Table 2. Major Secondary Endpoints of Induction Studies in the Overall Population and Japanese Subpopulation.
Endpoints | UNITI-1 | UNITI-2 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo | 130 mg | ~6 mg/kg | Placebo | 130 mg | ~6 mg/kg | |||||||
Japan | All | Japan | All | Japan | All | Japan | All | Japan | All | Japan | All | |
Number | 18 | 247 | 19 | 245 | 19 | 249 | 9 | 209 | 8 | 209 | 9 | 209 |
Clinical response at wk 8 | 27.8 | 20.2 | 21.1 | 33.5a | 52.6 | 37.8b | 0 | 32.1 | 37.5 | 47.4b | 66.7 | 57.9b |
Clinical remission at wk 8 | 5.6 | 7.3 | 10.3 | 15.9a | 26.3 | 20.9b | 0 | 19.6 | 25.0 | 30.6a | 22.2 | 40.2b |
70-Point response at wk 3 | 27.8 | 27.1 | 42.1 | 38.4a | 42.1 | 40.6a | 11.1 | 31.6 | 25.0 | 49.3b | 44.4 | 50.7b |
70-Point response at wk 6 | 44.4 | 30.4 | 42.1 | 46.1b | 52.6 | 43.8a | 11.1 | 38.8 | 50.0 | 58.9b | 77.8 | 64.6b |
Values are presented as percentage.
aP<0.01 vs. placebo.
bP<0.001 vs. placebo.