*Exposure adjusted incidence rates (EAIR) are reported for malignancy, MACE, VTE, and death; exposure adjusted event rates (EAER) are reported for the remaining events. Data include all patients receiving RINVOQ or ADA, including rescue groups, with assignment based on drug exposure at the time of event. One treatment-emergent adjudicated GI perforation (preferred term: anal fistula) was identified in the RINVOQ-treatment group.
†Majority of cases on RINVOQ were non-serious and involved 1 or 2 dermatomes. Three events were reported as ophthalmic HZ (2 on RINVOQ and 1 on ADA). No events were reported as having central nervous system or other noncutaneous involvement.
‡Opportunistic infections (excluding TB, HZ, and oral candidiasis): RINVOQ: 4 esophageal candidiasis, 2 oral fungal infection, 1 bronchopulmonary aspergillosis, 1 fungal pharyngitis, 1 GI candidiasis, and 1 meningitis listeria. ADA: 1 esophageal candidiasis and 1 sinusitis fungal. Event rates for oral candidiasis were 0.2 and 0.3 E/100PY for RINVOQ and ADA, respectively.
§Malignancies, excluding NMSC: RINVOQ: 3 lung cancer, 3 malignant melanoma, 2 breast cancer; all other malignancies occurred in a single patient, including colon cancer, myxoid liposarcoma, laryngeal cancer, glioblastoma, endometrial adenocarcinoma, gastric adenocarcinoma, squamous cell carcinoma of the oral cavity, metastatic squamous cell carcinoma, adenocarcinoma, and malignant neoplasm of unknown primary site. ADA: 2 lung cancer, 1 malignant melanoma, 3 colon cancer, and 1 B-cell lymphoma.
IIMACE (includes CV death, non-fatal MI, non-fatal stroke): RINVOQ: 2 non-fatal strokes, 4 non-fatal MIs, 4 CV deaths; ADA: 3 non-fatal strokes, 1 CV death.
¶VTE: RINVOQ: 1 venous thromboembolic death, 3 non-fatal DVT, 3 non-fatal PE, 2 concurrent DVT and PE; ADA: 4 PE, 1 DVT.
#Hepatic disorders: majority were ALT/AST elevations, with no Hy’s law case identified.
**CPK elevation: a majority were mild or moderate, asymptomatic, and transient.
††Deaths (including non-treatment emergent deaths defined as having occurred >30 days after last dose of RINVOQ or >70 days after last dose of ADA): RINVOQ: per CAC Decision, 4 CV deaths (CV; such as acute myocardial infarction, cardiac failure, sudden death) and 12 non-CV deaths including infections (sepsis, meningitis, nosocomial infection), cancers, and other non-CV causes of death (such as pelvic fracture) or undetermined/unknown causes. ADA: based on CAC decision, 2 CV deaths (such as left ventricular failure) and 7 non-CV deaths including infections (pneumonia), cancers, and other non-CV causes of death (such as craniocerebral injury) or undetermined/unknown cause.