Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme
Authors' conclusion
An increased risk of MACE, malignancy (excluding NMSC) and VTE was observed in higher-risk populations with RA, yet risk was comparable between upadacitinib-treated and adalimumab-treated patients. Higher rates of NMSC and HZ were observed with upadacitinib versus comparators across all populations, and increased rates of serious infections were detected in upadacitinib-treated patients at higher CV risk.
Study context
- Population
- Patients with rheumatoid arthritis (RA) in six phase III trials, overall and a higher cardiovascular (CV) risk subset (aged ≥50 years, ≥1 CV risk factor); higher-risk patients from SELECT-COMPARE assessed in parallel≈54% in higher-risk populations
- Participants
- 3,209 / 579 / 314
- Comparison
- Upadacitinib 15 mg once daily vs adalimumab 40 mg every other week with methotrexate (MTX) vs MTX monotherapy
- Upadacitinib 15 mgn = 3,209
- Adalimumabn = 579reference
- MTX monotherapyn = 314reference
- Primary endpoint
- Exposure-adjusted incidence rates of treatment-emergent adverse events (AEs)
Methodological detailsSELECT programme, pooled safety data
- SELECT programme
- Pooled safety data
Primary result
As reported in the abstract
Major adverse cardiovascular events (MACE), malignancy (excluding NMSC) and venous thromboembolism (VTE)
- More frequent in higher-risk cohorts vs overall population but generally similar across treatment groups
- Post hoc
Safety
Serious infections (higher-risk populations)
- Higher with upadacitinib 15 mg than comparators
Herpes zoster and non-melanoma skin cancer (NMSC) (all populations)
- Higher with upadacitinib 15 mg than comparators
Original publication
Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme. Ann Rheum Dis. Published 12 June 2023. doi:10.
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