Table 3 Summary statistics of the patient population for clinical remission at 52 weeks. No missing values were reported.
Grouped by clinical remission at week 52 | |||||
|---|---|---|---|---|---|
Overall | No | Yes | P-Value | ||
n | 227 | 103 | 124 | ||
Active principle of biological treatment, n (%) | Ustekinumab | 135 (59.5) | 65 (63.1) | 70 (56.5) | 0.38 |
Vedolizumab | 92 (40.5) | 38 (36.9) | 54 (43.5) | ||
Sex, n (%) | Female | 120 (52.9) | 62 (60.2) | 58 (46.8) | 0.06 |
Male | 107 (47.1) | 41 (39.8) | 66 (53.2) | ||
Family history of IBD, n (%) | First degree relative | 24 (10.6) | 10 (9.7) | 14 (11.3) | 0.77 |
No relative | 196 (86.3) | 89 (86.4) | 107 (86.3) | ||
Second degree relative | 7 (3.1) | 4 (3.9) | 3 (2.4) | ||
Location of CD (Crohn’s disease), n (%) | Non-Corresponding Subtypea | 58 (25.6) | 25 (24.3) | 33 (26.6) | 0.53 |
Colonic | 40 (17.6) | 14 (13.6) | 26 (21.0) | ||
Ileal | 1 (0.4) | 1 (1.0) | |||
Ileocolonic | 78 (34.4) | 39 (37.9) | 39 (31.5) | ||
Ileal + Upper | 47 (20.7) | 23 (22.3) | 24 (19.4) | ||
Ileocolonic + Upper | 3 (1.3) | 1 (1.0) | 2 (1.6) | ||
Behavior of CD, n (%) | Non-Corresponding Subtypea | 58 (25.6) | 25 (24.3) | 33 (26.6) | 0.12 |
Fistulizing | 32 (14.1) | 15 (14.6) | 17 (13.7) | ||
Inflammatory | 76 (33.5) | 28 (27.2) | 48 (38.7) | ||
Stenosing | 61 (26.9) | 35 (34.0) | 26 (21.0) | ||
Extent of UC (ulcerative colitis), n (%) | Non-Corresponding Subtypea | 169 (74.4) | 78 (75.7) | 91 (73.4) | 0.87 |
Left-sided colitis | 24 (10.6) | 9 (8.7) | 15 (12.1) | ||
Pancolitis | 25 (11.0) | 12 (11.7) | 13 (10.5) | ||
Proctitis | 9 (4.0) | 4 (3.9) | 5 (4.0) | ||
Type of IBD, n (%) | Crohn’s disease | 169 (74.4) | 78 (75.7) | 91 (73.4) | 0.80 |
Ulcerative colitis | 58 (25.6) | 25 (24.3) | 33 (26.6) | ||
Previous TNF, n (%) | Yes | 172 (75.8) | 79 (76.7) | 93 (75.0) | 0.89 |
No | 55 (24.2) | 24 (23.3) | 31 (25.0) | ||
Previous Ustekinumab, n (%) | Yes | 2 (0.9) | 1 (1.0) | 1 (0.8) | 1.00 |
No | 225 (99.1) | 102 (99.0) | 123 (99.2) | ||
Previous Vedolizumab, n (%) | Yes | 22 (9.7) | 15 (14.6) | 7 (5.6) | 0.04 |
No | 205 (90.3) | 88 (85.4) | 117 (94.4) | ||
Preexistence: smoker, n (%) | Ex-smoker | 38 (16.7) | 21 (20.4) | 17 (13.7) | 0.07 |
Nonsmoker | 131 (57.7) | 51 (49.5) | 80 (64.5) | ||
Smoker | 58 (25.6) | 31 (30.1) | 27 (21.8) | ||
Extraintestinal manifestations (EIMs), n (%) | Yes | 94 (41.4) | 52 (50.5) | 42 (33.9) | 0.02 |
No | 133 (58.6) | 51 (49.5) | 82 (66.1) | ||
Age at start of drug (years), median [Q1, Q3] | 43.0 [35.0,56.0] | 42.0 [36.0,54.5] | 45.5 [33.0,60.0] | 0.35 | |
Years with disease, median [Q1, Q3] | 10.0 [4.0,17.0] | 11.0 [4.5,17.0] | 9.0 [4.0,17.0] | 0.59 | |
Corticosteroids in previous 12 months, n (%) | Yes | 135 (59.5) | 66 (64.1) | 69 (55.6) | 0.25 |
No | 92 (40.5) | 37 (35.9) | 55 (44.4) | ||
Preexistence: diabetes, n (%) | Yes | 19 (8.4) | 11 (10.7) | 8 (6.5) | 0.37 |
No | 208 (91.6) | 92 (89.3) | 116 (93.5) | ||
Preexistence: asthma, n (%) | Yes | 25 (11.0) | 17 (16.5) | 8 (6.5) | 0.03 |
No | 202 (89.0) | 86 (83.5) | 116 (93.5) | ||
Preexistence: migraine, n (%) | Yes | 21 (9.3) | 13 (12.6) | 8 (6.5) | 0.17 |
No | 206 (90.7) | 90 (87.4) | 116 (93.5) | ||
Fecal calprotectin (µg/g), median [Q1, Q3] | 238.5 [106.3,746.6] | 288.0 [69.7,764.1] | 236.7 [119.2,655.6] | 0.70 | |
Erythrocyte sedimentation rate (mm/h), median [Q1, Q3] | 12.0 [7.0,22.1] | 11.9 [7.0,19.1] | 12.0 [7.3,23.2] | 0.32 | |
Total protein (g/dL), median [Q1, Q3] | 7.2 [6.8,7.4] | 7.1 [6.7,7.4] | 7.2 [6.9,7.4] | 0.89 | |
Vitamin B12 (pg/mL), median [Q1, Q3] | 360.0 [288.5,438.0] | 358.1 [279.5,431.0] | 361.5 [309.1,449.2] | 0.43 | |
Creatinine (mg/dL), median [Q1, Q3] | 0.8 [0.7,0.9] | 0.7 [0.7,0.9] | 0.8 [0.7,0.9] | 0.31 | |
C-reactive protein (mg/L), median [Q1, Q3] | 5.2 [2.0,15.0] | 5.0 [2.0,16.4] | 5.3 [2.0,13.7] | 0.93 | |
Lymphocytes count (× 10^3/µL), median [Q1, Q3] | 2.3 [1.8,2.8] | 2.2 [1.7,2.8] | 2.4 [1.9,2.7] | 0.62 | |
White blood cells count (× 10^3/µL), median [Q1, Q3] | 8.5 [7.3,10.7] | 8.7 [7.5,11.5] | 8.4 [7.2,10.1] | 0.15 | |
