Statin Use May Mitigate Major Cardiovascular Event Risk With Tofacitinib in Rheumatoid Arthritis
METHODOLOGY:
- Researchers conducted post hoc analyses of a phase 3b/4 randomized noninferiority study (March 2014-July 2020), involving 4362 patients aged 50 years or older with active RA despite methotrexate treatment and with at least one additional cardiovascular risk factor.
- Participants were randomly assigned 1:1:1 to receive tofacitinib 5 mg (n = 1455) or 10 mg (n = 1456) twice daily or a TNF inhibitor (n = 1451), with North American participants receiving adalimumab and others receiving etanercept.
- Baseline cholesterol-lowering treatments included statins, which were classified as high-, moderate-, or low-intensity based on US guidelines, with lipid levels monitored at multiple intervals.
- Nearly 15% of participants had a history of ASCVD, a composite of coronary artery disease, cerebrovascular disease, or peripheral artery disease.
- The study assessed the association between statin use and incident MACE, defined as a composite of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death.
TAKEAWAY:
- Statin initiation was low in the first 15 weeks, with only 1.1% and 0.7% of patients on 5 mg and 10 mg tofacitinib, respectively, initiating statins compared with 0.6% of those on TNF inhibitors. Initiation rates increased over a median follow-up of 4 years to 10.7% and 11.5%, respectively, compared with 6.1%. Levels of low- and high-density lipoprotein cholesterol increased more with tofacitinib than with TNF inhibitors, regardless of statin use.
- Compared with no statin use, statin use at any time during the study was associated with a reduced occurrence of MACE in tofacitinib-treated patients with a history of ASCVD (hazard ratio [HR], 0.49; 95% CI, 0.25-0.95). This trend was not seen in patients treated with TNF inhibitors who had a history of ASCVD.
- In patients with a history of ASCVD and no statin use, the occurrence of MACE was higher with tofacitinib than with TNF inhibitors (HR, 4.07; 95% CI, 1.20-13.82), but no difference was seen between treatments in the incidence of MACE when statins were used.
- Among participants with no history of ASCVD with or without statin use, the occurrence of MACE was similar with tofacitinib and TNF inhibitors.
Our analysis highlights the particular importance of adequate CVD prevention measures when considering treatment with tofacitinib for patients with RA and elevated CV risk, and particularly those with a history of ASCVD,
https://www.medscape.com/viewarticle/statin-use-may-mitigate-major-cardiovascular-event-risk-2025a1000rho