Pooled placebo | 0.5 mg LAQ | 1.0 mg LAQ | 1.5 mg LAQ | 2.0 mg LAQ (n=29) | |
---|---|---|---|---|---|
N | 63 | 29 | 30 | 29 | 29 |
Age, years mean (SD) | 35.1 (10.9) | 39.6 (14.8) | 38.2 (11.3) | 40.9 (14.5) | 37.4 (9.9) |
Female %* | 42.9 | 55.2 | 56.7 | 72.4 | 58.6 |
Predominately inflammatory disease %† | 54.0 | 75.9 | 66.7 | 41.4 | 41.4 |
CDAI score mean (SD) | 311.2 (74.5) | 288.3 (56.0) | 291.9 (57.5) | 297.8 (59.1) | 313.2 (58.9) |
CRP concentration (mg/L) | 21.3 (27.8) | 17.1 (18.3) | 6.7 (12) | 15.1 (22.3) | 6.5 (17.1) |
Median (IQR) Min–max | 1.8–85.7 | 2.2–127.5 | 1.0–153.6 | 1.0–79.8 | 1.0–153.2 |
CRP ≥5 mg/L at baseline % | 81 | 86 | 57 | 66 | 45 |
Faecal calprotectin concentration (µg/g) median (IQR) | 475 (802) | 468 (1434) | 543 (813) | 318 (500) | 270 (422) |
Min–max | 19.0–6559 | 15.0–6551 | 15.0–5563 | 18.0–8000 | 15.0–3994 |
Faecal calprotectin concentrations ≥250 µg/g at baseline % | 69.8 | 62.1 | 60 | 51.7 | 37.9 |
Previous CD operations % | 33.3 | 17.2 | 40.0 | 44.8 | 44.8 |
Current treatment with either azathioprine, 6-mercaptopurine or methotrexate % | 31.7 | 27.6 | 36.7 | 37.9 | 24.1 |
Current treatment with 5-aminosalicylates % | 36.5 | 27.6 | 43.3 | 34.5 | 41.4 |
Current treatment with antibiotics % | 4.8 | 6.9 | 3.3 | 0 | 3.4 |
Current treatment with steroids % | 27 | 34.5 | 40 | 31 | 17.2 |
Previous use of anti-TNF in past year % | 42.9 | 27.6 | 16.7 | 41.4 | 41.4 |
*% indicates per cent of patients.
†Montreal definition.
CD, Crohn's disease; CDAI, CD Activity Index; TNF, tumour necrosis factor.