Baseline characteristics of CLASSIC II patients
| Randomised cohort | OL cohort total | |||
|---|---|---|---|---|
| Placebo | Adalimumab 40 mg every other week | Adalimumab 40 mg weekly | ||
| *Baseline of CLASSIC II corresponds to week 4 of CLASSIC I. | ||||
| †Scores for the IBDQ can range from 32 to 224; greater scores indicate a better quality of life. | ||||
| ‡High sensitivity cardiology assay for C-reactive protein; normal range is <0.283 mg/dl. | ||||
| §Prednisone, prednisolone, methylprednisolone. | ||||
| ¶Aminosalicylic acid, mesalazine, and sulfasalazine. | ||||
| **Metronidazole and ciprofloxacin. | ||||
| ††Excludes 17 patients who discontinued at or before week 4. | ||||
| CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; IBDQ, Inflammatory Bowel Disease Questionnaire; OL, open-label. | ||||
| Characteristic | n = 18 | n = 19 | n = 18 | n = 204†† |
| Female patients (n (%)) | 12 (67) | 12 (63) | 9 (50) | 104 (51) |
| Male patients (n (%)) | 6 (33) | 7 (37) | 9 (50) | 100 (49) |
| Age (years) (mean (SD)) | 36 (13) | 34 (12) | 38 (10) | 40 (12) |
| Body weight (kg) (mean (SD)) | 70 (13) | 69 (19) | 72 (20) | 77 (18) |
| Duration of Crohn’s disease (years) (mean (SD)) | 8.24 (8.3) | 7.73 (6.5) | 9.13 (9.8) | 9.58 (8.8) |
| Patients who smoked (n (%)) | 12 (67) | 13 (68) | 19 (56) | 120 (59) |
| Enterocutaneous or perianal fistula* (n (%)) | 3 (17) | 2 (11) | 0 (0) | 30 (15) |
| CDAI score* (mean (SD)) | 107 (62) | 106 (33) | 88 (50) | 245 (73) |
| IBDQ* (median (range))† | 191 (138 to 224) | 188 (128 to 213) | 200 (138 to 216) | 149 (58 to 216) |
| CLASSIC I week-0 CRP (mg/dl)‡ | ||||
| Mean (SD) | 0.9 (1.0) | 3.0 (3.0) | 2.5 (3.3) | 1.6 (2.4) |
| Median (range) | 0.5 (0.0 to 3.0) | 2.2 (0.0 to 11.3) | 0.7 (0.1 to 9.3) | 0.8 (0.0 to 17.3) |
| CRP* (mg/dl)‡ | ||||
| Mean (SD) | 0.2 (0.2) | 0.8 (0.8) | 0.6 (0.9) | 1.3 (2.9) |
| Median (range) | 0.2 (0.0 to 0.6) | 0.5 (0.0 to 2.7) | 0.2 (0.0 to 3.6) | 0.5 (0.0 to 34.0) |
| Concomitant drug treatment (n (%)) | ||||
| Any corticosteroid | 10 (56) | 8 (47) | 9 (50) | 74 (36) |
| Systemic corticosteroid§ | 6 (33) | 4 (21) | 5 (28) | 34 (17) |
| Budesonide | 4 (22) | 4 (21) | 4 (22) | 23 (11) |
| Any immunosuppressive agent | 3 (17) | 4 (21) | 5 (28) | 67 (33) |
| Azathioprine | 1 (6) | 4 (21) | 2 (11) | 33 (16) |
| 6-Mercaptopurine | 1 (6) | 0 (0) | 3 (17) | 25 (12) |
| Methotrexate | 1 (6) | 0 (0) | 0 (0) | 6 (3) |
| Crohn’s-related antibiotics** | 1 (6) | 0 (0) | (0) | 25 (12) |
| 5-Aminosalicylates¶ | 8 (44) | 14 (74) | 12 (67) | 110 (54) |