TABLE 1.
Characteristics | Ustekinumab Every 4 Weeks (n = 64) | Ustekinumab Every 6 Weeks (n = 55) | P a |
---|---|---|---|
Age, mean y | 42.2 | 40.3 | 0.44 |
Sex, % | 0.27 | ||
Female | 60.9 | 50.9 | |
Male | 39.1 | 49.1 | |
Race, % | 0.12 | ||
Asian | 3.1 | 0.0 | |
Black | 0.0 | 5.5 | |
Hispanic | 0.0 | 1.8 | |
Unknown | 0.8 | 3.6 | |
White | 89.1 | 89.1 | |
Age of IBD diagnosis, mean, y | 25.0 | 26.5 | 0.55 |
Disease duration at ustekinumab start, mean, y | 15.5 | 12.7 | 0.08 |
Time on ustekinumab before intensification, mean, d | 363.8 | 368.7 | 0.92 |
Ustekinumab level before intensification, mean, ug/mL, n = 14, n = 4 | 2.0 | 1.3 | 0.54 |
Current smoking, % | 4.7 | 18.2 | 0.02 |
Current cannabis, % | 15.6 | 29.1 | 0.08 |
Current opioids, % | 35.9 | 27.3 | 0.31 |
HBI within 3 months before intensification %, n = 60 | 0.66 | ||
Remission (<5) | 31.7 | 30.8 | |
Mild (5–7) | 23.3 | 30.8 | |
Moderate (8–16) | 43.3 | 34.6 | |
Severe (>16) | 1.7 | 3.9 | |
Extraintestinal manifestations, % | 54.7 | 47.3 | 0.42 |
Prior IBD surgery, % | 64.1 | 63.6 | 0.96 |
Prior anti-TNF, % | 100.0 | 100.0 | n/a |
>1 prior anti-TNF, % | 81.3 | 67.3 | 0.08 |
Prior anti-integrin, % | 48.4 | 47.3 | 0.90 |
Current corticosteroids, % | 31.3 | 14.6 | 0.03 |
CD Location (Montreal classification), % | 0.32 | ||
L1 Terminal ileum | 10.9 | 16.4 | |
L2 Colon | 18.8 | 25.5 | |
L3 Ileocolon | 67.2 | 56.4 | |
L4 Upper GI | 0.0 | 1.8 | |
L3+L4 Ileocolon + Upper GI | 3.1 | 0.0 | |
CD Behavior (Montreal classification), % | 0.36 | ||
B1 Nonstricturing, nonpenetrating | 21.9 | 32.7 | |
B2 Stricturing | 17.2 | 18.2 | |
B3 Penetrating | 60.9 | 49.1 | |
Perianal disease, % | 37.5 | 47.3 | 0.28 |
Lab markers within 3 months before intensification | |||
Fecal calprotectin >120 mcg/g, %, n = 25; n = 7 | 88.0 | 100.0 | 0.34 |
Albumin to CRP ratio, mean, n = 54, n = 46 | 82.3 | 237.6 | 0.08 |
a Calculated by Student t test or Pearson χ 2 test