Table 3.
Reported adverse events of special interest
| Study period | Induction period | Maintenance period | |||
|---|---|---|---|---|---|
| Placebo | Mirikizumab | Mirikizumab 250 mg/placebo | Mirikizumab 250 mg/mirikizumab 125 mg | Mirikizumab 250 mg/mirikizumab 250 mg | |
| Number | 107 | 422 | 91 | 90 | 91 |
| Infections and infestations (SOC) | 21 (19·6) | 116 (27·5) | 27 (30) | 34 (38) | 39 (43) |
| Injection‐site reactions (HLT) | 5 (4·7) | 28 (6·6) | 2 (2) | 6 (7) | 8 (9) |
| Cerebrocardiovascular events | 0 | 1 (0·2)a | 1 (1)d | 1 (1)d | 0 |
| MACE | 0 | 1 (0·2)a | 1 (1)d | 0 | 0 |
| Malignancies | 0 | 1 (0·2)b | 0 | 0 | 0 |
| Immediate hypersensitivity reaction (narrow/algorithmic) | 0 | 3 (0·7)c | 2 (2)e | 0 | 0 |
| Nonimmediate hypersensitivity reaction (narrow/algorithmic) | 4 (3·7) | 13 (3·1) | 3 (3) | 6 (7) | 3 (3) |
The data are presented as n (%). HLT, higher‐level term as defined in the Medical Dictionary for Regulatory Activities; MACE, major adverse cardiovascular event; SOC, system organ class. aAdjudicated and confirmed, preferred term: cerebral infarction. bPreferred term: basal cell carcinoma. cPreferred terms: two eczema and one rhinitis allergic. dAdjudicated and confirmed: acute myocardial infarction (mirikizumab 250 mg/placebo) and atrial fibrillation (mirikizumab 250 mg/mirikizumab 125 mg), eNarrow/algorithmic term: both urticaria.