Table 4.
Treatment-emergent adverse events following mirikizumab administered with either prefilled syringe or autoinjector
| Participants with event, n (%) | Study AMBW (mirikizumab 200 mg) | Study AMBX (mirikizumab 300 mg) | ||
|---|---|---|---|---|
| PFS (N = 120) | Autoinjector (N = 120) | PFS (N = 117) | Autoinjector (N = 120) | |
| All TEAEs | 43 (35.8) | 39 (32.5) | 39 (33.3) | 45 (37.5) |
| Treatment-related TEAEs | 18 (15.0) | 21 (17.5) | 12 (10.3) | 15 (12.5) |
| Device-related TEAEs | 8 (6.7) | 11 (9.2) | 2 (1.7) | 11 (9.2) |
| SAEs | 0 | 0 | 0 | 1 (0.8) |
| Deaths | 0 | 0 | 0 | 0 |
| AEs leading to study discontinuation | 0 | 0 | 2 (1.7) | 0 |
| Infection TEAEs | 7 (5.8) | 11 (9.2) | 10 (8.5) | 13 (10.8) |
| Systemic allergic/hypersensitivity TEAEs | 0 | 0 | 0 | 0 |
AE adverse event, PFS prefilled syringe, SAE serious adverse event, TEAE treatment-emergent adverse event