Table II.
Adverse event interim analysis summary
| Treatment-emergent AE | Double-blind period |
During the administration of upadacitinib∗ |
|||
|---|---|---|---|---|---|
| Patients, n (%) |
Event (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 | |
| Any TEAE | 38 (42.2) | 51 (56.0) | 58 (63.7) | 208 (251.3) | 245 (300.7) |
| Adults | 32 | 42 | 50 | 181 | 212 |
| Adolescents | 6 | 9 | 8 | 27 | 33 |
| Serious AE† | 1 (1.1) | 1 (1.1) | 1 (1.1) | 4 (4.8) | 3 (3.7) |
| Adults | 1 | 1 | 1 | 4 | 3 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| AE leading to discontinuation of the study drug‡ | 1 (1.1) | 2 (2.2) | 1 (1.1) | 4 (4.8) | 1 (1.2) |
| Adults | 1 | 2 | 1 | 3 | 1 |
| Adolescents | 0 | 0 | 0 | 1 | 0 |
| Deaths | 0 | 0 | 0 | 0 | 0 |
| TEAE reported by ≥5% of patients in any group | |||||
| Acne | 5 (5.6) | 12 (13.2) | 18 (19.8) | 24 (29.0) | 39 (47.9) |
| Adults | 4 | 9 | 15 | 20 | 34 |
| Adolescents | 1 | 3 | 3 | 4 | 5 |
| Arthralgia | 0 | 0 | 5 (5.5) | 0 | 8 (9.8) |
| Adults | 0 | 0 | 5 | 0 | 8 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| Herpes zoster | 0 | 0 | 4 (4.4) | 5 (6.0) | 11 (13.5) |
| Adults | 0 | 0 | 4 | 5 | 11 |
| Adolescents | 0 | 0 | 0 | 0 | 0 |
| Nasopharyngitis | 14 (15.6) | 12 (13.2) | 14 (15.4) | 30 (36.2) | 38 (46.6) |
| Adults | 11 | 11 | 13 | 27 | 32 |
| Adolescents | 3 | 1 | 1 | 3 | 6 |
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.
AE, Adverse event; E, event; MACE, major adverse cardiovascular events; PYs, patient-years; TEAE, treatment-emergent adverse 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.
The serious AE in the double-blind period was cholelithiasis (n = 1) for placebo, cerebellar hemorrhage (n = 1) for 15 mg of upadacitinib, and herpes simplex infection (n = 1) for 30 mg of upadacitinib; the serious AEs during the administration of upadacitinib were cellulitis (n = 1), herpes zoster infection (n = 1), Pneumocystis jirovecii pneumonia (n = 1), and cerebellar hemorrhage (n = 1) for 15 mg of upadacitinib and herpes simplex (n = 1) and herpes zoster infections (n = 2) for 30 mg of upadacitinib.
The AEs leading to the discontinuation of the study drug during the double-blind period were dermatitis atopic (n = 1) for placebo, Kaposi's varicelliform eruption (n = 1) and cerebellar hemorrhage (n = 1) for 15 mg of upadacitinib, and peripheral edema (n = 1) for 30 mg of upadacitinib; the AEs leading to the discontinuation of the study drug during the administration of upadacitinib were Kaposi varicelliform eruption (n = 1), P jirovecii pneumonia (n = 1), cerebellar hemorrhage (n = 1), and atopic dermatitis for 15 mg of upadacitinib and peripheral edema (n = 1) for 30 mg of upadacitinib.