Table 2.
Adverse events from ASCLEPIOS I/II and long-term exposure in core and ALITHIOS extension trials as of first dose of ofatumumab (safety analysis set)
| Patients with at least one event, n (%) | ASCLEPIOS I/II ofatumumab (n = 946) | ASCLEPIOS I/II teriflunomide (n = 936) | Long-term (core + ALITHIOS extension) overall ofatumumab (n = 1969)a | |||
|---|---|---|---|---|---|---|
| n (%) | EAIR (95% CI) | n (%) | EAIR (95% CI) | n (%) | EAIR (95% CI) | |
| Patients with at least one AE | 791 (83.6) | 188.6 [175.9, 202.2] | 788 (84.2) | 188.9 [176.2, 202.6] | 1698 (86.2) | 135.1 [128.8, 141.7] |
| Patients with at least one SAE | 83 (8.8) | 5.6 [4.5, 6.9] | 73 (7.8) | 4.9 [3.9, 6.2] | 242 (12.3) | 5.0 [4.4, 5.6] |
| AEs leading to treatment discontinuation | 54 (5.7) | – | 49 (5.2) | – | 128b (6.5) | – |
| Infections | 488 (51.6) | 51.1 [46.8, 55.9] | 493 (52.7) | 52.6 [48.1, 57.4] | 1149 (58.4) | 41.0 [38.7, 43.4] |
| Serious infections | 24 (2.5) | 1.6 [1.0, 2.3] | 17 (1.8) | 1.1 [0.7, 1.8] | 78 (4.0) | 1.5 [1.2, 1.9] |
| Injection-related systemic reactions | 195 (20.6) | 15.5 [13.5, 17.8] | 143 (15.3) | 10.9 [9.3, 12.8] | 492 (25.0) | 12.4 [11.3, 13.5] |
| Injection site reactions | 103 (10.9) | 7.2 [5.9, 8.7] | 52 (5.6) | 3.5 [2.7, 4.7] | 233 (11.8) | 5.0 [4.4, 5.7] |
| Malignancies | 5 (0.5) | 0.3 [0.1, 0.8] | 4 (0.4) | 0.3 [0.1, 0.7] | 17 (0.9) | 0.3 [0.2, 0.5] |
| Deaths | 0 | 0 | 1 (0.1) | – | 6c (0.3) | – |
Only patients with SAEs that occurred until the last dosing date + 100 days are considered
AE adverse event, CI confidence interval, EAIR exposure-adjusted incidence rate, IgM immunoglobulin M, OMB ofatumumab, SAE serious adverse event
aAt least 1 dose of ofatumumab in core studies (ASCLEPIOS I/II, APLIOS, APOLITOS) or extension (ALITHIOS); cut-off date 25 September 2021bAEs related to reduced IgM levels were the most common reason for treatment discontinuation [71 (3.6%)]cPreferred term for these 6 cases includes sudden death (n = 1), completed suicide (n = 1), COVID-19 and COVID-19 pneumonia (n = 1), COVID-19 (n = 1), intestinal metastasis (n = 1), pneumonia and septic shock (n = 1)