Table 1 Baseline patient characteristics
Safety analysis population | |||||||
|---|---|---|---|---|---|---|---|
Overall (%) | Continuously treated patients (%) | Newly treated patients (%) | |||||
n = 82 | n = 17 | n = 65 | |||||
Sex | Male | 12 | (14.6) | 3 | (17.6) | 9 | (13.8) |
Female | 70 | (85.4) | 14 | (82.4) | 56 | (86.2) | |
Pregnancy/Breastfeeding (for women) | Not pregnant/Not breastfeeding | 70 | (100.0) | 14 | (100.0) | 56 | (100.0) |
Not specified | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | |
Age (year) | Mean (SD) | 14.0 (6.8) | 15.6 (6.1) | 13.5 (6.9) | |||
Minimum, Maximum | 2, 52 | 8, 36 | 2, 52 | ||||
Height (cm) | Mean (SD) | 144.9 (18.4) | 153.4 (10.4) | 142.6 (19.4) | |||
Minimum, Maximum | 86.3, 174.0 | 132.0, 174.0 | 86.3, 164.8 | ||||
Weight (kg) | Mean (SD) | 41.1 (13.6) | 47.2 (11.3) | 39.5 (13.7) | |||
Minimum, Maximum | 11.4, 74.0 | 29.6, 74.0 | 11.4, 67.0 | ||||
Reasons for treatment with abatacept | Active polyarticular juvenile idiopathic arthritis with insufficient effectiveness of existing treatments | 82 | (100.0) | 17 | (100.0) | 65 | (100.0) |
Others | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | |
ILAR classification at diagnosis | Systemic | 2 | (2.4) | 0 | (0.0) | 2 | (3.1) |
Oligoarticular | 10 | (12.2) | 1 | (5.9) | 9 | (13.8) | |
RF-negative polyarticular | 23 | (28.0) | 6 | (35.3) | 17 | (26.2) | |
RF-positive polyarticular | 45 | (54.9) | 9 | (52.9) | 36 | (55.4) | |
Psoriatic | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | |
Enthesitis-related | 2 | (2.4) | 1 | (5.9) | 1 | (1.5) | |
Undifferentiated | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | |
Unknown | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | |
Duration of disease (year) | Mean (SD) | 5.43 (6.13) | 6.41 (4.13) | 5.19 (6.54) | |||
Minimum, Maximum | 0.3, 42.2 | 2.6, 20.8 | 0.3, 42.2 | ||||
Medical history | No | 66 | (80.5) | 16 | (94.1) | 50 | (76.9) |
Yes | 16 | (19.5) | 1 | (5.9) | 15 | (23.1) | |
Comorbidity | No | 32 | (39.0) | 4 | (23.5) | 28 | (43.1) |
Yes | 50 | (61.0) | 13 | (76.5) | 37 | (56.9) | |
History of prior treatment with bDMARD | No | 25 | (30.5) | 0 | (0.0) | 25 | (38.5) |
Yes | 57 | (69.5) | 17 | (100.0) | 40 | (61.5) | |
Tocilizumab | 32 | (39.0) | 4 | (23.5) | 28 | (43.1) | |
Etanercept | 16 | (19.5) | 3 | (17.6) | 13 | (20.0) | |
Adalimumab | 27 | (32.9) | 4 | (23.5) | 23 | (35.4) | |
Others | 22 | (26.8) | 17 | (100.0) | 5 | (7.7) | |
Unknown | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | |
History of prior treatment with corticosteroids | No | 25 | (30.5) | 7 | (41.2) | 18 | (27.7) |
Yes | 57 | (69.5) | 10 | (58.8) | 47 | (72.3) | |
History of prior treatment with MTX | No | 4 | (4.9) | 0 | (0.0) | 4 | (6.2) |
Yes | 78 | (95.1) | 17 | (100.0) | 61 | (93.8) | |
Unknown | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | |
MTX dose at the initiation of abatacept administration (mg/m2/week) | N | 55 | - | - | |||
Mean (SD) | 8.0 (2.2) | - | - | ||||
Minimum, Maximum | 3.8, 14.2 | - | - | ||||