Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
To compare baseline disease characteristics of pediatric patients (pts) with enthesitis-related arthritis (ERA) and polyarticular juvenile idiopathic arthritis (pJIA) from clinical trials with adalimumab (ADA).
Methods:
Baseline (BL) data were derived from 1 study in ERA (M11-328) and 2 studies in pJIA (M10-444, DE038). M11-328 was a Phase 3, double-blind (DB), placebo-controlled, multicenter study in pediatric pts aged 6–17 years (yrs) at BL with ERA as defined by International League of Associations for Rheumatology (ILAR). Disease activity was defined by 1) ≥3 active joints (swelling not due to deformity or joints with limitation of motion (LOM) plus pain and/or tenderness) AND evidence of enthesitis in ≥1 location (either past or present at BL). Pts were inadequate responders or intolerant to ≥1 nonsteroidal anti-inflammatory drug (NSAID) and ≥1 disease-modifying antirheumatic drug (DMARD). M10-444 was a Phase 3b open-label multicenter study in pts aged 2 to <4 yrs and age ≥4 yrs weighing <15 kg with moderately to severely active pJIA (ILAR categories: polyarticular rheumatoid factor (RF) positive, polyarticular RF negative, extended oligoarthritis, undifferentiated, and systemic arthritis). Active disease was defined as arthritis affecting ≥5 joints at BL. EU pts must have previously failed, had insufficient response to, or intolerance to ≥1 DMARD. Study DE038 was a multicenter, Phase 3, randomized, DB study in pts aged 4–17 yrs with pJIA by American College of Rheumatology (ACR) criteria (onset may have been systemic, polyarticular, or oligoarticular/pauciarticular). Active disease was defined as ≥5 swollen joints (SJC) and ≥3 joints with LOM at screening. A trial of NSAIDs was required, and pts were stratified according to methotrexate use.
Results:
203 pJIA pts (M10-444, n=32, DE038, n=171) and 46 ERA pts were evaluated. Polyarticular JIA pts were predominantly female compared to ERA pts (pJIA, 79–88% vs ERA, 33%). (Table) C-reactive protein (CRP) was elevated at BL in 66% of pts in DE038 compared to about 39% of the 2–4 year-old pJIA pts and ERA pts. Mean active joint count (AJC) at BL was greater in pJIA pts than in ERA pts (10 and 17.2 vs 7.8 joints). Mean BL tender joint count (TJC) was similar in pJIA study DE038 and M11-328 compared to a lower TJC in the younger age group enrolled in M10-444. Mean physician’s global assessment of disease activity, parent’s global assessment (PaGA) of pt’s overall well-being, PaGA of pt’s pain, and childhood health assessment questionnaire scores were similar across JIA subtypes.
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Table. Baseline Demographics and Disease Characteristics |
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Polyarticular JIA |
ERA |
|
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M10-444 N = 32 |
DE038 N = 171 |
M11-328 N = 46 |
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Demographics |
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Age, years |
3.0 (0.7) |
11.3 (3.5) |
12.9 (2.9) |
|
Female, n (%) |
28 (87.5) |
135 (78.9) |
15 (32.6) |
|
White, n (%) |
25 (78.1) |
157 (91.8) |
35 (76.1) |
|
Body mass index, kg/m2 |
15.5 (1.3) |
19.4 (5.1) |
19.7 (4.4) |
|
HLA-B27 positive, n (%) |
1 (3.1) |
37 (22.0)a |
29 (67.4)b |
|
RF positive, n (%) |
1 (3.1) |
37 (22.0) |
0 |
|
Prior JIA medications, n (%) |
31 (96.9) |
-* |
46 (100) |
|
Prior NSAIDs, n (%) |
20 (62.5) |
-* |
46 (100) |
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Prior DMARDs, n (%) |
25 (78.1) |
110 (64,3) |
42 (91.3) |
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Methotrexate, n (%) |
25 (78.1) |
103 (60.2) |
29 (63.0) |
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Prior corticosteroids, n (%) |
22 (68.8) |
-* |
21 (45.7) |
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Disease duration, years |
1.0 (0.8) |
3.8 (3.9)c |
1.9 (2.1) |
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Disease Characteristics |
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AJC (0–73) |
10.0 (7.5) |
17.2 (10.4) |
7.8 (6.6)d |
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TJC (0–75) |
3.8 (5.0) |
11.4 (12.4) |
12.9 (10.1)d |
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SJC (0–66) |
8.9 (7.4) |
14.8 (9.4) |
6.2 (6.4)d |
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LOM (0–69) |
8.6 (7.7) |
13.5 (9.2) |
4.9 (3.5)d |
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PGA of disease activity (0–10 cm VAS) |
5.5 (2.0) |
5.9 (1.8) |
5.3 (2.2) |
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PaGA of pt’s overall well-being (0–10 cm VAS) |
4.8 (2.6) |
4.8 (2.3) |
5.1 (2.4) |
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PaGA of pt’s pain (0–10 cm VAS) |
4.6 (2.6) |
5.0 (2.5)c |
5.6 (2.3) |
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CHAQ (0–3) |
1.2 (0.7) |
1.1 (0.7) |
0.8 (0.6) |
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Elevated CRP, n (%) |
12 (38.7)e |
112 (65.9)c |
18 (39.1) |
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CRP (mg/dL) |
1.6 (2.4)e |
2.6 (4.1)c |
9.0 (16.0)f |
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Values are the mean (standard deviation) unless otherwise stated. *Data not available. aN=168. bN=43. cN=170. dAJC 0-68, TJC 0–72, SJC 0–68, LOM 0–66. eN=31. fhigh-sensitivity CRP, mg/L. AJC, active joint count; CHAQ, childhood health assessment questionnaire; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; ERA, enthesitis-related arthritis; JIA, juvenile idiopathic arthritis; LOM, limitation of motion; PaGA, parent’s global assessment; PGA, physician’s global assessment; SJC, swollen joint count; TJC, tender joint count; VAS, visual analog scale. |
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Conclusion:
In this comparison of JIA pts enrolled in ERA and pJIA studies, at baseline the burden of inflammatory disease as measured by AJC and SJC was slightly higher in pJIA as compared to ERA. However, AJC and SJC do not encompass all aspects of disease in JIA and overall, physicians and parents assessed disease burden similarly with similar impairment in physical function observed in children with ERA and pJIA.
Disclosure:
P. Quartier,
AbbVie, Novartis, Pfizer, and Roche/Chugai ,
2,
AbbVie, BMS, MedImmune, Novartis, Pfizer, Roche/Chugai, Servier, and Sobi,
5;
J. Kalabic,
AbbVie,
1,
AbbVie,
3;
Z. Zuber,
None;
K. Minden,
AbbVie and Pfizer,
2,
AbbVie, Pfizer, and Roche/Chugai,
5,
Pfizer, Pharm-Allergan, and Roche/Chugai,
8;
J. K. Anderson,
AbbVie,
1,
AbbVie,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/disease-burden-is-comparable-in-children-with-enthesitis-related-arthritis-and-polyarticular-juvenile-idiopathic-arthritis/