Table 3.
PK/PD Levels at Time of Detection of N/NE T2 Lesions in Q6W and Q4W Groups
Participant no. | Visit when N/NE T2 lesions identified | Natalizumab Ctrough at time of N/NE T2 lesions (μg/mL) | α4-Integrin saturation on MNC at time of N/NE T2 lesions (%) | |
Q6W | 09 | Week 24 | 10.8 (week 12)a | 69.3 (week 12)a |
14 | Week 48 | 0 | 30.4 | |
15 | Week 72 | 17.6 | 80.0 | |
18 | Week 24 | 7.68 | 69.1 | |
19 | Week 72 | 0 | 64.6 (week 60)a | |
20 | Week 48 | 7.5 | 72.8 | |
25 | Week 48 | 0 | 23.5 (week 36)a | |
26 | Week 48 | 12.8 | 69.4 | |
28 | Week 24 | 24.8 | 84.8 | |
Q4W | 02 | Week 24 | 1.89 | 53.1 |
07 | Week 24 | 61.4 | 84.9 | |
08 | Week 72 | 38.5 | 89.9 | |
10 | Week 72 | 52.1 | 85.8 | |
22 | Week 48 | 14.4 | 76.3 | |
23 | Week 48 | 25.8 | 79.5 | |
24 | Week 48 | 9.52 | 77.2 | |
27 | Week 24 | 54.5 | 65.4 |
Abbreviations: Ctrough = trough concentrations; MNC = mononuclear cell; N/NE = new/newly enlarging; PD = pharmacodynamic; PK = pharmacokinetic; Q4W = every 4 weeks; Q6W = every 6 weeks.
Ctrough and/or α-integrin saturation were not available at the time of lesion identification; data from the visit closest to lesion detection (week in parentheses) are shown.