Background Patients with rheumatoid arthritis (RA) have an increased risk for cardiovascular disease (CVD). No long-term intervention trials on CVD risk factors have been published, and a debate on the efficacy of controlling traditional risk factors in RA is ongoing. We aimed to evaluate a treat-to-target approach versus usual care regarding traditional CVD risk factors in patients with RA.
Methods In this open-label, randomised controlled trial, patients with RA aged <70 years without prior CVD or diabetes mellitus were randomised 1:1 to either a treat-to-target approach or usual care of traditional CVD risk factors. The primary outcome was defined as change in carotid intima media thickness (cIMT) over 5 years, and the secondary outcome was a composite of first occurrence of fatal and non-fatal cardiovascular events.
Results A total of 320 patients (mean age 52.4 years; 69.7% female) with RA underwent randomisation and 219 patients (68.4%) completed 5 years of follow-up. The mean cIMT progression was significantly reduced in the treat-to-target group compared with usual care (0.023 [95% CI 0.011 to 0.036] mm vs 0.045 [95% CI 0.030 to 0.059] mm; p=0.028). Cardiovascular events occurred in 2 (1.3%) of the patients in the treat-to-target group vs 7 (4.7%) in those receiving usual care (p=0.048 by log-rank test).
Conclusion This study provides evidence on the benefit of a treat-to-target approach of traditional CVD risk factors for primary prevention in patients with well-treated RA.
Trial registration number NTR3873.
- cardiovascular risk
- rheumatoid arthritis
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Handling editor Professor Josef S Smolen
Contributors DFvB-vdS, JvZ and MCC conceived and designed the study. BB, MAdV, DFvB-vdS, BK and NvdM performed the study. BB, EB and MCC performed the statistical analysis. BB and MCC drafted the manuscript. All authors contributed to interpretation and edited the draft report. BB and MCC had full access to the data and take responsibility for the integrity of the data and the accuracy of the data analysis.
Funding This work was part of the FRANCIS study, which is supported by the board of directors of the Franciscus Gasthuis & Vlietland, the Foundation for Research and Development of the Department of Internal Medicine and the Coolsingel Foundation, Rotterdam. The latter is a public research fund with no involvement in the study or in the submitted manuscript.
Competing interests MCC served as a consultant for Merck and received lecture honoraria from Merck.
Patient consent for publication Obtained.
Ethics approval The study was approved by the Institutional Review Board of Franciscus Gasthuis, Rotterdam, the Netherlands and the regional independent medical research ethics committee TWOR, Rotterdam.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Original data are available upon reasonable request.