Table 2.
Categorized safety information on adverse and serious adverse events
| Total sample | Total sample (N = 381) | oPsA | oPsA (N = 149) | pPsA | pPsA (N = 232) | |
|---|---|---|---|---|---|---|
| Ne | NP (%) | Ne | NP (%) | Ne | NP (%) | |
| AE (any) | 483 | 211 (55.4%) | 229 | 91 (61.1%) | 254 | 120 (51.7%) |
| SAE (any) | 41 | 26 (6.8%) | 20 | 10 (6.7%) | 21 | 16 (6.9%) |
| AEs leading to discontinuation of the study drug | 143 | 95 (24.9%) | 68 | 36 (24.2%) | 75 | 59 (25.4%) |
| AEs possibly related to study drug intake | 213 | 127 (33.3%) | 101 | 56 (37.6%) | 112 | 71 (30.6%) |
| Infections and infestations | 125 | 94 (24.7%) | 51 | 38 (25.5%) | 74 | 56 (24.1%) |
| COVID-19 | 36 | 35 (9.2%) | 16 | 15 (10.1%) | 20 | 20 (8.6%) |
| Herpes zoster | 1 | 1 (0.3%) | 0 | 0 (0%) | 1 | 1 (0.4%) |
| Opportunistic and serious infections | 86 | 63 (16.5%) | 29 | 20 (13.4%) | 57 | 43 (18.5%) |
| Gastrointestinal disorders | 53 | 37 (9.7%) | 34 | 21 (14.1%) | 19 | 16 (6.9%) |
| Skin and subcutaneous tissue disorders | 31 | 28 (7.4%) | 15 | 14 (9.4%) | 16 | 14 (6.0%) |
| Acne | 5 | 4 (1.1%) | 1 | 1 (0.7%) | 4 | 3 (1.3%) |
| Weight increase | 8 | 7 (1.8%) | 6 | 5 (3.4%) | 2 | 2 (0.9%) |
| Abnormal liver function | 1 | 1 (0.3%) | 1 | 1 (0.7%) | 0 | 0 (0%) |
| VTEs | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) |
| MACE | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) |
| Malignancies | 4 | 4 (1.1%) | 1 | 1 (0.7%) | 3 | 3 (1.3%) |
AE adverse event, COVID-19 coronavirus disease, MACE major adverse cardiovascular event, Ne number of events, Np number of patients with event, SAE serious adverse event, VTE venous thromboembolism