TABLE 1.

Baseline Characteristics of Ustekinumab Response Cohort

Placebo (N = 36)Ustekinumab (N = 70)P
Mean age, years ± SD43 ± 1438 ± 120.10
Female sex, N (%)18 (50)40 (57)0.48
Race, N (%)0.42
 White32 (89)60 (86)
 African American1 (3)6 (9)
 Asian or other3 (9)4(5)
Average BMI ± SD, kg/m226.2 ± 6.026.0 ± 5.80.46
Disease duration, y [IQR]6.4 [2.4 15.9]4.0 [1.5, 13.4]0.15
Disease phenotype, N (%)
 Fistulizing2 (6)5 (7)0.76
 Fibrostenotic8 (22)14 (20)0.18
Disease location, N (%)0.42
 Ileum only12 (33)17 (24)
 Colon only19 (53)34 (49)
 Ileum and colon5 (14)18 (26)
Concomitant Medication Use, N (%)
 Immunomodulator14 (39%)23 (33)0.54
 Corticosteriods11 (31%)24 (34)0.70
Prior anti-TNF exposure, N (%)14 (48)27 (40)0.43
CRP2.8 [1.0, 14.4]5.1 [2.4, 10.6]0.55
Fecal calprotectin, median μg/g [IQR]281.9 [76.0, 1252.9]221.5 [28.0, 560.8]0.31
Placebo (N = 36)Ustekinumab (N = 70)P
Mean age, years ± SD43 ± 1438 ± 120.10
Female sex, N (%)18 (50)40 (57)0.48
Race, N (%)0.42
 White32 (89)60 (86)
 African American1 (3)6 (9)
 Asian or other3 (9)4(5)
Average BMI ± SD, kg/m226.2 ± 6.026.0 ± 5.80.46
Disease duration, y [IQR]6.4 [2.4 15.9]4.0 [1.5, 13.4]0.15
Disease phenotype, N (%)
 Fistulizing2 (6)5 (7)0.76
 Fibrostenotic8 (22)14 (20)0.18
Disease location, N (%)0.42
 Ileum only12 (33)17 (24)
 Colon only19 (53)34 (49)
 Ileum and colon5 (14)18 (26)
Concomitant Medication Use, N (%)
 Immunomodulator14 (39%)23 (33)0.54
 Corticosteriods11 (31%)24 (34)0.70
Prior anti-TNF exposure, N (%)14 (48)27 (40)0.43
CRP2.8 [1.0, 14.4]5.1 [2.4, 10.6]0.55
Fecal calprotectin, median μg/g [IQR]281.9 [76.0, 1252.9]221.5 [28.0, 560.8]0.31
TABLE 1.

Baseline Characteristics of Ustekinumab Response Cohort

Placebo (N = 36)Ustekinumab (N = 70)P
Mean age, years ± SD43 ± 1438 ± 120.10
Female sex, N (%)18 (50)40 (57)0.48
Race, N (%)0.42
 White32 (89)60 (86)
 African American1 (3)6 (9)
 Asian or other3 (9)4(5)
Average BMI ± SD, kg/m226.2 ± 6.026.0 ± 5.80.46
Disease duration, y [IQR]6.4 [2.4 15.9]4.0 [1.5, 13.4]0.15
Disease phenotype, N (%)
 Fistulizing2 (6)5 (7)0.76
 Fibrostenotic8 (22)14 (20)0.18
Disease location, N (%)0.42
 Ileum only12 (33)17 (24)
 Colon only19 (53)34 (49)
 Ileum and colon5 (14)18 (26)
Concomitant Medication Use, N (%)
 Immunomodulator14 (39%)23 (33)0.54
 Corticosteriods11 (31%)24 (34)0.70
Prior anti-TNF exposure, N (%)14 (48)27 (40)0.43
CRP2.8 [1.0, 14.4]5.1 [2.4, 10.6]0.55
Fecal calprotectin, median μg/g [IQR]281.9 [76.0, 1252.9]221.5 [28.0, 560.8]0.31
Placebo (N = 36)Ustekinumab (N = 70)P
Mean age, years ± SD43 ± 1438 ± 120.10
Female sex, N (%)18 (50)40 (57)0.48
Race, N (%)0.42
 White32 (89)60 (86)
 African American1 (3)6 (9)
 Asian or other3 (9)4(5)
Average BMI ± SD, kg/m226.2 ± 6.026.0 ± 5.80.46
Disease duration, y [IQR]6.4 [2.4 15.9]4.0 [1.5, 13.4]0.15
Disease phenotype, N (%)
 Fistulizing2 (6)5 (7)0.76
 Fibrostenotic8 (22)14 (20)0.18
Disease location, N (%)0.42
 Ileum only12 (33)17 (24)
 Colon only19 (53)34 (49)
 Ileum and colon5 (14)18 (26)
Concomitant Medication Use, N (%)
 Immunomodulator14 (39%)23 (33)0.54
 Corticosteriods11 (31%)24 (34)0.70
Prior anti-TNF exposure, N (%)14 (48)27 (40)0.43
CRP2.8 [1.0, 14.4]5.1 [2.4, 10.6]0.55
Fecal calprotectin, median μg/g [IQR]281.9 [76.0, 1252.9]221.5 [28.0, 560.8]0.31
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