Table III.
Adverse event of special interest interim analysis summary
| Event | Double-blind period |
During the administration of upadacitinib∗ |
|||
|---|---|---|---|---|---|
| Patients, n (%) |
Events (E/100 PYs) |
||||
| Placebo (n = 90) | Upadacitinib 15 mg (n = 91) | Upadacitinib 30 mg (n = 91) | Upadacitinib 15 mg (n = 133) PYs = 82.8 | Upadacitinib 30 mg (n = 136) PYs = 81.5 | |
| Adjudicated VTE | 0 | 0 | 0 | 0 | 0 |
| Adjudicated MACE | 0 | 1 (1.1) | 0 | 1 (1.2) | 0 |
| Adults | 0 | 1 | 0 | 1 | 0 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| Serious infections | 0 | 0 | 1 (1.1) | 3 (3.6) | 3 (3.7) |
| Adults | 0 | 0 | 1 | 3 | 3 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| Opportunistic infections (excluding tuberculosis and herpes zoster) | 0 | 3 (3.3) | 1 (1.1) | 5 (6.0) | 2 (2.5) |
| Kaposi's varicelliform eruption (eczema herpeticum) | 0 | 3 (3.3) | 1 (1.1) | 4 (4.8) | 2 (2.5) |
| Adults | 0 | 2 | 1 | 3 | 2 |
| Adolescents | 0 | 1 | 0 | 1 | 0 |
| Pneumocystis jirovecii pneumonia | 0 | 0 | 0 | 1 (1.2) | 0 |
| Adults | 0 | 0 | 0 | 1 | 0 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| Malignancy | 0 | 0 | 0 | 0 | 0 |
| Lymphoma | 0 | 0 | 0 | 0 | 1 (1.2)† |
| Adults | 0 | 0 | 0 | 0 | 0 |
| Adolescents | 0 | 0 | 0 | 0 | 1 |
| Hepatic disorder | 0 | 1 (1.1) | 1 (1.1) | 7 (8.5) | 6 (7.4) |
| Adults | 0 | 1 | 1 | 7 | 6 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal perforations | 0 | 0 | 0 | 0 | 0 |
| Anemia | 0 | 0 | 1 (1.1) | 2 (2.4) | 5 (6.1) |
| Adults | 0 | 0 | 1 | 2 | 5 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 0 | 1 (1.1) | 4 (4.4) | 1 (1.2) | 6 (7.4) |
| Adults | 0 | 1 | 4 | 1 | 6 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| Lymphopenia | 0 | 0 | 0 | 0 | 0 |
| Herpes zoster | 0 | 0 | 4 (4.4) | 6 (7.2) | 12 (14.7) |
| Adults | 0 | 0 | 4 | 6 | 12 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| CPK elevation | 0 | 1 (1.1)‡ | 2 (2.2)§ | 2 (2.4) | 4 (4.9) |
| Adults | 0 | 0 | 2 | 1 | 4 |
| Adolescents | 0 | 1 | 0 | 1 | 0 |
| Renal dysfunction | 0 | 0 | 0 | 0 | 0 |
| Active tuberculosis | 0 | 0 | 0 | 0 | 0 |
Adults were aged ≥18 years, and adolescents were aged <18 years. The number of adults and adolescents was 81 and 9, respectively, for the placebo and 81 and 10 for 15 and 30 mg of upadacitinib each; the patient-years were 72.8 and 10.0, respectively, for 15 mg of upadacitinib and 72.8 and 8.6, respectively, for 30 mg of upadacitinib.
CPK, Creatine phosphokinase; E, event; MACE, major adverse cardiovascular events; PYs, patient-years; VTE, venous thromboembolic event.
Included data up to the cutoff date for all patients with ≥1 dose of upadacitinib. The mean (SD) duration of exposure to study drug from the first dose to the analysis cutoff date in the 15-mg upadacitinib group and 30-mg upadacitinib group was 227.3 (82.8) and 218.8 (84.1) days, respectively.
Event of atypical lymphocytes seen in peripheral blood that was not a malignancy.
Maximum CPK elevation = 2052 U/L.
Maximum CPK elevation = 1660 U/L.