Table 2.
Adverse events through end of study in LOTUS
| Placebo (weeks 0–52) |
Ustekinumab (weeks 0–52) |
Placebo→ ustekinumab (weeks 52–176) | Ustekinumab (weeks 52–176) |
All ustekinumab* | |
| Patients, n | 208 | 307 | 88 | 134 | 395 |
| Mean duration of follow-up (weeks) | 50.4 | 50.1 | 29.7 | 29.7 | 55.6 |
| Patients with ≥1 AE | 155 (74.5) | 214 (69.7) | 26 (29.5) | 37 (27.6) | 246 (62.3) |
| Patients with ≥1 SAE | 28 (13.5) | 37 (12.1) | 5 (5.7) | 7 (5.2) | 49 (12.4) |
| Patients with ≥1 infection | 92 (44.2) | 132 (43.0) | 9 (10.2) | 23 (17.2) | 149 (37.7) |
| Patients with ≥1 serious infection | 8 (3.8) | 15 (4.9) | 0 | 4 (3.0) | 19 (4.8) |
| COVID-19-related AEs | 0 | 2 (0.7) | 0 | 4 (3.0) | 6 (1.5) |
| COVID-19-related SAEs | 0 | 2 (0.7) | 0 | 2 (1.5) | 4 (1.0) |
| Patients with ≥1 infusion reaction | 0 | 5 (1.6) | -- | -- | -- |
| Patients with ≥1 injection-site reaction | 0 | 5 (1.6) | 1 (1.1) | 0 | 6 (1.5) |
| AEs leading to discontinuation | 9 (4.3) | 11 (3.6) | 0 | 1 (0.7) | 12 (3.0) |
| Deaths† | 1 (0.5) | 4 (1.3) | 0 | 1 (0.7) | 5 (1.3) |
*All patients who received ≥1 dose of ustekinumab, including patients who crossed over from placebo.
†One death occurred in the placebo group (splenic rupture). In the ustekinumab group, 4 deaths occurred prior to week 52 (hypovolaemic shock, cardiac failure due to systemic lupus erythematosus myocarditis (patient was discharged against medical advice), haemorrhagic stroke (patient had a history of arterial hypertension) and staphylococcal endocarditis), and one death (COVID-19; history of asthma) occurred after week 52.
AE, adverse event; SAE, serious adverse event.