Rheumatoid arthritis

Benefit–risk analysis of upadacitinib versus adalimumab in patients with rheumatoid arthritis and higher or lower risk of cardiovascular disease

RMD OpenPublished Post hoc analysis of the SELECT-COMPARE randomised trial

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

Composed by AI from the published abstract and checked against it. How Briefs are made →

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