Table 1

Demographics and clinical characteristics of patients at baseline (date of first canakinumab administration and at the time of entry into the LTE study)

CharacteristicsBaselineLTE study*Early responders (LTE study entry data)*Late responders (LTE study entry data)*
(n=177†)(n=144†)(n=96†)(n=48†)
Female98 (55%)79 (55%)53 (55%)26 (54%)
Age (years)8.0 (5.0–12.0)9.0 (6.0–13.0)9.0 (6.0–13.0)9.0 (5.5–11.5)
Body weight (kg)n=167
25.8 (17.8–42.9)
n=142
29.6 (20.1–46.0)
n=94
31.4 (21.0–51.2)
26.3 (18.1–38.5)
Disease duration (years)n=124
2.1 (0.8–4.3)
n=101
2.3 (0.9–4.4)
n=71
2.1 (0.8–4.3)
n=30
2.8 (1.3–4.8)
Physician’s global assessment of disease activity (VAS) (mm)70.0 (55–80)7.0 (0–33.0)1.0 (0–19.0)29.0 (9.5–47.5)
Parent or patient’s assessment of overall well-being (VAS) (mm)n=176
63.5 (45.0–80.0)
6.0 (1.0–44.5)2.0 (0–26.5)29.0 (8.0–52.0)
Number of joints with active arthritis‡10.0 (4.0–22.0)1.0 (0–5.0)0 (0–2.5)3.5 (1.5–12.5)
Number of joints with limited range of motion§9.0 (4.0–23.0)1.5 (0–5.0)0 (0–3.0)5.0 (1.5–15.5)
CHAQ score1.8 (1.1–2.3)0.3 (0–1.1)0 (0–0.9)0.8 (0.2–1.6)
C-reactive protein (mg/L)160.0 (88–271.0)16.0 (3.30–87.6)6.6 (2.0–42.5)83.1 (22.8–133.2)
Fever161 (91%)25 (17.4%)11 (11.5%)14 (29.2%)
JADAS scoren=176
32.5 (26.0–43.3)
7.85 (0.3–19.6)1.85 (0.1–12.2)18.85 (8.2–28.3)
JADAS high disease activity (>10.5)175 (99.4%)63 (43.8%)30 (31.3%)33 (68.8%)
JADAS low disease activity (≤3.8)067 (46.5%)59 (61.5%)8 (16.7%)
JADAS CID (≤1)048 (33.3%)46 (47.9%)2 (4.2%)
Use of methotrexate at baseline94 (53%)76 (52.8%)49 (51.0%)27 (56.3%)
Prior use of biologics¶116 (66%)93 (64.6%)**55 (57.3%)38 (79.2%)
 Anakinra83 (47%)65 (45.1%)**44 (45.8%)21 (43.8%)
 Tocilizumab10 (6%)7 (4.9%)**5 (5.2%)2 (4.2%)
 Anti-TNF agent or other biologic agent62 (35%)50 (34.7%)**25 (26.0%)25 (52.1%)
Prednisone therapy at baseline128 (72%)63 (43.8%)20 (20.8%)43 (89.6%)
Prednisone equivalent dose†† (mg/kg/day)n=128
0.27 (0.17–0.54)
n=63
0.23 (0.16–0.49)‡‡
n=20
0.17 (0.08–0.20)
n=43
0.36 (0.21–0.55)
  • Data are n (%) or medians (first to third quartiles).

  • Patients entering the LTE are divided into those coming from the double-blind placebo-controlled withdrawal part (early responders who were patients randomised in the withdrawal part) or from the open-label part of trial 2 (late responders who failed to achieve an adapted juvenile idiopathic arthritis American College of Rheumatology (aJIA-ACR) 30 response or to taper glucocorticoids in part I).

  • *Baseline characteristics are carried forward from last non-missing values of previous study.

  • †n is indicated in the rows only if the total number is different from the heading column.

  • ‡The range of possible values for number of joints with active arthritis was 0–73.

  • §The range of possible values for number of joints with limited range of motion was 0–69.

  • ¶A patient could have received one or more biologic agents previously.

  • **Patients were not allowed to take any biologics during treatment. These were patients with prior use of biologics before the core study.

  • ††Median dose provided for the patients who were on steroids at study entry.

  • ‡‡Median dose of the subgroups from part I and part II with great difference in the median steroid doses as demonstrated in the adjacent columns.

  • CHAQ, Childhood Health Assessment Questionnaire; CID, clinically inactive disease; JADAS, Juvenile Arthritis Disease Activity Score; LTE, long-term extension; n, number of observations; TNF, tumour necrosis factor; VAS, visual analogue scale.