Table 1.
Demographic and baseline characteristics at I-week 0 (full analysis set for the induction, DB-maintenance and OL-maintenance phases)
| Induction phase | DB-Maintenance phase | OL-Maintenance phase | ||
|---|---|---|---|---|
| Golimumab SC 200 mg | Golimumab SC 100 mg | Placebo* 100 mg | Golimumab SC 100 mg | |
| N | 144 | 32 | 31 | 60 |
| Sex, male, n (%) | 98 (68%) | 19 (59%) | 19 (61%) | 42 (70%) |
| Age (years) | 42.40 (14.74) | 39.30 (12.00) | 42.90 (14.41) | 42.10 (16.16) |
| Weight (kg) | 61.51 (11.18) | 64.59 (14.73) | 59.48 (9.73) | 60.97 (9.74) |
| Height (cm) | 165.63 (7.50) | 163.77 (7.05) | 163.49 (6.21) | 167.09 (7.77) |
| BMI (kg/m2) | 22.38 (3.69) | 24.07 (5.44) | 22.22 (3.24) | 21.78 (2.77) |
| Disease durationa, years | 5.08 (0.1;27.4) | 5.35 (0.5;24.7) | 5.74 (0.3;21.6) | 4.57 (0.3;27.4) |
| Extent of disease, n (%) | ||||
| Limited to left side of colon | 89 (62%) | 20 (63%) | 19 (61%) | 37 (62%) |
| Extensive | 55 (38%) | 12 (38%) | 12 (39%) | 23 (38%) |
| Mayo scorea (0–12) | 8.0 (6;12) | 8.0 (6;11) | 8.0 (6;12) | 8.0 (6;11) |
| Severity of UC disease, n (%) | ||||
| Moderate | 141 (98%) | 31 (97%) | 30 (97%) | 59 (98%) |
| CRP (mg/L) | 4.90 (10.95) | 5.31 (14.79) | 4.06 (7.74) | 4.68 (11.06) |
| Any UC medication, n (%) | 141 (98%) | 32 (100%) | 30 (97%) | 59 (98%) |
| Corticosteroid# | 42 (29%) | 9 (28%) | 9 (29%) | 19 (32%) |
| ≥20 mg/day P.Eq | 12 (8%) | 4 (13%) | 5 (16%) | 3 (5%) |
| <20 mg/day P.Eq | 30 (21%) | 5 (16%) | 4 (13%) | 16 (27%) |
| Budesonide | 0 | 0 | 0 | 0 |
| Immunomodulatory drugs | ||||
| 6-MP/AZA | 64 (44%) | 16 (50%) | 13 (42%) | 28 (47%) |
| Methotrexate | 0 | 0 | 0 | 0 |
| Aminosalicylates | 128 (89%) | 29 (91%) | 27 (87%) | 55 (92%) |
All values expressed as mean (SD) unless otherwise mentioned
6-MP 6-mercaptopurine, AZA azathioprine, BMI body mass index, CRP C-reactive protein, DB double-blind, OL open-label, SC subcutaneous injection, SD standard deviation, UC ulcerative colitis
aValues expressed in median (range)
* Patients who were in clinical response to golimumab induction therapy and were randomized to the placebo in the maintenance phase; #excluding budesonide