-Sak L

Ferrandiz MA

Wulffraat NM

Brik R

Kallinich T

Erguven M

Berkun Y

Constantin T

Quartier P

Horneff G

Brunner H

Ruperto N

Lheritier K

Preiss R

Tseng L

Martini A

Lovell DJ

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ORAL PRESENTATION Open Access
Efficacy and safety of canakinumab, a long
acting fully human anti-Interleukin-1b antibody,
in systemic juvenile idiopathic arthritis with
active systemic features: results from a phase III
study
N Ruperto1*, H Brunner2, G Horneff1, P Quartier1, T Constantin1, Y Berkun1, M Erguven1, T Kallinich1, R Brik1,
NM Wulffraat1, MA Ferrandiz1, L Rutkowska-Sak1, H Ozdogan1, L McCann1, K Lheritier3, R Preiss4, L Tseng4,
A Martini1, DJ Lovell2,
For the Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology
Collaborative Study Group (PRCSG)
From 18th Pediatric Rheumatology European Society (PReS) Congress
Bruges, Belgium. 14-18 September 2011
Objectives
To assess the efficacy and safety of canakinumab, in sys-
temic juvenile idiopathic arthritis (sJIA) with active sys-
temic features at enrollment.
Methods
In this 4-week randomized, controlled, double-blind
study, sJIA patients received a single subcutaneous dose
of canakinumab 4 mg/kg (maximum 300 mg) or placebo
at Day 1. The primary objective was to show superior
efficacy of canakinumab vs placebo in achieving an
adapted ACR Ped30 (ACR criteria plus absence of fever)
treatment response at Day 15.
Results
In total, 84 patients (age 2–19 yrs) received treatment
(canakinumab, n=43; placebo, n=41). Baseline demo-
graphics and characteristics were comparable between
groups, except for age. The overall group means were:
disease duration 3.4 yrs; CRP 200.6 mg/L (normal range
0-10 mg/L); number of active joints 14.1; and predni-
sone equivalent therapy 0.6 mg/kg/day. At Day 15, cana-
kinumab was superior to placebo for the primary and
secondary endpoints: ACR Ped30, 83.7 vs 9.8%; ACR
Ped50, 67.4 vs 4.9%; ACR Ped100, 32.6% vs 0, respec-
tively (all p<0.0001). ACR Ped30/50 responses with
canakinumab remained significantly higher than with
placebo at Day 29 (both p<0.0001). Six patients on cana-
kinumab and 37 patients on placebo discontinued due
to unsatisfactory therapeutic effects. Adverse events
(AEs) occurred in 55.8% of canakinumab and 39.0% of
placebo-treated patients. No discontinuations occurred
due to AEs. Two non-fatal serious AEs were reported in
each group.
Conclusions
Canakinumab has superior efficacy to placebo in sJIA,
providing rapid onset of action and robust response (at
least ACR Ped50 with fever disappearance) in the major-
ity of patients.
Disclosure of Interest
K. Lheritier Shareholder of: Novartis, Employee of:
Novartis; R. Preiss Shareholder of: Novartis, Employee
of: Novartis; L. Tseng Shareholder of: Novartis,
Employee of: Novartis
* Correspondence: nicolaruperto@ospedale-gaslini.ge.it
1PRINTO-IRCCS, Genova, Italy
Full list of author information is available at the end of the article
Ruperto et al. Pediatric Rheumatology 2011, 9(Suppl 1):O21
http://www.ped-rheum.com/content/9/S1/O21
© 2011 Ruperto et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Author details
1PRINTO-IRCCS, Genova, Italy. 2PRCSG, Cincinnati, USA. 3Novartis Pharma AG,
Basel, Switzerland. 4Novartis Pharmaceuticals Corporation, NJ, USA.
Published: 14 September 2011
doi:10.1186/1546-0096-9-S1-O21
Cite this article as: Ruperto et al.: Efficacy and safety of canakinumab, a
long acting fully human anti-Interleukin-1b antibody, in systemic
juvenile idiopathic arthritis with active systemic features: results from
a phase III study. Pediatric Rheumatology 2011 9(Suppl 1):O21.
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Ruperto et al. Pediatric Rheumatology 2011, 9(Suppl 1):O21
http://www.ped-rheum.com/content/9/S1/O21
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Efficacy and safety of canakinumab, a long acting fully human anti-Interleukin-1β antibody, in systemic juvenile idiopathic arthritis with active systemic features: results from a phase III study

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