TABLE 2.
Demographics and disease characteristics at baseline (study inclusion)
| Baseline demographics and disease characteristics | All patients (IBD) | Crohn’s disease | Ulcerative colitis |
|---|---|---|---|
| IBD diagnosis, n (%) | 89 (100) | 48 (53.9) | 41 (46.1) |
| Age at baseline (years), Md (range) | 44 (20–82) | 46.5 (23–82) | 37 (20–82) |
| Age at diagnosis (years), Md (range) | 24 (9–76) | 23.5 (9–74) | 26 (14–76) |
| Height at baseline (cm), Mn (SD) | 174.2 (±11.6) | 173.2 (±11.5) | 175.5 (±11–8) |
| Weight at baseline (kg), Mn (SD) | 79.4 (±16.2) | 77.7 (±17.5) | 81.5 (±14.4) |
| Female:Male ratio, n (%) | 43:46 (48.3:51.7) | 25:23 (52.1:47.9) | 18:23 (43.9:56.1) |
| Montreal classification, n (%) | |||
| Age at diagnosis | |||
| A1 (<17 years) | 10 (11.2) | 7 (14.6) | 3 (7.3) |
| A2 (17–40 years) | 62 (69.7) | 36 (75) | 26 (63.4) |
| A3 (>40 years) | 17 (19.1) | 5 (10.4) | 12 (29.3) |
| Disease location (Crohn’s disease) | |||
| L1 (ileal ± cecal disease) | 10 (20.8) | ||
| L2 (colonic) | 12 (25) | ||
| L3 (ileocolonic) | 19 (39.6) | ||
| L3L4 (ileocolonic and upper gastrointestinal tract) | 7 (14.6) | ||
| Disease behaviour (Crohn’s disease) | |||
| B1 (uncomplicated) | 28 (58.3) | ||
| B2 (structuring) | 14 (29.2) | ||
| B3 (penetrating) | 1 (2.1) | ||
| B2B3 (stricturing, penetrating) | 5 (10.4) | ||
| p (perianal) a | 10 (20.9) | ||
| Disease extent (ulcerative colitis) | |||
| E1 (proctitis) | 5 (12.2) | ||
| E2 (left‐sided) | 15 (36.6) | ||
| E3 (extensive/pancolitis) | 21 (51.2) | ||
| Smoking status, n (%) | |||
| Never | 53 (59.6) | 29 (60.4) | 24 (58.5) |
| Previous | 29 (32.6) | 13 (27.1) | 16 (39.0) |
| Active | 7 (7.9) | 6 (12.5) | 1 (2.4) |
| Baseline data | |||
| Faecal calprotectin (μg/g), Median (IQR) | 39.0 (12.5–135) | 64.0 (12.5–238.5) | 12.5 (12.5–96.5) |
| Plasma CRP (mg/L), Median (IQR) | 2.0 (2.0–2.0) | 2.0 (2.0–2.0) | 2.0 (2.0–2.0) |
| Serum vedolizumab trough levels (μg/ml), Median (IQR) | 8.1 (5.2–14.0) | 8.7 (4.9–14.0) | 7.9 (5.3–12.5) |
| Patient‐based Harvey Bradshaw Index, Median (IQR) | 3.0 (1.0–5.8) | ||
| PRO2‐CD, Median (IQR) | 5.0 (0.5–12.5) | ||
| Simple Clinical Colitis Activity Index, Median (IQR) | 2.0 (1.0–3.0) | ||
| PRO2‐UC, Median (IQR) | 0.0 (0.0–0.0) | ||
| Short Health Scale composite score, Mean (SD) | 4.7 (±3.1) | 5.1 (±3.0) | 4.2 (±3.2) |
| IBD treatment at baseline | |||
| Conventional oral treatment, n (%) | |||
| 5‐aminosalisylic acid | 31 (34.8) | 9 (18.8) | 22 (53.7) |
| Azathioprine | 11 (12.4) | 3 (6.3) | 8 (19.5) |
| 6‐mercaptopurine | 2 (2.2) | 0 (0.0) | 2 (4.9) |
| Methotrexate | 2 (2.2) | 0 (0.0) | 2 (4.9) |
| Prednisolone | 4 (4.5) | 2 (4.2) | 2 (4.9) |
| Budesonide | 3 (3.4) | 2 (4.2) | 1 (2.4) |
| Topical treatment, n (%) | |||
| 5‐aminosalisylic acid | 3 (3.4) | 0 (0.0) | 3 (7.3) |
| Corticosteroids b | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Concomitant biologic treatment, n (%) | |||
| Adalimumab | 2 (2.2) | 1 (2.1) | 1 (2.4) |
| Time on IV vedolizumab (months), Median (IQR) | 26.1 (9.5–52.9) | 26.1 (8.7–53.1) | 27.4 (10.8–51.5) |
| IV vedolizumab dose | |||
| 300 mg, n (%) | 87 (97.8) | 46 (95.8) | 41 (100) |
| 600 mg, n (%) | 2 (2.2) | 2 (4.2) | 0 (0) |
| IV vedolizumab infusion interval, n (%) | |||
| 8 weeks | 71 (79.8) | 38 (79.2) | 33 (80.5) |
| 4 weeks | 9 (10.1) | 2 (4.2) | 7 (17.1) |
| Other (5–7 weeks) | 9 (10.1) | 8 (16.7) | 1 (2.4) |
Abbreviations: CRP, C‐reactive protein; IBD, inflammatory bowel disease; IQR, interquartile range; IV, intravenous; n, number of patients; PRO2‐CD, Crohn’s Disease Activity Index‐based patient‐reported outcome for Crohn’s disease; PRO2‐UC, Mayo‐based patient‐reported outcome for ulcerative colitis; SD, standard deviation.
a
May coexist with B1‐B3.
b
Prednisolone or budesonide.