Table 2. Time to Retreatment in Weeks by Ofatumumab Treatment Course in Each Study.
| Ofatumumab Treatment Course | |||||||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | |
| OFA110635 | N = 243 | N = 198 | N = 136 | N = 72 | N = 31 | N = 11 | N = 2 |
| Number retreated | 198 | 136 | 72 | 31 | 11 | 2 | 0 |
| Mean (SD) | 34.3 (15.8) | 34.5 (15.2) | 28.8 (10.7) | 20.8 (7.0) | 19.9 (5.4) | 17.9 (0.4) | NA |
| Median (min, max) | 30.2 (16.0, 97.3) | 31.9 (16.0, 85.4) | 28.0 (16.0, 58.1) | 16.9 (16.0, 40.0) | 17.0 (16.0, 31.9) | 17.9 (17.6, 18.1) | NA |
| OFA110634 | N = 148 | N = 93 | N = 63 | N = 30 | N = 13 | N = 6 | - |
| Number retreated | 93 | 63 | 30 | 13 | 6 | 0 | |
| Mean (SD) | 32.8 (12.0) | 28.6 (11.1) | 24.6 (8.1) | 23.9 (6.1) | 19.1 (2.8) | NA | - |
| Median (min, max) | 28.0 (16.0, 65.9) | 25.0 (16.0, 65.0) | 23.4 (16.0, 39.7) | 23.7 (16.1, 32.9) | 17.9 (16.3, 23.1) | NA | - |
| OFA111752 | N = 92 | N = 73 | N = 53 | N = 20 | N = 8 | N = 6 | N = 2 |
| Number retreated | 73 | 53 | 20 | 8 | 4 | 2 | 0 |
| Mean (SD) | 41.6 (18.2) | 47.0 (17.5) | 33.7 (13.4) | 22.1 (2.7) | 23.1 (3.2) | 17.1 (0.0) | NA |
| Median (min, max) | 36.0 (18.3, 98.3) | 49.4 (18.6, 81.4) | 30.1 (17.9, 60.1) | 22.9 (17.9, 25.9) | 22.3 (20.4, 27.4) | 17.1 (17.1, 17.1) | NA |
Time to retreatment was defined as the interval between infusion A of treatment course n and infusion A of treatment course n+1. For each patient’s final treatment course, the time was defined as the interval from infusion A to the date of withdrawal or completion. The minimum period allowed per protocol before retreatment was 16 weeks, except for the first course of ofatumumab in the double-blind period of OFA110635 and OFA110634 for which the minimum period allowed before retreatment was 24 weeks. Data from the final treatment course when patients withdrew due to early termination of the study were not included in this analysis.