Session Information
Date: Sunday, November 5, 2017
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Still’s disease presents in pediatric and adult patients as a disease continuum with similar symptoms and pathophysiology.1,2 The objective of this analysis was to evaluate the efficacy and safety of canakinumab, a selective human anti-IL1 β monoclonal antibody, in systemic juvenile idiopathic arthritis (SJIA) patients from pooled data across three age groups: children, adolescents and adults (the latter representing adult-onset Still’s disease [AOSD] population).
Methods: Data of canakinumab treated patients were pooled from 4 SJIA studies (NCT00426218, NCT00886769, NCT00889863, NCT00891046). Canakinumab was administered at 4 mg/kg every 4 weeks in majority of the patients. Efficacy parameters (adapted American College of Rheumatology [aACR] pediatric responses, juvenile idiopathic arthritis [JIA] ACR responses, patients with inactive disease), C-reactive protein (CRP) levels over 12 weeks and safety were assessed by age groups. One study (NCT00426218) was excluded for efficacy outcomes.
Results: 216 children (2–<12 years), 56 adolescents (12–<16 years) and 29 adults (≥16 years) were analyzed for efficacy outcomes. The efficacy parameters across the three age groups were comparable (Table 1). The safety profile of canakinumab was similar across age groups (Table 2). One patient from the adolescents group died because of pulmonary hypertension that was associated with macrophage activation syndrome. Clinical, laboratory and immunogenicity data showed no notable differences between the age groups.
Table 1. Efficacy: responses by age group and time point
|
Age group |
% |
aACR pediatric; n/N (%) |
JIA ACR; n/N (%) |
||
|
Day 15 |
Day 85 |
Day 15 |
Day 85 |
||
|
Children |
≥30 |
158/216 (73.1) |
90/133 (67.7) |
169/216 (78.2 |
93/133 (69.9) |
|
≥70 |
109/216 (50.5) |
77/133 (57.9) |
111/216 (51.4) |
77/133 (57.9) |
|
|
≥100 |
46/216 (21.3) |
42/133 (31.6) |
47/216 (21.8) |
42/133 (31.6) |
|
|
Adolescents |
≥30 |
47/56 (83.9) |
20/27 (74.1) |
47/56 (83.9) |
20/27 (74.1) |
|
≥70 |
33/56 (58.9) |
18/27 (66.7) |
33/56 (58.9) |
18/27 (66.7) |
|
|
≥100 |
15/56 (26.8) |
8/27 (29.6) |
15/56 (26.8) |
8/27 (29.6) |
|
|
Adults |
≥30 |
25/29 (86.2) |
15/18 (83.3) |
25/29 (86.2) |
15/18 (83.3) |
|
≥70 |
19/29 (65.5) |
13/18 (72.2) |
19/29 (65.5) |
12/18 (66.7) |
|
|
≥100 |
4/29 (13.8) |
4/29 (13.8) |
4/18 (22.2) |
4/18 (22.2) |
|
|
|
|
Inactive disease; n/N (%) |
CRP, median; mg/L (n/N) |
||
|
Age group |
Day 15 |
Day 85 |
Day 15 |
Day 85 |
|
|
Children |
40/216 (18.5) |
32/133 (24.1) |
12.00 (211/216) |
9.75 (168/216) |
|
|
Adolescents |
18/56 (32.1) |
10/27 (37.0) |
10.00 (55/56) |
8.40 (45/56) |
|
|
Adults |
6/29 (20.7) |
8/18 (44.4) |
4.50 (26/29) |
7.80 (23/29) |
|
|
aACR, adapted American College of Rheumatology; CRP, C-reactive protein; JIA, juvenile idiopathic arthritis |
|||||
Table 2. Safety: adverse events
|
Children, n (%) |
Adolescents, n (%) |
Adults, n (%) |
|
|
AEs (at least one) |
202 (86.7) |
53 (88.3) |
27 (87.1) |
|
AEs leading to study drug discontinuation |
26 (11.2) |
10 (16.7) |
6 (19.4) |
|
AEs most common/special interest |
|
|
|
|
Infections and infestations |
176 (75.5) |
42 (70.0) |
23 (74.2) |
|
Gastrointestinal disorders |
122 (52.4) |
32 (53.3) |
18 (58.1) |
|
Musculoskeletal and connective tissue disorders |
119 (51.1) |
33 (55.0) |
16 (51.6) |
|
Opportunistic infections |
3 (1.3) |
4 (6.7) |
1 (3.3) |
|
Neutropenia |
11 (4.7) |
2 (3.3) |
0 |
|
SAEs (at least one) |
81 (34.8) |
25 (41.7) |
9 (29.0) |
|
AEs, adverse events; SAEs, serious adverse events |
|||
Conclusion: Pooled analyses indicate similar efficacy of canakinumab across all the age groups of children, adolescents and adult SJIA patients. There were no meaningful differences in safety profiles across the different age groups. These analyses suggest similar efficacy of canakinumab in AOSD patients as observed in the SJIA patients.
References: 1. Jamilloux. Immunol Res 2015;61:53-62. 2. Nirmala. Pediatric Rheumatol 2015;13:50.
To cite this abstract in AMA style:
Feist E, Quartier P, Fautrel B, Schneider R, Sfriso P, Efthimiou P, Cantarini L, Lheritier K, Leon K, Speziale A. Canakinumab Treatment in Patients with Still’s Disease: A Pooled Analysis of Systemic Juvenile Idiopathic Arthritis Data By Age Groups [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/canakinumab-treatment-in-patients-with-stills-disease-a-pooled-analysis-of-systemic-juvenile-idiopathic-arthritis-data-by-age-groups/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/canakinumab-treatment-in-patients-with-stills-disease-a-pooled-analysis-of-systemic-juvenile-idiopathic-arthritis-data-by-age-groups/