Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Efficacy and safety of canakinumab (CAN), a selective, human, anti-IL-1β monoclonal antibody, was previously demonstrated in 2 phase III trials.1 Out of these trials ≥60% of the patients (pts) received a previous biologic and were switched to CAN due to lack of efficacy or for safety reasons, and may be more refractory to another biologic therapy. Efficacy of CAN in biologic-naïve (BN) pts and those previously exposed to biologics (BE) during the first 12-weeks are evaluated.
Methods: Pooled data from CAN naïve pts, enrolled in two phase III trials1 and an extension phase (up to interim data lock 10 August 2012) were considered. Pts (2–19 yrs) with active SJIA were enrolled and received CAN 4 mg/kg for 12 weeks. CAN naïve pts who entered the trials and received at least one dose of CAN were included in this analysis (N=178 CAN naïve pts). Descriptive efficacy analyses of adapted ACR-JIA responses at Week 12 are provided for the BN and BE pts groups.
Results: At baseline, there were 66 (37%) BN pts whereas anakinra (ANA), tocilizumab (TCZ), etanercept (ETN) and adalimumab (ADA), were the biologics received by 78 (44%), 10 (6%), 58 (33 %) and 9 (5%) pts, respectively. The main reasons for discontinuation of biologics in BE group (n=112) was lack of efficacy (ANA, n=32; TCZ, n=7; ETN, n=56; ADA, n=9) or safety/tolerability (ANA, n=20; TCZ, n=4, ETN, n=0). At Week 12, the BN and BE groups were similar in aACR-JIA 30 and 50 response rates. Numerically higher aACR-JIA 70 and 90 response rates were achieved in BN vs BE pts (Table). aACR-JIA 70 and 90 response rates were similar in pts previously exposed to ANA vs those not exposed to ANA at 12 weeks (aACR-JIA70: 58% vs 63% and aACR-JIA 90:47% vs 50% ). Compared to pts who discontinued ANA due to lack of efficacy, there was a trend towards numerically higher aACR-JIA 70 and 90 response rates at Week 12 in pts who stopped ANA for other reasons (aACR-JIA70: 34% vs74%; aACR-JIA90: 25% vs 63%). A numerically higher aACR-JIA 30, 50, 70 and 90 response rates were observed in TCZ naïve pts vs. those pts exposed to TCZ (n=10) at week 12 [aACR-JIA30: 71% vs 50%; aACR-JIA50: 70% vs 50%; aACR-JIA70: 61% vs 50%; aACR-JIA90: 49% vs 40%]. Numerically higher aACR-JIA 70 and 90 responses were observed for ETN naïve pts vs those exposed to ETN at week 12 [aACR-JIA70: 67% vs 48%; aACR-JIA90: 58% vs 31%]; while ADA- naïve pts had similar responses to CAN as ADA-exposed pt (aACR-JIA 70: 61% vs 56%) and they had higher aACR-JIA 90 response (aACR-JIA90: 50% vs 22%) at week 12.
Table. Percentage of patients with adapted JIA ACR (aACR) response* at Week 2, 4 & 12
|
Total patients N=178 |
Previous exposure to biologics |
|||||
|
Week 2 |
Week 4 |
Week 12 |
||||
|
No (n=66) |
Yes (n=112) |
No (n=66) |
Yes (n=112) |
No (n=66) |
Yes (n=112) |
|
|
aACR50 |
75.8% |
67.0% |
77.3% |
69.6% |
74.2% |
65.2% |
|
aACR70 |
66.7% |
51.8% |
72.7% |
53.6% |
69.7% |
55.4% |
|
aACR90 |
36.4% |
36.6% |
54.5% |
34.8% |
60.6% |
42.0% |
*aACR response= ACR response level plus absence of fever
Conclusion: In general, BE pts achieved aACR-JIA 50,70 and 90 responses to CAN quickly in the first 2 weeks, and maintained their response up to Week 12; albeit at a numerically lower level than BN pts. These data support the consistent efficacy of CAN across different subgroups of pts.
Reference: Ruperto N, et al. N Engl J Med 2012;367(25).
Disclosure:
A. Grom,
Novartis, Roche, NovImmune,
5;
P. Quartier,
Abbvie, BMS, Novartis,
2,
Abbvie, BMS, Chugai-Roche, Novartis, Pfizer, SOBI, MEDIMMUNE,
5,
Chugai-Roche,Novartis,
8;
N. Ruperto,
To Gaslini Hospital: Abbott, Astrazeneca, BMS, Centocor Research & Development, Eli Lilly and Company, ,
2,
Astrazeneca, Bristol Myers and Squibb, Janssen Biologics B.V.,Roche, Wyeth/Pfizer,
8;
H. I. Brunner,
Novartis, Roche, BMS, Pfizer, Biogen, Boehringer-Ingelheim, Jannsen, Astazeneca,
5,
Novartis, Roche,
8;
K. Schikler,
Pfizer, Novartis, Abbvie, Roche, Genentech, Forest,,
2,
Abbvie, Novartis,
8;
M. Erguven,
Novartis,
2;
L. Goffin,
None;
M. Hofer,
Novartis, Pfizer, Abbvie,
2;
T. Kallinich,
Novartis ,
2,
Roche, Novartis, ALK,
8;
K. Marzan,
Novartis,
2;
C. Gaillez,
Novartis,
3;
K. Lheritier,
Novartis,
1,
Novartis,
3;
K. Abrams,
Novartis,
1,
Novartis,
3;
A. Martini,
Abbott Bristol Myers and Squibb, Francesco Angelini S.P.A, Glaxo Smith and Kline, Janssen Biotech Inc, Novartis, Pfizer Inc, Roche, Sanofi Aventis, Schwarz,
2,
Abbott, Amgen, Biogenidecm Bristol Myers Squibb, Astellas, Behringer, Italfarmaco, Janssen, MedImmune, Novartis, NovoNordisk, Pfizer, Sanofi, Roche, Servier,
8,
Abbott, Amgen, Biogenidecm Bristol Myers Squibb, Astellas, Behringer, Italfarmaco, Janssen, MedImmune, Novartis, NovoNordisk, Pfizer, Sanofi, Roche, Servier,
5;
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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