TABLE 5.
Analysis of change from baseline in fecal biomarker levels by visit
| Mesalamine dose groups | |||
| Biomarker | Low dose (n = 41) | High dose (n = 41) | P* |
| Fecal lactoferrin, μg/g | |||
| Week 3 | n = 33 | n = 33 | 0.0667 |
| Baseline mean (±SE) | 505 (± 132) | 583 (± 179) | |
| Mean change (±SE) | 22 (± 146) | −224 (± 139) | |
| Patients with reduction, n (%) | 20 (60.6) | 20 (60.6) | |
| Week 6 | n = 30 | n = 30 | 0.1537 |
| Baseline mean (±SE) | 353 (± 85) | 582 (± 192) | |
| Mean change (±SE) | 105 (± 142) | −176 (± 84) | |
| Patients with reduction, n (%) | 17 (56.7) | 21 (70.0) | |
| Fecal calprotectin, μg/g | |||
| Week 3 | n = 33 | n = 32 | 0.8388 |
| Baseline mean (±SE) | 1215 (± 338) | 1710 (± 409) | |
| Mean change (±SE) | −234 (± 218) | −275 (± 435) | |
| Patients with reduction, n (%) | 20 (60.6) | 22 (68.8) | |
| Week 6 | n = 30 | n = 29 | 0.8142 |
| Baseline mean (±SE) | 902 (± 199) | 1699 (± 451) | |
| Mean change (±SE) | −189 (± 216) | −762 (± 483) | |
| Patients with reduction, n (%) | 16 (53.3) | 22 (75.9) | |
*P values for mean change difference between the 2 dose groups based on Koch nonparametric analysis of covariance test with fixed effects for treatment, bodyweight group, and disease severity. SE = standard error of the mean.