Poster Session B - Monday Morning
Category: IBD
David T. Rubin, MD, FACG
University of Chicago Medicine Inflammatory Bowel Disease Center
Chicago, IL
| Mental Component Score (MCS) | Physical Component Score (PCS) | ||||||
Induction Period | PBO (N=64) | 200 mg IV miri (N=31) | 600 mg IV miri (N=32) | 1000 mg IV miri (N=64) | PBO (N=64) | 200 mg IV miri (N=31) | 600 mg IV miri (N=32) | 1000 mg IV miri (N=64) |
W0 Baseline (Mean ± SD) | 37.0 ± 13.2 | 35.2 ± 10.2 | 41.1 ± 10.4 | 40.4 ± 11.6 | 38.9 ± 8.3 | 38.4 ± 6.4 | 42.9 ± 7.8 | 39.5 ± 8.6 |
W4 CFBL | 1.9 ± 1.0 | 2.6 ± 1.4 | 5.2 ± 1.4* | 3.1 ± 1.0 | 2.4 ± 0.7 | 3.3 ± 1.0 | 3.4 ± 1.0 | 4.2 ± 0.7 |
W12 CFBL (LSM ± SE) | 2.3 ± 1.1 | 7.5 ± 1.6* | 6.5 ± 1.6* | 6.1 ± 1.2* | 3.1 ± 0.8 | 4.7 ± 1.1 | 8.0 ± 1.1** | 6.7 ± 0.8** |
Maintenance Period | PBO-1000mg IV miri (N=59) | NI-1000mg IV miri (N=30) | All IV-IV miri (N=41) | All IV-SC miri (N=46) | PBO-1000mg IV miri (N=59) | NI-1000mg IV miri (N=30) | All IV-IV miri (N=41) | All IV-SC miri (N=46) |
W0 Baseline | 37.2 ±13.0 | 38.0 ±11.2 | 42.0 ± 10.1 | 38.7 ±10.7 | 39.5 ± 8.1 | 40.8 ± 8.3 | 41.1 ± 8.5 | 38.1 ± 7.1 |
W24 CFBL (Mean ± SD) | 7.4 ± 8.7 | 7.7 ± 11.7 | 7.0 ± 10.6 | 5.9 ± 13.1 | 6.8 ± 7.3 | 7.1 ± 7.8 | 9.6 ± 5.6 | 7.1 ± 8.3 |
W52 CFBL (Mean ± SD) | 7.1 ± 10.6 | 7.3 ± 9.8 | 8.5 ± 11.3 | 11.5 ± 11.4 | 9.9 ± 7.2 | 7.1 ± 8.2 | 10.2 ± 8.7 | 10.7 ± 7.9 |
Abbreviations: CFBL = change from baseline; IV = intravenous; IV-IV = pooled maintenance IV treatment arms for patients at each miri induction dose level who achieved ≥1-point improvement in SES-CD at W12 who were re-randomized to continued induction IV treatment assignment during maintenance; IV-SC = pooled maintenance SC treatment arms for patients at each miri induction dose level who achieved ≥1-point improvement in SES-CD at W12 who were re-randomized to SC 300mg miri Q4W during maintenance; LSM = least squares mean; NI = SES-CD non-improver (a patient who received miri during induction who did not achieve a ≥1-point improvement in SES-CD at W12); PBO = placebo; SC = subcutaneous; SD = standard deviation; SE = standard error; W = week. For statistical comparisons across induction treatment groups, a mixed model for repeated measures was used. The model includes treatment, region, prior biologic CD therapy used, baseline, visit and baseline by visit, and treatment by visit.
p-values versus PBO: *p< 0.05; ** p≤0.001. Bolded values are statistically different versus PBO. |