Table 3.
Injection- or infusion-related reactions with ofatumumab across SC and IV studies
| Patients with at least one event, n (%) | SC doses | IV doses | ||||||
|---|---|---|---|---|---|---|---|---|
| 3 mg q12wa (n = 34) | 20 mg q4w (n = 1873) | 30 mg q12wa (n = 32) | 60 mg q12wa (n = 34) | 60 mg q4wa (n = 64) | 100 mg (n = 12) | 300 mg (n = 15) | 700 mg (n = 11) | |
| Injection- or infusion-related reactions | 13 (38.2) | 435 (23.2) | 11 (34.4) | 14 (41.2) | 30 (46.9) | 8 (66.7) | 12 (80.0) | 10 (90.9) |
| Injection- or infusion-related reactions with first injection/infusion | 3 (8.8) | 322 (17.2) | 9 (28.1) | 7 (20.6) | 15 (23.4) | 6 (50.0) | 9 (60.0) | 6 (54.5) |
| Serious reaction | 0 | 2 (0.1) | 0 | 1 (2.9) | 2 (3.1) | 0 | 0 | 0 |
| Treatment discontinuation | 1 (2.9) | 1 (0.1) | 1 (3.1) | 0 | 1 (1.6) | 0 | 1 (6.7) | 0 |
| Treatment interrupted | 0 | 0 | 0 | 0 | 0 | 5 (41.7)b | 9 (60.0)b | 8 (72.7)b |
| Severe injection- or infusion-related reactions (Grade ≥ 3) | 1 (2.9) | 4 (0.2) | 0 | 1 (2.9) | 1 (1.6) | 0 | 0 | 2 (18.2) |
| Cytokine release syndrome | 0 | 0 | 0 | 1 (2.9) | 0 | 0 | 2 (13.3) | 0 |
AE adverse event, IV intravenous, n number of patients, q4w every 4 weeks, q12w every 12 weeks, SC subcutaneous
aUnlike the ASCLEPIOS I/II trials, no initial loading dose regimen was used in the MIRROR study
bInfusion paused and restarted