Table 3.
Summary of safety
| Adverse event (AE), n (%) | Placebo n=66 |
Deucravacitinib | |
| 6 mg once a day n=70 |
12 mg once a day n=67 |
||
| Total AEs | 28 (42.4) | 46 (65.7) | 44 (65.7) |
| Treatment-related AEs | 6 (9.1) | 22 (31.4) | 17 (25.4) |
| Deaths | 0 | 0 | 0 |
| Serious AEs | 1 (1.5) | 0 | 0 |
| Treatment discontinuation due to AEs | 1 (1.5) | 3 (4.3) | 4 (6.0) |
| AEs occurring in ≥5% of patients in any treatment group | |||
| Nasopharyngitis | 5 (7.6) | 4 (5.7) | 12 (17.9) |
| Upper respiratory tract infection | 0 | 4 (5.7) | 1 (1.5) |
| Sinusitis | 0 | 0 | 5 (7.5) |
| Bronchitis | 1 (1.5) | 4 (5.7) | 0 |
| Headache | 3 (4.5) | 5 (7.1) | 1 (1.5) |
| Rash | 0 | 3 (4.3) | 4 (6.0) |
| Diarrhoea | 0 | 4 (5.7) | 0 |
Includes events with a start date between the first dose and the week 16 visit date (inclusive), or between the first dose and 30 days after the last dose of study drug for patients who discontinued early.