Table 2.
Summary of adverse events through 12 weeks
| AEs | Placebo (n = 49) | Upadacitinib 7.5 mg QD (n = 49) | Upadacitinib 15 mg QD (n = 49) | Upadacitinib 30 mg QD (n = 50) |
|---|---|---|---|---|
| Total AEs | 24 (49.0) | 29 (59.2) | 28 (57.1) | 37 (74.0) |
| Serious AEs | 0 | 1 (2.0) | 1 (2.0) | 5 (10.0) |
| AEs leading to discontinuation of study drug | 0 | 0 | 1 (2.0) | 7 (14.0) |
| Deaths | 0 | 0 | 0 | 0 |
| Infections | 11 (22.4) | 18 (36.7) | 16 (32.7) | 22 (44.0) |
| Serious infection | 0 | 0 | 1 (2.0) | 3 (6.0) |
| Opportunistic infection | 0 | 0 | 0 | 2 (4.0) |
| Herpes zostera | 1 (2.0) | 1 (2.0) | 0 | 3 (6.0) |
| Active/latent tuberculosis | 0 | 0 | 0 | 0 |
| Malignancy (including NMSC) | 0 | 0 | 0 | 0 |
| Hepatic disorder | 2 (4.1) | 0 | 2 (4.1) | 1 (2.0) |
| Gastrointestinal perforation | 0 | 0 | 0 | 0 |
| Adjudicated cardiovascular event | 0 | 1 (2.0) | 0 | 0 |
| Adjudicated MACE | 0 | 0 | 0 | 0 |
| Other adjudicated cardiovascular event | 0 | 1 (2.0) | 0 | 0 |
| Adjudicated venous thromboembolic event | 0 | 0 | 0 | 0 |
All values presented as n (%).
a
Including two cases of serious herpes zoster, one in the upadacitinib 7.5 mg group and one in the upadacitinib 30 mg group. AE: adverse event; MACE, major adverse cardiovascular event; NMSC: non-melanoma skin cancer; QD: once daily.