Table 1.
Baseline characteristics and comparison between thiopurine withdrawal and continuation groups, n (%)/mean ± SD/ median (interquartile range)
|
|
Total (n = 62)
|
Withdrawal group (n = 42)
|
Continuation group (n = 20)
|
| Demographics | |||
| Female sex | 26 (41.9) | 21 (50) | 5 (25) |
| Age (years) | 43.4 ± 18.0 | 43.7 ± 19.0 | 42.8 ± 16.1 |
| Current/ex-smoker | 16 (25.8) | 11 (26.2) | 5 (25) |
| Disease extent | |||
| Left sided colitis | 41 (66.1) | 27 (64.3) | 14 (70) |
| Pancolitis | 21 (33.9) | 15 (35.7) | 6 (30) |
| Disease duration (years) | 7.5 (4-12) | 8 (3-13) | 6.5 (4-11.8) |
| Prior treatments | |||
| Corticosteroids | 57 (91.9) | 39 (92.9) | 18 (90) |
| Immunomodulators | 62 (100) | 42 (100) | 20 (100) |
| Anti-TNF | 14 (22.6) | 10 (23.8) | 4 (20) |
| Baseline assessment | |||
| Partial mayo score | 0 (0-0) | 0 (0-0) | 0 (0-0) |
| Mayo endoscopic score, 0-1 (n = 57) | 57 (100) | 42 (100) | 20 (100) |
| Histologic remission (n = 54) | 41 (75.9) | 25 (69.4) (n = 36) | 16 (88.9) (n = 18) |
| Laboratory values at baseline | |||
| Hemoglobin (g/L) | 139.6 ± 12.9 | 137.8 ± 13.8 | 143.2 ± 10.5 |
| Fecal calprotectin (µg/g) | 23.7 (7.9-65) | 17.7 (6.7-51.8) | 44.3 (10.5-124.6) |
| Albumin (g/L) | 41.4 ± 4.5 | 41.4 ± 5.0 | 41.2 ± 3.2 |
| CRP (mg/L) | 1.25 (0.5-3) | 1.3 (0.5-3.3) | 0.9 (0.2-2.5) |
| Vedolizumab serum trough concentrations | |||
| Week 0 (µg/mL) | 15.6 (10.8-20.8) | 16.2 (11.5-22.2) | 15.2 (10.3-16.9) |
| Week 24 (µg/mL) (n= 57) | 16.9 (12.0-22.1) | 17.8 (10.5-25.7) | 14.7 (12.2-19.7) |
| Week 48 (µg/mL) (n= 61) | 15.4 (11.3-21.7) | 15.9 (10.3-22.5) | 14.7 (12.4-18.4) |
| Outcomes at week 48 | |||
| Partial mayo score | 0 (0-0) | 0 (0-0) | 0 (0-0) |
| Clinical remission | 51 (82.3) | 33 (78.6) | 18 (90) |
| CRP (mg/L) | 1.2 (0-3.4) | 2.4 (0-6.4) (n = 32) | 1.2 (0-2.8) (n = 17) |
| CRP remission | 39 (79.6) | 24 (75) | 15 (88.2) |
| Fecal calprotectin (µg/g) | 15.4 (5.5-47.7) | 15.3 (5.5-43.2) (n = 31) | 17.5 (6.4-48.2) (n = 16) |
| Fecal calprotectin remission | 43 (91.5) | 27 (87.1) | 16 (100) |
| Endoscopic improvement (n = 57) | 39 (68.4) | 23 (62.6) (n = 37) | 16 (80) (n = 20) |
| Histologic remission (n = 55) | 32 (58.2) | 18 (48.7) (n = 37) | 14 (77.8) (n = 18) |
| Histo-endoscopic remission (n = 55) | 25 (45.5) | 12 (32.4) (n = 37) | 13 (72.2) (n = 18) |
| Clinical remission at 2 years | 48 (77.4) | 30 (71.4) | 18 (90) |
Anti-TNF: Anti-tumor necrosis factor; CRP: C-reactive protein.