Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose Key objectives of biologic therapies in systemic juvenile idiopathic arthritis (SJIA) are to induce and maintain inactive disease, according to the ACR 2011 definition. Recent advances in the management of SJIA consider the induction or maintenance of inactive disease according to the JADAS 10-CRP (J10) or 27-CRP (J27) scoring system1, 2. The efficacy of canakinumab (CAN), a selective, human, anti-IL-1β monoclonal antibody, was demonstrated in the withdrawal phase of 2 phase III trials3, but was not evaluated at the individual level. Here, we assessed the maintenance of efficacy at individual level from Week 2 to 12, using the adapted ACRJIA response criteria (aACR) as well as J10 and J27 on the 12-week pooled data set (3 phase III studies).
Methods For this post-hoc analysis of the CAN Phase III program in SJIA, the change in disease states between Day (D) 15 and D85 for a total of 178 CAN-naïve patients was assessed. Subjects were 2–19 years of age and had active SJIA at enrollment. This shift analysis considered the aACR response and disease activity states related to J10 and J27: Inactive Disease (ID), Low Disease Activity (LDA), Moderate Disease Activity (MDA); High Disease Activity (HDA).
Results
J10 changes during the study period are provided in Table 1. Results for the J27 were very similar to the J10 observations. The D15-D85 aACR shift analyses, including only patients who had a D15 and a D85 value, likewise indicated that the majority of patients maintained or improved their response: NR (n=32): 12.5% of patients improved; aACR30 (n=14): 0.0% were maintained/78.6% improved; aACR50 (n=21): 33.3% were maintained/42.9% improved; aACR70 (n=36): 25.0% were maintained/58.3% improved; aACR90 (n=26): 30.8% were maintained/57.7% improved; aACR100 (n=34): 82.4% were maintained.
Table 1 J10 shift analysis table from D15 to D85*
|
N (%) |
Disease state at Day 15* |
Disease state at Day 85* |
|||
|
ID |
LDA |
MDA |
HDA |
||
|
ID |
28 (100) |
24 (85.7) |
1 (3.6) |
3 (10.7) |
0 (0.0) |
|
LDA |
20 (100) |
10 (50.0) |
10 (50.0) |
0 (0.0) |
0 (0.0) |
|
MDA |
30 (100) |
5 (16.7) |
12 (40.0) |
10 (33.3) |
3 (10.0) |
|
HDA |
44 (100) |
2 (4.5) |
6 (13.6) |
8 (18.2) |
28 (63.6) |
|
*Only patients with both a Day 15 and a Day 85 value are included. |
|||||
Conclusion A majority of SJIA patients treated with CAN either maintained or improved their JADAS status or aACR response level from Week 2 to 12. These data confirm the consistent maintenance of efficacy of CAN at the individual level in the first 3 months, irrespective of the measure of treatment response, that is aACR criteria or JADAS-derived criteria, and extend previous findings at group level.
References
- Consolaro et al. Arthritis Rheum. 2009;61(5).
- Nordal et al. Ann Rheum Dis. 2012;71(7).
Disclosure:
A. Ravelli,
Pfizer Inc,
2,
Abbvie, Bristol Myers Squibb, Novartis, Pfizer, Roche and Johnson & Johnson,
8,
Abbvie, Bristol Myers Squibb, Novartis, Pfizer, Roche and Johnson & Johnson,
5;
H. I. Brunner,
Roche, Novartis,
8,
Novartis, Roche, BMS, Pfizer, Biogen, Boehringer-Ingelheim, Jannsen, Astrazeneca,
5;
N. Ruperto,
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.,
2,
AstraZeneca, Bristol Myers and Squibb, Janssen Biologics B.V.,Roche, Wyeth/Pfizer,
8;
P. Quartier,
Abbvie, BMS, Novartis,
2,
Abbvie, BMS, Chugai-Roche, Novartis, Pfizer, MEDIMMUNE and SOBI,
5,
Novartis, Chugai-Roche,
8;
A. Consolaro,
Novartis.,
5;
N. M. Wulffraat,
Novartis, Pfizer,
5,
Abb Vie,
2;
K. Lheritier,
Novartis.,
3,
Novartis.,
1;
C. Gaillez,
Novartis.,
1,
Novartis.,
3;
A. Martini,
Abbott, Bristol Myers and Squibb, Francesco Angelini S.P.A., Glaxo Smith Kline, Janssen Biotech Inc, Novartis, Pfizer Inc, Roche, Sanofi Aventis, Schwarz,
2,
Abbott, Amgen, Biogenidecm Bristol MyersSquibb, Astellas, Behringer, Italfarmaco, Janssen, MedImmune, Novartis, NovoNordisk, Pfizer, Sanofi, Roche, Servier,
5,
Abbott, Amgen, Biogenidecm Bristol MyersSquibb, Astellas, Behringer, Italfarmaco, Janssen, MedImmune, Novartis, NovoNordisk, Pfizer, Sanofi, Roche, Servier,
8;
D. J. Lovell,
National Institutes of Health- NIAMS ,
2,
Astra-Zeneca, Centocor, Amgen, Bristol Meyers Squibb, Abbott, Pfizer, Regeneron, Roche, Novartis, UBC, Forest Research Institute, Horizon, Johnson & Johnson,
5,
Novartis, Roche,
8.
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