Table 1.
Summary of treatment-emergent adverse events incidence rate per 100 patient-years in patients who received upadacitinib over 84 weeks (safety analysis set)
| AE, incidence (n/100 PY) | Upadacitinib 7.5 mg QD (n = 65) | Upadacitinib 15 mg QD (n = 64) | Upadacitinib 30 mg QD (n = 66) |
|---|---|---|---|
| AEs | 64 (316.8) | 64 (369.9) | 66 (458.3) |
| Serious AEs | 13 (10.8) | 17 (15.3) | 20 (20.3) |
| AEs leading to discontinuation of study drug | 6 (4.6) | 8 (6.4) | 20 (18.6) |
| Deaths† | 0 | 0 | 2 (1.8) |
| Infection | 52 (117.1) | 57 (140.0) | 58 (167.1) |
| Serious infection | 6 (4.7) | 8 (6.7) | 13 (12.7) |
| Opportunistic infection | 1 (0.8) | 4 (3.3) | 8 (7.6) |
| Herpes zoster | 9 (7.3) | 14 (12.3) | 16 (16.5) |
| Active/latent tuberculosis | 0 | 0 | 1 (0.9) |
| Malignancy (incl. NMSC) | 0 | 1 (0.8) | 1 (0.9) |
| Hepatic disorder | 7 (5.8) | 7 (6.1) | 8 (8.1) |
| Gastrointestinal perforation | 0 | 1 (0.8) | 1 (0.9) |
| MACE‡ | 1 (0.8) | 0 | 1 (0.9) |
| Adjudicated VTE | 0 | 0 | 1 (0.9) |
| Anemia | 0 | 2 (1.6) | 5 (4.9) |
| Neutropenia | 1 (0.8) | 2 (1.7) | 7 (7.1) |
| Lymphopenia | 5 (3.9) | 7 (5.9) | 8 (7.8) |
| CPK elevation | 5 (4.0) | 7 (6.1) | 8 (8.2) |
| Renal dysfunction | 0 | 0 | 1 (0.9) |
Two subjects treated with placebo in period 1 discontinued treatment and thus were not included in the safety analysis set
AE adverse event, CPK creatine phosphokinase, MACE, major adverse cardiovascular event, NMSC nonmelanoma skin cancer, PY patient-years, QD once daily, VTE, venous thromboembolism
†Includes non-treatment-emergent deaths
‡Defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke