Table 2. Further secondary end-point analyses.
| Placebo (n=40) | 0.8 g LT-02 (n=40) | 1.6 g LT-02 (n=41) | 3.2 g LT-02 (n=35) | All LT-02 (n=116) | P valuea | ||
|---|---|---|---|---|---|---|---|
| Complete remissionb | n (%) | 6 (15.0%)c | 11 (27.5%) | 9 (22.0%) | 11 (31.4%)c | 31 (26.7%)c | P=0.120c |
| 5 (12.5%)d | 11 (27.5%) | 9 (22.0%) | 10 (28.6%)d | 30 (25.9%)d | P=0.067d | ||
| Clinical responsec,e | n (%) | 24 (60%) | 31 (77.5%) | 30 (73.2%) | 29 (82.9%) | 90 (77.6%) | P=0.035c |
| Mucosal healing (EMS ≤1) | n (%) | 16 (40.0%)c | 23 (57.5%)c | 23 (56.1%)c | 18 (51.4%)c | 64 (55.2%)c | P=0.097c |
| 12 (30.0%)d | 21 (52.5%)d | 22 (53.7%)d | 17 (48.6%)d | 60 (51.7%)d | P=0.016d | ||
| Achievement of mucosal healing (EMS ≤1 plus EMS improvement ≥1) | n (%) | 13 (32.5%)c | 19 (47.5%)c | 20 (48.8%)c | 16 (45.7%)c | 55 (47.4%)c | P=0.098c |
| 11 (27.5%)d | 19 (47.5%)d | 19 (46.3%)d | 15 (42.9%)d | 53 (45.7%)d | P=0.040d | ||
| Histologic remission (HI=1) | n (%) | 8 (20.0%)c | 16 (40%)c | 17 (41.5%)c | 14 (40%)c | 47 (40.5%) | P=0.016c |
EMS, Endoscopic Mayo Score; HI, Histologic Index (varies from 1 to 4, with 1 showing remission and 4 being the worst disease activity).
a
Analysis of placebo vs. pooled LT-02 patients; two-sided P values of likelihood ratio (LR) χ2 testing.
b
Complete remission was defined by a mean Simple Clinical Colitis Activity Index (SCCAI) of <3 without blood in stool.
c
Last observation carried forward (LOCF).
d
Data with dropouts considered as failures—sensitivity analyses upon request of reviewers to adjust for possible underestimations of treatment effects (28).
e
Clinical response was a decrease from baseline by at least 2.