Table 1.
Patient demographic and baseline clinical characteristics*
| Part 1 | Part 2 | ||||
|---|---|---|---|---|---|
|
Cohort 1 (n = 68) |
Cohort 2 (n = 98) |
Total (n = 166) |
Dose reduction arm (n = 38) |
Dose interval prolongation arm (n = 37) |
|
| Age, years | 12 (8–15) | 8 (5–12) | 9 (6–14) | 10.5 (7–15) | 11 (9–14) |
| Female sex, no. (%) | 34 (50) | 56 (57.1) | 90 (54.2) | 19 (50) | 20 (54.1) |
| Weight, kg | 39.0 (28.4–54.3) | 26.5 (19.4–41.8) | 31.8 (22–48.4) | 35.1 (23.4–55.2) | 41.3 (29–54.2) |
| Parent or patient global assessment of overall well‐being, 0–100‐mm VAS | 2 (0–8) | 42 (17–65) | 18.5 (2–52) | 5 (0–46) | 1 (0–10) |
| Physician global assessment of disease activity, 0–100‐mm VAS | 0 (0–2) | 51 (38–63) | 32 (0–54) | 0 (0–11) | 0 (0–26) |
| C‐HAQ score | 0 (0–0.4) | 1.3 (0.5–1.8) | 0.7 (0–1.5) | 0 (0–1) | 0.1 (0–0.6) |
| Number of joints with active arthritis | 0 (0–0) | 3 (2–8) | 1 (0–5) | 0 (0–0) | 0 (0–0) |
| Standardized CRP level, mg/liter† | 5.6 (0.6–9.7) | 88.8 (24.3–255.7) | 18.5 (4–114.2) | 5.9 (0.5–10) | 5.5 (2–10) |
| Systemic glucocorticoid use at baseline, no. (%) | 23 (33.8) | 50 (51) | 73 (44) | 7 (18.4) | 10 (27) |
| Methotrexate use at baseline, no. (%) | 31 (45.6) | 32 (32.7) | 63 (38) | 11 (28.9) | 4 (10.8) |
| Prior use of anakinra, no. (%) | 22 (32.4) | 15 (15.3) | 37 (22.3) | 16 (42.1) | 11 (29.7) |
| Prior use of tocilizumab, no. (%) | 15 (22.1) | 20 (20.4) | 35 (21.1) | 9 (23.7) | 5 (13.5) |
| Prior use of any biologic agents, no. (%)‡ | 41 (60.3) | 36 (36.7) | 77 (46.4) | 23 (60.5) | 15 (40.5) |
*
Except where indicated otherwise, values are the median (interquartile range). VAS = visual analog scale; C‐HAQ = Childhood Health Assessment Questionnaire.
†
C‐reactive protein (CRP) analyses were performed by local laboratories and standardized for comparison across sites and patients.
‡
Includes anakinra, tocilizumab, abatacept, etanercept, and adalimumab.