Table 1.
Baseline demographic and clinical characteristics of patients with UC treated with budesonide MMX system
| No transition to Prednisone (n = 52) |
Transition to Prednisone (n = 44) |
p value | |||
|---|---|---|---|---|---|
| n | % | n | % | ||
| Gender, male | 10 | 19 | 17 | 39 | 0.035 |
| Race | 0.032 | ||||
| White, non-Hispanic | 40 | 77 | 40 | 91 | |
| Black, non-Hispanic | 9 | 17 | 1 | 2 | |
| Hispanic | 3 | 6 | 1 | 2 | |
| Asian | 0 | 0 | 2 | 5 | |
| Age at diagnosis, median IQR | 29 | 20–44 | 23.5 | 18–31 | 0.034 |
| Disease duration, median IQR | 10 | 6–14 | 13 | 7–17 | 0.290 |
| BMI at time of budesonide MMX initiation, median IQR | 23.9 | 21.8–28.7 | 24.9 | 22.6–28.4 | 0.514 |
| Indication for budesonide MMX | 0.731 | ||||
| Prior adverse effects with prednisone | 8 | 16 | 5 | 12 | |
| Prevent adverse effects of prednisone | 19 | 39 | 15 | 36 | |
| Other/unknown | 22 | 45 | 22 | 52 | |
| Disease extent | 0.752 | ||||
| Proctitis | 4 | 8 | 3 | 7 | |
| Left-sided colitis | 22 | 42 | 22 | 50 | |
| Extensive colitis | 26 | 50 | 19 | 43 | |
| Tobacco use | 0.403 | ||||
| Never smoker | 41 | 79 | 35 | 80 | |
| Former smoker | 10 | 19 | 6 | 14 | |
| Current smoker | 1 | 2 | 3 | 7 | |
| Therapy prior to budesonide MMX | 0.784 | ||||
| None | 5 | 10 | 3 | 7 | |
| Aminosalicylate | 28 | 56 | 25 | 57 | |
| Immunomodulator monotherapy | 10 | 20 | 7 | 16 | |
| Biologic a | 7 | 14 | 9 | 20 | |
| Mayo endoscopy subscore prior to budesonide MMX initiation b | 0.511 | ||||
| Mayo 0 | 1 | 4 | 0 | 0 | |
| Mayo 1 | 9 | 39 | 2 | 18 | |
| Mayo 2 | 12 | 52 | 8 | 72 | |
| Mayo 3 | 1 | 4 | 1 | 9 | |
| Mayo endoscopy subscore after treatment with budesonide MMX C | 0.601 | ||||
| Mayo 0 | 1 | 17 | 1 | 5 | |
| Mayo 1 | 1 | 17 | 3 | 14 | |
| Mayo 2 | 3 | 50 | 9 | 41 | |
| Mayo 3 | 1 | 17 | 9 | 41 | |
| Concomitant therapy at the time of budesonide MMX initiation | 0.942 | ||||
| None | 7 | 13 | 5 | 11 | |
| Aminosalicylate | 25 | 48 | 21 | 48 | |
| Biologic and/or immunomodulator | 20 | 38 | 18 | 41 | |
| Hospitalization after budesonide MMX initiation | 2 | 4 | 4 | 9 | 0.408 |
MMX, multimatrix; IQR, interquartile range; BMI, body mass index; UC, ulcerative colitis.
a
Biologic therapy defined as monotherapy with infliximab, adalimumab, golimumab, vedolizumab or any of these agents in combination with an immunomodulator.
b
Mayo endoscopy subscore available for 34 patients prior to initiation (23 patients with no transition to prednisone, 11 patients with transition).
c
Mayo endoscopy subscore available for 28 patients after initiation (6 patients with no transition to prednisone, 22 patients with transition).