Table 2 Summary of Antidrug Antibody Evaluations in study patients (Immunogenicity Population)
Visit | DRL_RI (N = 69) | RP/RMP (N = 68) | Total (N = 137) |
|---|---|---|---|
Baseline | |||
ADA Positive, n (%) | 3 (4.3) | 1 (1.5) | 4 (2.9) |
NAb Positive, n (%) | 0 | 0 | 0 |
Titre: Median [Q1, Q3] | 360 [180, 720] | 360 [360, 360] | 360 [270, 540] |
Day 15 | |||
ADA Positive, n (%) | 1 (1.4) | 0 | 1 (0.7) |
NAb Positive, n (%) | 0 | 0 | 0 |
Titre: Median [Q1, Q3] | 180 [180, 180] | - | 180 [180, 180] |
Week 4 | |||
ADA Positive, n (%) | 0 | 0 | 0 |
NAb Positive, n (%) | 0 | 0 | 0 |
Titre: Median [Q1, Q3] | 0 | 0 | 0 |
Week 8 | |||
ADA Positive, n (%) | 1 (1.4) | 0 | 1 (0.7) |
NAb Positive, n (%) | 1 (1.4) | 0 | 1 (0.7) |
Titre: Median [Q1, Q3] | 1440 [1440, 1440] | - | 1440 [1440, 1440] |
Week 12 (end of study) | |||
ADA Positive, n (%) | 1 (1.4) | 2 (2.9) | 3 (2.2) |
NAb Positive, n (%) | 0 | 0 | 0 |
Titre: Median [Q1, Q3] | 720 [720, 720] | 540 [360, 720] | 720 [360, 720] |