Table 3.
AEs in RDTN participants from the ASCLEPIOS I and II trials (safety analysis set).
| Safety event | Ofatumumab (N = 314) | Teriflunomide (N = 301) |
|---|---|---|
| AEs | 266 (84.7) | 259 (86.0) |
| AEs leading to treatment discontinuation | 19 (6.1) | 7 (2.3) |
| Most common AEs (⩾10% in any group) | ||
| Nasopharyngitis | 78 (24.8) | 70 (23.3) |
| Injection-related systemic reaction | 63 (20.1) | 45 (15.0) |
| Headache | 45 (14.3) | 47 (15.6) |
| Upper respiratory tract infection | 40 (12.7) | 49 (16.3) |
| Fatigue | 28 (8.9) | 30 (10.0) |
| Alopecia | 16 (5.1) | 50 (16.6) |
| Infections (all) | 176 (56.1) | 170 (56.5) |
| SAEs | 22 (7.0) | 16 (5.3) |
| Infections a | 6 (1.9) | 2 (0.7) |
| Malignancy | 2 (0.6) b | 1 (0.3) c |
| Deaths | 0 (0.0) | 0 (0.0) |
AE: adverse event; N: total number of participants included in the analysis; RDTN: recently diagnosed, treatment-naive; SAE: serious AE.
Data are shown as the number of participants (%) with at least one event.
a
Three cases of appendicitis, one case of influenza, one case of neutropenic sepsis, one case of upper respiratory tract infection in the ofatumumab group, one case of appendicitis and one case of pneumonia in the teriflunomide group.
b
All malignancies were basal cell carcinomas.
c
One case of basal cell carcinoma was not listed as an SAE.