Table 1.
Baseline characteristics of patients by age at time of trial entry, and by treatment strategy assignment
| Age <60y | Age ≥60y | ||||
|---|---|---|---|---|---|
| Conventional Management (n=760) |
Early combined immunosuppr ession (n=910) |
Conventional Management (n=138) |
Early combined immunosuppr ession (n=173) |
||
| Male, n (%) | 324 (42.6%) | 384 (42.2%) | 58 (42.0%) | 72 (41.6%) | |
|
Disease Duration (in months), mean |
143.7 | 138.3 | 219.0 | 213.4 | |
| Current Smoker, n (%) | 142 (18.7%) | 235 (25.9%) | 21 (15.2%) | 36 (20.8%) | |
| Medications | |||||
| Corticosteroids, n (%) | 126 (16.6%) | 177 (19.5%) | 28 (20.3%) | 29 (16.8%) | |
| Antimetabolites, n (%)* | 213 (28.0%) | 299 (32.9%) | 38 (27.5%) | 61 (35.3%) | |
| TNFα-Antagonists, n (%)* | 175 (23.0%) | 196 (21.5%) | 21 (15.2%) | 18 (10.4%) | |
| Combination therapy, n (%) | 101 (13.3%) | 115 (12.6%) | 15 (10.9%) | 13 (7.5%) | |
| Previous surgery for CD, n (%) | 354 (46.6%) | 407 (44.8%) | 77 (55.8%) | 95 (54.9%) | |
| Disease Location | |||||
| Colon, n (%) | 151 (19.9%) | 207 (23.0%) | 27 (19.7%) | 50 (29.1%) | |
| Small bowel, n (%) | 263 (34.7%) | 281 (31.2%) | 56 (40.9%) | 61 (35.5%) | |
| Both, n (%) | 344 (45.4%) | 413 (45.8%) | 54 (39.4%) | 61 (35.5%) | |
| Fistula, active, n (%) | 67 (8.8%) | 65 (7.2%) | 4 (2.9%) | 8 (4.7%) | |
| Steroid-free clinical remission | 395 (53.6%) | 499 (56.4%) | 77 (59.2%) | 99 (58.2%) | |
*
Antimetabolites and TNF-Antagonists are reported here as not in combination with one another, that is, if on both TNF-antagonists and antimetabolites, they will not be included in the number & percentage of subjects on antimetabolites but will be included with those on combination therapy Steroid-free clinical remission was defined as Harvey Bradshaw Index ≤4 while being steroid-free.