Table 1.
Baseline characteristics of patients included in the study
| Control group | Early proactive TDM group | P value | ||
|---|---|---|---|---|
| n | 76 | 81 | ||
| Sex, male (%) | 38 (50.0) | 48 (59.3) | .32 | |
| Age at diagnosis (y), median (IQR) | 29 (20–38) | 32 (20–42) | .22 | |
| Age at start of infliximab (y), median (IQR) | 38 (24–49) | 41 (29–50) | .17 | |
| Weight (kg), median (IQR) | 67.8 (57–80) | 69.4 (56–82) | .63 | |
| Body mass index (kg m −2 ), median (IQR) | 24.2 (21.1–27.5) | 24.6 (21.4–28.0) | .58 | |
| IBD type | CD, n (%) | 61 (80.3) | 56 (69.1) | .16 |
| UC, n (%) | 15 (19.7) | 25 (30.9) | ||
| CD Location a | L1 (ileal), n (%) | 30 (49.2) | 33 (58.9) | .71 |
| L2 (colonic), n (%) | 8 (13.1) | 4 (7.2) | ||
| L3 (ileocolonic), n (%) | 23 (37.7) | 19 (33.9) | ||
| L4 (upper GI disease), n (%) | 2 (3.3) | 1 (1.8) | ||
| CD behaviour | B1 (nonstricturing, nonpenetrating), n (%) | 23 (37.7) | 26 (46.4) | .62 |
| B2 (stricturing), n (%) | 8 (13.1) | 7 (12.5) | ||
| B3 (penetrating), n (%) | 30 (49.2) | 23 (41.1) | ||
| Perianal fistulizing disease, n (%) | 19 (25.0) | 14 (17.3) | .32 | |
| UC extent | E1 (proctitis), n (%) | 3 (20.0) | 9 (36.0) | .56 |
| E2 (left‐side colitis), n (%) | 3 (20.0) | 4 (16.0) | ||
| E3 (pancolitis), n (%) | 9 (60.0) | 12 (48.0) | ||
| Extraintestinal manifestations, n (%) | 28 (36.8) | 24 (29.6) | .72 | |
| Musculoskeletal, n (%) | 22 (28.9) | 19 (23.5) | ||
| Dermatologic, n (%) | 4 (5.3) | 1 (1.2) | ||
| Other, n (%) | 2 (2.6) | 4 (4.9) | ||
| Concomitant IMM at start of infliximab, n (%) | 59 (77.6) | 60 (74.1) | .73 | |
| Thiopurines (azathioprine, 6‐MP), n (%) | 53 (69.7) | 57 (7.4) | ||
| Methotrexate, n (%) | 6 (7.9) | 3 (3.7) | ||
| CRP at diagnosis (mg dL −1 ), median (IQR) | 1.1 (0.1–3.1) | 1.3 (0.1–3.7) | .72 | |
| FCP at diagnosis (mg kg −1 ), median (IQR) | NA | 222.0 (15–3590) | ‐ | |
ATI: antidrug antibody; CD: Crohn's disease; CRP: C‐reactive protein; FCP: faecal calprotectin; GI: gastrointestinal; IBD: inflammatory bowel disease; IMM: immunomodulators; NA: not available; TDM: therapeutic drug monitoring; UC: ulcerative colitis.
a Patients could present several locations (L) of the CD lesion.