. | Placebo (N = 36) . | Ustekinumab (N = 70) . | P . |
---|---|---|---|
Mean age, years ± SD | 43 ± 14 | 38 ± 12 | 0.10 |
Female sex, N (%) | 18 (50) | 40 (57) | 0.48 |
Race, N (%) | 0.42 | ||
White | 32 (89) | 60 (86) | |
African American | 1 (3) | 6 (9) | |
Asian or other | 3 (9) | 4(5) | |
Average BMI ± SD, kg/m2 | 26.2 ± 6.0 | 26.0 ± 5.8 | 0.46 |
Disease duration, y [IQR] | 6.4 [2.4 15.9] | 4.0 [1.5, 13.4] | 0.15 |
Disease phenotype, N (%) | |||
Fistulizing | 2 (6) | 5 (7) | 0.76 |
Fibrostenotic | 8 (22) | 14 (20) | 0.18 |
Disease location, N (%) | 0.42 | ||
Ileum only | 12 (33) | 17 (24) | |
Colon only | 19 (53) | 34 (49) | |
Ileum and colon | 5 (14) | 18 (26) | |
Concomitant Medication Use, N (%) | |||
Immunomodulator | 14 (39%) | 23 (33) | 0.54 |
Corticosteriods | 11 (31%) | 24 (34) | 0.70 |
Prior anti-TNF exposure, N (%) | 14 (48) | 27 (40) | 0.43 |
CRP | 2.8 [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 ± SD | 43 ± 14 | 38 ± 12 | 0.10 |
Female sex, N (%) | 18 (50) | 40 (57) | 0.48 |
Race, N (%) | 0.42 | ||
White | 32 (89) | 60 (86) | |
African American | 1 (3) | 6 (9) | |
Asian or other | 3 (9) | 4(5) | |
Average BMI ± SD, kg/m2 | 26.2 ± 6.0 | 26.0 ± 5.8 | 0.46 |
Disease duration, y [IQR] | 6.4 [2.4 15.9] | 4.0 [1.5, 13.4] | 0.15 |
Disease phenotype, N (%) | |||
Fistulizing | 2 (6) | 5 (7) | 0.76 |
Fibrostenotic | 8 (22) | 14 (20) | 0.18 |
Disease location, N (%) | 0.42 | ||
Ileum only | 12 (33) | 17 (24) | |
Colon only | 19 (53) | 34 (49) | |
Ileum and colon | 5 (14) | 18 (26) | |
Concomitant Medication Use, N (%) | |||
Immunomodulator | 14 (39%) | 23 (33) | 0.54 |
Corticosteriods | 11 (31%) | 24 (34) | 0.70 |
Prior anti-TNF exposure, N (%) | 14 (48) | 27 (40) | 0.43 |
CRP | 2.8 [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 ± SD | 43 ± 14 | 38 ± 12 | 0.10 |
Female sex, N (%) | 18 (50) | 40 (57) | 0.48 |
Race, N (%) | 0.42 | ||
White | 32 (89) | 60 (86) | |
African American | 1 (3) | 6 (9) | |
Asian or other | 3 (9) | 4(5) | |
Average BMI ± SD, kg/m2 | 26.2 ± 6.0 | 26.0 ± 5.8 | 0.46 |
Disease duration, y [IQR] | 6.4 [2.4 15.9] | 4.0 [1.5, 13.4] | 0.15 |
Disease phenotype, N (%) | |||
Fistulizing | 2 (6) | 5 (7) | 0.76 |
Fibrostenotic | 8 (22) | 14 (20) | 0.18 |
Disease location, N (%) | 0.42 | ||
Ileum only | 12 (33) | 17 (24) | |
Colon only | 19 (53) | 34 (49) | |
Ileum and colon | 5 (14) | 18 (26) | |
Concomitant Medication Use, N (%) | |||
Immunomodulator | 14 (39%) | 23 (33) | 0.54 |
Corticosteriods | 11 (31%) | 24 (34) | 0.70 |
Prior anti-TNF exposure, N (%) | 14 (48) | 27 (40) | 0.43 |
CRP | 2.8 [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 ± SD | 43 ± 14 | 38 ± 12 | 0.10 |
Female sex, N (%) | 18 (50) | 40 (57) | 0.48 |
Race, N (%) | 0.42 | ||
White | 32 (89) | 60 (86) | |
African American | 1 (3) | 6 (9) | |
Asian or other | 3 (9) | 4(5) | |
Average BMI ± SD, kg/m2 | 26.2 ± 6.0 | 26.0 ± 5.8 | 0.46 |
Disease duration, y [IQR] | 6.4 [2.4 15.9] | 4.0 [1.5, 13.4] | 0.15 |
Disease phenotype, N (%) | |||
Fistulizing | 2 (6) | 5 (7) | 0.76 |
Fibrostenotic | 8 (22) | 14 (20) | 0.18 |
Disease location, N (%) | 0.42 | ||
Ileum only | 12 (33) | 17 (24) | |
Colon only | 19 (53) | 34 (49) | |
Ileum and colon | 5 (14) | 18 (26) | |
Concomitant Medication Use, N (%) | |||
Immunomodulator | 14 (39%) | 23 (33) | 0.54 |
Corticosteriods | 11 (31%) | 24 (34) | 0.70 |
Prior anti-TNF exposure, N (%) | 14 (48) | 27 (40) | 0.43 |
CRP | 2.8 [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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