Table 2 Efficacy variables at day 28: groups I and II combined.
Day 28 result | Placebo (n = 43) | Fontolizumab (n = 45 in each group) | |
---|---|---|---|
4 mg/kg (p value*) | 10 mg/kg (p value*) | ||
Clinical response (CDAI drop of ⩾100 points) | 14 (33%) | 17 (38%) (0.66) | 19 (44%) (0.38) |
Clinical remission (CDAI ⩽150) | 5 (12%) | 14 (31%) (0.04) | 8 (19%) (0.55) |
CDAI change from baseline (mean) | −61.8 | −99.8 (0.02) | −97.8 (0.04) |
CRP change from baseline (median) (mg/l) | 0.00 | −0.05 (0.41) | −2.40 (<0.01) |
*Compared with placebo group.
CRP, C reactive protein; CDAI, Crohn's disease activity index.