Table 1 Summary statistics of the patient population for clinical response at 26 weeks. No missing values were reported.
Grouped by clinical response at week 26 | |||||
|---|---|---|---|---|---|
Overall | No | Yes | P-Value | ||
n | 227 | 49 | 178 | ||
Active principle of biological treatment, n (%) | Ustekinumab | 135 (59.5) | 28 (57.1) | 107 (60.1) | 0.83 |
Vedolizumab | 92 (40.5) | 21 (42.9) | 71 (39.9) | ||
Sex, n (%) | Female | 120 (52.9) | 26 (53.1) | 94 (52.8) | 1.00 |
Male | 107 (47.1) | 23 (46.9) | 84 (47.2) | ||
Family history of IBD, n (%) | First degree relative | 24 (10.6) | 5 (10.2) | 19 (10.7) | 0.90 |
No relative | 196 (86.3) | 42 (85.7) | 154 (86.5) | ||
Second degree relative | 7 (3.1) | 2 (4.1) | 5 (2.8) | ||
Location of CD (Crohn’s disease), n (%) | Non-Corresponding Subtypea | 58 (25.6) | 14 (28.6) | 44 (24.7) | 0.54 |
Colonic | 40 (17.6) | 5 (10.2) | 35 (19.7) | ||
Ileal | 78 (34.4) | 20 (40.8) | 58 (32.6) | ||
Ileocolonic | 47 (20.7) | 10 (20.4) | 37 (20.8) | ||
Ileal + Upper | 1 (0.4) | 1 (0.6) | |||
Ileocolonic + Upper | 3 (1.3) | 3 (1.7) | |||
Behavior of CD, n (%) | Non-Corresponding Subtypea | 58 (25.6) | 14 (28.6) | 44 (24.7) | 0.27 |
Fistulizing | 32 (14.1) | 7 (14.3) | 25 (14.0) | ||
Inflammatory | 76 (33.5) | 11 (22.4) | 65 (36.5) | ||
Stenosing | 61 (26.9) | 17 (34.7) | 44 (24.7) | ||
Extent of UC (ulcerative colitis), n (%) | Non-Corresponding Subtypea | 169 (74.4) | 35 (71.4) | 134 (75.3) | 0.10 |
Left-sided colitis | 24 (10.6) | 2 (4.1) | 22 (12.4) | ||
Pancolitis | 25 (11.0) | 9 (18.4) | 16 (9.0) | ||
Proctitis | 9 (4.0) | 3 (6.1) | 6 (3.4) | ||
Type of IBD, n (%) | Crohn’s disease | 169 (74.4) | 35 (71.4) | 134 (75.3) | 0.72 |
Ulcerative colitis | 58 (25.6) | 14 (28.6) | 44 (24.7) | ||
Previous TNF, n (%) | Yes | 172 (75.8) | 34 (69.4) | 138 (77.5) | 0.33 |
No | 55 (24.2) | 15 (30.6) | 40 (22.5) | ||
Previous Ustekinumab, n (%) | Yes | 2 (0.9) | 2 (1.1) | 1.00 | |
No | 225 (99.1) | 49 (100.0) | 176 (98.9) | ||
Previous Vedolizumab, n (%) | Yes | 22 (9.7) | 5 (10.2) | 17 (9.6) | 1.00 |
No | 205 (90.3) | 44 (89.8) | 161 (90.4) | ||
Preexistence: smoker, n (%) | Ex-smoker | 38 (16.7) | 11 (22.4) | 27 (15.2) | 0.48 |
Nonsmoker | 131 (57.7) | 26 (53.1) | 105 (59.0) | ||
Smoker | 58 (25.6) | 12 (24.5) | 46 (25.8) | ||
Extraintestinal manifestations (EIMs), n (%) | Yes | 94 (41.4) | 20 (40.8) | 74 (41.6) | 1.00 |
No | 133 (58.6) | 29 (59.2) | 104 (58.4) | ||
Age at start of drug (years), median [Q1, Q3] | 43.0 [35.0,56.0] | 43.0 [35.0,52.0] | 43.5 [35.2,58.8] | 0.28 | |
Years with disease, median [Q1, Q3] | 10.0 [4.0,17.0] | 8.0 [4.0,17.0] | 11.0 [4.2,17.0] | 0.23 | |
Corticosteroids in Previous 12 Months, n (%) | Yes | 135 (59.5) | 32 (65.3) | 103 (57.9) | 0.44 |
No | 92 (40.5) | 17 (34.7) | 75 (42.1) | ||
Preexistence: diabetes, n (%) | Yes | 19 (8.4) | 7 (14.3) | 12 (6.7) | 0.14 |
No | 208 (91.6) | 42 (85.7) | 166 (93.3) | ||
Preexistence: Asthma, n (%) | Yes | 25 (11.0) | 10 (20.4) | 15 (8.4) | 0.03 |
No | 202 (89.0) | 39 (79.6) | 163 (91.6) | ||
Preexistence: migraine, n (%) | Yes | 21 (9.3) | 7 (14.3) | 14 (7.9) | 0.17 |
No | 206 (90.7) | 42 (85.7) | 164 (92.1) | ||
Fecal calprotectin (µg/g), median [Q1, Q3] | 238.5 [106.3,746.6] | 328.1 [103.3,959.1] | 231.0 [106.7,610.0] | 0.18 | |
Erythrocyte sedimentation rate (mm/h), median [Q1, Q3] | 12.0 [7.0,22.1] | 12.0 [7.0,22.0] | 11.9 [7.0,22.2] | 0.96 | |
Total protein (g/dL), median [Q1, Q3] | 7.2 [6.8,7.4] | 7.0 [6.8,7.4] | 7.2 [6.8,7.4] | 0.37 | |
Vitamin B12 (pg/mL), median [Q1, Q3] | 360.0 [288.5,438.0] | 342.5 [275.9,409.0] | 368.1 [305.6,442.8] | 0.42 | |
Creatinine (mg/dL), median [Q1, Q3] | 0.8 [0.7,0.9] | 0.8 [0.7,0.9] | 0.8 [0.7,0.9] | 0.29 | |
C-reactive protein (mg/L), median [Q1, Q3] | 5.2 [2.0,15.0] | 5.6 [2.4,22.9] | 5.1 [2.0,11.9] | 0.21 | |
Lymphocytes count (× 10^3/µL), median [Q1, Q3] | 2.3 [1.8,2.8] | 2.2 [1.5,2.6] | 2.4 [1.9,2.8] | 0.22 | |
White blood cells count (× 10^3/µL), median [Q1, Q3] | 8.5 [7.3,10.7] | 8.6 [6.8,10.7] | 8.5 [7.3,10.6] | 0.91 | |
