Benefit–risk analysis of upadacitinib versus adalimumab in patients with rheumatoid arthritis and higher or lower risk of cardiovascular disease
Authors' conclusion
Regardless of baseline CV risk, upadacitinib demonstrated comparable safety to adalimumab, except for higher rates of herpes zoster in both CV risk groups and NMSC and serious infections in the higher-risk group.
Study context
- Population
- Rheumatoid arthritis (RA) patients with inadequate response to MTX in SELECT-COMPARE, with lower or higher cardiovascular (CV) risk211 lower-risk, 767 higher-risk
- Participants
- 129 / 82 / 522 / 245
- Comparison
- Upadacitinib 15 mg vs adalimumab 40 mg every other week, with background MTX, by CV risk
- Upadacitinib, lower riskn = 129
- Adalimumab, lower riskn = 82reference
- Upadacitinib, higher riskn = 522
- Adalimumab, higher riskn = 245reference
Methodological detailsstratified by CV risk
- Stratified by CV risk
Primary result
As reported in the abstract
~6 months and 5 years
- Malignancy excluding nonmelanoma skin cancer (NMSC), MACE and VTE rates comparable between upadacitinib and adalimumab in both risk groups, numerically higher in the higher-risk group
- Better efficacy with upadacitinib, incl. DAS28-CRP <2.6, CDAI remission and Boolean remission at 6 months, generally maintained through 5 years
- Post hoc analysis
Safety
Herpes zoster
- Higher rates with upadacitinib vs adalimumab in both risk groups
Serious infection and NMSC
- Numerically higher rates with upadacitinib in the higher-risk group
Original publication
Benefit–risk analysis of upadacitinib versus adalimumab in patients with rheumatoid arthritis and higher or lower risk of cardiovascular disease. RMD Open. Published 3 June 2025. doi:10. 1136/ rmdopen-2024-005371
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