Table 2.
Summary of Anti‐KHK4083 Antibody Results: (A) Single Intravenous or Subcutaneous Dose of KHK4083 in Positive Samples of Healthy Japanese or Caucasian Subjects; (B) Intravenous Dose of 10 mg/kg KHK4083 Every 2 Weeks in Positive Samples of Japanese UC Patients
| (A) Single Intravenous or Subcutaneous Dose of KHK4083 in Healthy Japanese or Caucasian Subjects–Positive Samples | |||||||
|---|---|---|---|---|---|---|---|
| Point | |||||||
| Day 1 (Week 0) | Day 29 (Week 4) | Day 71 (Week 10) | Day 99 (Week 14) | Day 127 (Week 18) | End of Treatment | ||
| Dose | n | n/n1 (%) | n/n1 (%) | n/n1 (%) | n/n1 (%) | n/n1 (%) | n/n1 (%) |
| 1 mg/kg IV (cohort 1) | 6 | 0/6 | 0/6 | 0/6 | − | — | — |
| 3 mg/kg IV (cohort 2) | 6 | 0/6 | 1/6 (16.7) | 0/6 | 1/6 (16.7) | — | — |
| 3 mg/kg SC (cohort 3) | 6 | 0/6 | 1/6 (16.7) | 2/6 (33.3) | 4/6 (66.7) | — | — |
| 3 mg/kg SC (Caucasian) | |||||||
| (cohort 4) | 6 | 1/6 (16.7) | 1/6 (16.7) | 3/6 (50.0) | 3/6 (50.0) | — | — |
| 10 mg/kg IV (cohort 5) | 6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | — |
| 10 mg/kg IV (Caucasian) | |||||||
| (cohort 6) | 6 | 2/6 (33.3) | 3/6 (50.0) | 3/6 (50.0) | 3/5 (60.0) | 3/5 (60.0) | — |
| (B) Intravenous Dose of 10 mg/kg KHK4083 Q2W in Japanese UC Patients–Positive Samples | ||||||||
|---|---|---|---|---|---|---|---|---|
| Point | ||||||||
| Day 1 | Day 29 | Day 71 | Day 99 | Day 127 | Day 155 | End of | ||
| (Week 0) | (Week 4) | (Week 10) | (Week 14) | (Week 18) | (Week 22) | Treatment | ||
| Dose | n | n/n1 (%) | n/n1 (%) | n/n1 (%) | n/n1 (%) | n/n1 (%) | n/n1 (%) | n/n1 (%) |
|
10 mg/kg (UC) (cohort 7) |
8 | 1/8 (12.5) | 1/8 (12.5) | 0/8 | 0/8 | 1/8 (12.5) | 2/8 (25.0) | − |
IV, intravenous; Q2W, every 2 weeks; SC, subcutaneous; UC, ulcerative colitis; n, number of samples with antidrug antibody‐positive at each time; n1, number of samples at each time.
Percentages are shown in parentheses.