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  • Open Access

PReS-FINAL-2157: Efficacy of canakinumab in the treatment of systemic juvenile idiopathic arthritis: a 12-week pooled post-hoc analysis

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Pediatric Rheumatology201311 (Suppl 2) :P169

https://doi.org/10.1186/1546-0096-11-S2-P169

  • Published:

Keywords

  • Pool Analysis
  • Active Joint
  • Rapid Improvement
  • Important Improvement
  • Disability Score

Introduction

Interleukin-1β (IL-1β) plays a key role in the pathogenesis of systemic juvenile idiopathic arthritis (SJIA). Efficacy and safety of canakinumab (CAN), a selective, fully human, anti- IL-1β monoclonal antibody, have been demonstrated in 2 phase III trials. Here we present 12-week results of a post-hoc pooled analysis.

Objectives

To evaluate the 12-week efficacy of CAN 4 mg/kg in treatment naïve patients (pts).

Methods

Data from the 3 trials done as part of the phase III program were pooled for this analysis. Pts aged 2-19 yrs with active SJIA were enrolled and received subcutaneous CAN 4 mg/kg or placebo. The post-hoc analysis presented here focuses on SJIA response to CAN therapy in the initial treatment period of a total of 178 CAN-naïve pts. Methodological factors precluded a comparator group, so this analysis is of a descriptive nature.

Results

At baseline (BL), 94% of pts had intermittent spiking fever due to SJIA; and 73% were on steroids (mean dose of 0.38 mg/kg/d). In the pooled analysis (N = 178), by Week 2 evidence of profound clinical benefit was observed (Table 1) with 20% of pts even achieving inactive disease.
Table 1

Percentage of patients with adapted JIA ACR (aacr) response and inactive disease

CAN, N = 178

N(%)

Aacr30

Aacr50

Aacr70

Aacr90

Aacr100

Inactive disease

Week 2

142 (80%)

125 (70%)

102 (57%)

65 (37%)

38 (21%)

36 (20%)

Week 12

125 (70%)

122 (69%)

108 (61%)

87 (49%)

54 (30%)

50 (28%)

Data from missing patients not shown; aacr response = ACR response level plus absence of fever

The median CRP level of 158 mg/L at BL decreased by a median of 82% and 94% by weeks 2 and 12, respectively. Rapid improvements were also observed in the number of active joints. The median number of active joints decreased from 10 at BL to 2.5 at Week 2 and 0 at Week 12. Similarly, for joints with limitation of motion, median values decreased from 9 at BL to 2.5 and 1 at Week 2 and 12, respectively. While 94% pts had fever due to SJIA at BL, only 13% at Week 2 and 2% at Week 12 had fever. Notably, CAN therapy resulted in marked improvement in patient reported outcomes: parent/patient assessment of pain (0-100 mm, VAS) decreased from a mean of 67 mm at BL to 22 mm at Week 2 and 11 mm at Week 12. The median CHAQ disability score decreased from 1.8 at BL to 0.6 at Week 2 and 0.3 at Week 12. Between BL and Week 12, the median physicians' global assessment of SJIA activity (0-100 mm, VAS) decreased from 70 mm to 3 mm and the parents'/patients' assessment of overall well-being improved from 63 mm to 4.5 mm.

Conclusion

Based on this post-hoc analysis, response of the SJIA patients studied for the phase III program of CAN showed a rapid and clinically important improvement of their disease by Week 12 of therapy, with an aacr 50 or higher responses reached by the majority of the CAN-naïve pts within 2 weeks after the initial CAN dose.

Disclosure of interest

P. Quartier Grant/Research Support from: Abbvie, Chugai-Roche, Novartis, Pfizer, Consultant for: Abbott/Abbvie, BMS, Chugai-Roche, Novartis, Pfizer, Servier, SOBI, Speakers Bureau: Chugai-Roche, Novartis, Pfizer, H. Brunner Consultant for: Novartis, Genentech, Medimmune, EMD, Serono, AMS, Pfizer, UCB, Jannsen, Speakers Bureau: Genentech, T. Constantin: None declared., S. Padeh: None declared., I. Calvo: None declared., M. Erguven: None declared., L. Goffin: None declared., M. Hofer Grant/Research Support from: Novartis, T. Kallinich Grant/Research Support from: Novartis, Speakers Bureau: Roche, Novartis, ALK, S. Oliveira Grant/Research Support from: Novartis, Y. Uziel Consultant for: Novartis, S. Viola Consultant for: To Gaslini Hospital: Abbott, Astrazeneca, BMS, Centocor Research & Development, Eli Lilly and Company, "Francesco Angelini", Glaxo Smith & Kline, Italfarmaco, Novartis, Pfizer Inc., Roche, Sanofi Aventis, Schwarz Biosciences gmbh, Xoma, Wyeth Pharmaceuticals Inc., K. Nistala: None declared., C. Wouters Grant/Research Support from: Novartis Belgium, Roche Belgium, GSK immunoinflammation USA, K. Lheritier Employee of: Novartis, J. Hruska Employee of: Novartis, K. Abrams Shareholder of: Novartis, Employee of: Novartis, A. Martini Consultant for: To Gaslini Hospital: Abbott, Astrazeneca, BMS, Centocor Research & Development, Eli Lilly and Company, "Francesco Angelini", Glaxo Smith & Kline, Italfarmaco, Novartis, Pfizer Inc., Roche, Sanofi Aventis, Schwarz Biosciences gmbh, Xoma, Wyeth Pharmaceuticals Inc., Speakers Bureau: Bristol-Myers Squibb, Novartis, Astrazeneca, Glaxo Smith and Kline, N. Ruperto Grant/Research Support from: To Gaslini Hospital: Abbott, Astrazeneca, BMS, Centocor Research & Development, Eli Lilly and Company, "Francesco Angelini", Glaxo Smith & Kline, Italfarmaco, Novartis, Pfizer Inc., Roche, Sanofi Aventis, Schwarz Biosciences gmbh, Xoma, Wyeth Pharmaceuticals Inc., Speakers Bureau: Astrazeneca, Bristol Myers and Squibb, Janssen Biologics B.V., Roche, Wyeth/Pfizer, D. Lovell Grant/Research Support from: NIH, Consultant for: Astra-Zeneca, Centocor, Jansen, Wyeth, Amgen, Bristol-Meyers Squibb, Abbott, Pfizer, Regeneron, Hoffman La-Roche, Novartis, Genentech, Speakers Bureau: Genentech, Roche.

Authors’ Affiliations

(1)
Necker-Enfant Malades Hospital, Paris, France
(2)
PRCSG, Cincinnati, OH, USA
(3)
PRINTO-Istituto Gaslini, Genova, Italy
(4)
Novartis Pharma, Basel, Switzerland
(5)
Novartis Pharmaceuticals Corp, NJ, USA

Copyright

© Quartier et al.; licensee BioMed Central Ltd. 2013

This article is published under license to 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. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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