Table 2.
Pre-infliximab GI toxicity characteristics
Variable | (N=78) |
Time to onset of colitis (weeks) | |
Median (range) | 6 (0, 73) |
Type of GI toxicity | |
Colitis | 74 (95%) |
Upper GI | 3 (4%) |
Upper and lower GI tract | 1 (1%) |
Max CTCAE grade | |
2 | 4 (5%) |
3 | 49 (63%) |
4 | 18 (23%) |
5 | 6 (7%) |
Requiring hospitalization | |
Yes | 62 (79%) |
Time to commencement of steroids (days) | |
Median (range) | 2.5 (0, 50) |
Maximum steroid dose (mg)* | |
Median (range) | 100 (30, 1250) |
Type of steroid refractory toxicity | |
Primary refractory | 46 (59%) |
Rebound on wean | 32 (41%) |
Endoscopy pre-infliximab | |
No | 32 (41%) |
Sigmoidoscopy (±UGIE) | 24 (31%) |
Full colonoscopy (±UGIE) | 20 (26%) |
Upper GI endoscopy (UGIE) only | 2 (3%) |
Degree of inflammation endoscopically pre-infliximab | |
Endoscopically normal | 7 (15%) |
Rectum only | 3 (7%) |
Sigmoid only | 6 (13%) |
Left-sided (sigmoid+rectum) | 10 (22%) |
Pancolitis | 17 (37%) |
Upper GI tract only | 3 (7%) |
Time to first dose of infliximab (days) | |
Median (range) | 17.5 (1, 387) |
*Oral prednisolone equivalent.
CTCAE, Common Terminology Criteria for Adverse Events; GI, gastrointestinal; UGIE, Upper GI endoscopy.