AEs of special interest were pre-specified based on previous studies with RINVOQ or other JAK inhibitors, eg, serious infection, herpes zoster, malignancy, MACEs and VTEs. MACEs and VTEs were adjudicated by an independent external adjudication committee.

*Patients who were RINVOQ 45 mg QD 8-week induction responders and were enrolled under the protocol for 44 or 52 weeks’ maintenance treatment. ^†Defined as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. ^‡Defined as deep vein thrombosis and pulmonary embolism (fatal and non-fatal).

Patients who completed Period 1 of SELECT-AXIS 1 (up to Week 14) were eligible to enter Period 2 and receive open-label RINVOQ 15 mg QD for 90 weeks, up to week 104. Reported here are results at Week 64 (cutoff date January 31, 2020), when all ongoing patients had reached the Week-64 visit and had at least 52 weeks of RINVOQ exposure, including in the placebo-to-RINVOQ switch group.⁴

The most common adverse event with RINVOQ through Week 14 was increased creatine phosphokinase.⁷ No serious infections, active tuberculosis, venous thromboembolic events, gastrointestinal perforation, major adverse cardiovascular events, renal dysfunction, or deaths were reported. *Cardiovascular disorder, reported as mild circulation dysregulation. ^†Spinal osteoarthritis, reported as moderate worsening of cervical spondylosis 4/5. ^‡Dyspepsia (n=1), blood creatine phosphokinase increased (n=1), and atlantoaxial instability (n=1). ^§Otitis media (n=1) and myalgia (n=1). ^¶Esophageal candidiasis in patient with gastro-esophageal reflux disease; study drug continued after treatment with fluconazole. ^¥Including non-melanoma skin cancer, malignancy other than non-melanoma skin cancer, and lymphoma. ^#All seven hepatic disorders were based on asymptomatic alanine aminotransferase or aspartate aminotransferase increases, and none led to premature discontinuation of study drug. **All asymptomatic except for one patient in the placebo group. ^††Two non-serious events of esophageal candidiasis in the same patient. ^‡‡Five events in four patients; all non-serious and limited to one dermatome. ^##Majority based on asymptomatic alanine aminotransferase/aspartate aminotransferase elevations; all were non-serious and none led to study drug discontinuation. ^§§All events were nonserious and none led to study drug discontinuation. ^¥¥Squamous cell carcinoma of tongue in 61-year old former smoker; no reasonable possibility to be study drug related per investigator.

The overall safety profile of RINVOQ observed in patients with ulcerative colitis was generally consistent with that observed in patients with rheumatoid arthritis.^1,2
aSELECT-EARLY, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-NEXT, SELECT-BEYOND, and SELECT-CHOICE.
The most common AEs for RINVOQ 15 mg QD in the RA integrated safety analysis were upper respiratory tract infection, nasopharyngitis, and urinary tract infection.

*In RA studies, patients who switched from placebo, adalimumab, MTX, or abatacept to RINVOQ were included in the RINVOQ analysis set from the start of RINVOQ, while those who switched from RINVOQ to adalimumab were included in the adalimumab analysis set from the start of adalimumab and were censored at the time of switch. MTX monotherapy was censored at time of rescue to combination therapy (addition of RINVOQ).

^§Both treatment and non–treatment-emergent deaths. ^IIMACE defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. ^¶VTE defined as deep vein thrombosis and pulmonary embolism.