*SELECT-CHOICE was not included as part of RINVOQ's registrational clinical study program.
†Patients who switched to RINVOQ from placebo (PBO), ADA, MTX, or abatacept (ABA) were included in the RINVOQ analysis set from the start of RINVOQ treatment; those who switched from RINVOQ to ADA were included in the ADA analysis set from the start of ADA treatment.
‡Excluding tuberculosis, oral candidiasis, and herpes zoster. The most common opportunistic infections reported with UPA were esophageal candidiasis and oral fungal infection.
§Cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
IIDeep vein thrombosis and pulmonary embolism.
Only data from treatment groups with long-term exposures were analyzed, therefore, data for PBO or ABA (which were only available for the short-term, double-blind controlled periods) were not included. SELECT-CHOICE data was included in the analysis set, although it is not part of the SELECT registrational clinical trial program.
MTX monotherapy data were censored at the time of rescue to combination therapy (i.e., addition of RINVOQ).
Treatment-emergent adverse events (AEs) were defined as any AE with an onset date on or after the first dose of study drug and <30 days (70 days for ADA) after the last dose of study drug in the event of premature study drug discontinuation AEs were defined using standardized Medical Dictionary for Regulatory Activities (MedDRA) query or company MedDRA query search criteria.
All deaths and cardiovascular (CV) events, including venous thromboembolism (VTE), across the clinical program were adjudicated by a blinded external CV adjudication committee.
Exposure-adjusted event rates (EAERs; total number of events [including incident and recurrent events in the same patient] adjusted for RINVOQ total exposure, expressed as events/100 patient-years [E/100 PY]), were reported for AEs and AEs of special interest for each of the treatment groups.
MTX: methotrexate; PYs: patient years.