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PReS-FINAL-2158: Effect of canakinumab on functional ability and health-related quality of life in systemic juvenile idiopathic arthritis (SJIA) patients

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Pediatric Rheumatology201311(Suppl 2):P170

https://doi.org/10.1186/1546-0096-11-S2-P170

Published: 5 December 2013

Keywords

  • Visual Analog Scale
  • Pain Intensity
  • Functional Ability
  • Health Assessment Questionnaire
  • Disability Score

Introduction

Canakinumab (CAN), a selective, fully human, anti-interleukin-1β monoclonal antibody, has been shown to be efficacious in SJIA patients (pts) in 2 phase 3 trials: Trial 1 (4-wk, randomized placebo [PBO]-controlled) and Trial 2 (open-label CAN treatment [Part 1] followed by a randomized PBO-controlled withdrawal phase [Part 2]). In Trial 1, statistically significantly more CAN than PBO group pts achieved an adapted pediatric ACR 30 response and in Trial 2, CAN allowed successful reduction/discontinuation of steroids and significantly reduced risk of flare. Safety profile of CAN was in line with expectations for a biologic agent in active SJIA. The persistent disabling features of SJIA and chronic pain can have a negative impact on health-related quality of life (hrqol). These outcomes were evaluated in the CAN phase 3 program.

Objectives

To report pt-reported functional ability and hrqol outcomes from the CAN phase 3 program.

Methods

The phase 3 analysis included 84 pts (CAN, 43; PBO, 41) in Trial 1 and 177 pts in Trial 2 (71 from Trial 1 entered) in Part 1, and 100 rolled into Part 2 (CAN, 50; PBO, 50). Pt-reported assessments included functional ability (as measured by the Childhood Health Assessment Questionnaire [CHAQ©]), pain (measured on a visual analog scale [VAS] of 0-100 mm as part of the CHAQ©), and physical (phs) and psychosocial (pss) health status in 5-18 year old pts., according to the Child Health Questionnaire-Parent Form (CHQ-PF50).

Results

In Trial 1, CAN treatment was associated with a significant improvement in CHAQ disability score (estimated difference [ED] of -0.69 over time vs PBO in the least square mean [LSM] change from baseline [BL] [p = 0.0002]), which was ~3.6 × the minimal clinically important difference of -0.19. The LSM in overall pain intensity were significantly lower (both p < 0.0001) in the CAN group vs PBO both at Day 15 (ED, -46.42) and Day 29 (ED, -41.86). CHQ-PF50 phs and pss scores also showed significant improvements over time (ED CAN vs PBO in LSM change from BL, 12.07 and 7.28; p < 0.005 for both). Improvements in CHAQ disability, CHQ-PF50 phs and pss, and VAS pain scores were also observed in Trial 2 (Table 1).
Table 1

Patient- or Parent-reported functional ability and hrqol parameters in Trial 2

Outcome measure, mean (SD)

Baseline

CAN, N = 177

End of Part 1

CAN, N = 177

End of Part 2

CAN, N = 50

End of Part 2

PBO, N = 50

CHAQ disability score

1.7 (0.8)

0.74 (0.9)

0.5 (0.9)

0.6 (0.8)

Pain (VAS, 0-100 mm)

66.6 (23.3)

20.2 (25.8)

13.6 (26.9)

17.0 (24.2)

CHQ-PF50 phs score

16.1 (14.3)

37.7 (17.2)

43.6 (17.4)

39.0 (18.1)

CHQ-PF50 pss score

41.6 (11.1)

50.7 (11.1)

53.6 (11.3)

52.7 (9.8)

Results are based on patients with both baseline and post-baseline values. N18 years old.

Conclusion

Treatment with CAN demonstrated rapid, marked and continued improvement in patient-reported functional ability and hrqol of SJIA patients.

Disclosure of interest

P.Quartier Grant/Research Support from: Abbvie, Chugai-Roche, Novartis, Pfizer, Consultant for: Abbvie, BMS, Chugai-Roche, Novartis, Pfizer, Servier, Sweedish Orphan Biovitrum, Speakers Bureau: Chugai-Roche, Novartis, Pfizer, 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, N. Wulffraat Consultant for: Novartis, Pfizer, Roche, H. Brunner Consultant for: Novartis, Genentech, Medimmune, EMD Serono, AMS, Pfizer, UCB, Jannsen, Speakers Bureau: Genentech, R. Brik Grant/Research Support from: Novartis, Consultant for: Novartis, L. Mccann: None declared., H. Foster Grant/Research Support from: Pfizer, biomarin, Speakers Bureau: Pfizer, M. Frosch: None declared., V. Gerloni: None declared., L. Harel: None declared., C. Len: None declared., K. Houghton: None declared., R. Joos: None declared., K. Abrams Shareholder of: Novartis, Employee of: Novartis, K. Lheritier Shareholder of: Novartis, Employee of: Novartis, S. Kessabi Employee of: Novartis, A. Martini Grant/Research Support from: Abbott, Astrazeneca, Bristol Myers and Squibb, Janssen Biologics B.V., Ely Lilly and Company, "Francesco Angelini", Glaxo Smith & Kline, Italfarmaco, Novartis, Pfizer Inc., Roche, Sanofi Aventis, Schwarz Bisciences, gmbh, Xoma, Wyeth Pharmaceuticals Inc.(Consulting fee). The GASLINI hospital which is a public hospital where I work as full time employee has received contributions to support the research activities of the network of PRINTO (http://www.printo.it), Consultant for: Abbott, Astrazeneca, Bristol Myers and Squibb, Janssen Biologics B.V., Ely Lilly and Company, Francesco A, Glaxo Smith & Klime, Italfarmaco, Novartis, Pfizer Inc., Roche, Sanofi Aventis, Schwarz Biosciences gmbh, Xoma, Wyeth Pharmaceuticals, Speakers Bureau: Astellas, Astrazeneca, Bristol Myers and Squibb, Glaxo Smith & Kline, Italfarmaco, medimmune, Novartis, D. Lovell Grant/Research Support from: NIH, Consultant for: Astra-Zeneca, Centocor, Jannsen, 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)
PRINTO-Istituto Gaslini, Genova, Italy
(3)
PRCSG, Cincinnati, USA
(4)
Novartis Pharmaceuticals Corporation, EH, USA
(5)
Novartis Pharma AG, Basel, Switzerland

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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