Spondyloarthritis & psoriatic arthritis
MACE and venous thromboembolism (VTE) across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
Authors' conclusion
Rates of MACEs and VTE events with upadacitinib were consistent with previously reported data for patients receiving conventional synthetic and biologic disease-modifying anti-rheumatic drugs and comparable with active comparators adalimumab and methotrexate.
Study context
- Population
- Patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in phase 2b/3 upadacitinib clinical programmes (data as of 30 June 2021)
- Comparison
- Upadacitinib 15 mg QD and 30 mg QD, with adalimumab (RA and PsA) and MTX (RA) arms as comparators
- Upadacitinib 15 mgn = 4,298
- Upadacitinib 30 mgn = 2,125
- Outcome
- Adjudicated MACE and VTE events, exposure-adjusted rates per 100 patient-years (E/100 PY)
Methodological detailsintegrated safety analysis, adjudicated events, exposure-adjusted event rates (E/100 PY), univariable Cox proportional hazard regression
- Integrated safety analysis
- Adjudicated events
- Exposure-adjusted event rates (E/100 PY)
- Univariable Cox proportional hazard regression
Main finding
As reported in the abstract
as of 30 June 2021
- MACE in RA and PsA, similar across upadacitinib doses
- 0.3-0.6 E/100 PY
- VTE in RA and PsA, similar across upadacitinib doses
- 0.2-0.4 E/100 PY
- VTE in AS
- one VTE event
Further findings
- Most patients experiencing MACE or VTE had two or more baseline cardiovascular risk factors
Original publication
MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. Published 9 November 2023. doi:10.
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