Table 3.
Short-term incidence and long-term event rates for AESIs in the Rising Up study
| Parameter | Week 16, n (%) | Week 112, n/PY (n/100 PY) | |||
|---|---|---|---|---|---|
| Upadacitinib 15 mg + TCS (N = 91) |
Upadacitinib 30 mg + TCS (N = 91) |
Placebo + TCS (N = 90) |
Upadacitinib 15 mga (N = 133) |
Upadacitinib 30 mga (N = 136) |
|
| Serious infection | 0 | 1 (1.1) | 0 | 6/284.5 (2.1) | 4/279.8 (1.4) |
| Opportunistic infection excluding TB and herpes zosterb | 3 (3.3) | 1 (1.1) | 0 | 12/281.5 (4.3) | 6/279.9 (2.1) |
| Malignancy | 0 | 0 | 0 | 1/289.2 (0.3) | 0/287.7 |
| NMSC | 0 | 0 | 0 | 0/289.4 | 0/287.7 |
| Malignancy excluding NMSC | 0 | 0 | 0 | 1/289.2 (0.3) | 0/287.7 |
| Lymphomac | 0 | 0 | 0 | 0/289.4 | 1/287.6 (0.3) |
| Hepatic disorder | 1 (1.1) | 1 (1.1) | 0 | 10/278.8 (3.6) | 11/272.9 (4.0) |
| Gastrointestinal perforation | 0 | 0 | 0 | 0/289.4 | 0/287.7 |
| Anemia | 0 | 1 (1.1) | 0 | 4/285.8 (1.4) | 7/276.1 (2.5) |
| Neutropenia | 1 (1.1) | 4 (4.4) | 0 | 2/287.0 (0.7) | 7/273.9 (2.6) |
| Lymphopenia | 0 | 0 | 0 | 0/289.4 | 1/286.1 (0.3) |
| Herpes zosterd | 0 | 4 (4.4) | 0 | 20/268.6 (7.4) | 31/248.2 (12.5) |
| CPK elevation | 1 (1.1) | 2 (2.2) | 0 | 6/281.8 (2.1) | 12/274.2 (4.4) |
| Renal dysfunction | 0 | 0 | 0 | 0/289.4 | 0/287.7 |
| Active TB | 0 | 0 | 0 | 0/289.4 | 0/287.7 |
| Adjudicated MACEe,f | 1 (1.1) | 0 | 0 | 1/289.4 (0.3) | 0/287.7 |
| Adjudicated VTEg | 0 | 0 | 0 | 0/289.4 | 0/287.7 |
AESI adverse event of special interest, MACE major adverse cardiovascular event, MedDRA Medical Dictionary for Regulatory Activities Terminology, n/100 PY number of patients with at least one event per 100 patient-years, n/PY number of patients with at least one event divided by the total patient years for patients at risk of an event, NMSC non-melanoma skin cancer, TB tuberculosis, TCS topical corticosteroids, UPA upadacitinib, VTE venous thromboembolic events
aAfter week 16, the use of concomitant topical corticosteroids was no longer required and was administered per investigator discretion
bAll events were eczema herpeticum except for one case of Pneumocystis jirovecii pneumonia in the UPA 15 mg group and one case of Oesophageal candidiasis in the UPA 30 mg group
cAtypical lymphocytes seen in peripheral blood smear that resolved; event was not considered a malignancy
dOn the basis of group term search with the Company MedDRA Query
eMACE is defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke
f22-year-old male with no risk factors who experienced cerebellar hemorrhage on study day 65; assessed by investigator to be possibly related to study drug
gVTE is defined as deep vein thrombosis and pulmonary embolism (fatal and non-fatal)