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Intensive Lowering of LDL Cholesterol Levels With Evolocumab in Autoimmune or Inflammatory Diseases: An Analysis of
Andre Zimerman1, Ana Laura F Kunzler1, Brittany N Weber2
1Hospital Moinhos de Vento, Moinhos de Vento College of Health Sciences, Porto Alegre, Brazil (A.Z., A.L.F.K.).
Insights
Patients with autoimmune or inflammatory diseases (AIID) experienced greater cardiovascular event reduction with evolocumab. This PCSK9 inhibitor significantly lowered cardiovascular risk in AIID patients, suggesting tailored therapy benefits.
Area of Science:
- Cardiovascular Medicine
- Immunology
- Pharmacology
Background:
- Patients with autoimmune or inflammatory diseases (AIID) face elevated cardiovascular risk.
- Statins may offer greater benefits to these patients.
- The FOURIER trial investigated PCSK9 inhibition with evolocumab.
Purpose of the Study:
- To analyze the effect of evolocumab on cardiovascular events in patients with and without AIID.
- To assess if AIID influences the efficacy of evolocumab in reducing cardiovascular risk.
Main Methods:
- The FOURIER trial randomized 27,564 stable atherosclerosis patients on statins to evolocumab or placebo.
- This analysis specifically examined outcomes in patients with defined AIID.
- Primary endpoint: composite of cardiovascular death, myocardial infarction, stroke, unstable angina, or revascularization.
Main Results:
- 889 patients (3.2%) had AIID; rheumatoid arthritis and psoriasis were most common.
- Evolocumab consistently reduced LDL-C in both AIID and non-AIID groups.
- Evolocumab showed a 42% reduction in primary endpoint events for AIID patients (HR 0.58) vs. 14% for non-AIID patients (HR 0.86).
- A significant reduction in the key secondary endpoint was observed in AIID patients (58% reduction, HR 0.42).
Conclusions:
- Intensive LDL-C lowering with evolocumab may yield a greater relative reduction in cardiovascular events for patients with AIID.
- Evolocumab demonstrates significant efficacy in reducing cardiovascular events in patients with autoimmune or inflammatory diseases.
Background:
Patients with an autoimmune or inflammatory disease (AIID) are at increased cardiovascular risk and may benefit more from statin therapy. In the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor evolocumab lowered low-density lipoprotein cholesterol levels, but not hsCRP (high-sensitivity C-reactive protein) levels, and reduced the risk of cardiovascular events.
Methods:
FOURIER was a randomized trial of evolocumab versus placebo in 27 564 patients with stable atherosclerosis who were taking statins. This analysis focused on the effect of evolocumab in patients with or without an AIID, defined as any autoimmune or chronic inflammatory condition. The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, unstable angina, or coronary revascularization.
Results:
At baseline, 889 patients (3.2%) had an AIID, most commonly rheumatoid arthritis (33.7%) or psoriasis (15.6%). Median (interquartile range) low-density lipoprotein cholesterol levels were 90.0 mg/dL (79.5-105.5) and 91.5 mg/dL (79.5-108.5) in patients with or without an AIID, respectively (P=0.025), and the placebo-adjusted percent reduction with evolocumab was consistent (60.2% versus 59.0%; P=0.57). Baseline hsCRP was higher in patients with an AIID (median 2.1 versus 1.7 mg/L; P<0.001) and did not significantly change with evolocumab in either group. Compared with placebo, evolocumab reduced the rate of the primary end point by 14% in patients without an AIID (hazard ratio, 0.86 [95% CI, 0.80-0.93]) and by 42% in patients with an AIID (hazard ratio, 0.58 [95% CI, 0.38-0.89]; Pinteraction=0.066). Likewise, evolocumab reduced the key secondary end point of cardiovascular death, myocardial infarction, or stroke by 19% in patients without an AIID (hazard ratio, 0.81 [95% CI, 0.74-0.89]) and 58% in those with an AIID (hazard ratio, 0.42 [95% CI, 0.24-0.74]; Pinteraction=0.022).
Conclusions:
Intensive lowering of low-density lipoprotein cholesterol levels with evolocumab may lead to greater relative reduction in cardiovascular events in patients with an AIID.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01764633.
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