Table 2.
Summary of Efficacy Endpoints in the Efficacy Set
| Outcome | Placebo (n=13) | Abrilumab |
||
|---|---|---|---|---|
| 21 mg (n=10) | 70 mg (n=12) | 210 mg (n=9) | ||
| Remission rate at week 8a | 0 | 1 (10.0) | 2 (16.7) | 1 (11.1) |
| Response rate at week 8b | 7 (53.8) | 3 (30.0) | 6 (50.0) | 6 (66.7) |
| Mucosal healing rate at week 8c | 4 (30.8) | 1 (10.0) | 4 (33.3) | 4 (44.4) |
| Response rate at week 12d | 6 (46.2) | 3 (30.0) | 6 (50.0) | 6 (66.7) |
| Sustained responsee | 4 (30.8) | 3 (30.0) | 3 (25.0) | 4 (44.4) |
Values are presented as number (%).
a
Total Mayo score ≤2 points, and with no individual subscore >1 point.
b
Decrease in ≥3 points and 30% in total Mayo score compared with baseline (visit 1, week 4), and with an accompanying decrease in the subscore for rectal bleeding of ≥1 point or with an absolute subscore for rectal bleeding of 0 or 1.
c
An absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.
d
Reduction by ≥2 points and 25% in partial Mayo score compared with baseline (visit 1).
e
Achieving the criteria for response assessed by partial Mayo score at both week 12 and week 24.