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Abstract Number: 269

Marked Improvement In Patient Reported Outcomes Of Children With Active Systemic Juvenile Idiopathic Arthritis With Canakinumab Treatment – Results Of The Phase III Program

Rayfel Schneider1, Hermine Brunner1, Nicolino Ruperto2, Nico Wulffraat2, Pierre Quartier3, Riva Brik2, Liza McCann2, Helen E. Foster2, Michael Frosch2, Valeria Gerloni2, Liora Harel2, Claudio Len2, Kristin Houghton1, Rik Joos2, Ken Abrams4, Karine Lheritier5, Sophia Kessabi5, Alberto Martini2 and Daniel J. Lovell1, 1Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati, OH, 2Pediatric Rheumatology International Trials Organization (PRINTO)-Istituto Gaslini, Genova, Italy, 3Necker-Enfants Malades Hospital, Paris, France, 4Novartis Pharmaceuticals Corporation, East Hanover, NJ, 5Novartis Pharma AG, Basel, Switzerland

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: canakinumab, Interleukins (IL) and quality of life, Systemic JIA

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Session Information

Session Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects I: Juvenile Idiopathic Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Efficacy and safety of canakinumab (CAN), a selective, fully human, anti-interleukin-1β monoclonal antibody, in systemic juvenile idiopathic arthritis (SJIA) patients has been demonstrated in two phase 3 trials (1 and 2). 1 SJIA is associated with severe functional impairment and chronic pain that markedly affect the health-related quality of life (HRQoL). Here, we present the effects of CAN therapy on patient-reported outcomes (PROs) from the phase 3 studies.

Methods:

In Trial 1, 84 pts were randomized to CAN (43) and PBO (41) and followed for 1 month. In Trial 2, 177 pts (including 71 from Trial 1) received open label CAN in Part 1, of which 100 CAN-responders entered part 2 and were randomized 1:1 to placebo or continued CAN. PROs considered were functional ability by the Childhood Health Assessment Questionnaire [CHAQ©], pain as measured on a visual analog scale [VAS] of 0-100 mm, and HRQoL by the Child Health Questionnaire–Parent Form (CHQ-PF50 for pts age 5-18 yrs) with rating on physical (PhS) and psychosocial (PsS) health status. Between-treatment differences were evaluated using analysis covariance models with repeated measures adjusting for treatment group, time, stratification factors and the treatment group-by-time interaction as explanatory variables.

Results:

At the end of Trial 1, there was  significant improvement (p=0.0002) in functional ability with CAN, resulting in an estimated difference (ED) in CHAQ score of -0.69 between the CAN and PBO group  at Day 29 from baseline [BL]; this ED constitutes about 3.6x the minimal clinically important difference (-0.19) 2in the CHAQ score. Pain intensity significantly declined (both p <0.0001) in the CAN group vs. PBO both at Day 15 (ED, -46.42) and Day 29 (ED, -41.86). Similarly, HRQoL significantly improved from BL for CAN vs. PBO, with an ED in CHQ-PF50 PhS scores of 12.07 and 7.28 for the CHQ-PsS (both, p<0.005) over 1 month with CAN, respectively. Even more pronounced improvements in functional ability, pain and HRQoL were observed in Trial 2 (Table).

Patient Reported Outcomes 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 intensity by 0-100 mm VAS

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)

Note: Results are based on patients with both baseline and post-baseline values. n18 years old.*PBO pts received CAN during Part 1 of Trial 2.

Conclusion:

Treatment with CAN demonstrated rapid, marked and continued improvement in patient-reported outcome of SJIA patients, including a significant increase in functional ability, reduction of pain and HRQoL.

References

  1.       Ruperto N, et al. N Engl J Med 2012;367(25):2396–406.
  2.       Brunner HI, et al. J Clin Rheumatol 2005;32: 150–61.

Disclosure:

R. Schneider,

Hoffmann-La Roche, Inc.,

5,

Novartis Pharmaceutical Corporation,

5,

Innomar Strategies,

5;

H. Brunner,

Novartis, Genentech, Medimmune, EMD Serono, AMS, Pfizer, UCB, Jannsen,

5,

Genentech,

8;

N. Ruperto,

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 Pharmaceuti,

2,

Astrazeneca, Bristol Myers and Squibb, Janssen Biologics B.V., Roche, Wyeth, Pfizer,

8;

N. Wulffraat,

Novartis, Pfizer, Roche,

5;

P. Quartier,

Abbvie, Chugai-Roche, Novartis, Pfizer,

2,

Abbvie, BMS, Chugai-Roche, Novartis, Pfizer, Servier, Sweedish Orphan Biovitrum,

5,

Chugai-Roche, Novartis, Pfizer,

8;

R. Brik,

Novartis,

2,

Novartis,

5;

L. McCann,
None;

H. E. Foster,

Pfizer, BioMarin,

2,

Pfizer Inc,

8;

M. Frosch,
None;

V. Gerloni,
None;

L. Harel,
None;

C. Len,
None;

K. Houghton,
None;

R. Joos,
None;

K. Abrams,

Novartis Pharmaceutical Corporation,

3,

Novartis,

1;

K. Lheritier,

Novartis Pharma AG,

3,

Novartis,

1;

S. Kessabi,

Novartis Pharma AG,

3;

A. Martini,

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 Biosciences GmbH, Xoma, Wyeth Pharmaceuticals Inc.,

2,

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 Biosciences GmbH, Xoma, Wyeth Pharmaceuticals Inc.,

5,

Astellas, Astrazeneca, Bristol Myers and Squibb, -Glaxo Smith & Kline, Italfarmaco , MedImmune, Novartis ,

8;

D. J. Lovell,

NIH ,

2,

Astra-Zeneca, Centocor, Jansen, Wyeth, Amgen, Bristol-Meyers Squibb, Abbott, Pfizer, Regeneron, Hoffman La-Roche, Novartis, Genentech,

5,

Genentech, Roche,

8.

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