Table 2.
Week 4 and Week 12 clinical outcomes by initial therapy
| Outcome | Total (n=428) | 5-ASA (n=136) | Oral CS (n=144) | IV CS (n=148) | p-value |
|---|---|---|---|---|---|
| Week 4 | n=422 (99%) a | n=135 (99%) a | n=143 (99%) a | n=144 (97%) a | |
| Remission (PUCAI < 10 and no Additional Therapy/Colectomy) | 211 (50%) | 73 (54%) | 81 (57%) | 57 (40%) | 0.0079 * |
| Remission with fecal calprotectin <250 mcg/g b | 56/283 (20%) | 17/91 (19%) | 26/98 (27%) | 13/94 (14%) | 0.083 |
| Additional therapy or colectomy | 45 (11%) | 1 (1%) | 6 (4%) | 38 (26%) | <0.0001 ** |
| First additional therapy: | |||||
| Anti-TNF (± other additional therapies) | 39 (9%) | 0 (0%) | 4 (3%) | 35 (24%) | <0.0001 ** |
| Calcineurin inhibitor (without other additional therapy) | 1 (0%) | 0 (0%) | 0 (0%) | 1 (1%) | 1.00 # |
| Immunomodulator (without other additional therapy) | 4 (1%) | 1 (1%) | 2 (1%) | 1 (1%) | 0.84 # |
| Colectomy (± other additional therapy)# | 4 (1%) | 0 (0%) | 0 (0%) | 4 (3%) | 0.035* # |
| Week 12 | n=416 (97%)a | n=132 (97%) a | n=141 (98%) a | n=143 (97%) a | |
| CS-free remission | 141 (34%) | 64 (48%) | 47 (33%) | 30 (21%) | <0.0001 ** |
| CS-naïve remission among subset starting 5-ASA | 61 (46%) | ||||
| CS-free remission and fecal calprotectin < 250 mcg/g b | 56/282 (20%) | 25/90 (28%) | 17/103 (17%) | 14/89 (16%) | 0.073 |
| CS-free remission and Week 4 remission | 109 (26%) | 45 (34%) | 40 (28%) | 24 (17%) | 0.0038 * |
| Ever took CS through Week 12 among subset starting 5-ASA | 35 (27%) | ||||
| PUCAI < 10 w/o additional therapy or colectomy but not CS-free | 85 (20%) | 10 (8%) | 40 (28%) | 35 (24%) | <0.0001 ** |
| Additional therapy or colectomy | 82 (20%) | 9 (7%) | 21 (15%) | 52 (36%) | <0.0001 ** |
| First additional therapy: | |||||
| Anti-TNF (± other additional therapies) | 49 (12%) | 1 (1%) | 10 (7%) | 38 (27%) | <0.0001 ** |
| Calcineurin inhibitor (without other additional therapy) | 1 (0%) | 0 (0%) | 0 (0%) | 1 (1%) | 1.00 # |
| Immunomodulator (without other additional therapy) | 31 (7%) | 8 (6%) | 11 (8%) | 12 (8%) | 0.75 |
| Colectomy (±additional therapy) | 8 (2%) | 0 (0%) | 0 (0%) | 8 (6%) | 0.0004 ** |
Week 4 remission: PUCAI < 10 without additional therapy or colectomy.
#
one patient had colectomy with no additional therapy
Week 12 CS-free remission: PUCAI < 10 and no corticosteroids (CS) for 14 days without additional therapy or colectomy
*
p<0.05,
**
p < 0.001.
P-values comparing groups are from a chi-squared or Fisher’s exact test (noted by #) for categorical variables, a Mantel-Haenszel chi-squared test for ordinal variables, and ANOVA or Kruskal-Wallis test for continuous variables.
a
Evaluable population excludes participants who discontinued the study without additional therapy or colectomy.
b
remission with fecal calprotectin < 250 mcg/g is defined only within the subset with a stool sample