AISLE Study
Research type
Research Study
Full title
Effect of Anifrolumab on arterial Inflammation in Systemic Lupus Erythematosus
IRAS ID
349356
Contact name
Jason Tarkin
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Individuals with immune-mediated inflammatory diseases such as Systemic Lupus Erythematosus (SLE) have an increased risk of atherosclerotic cardiovascular disease (CVD), which can lead to heart attacks and stroke. Often these individuals lack traditional cardiovascular risk factors but develop CVD at a younger age than would be expected in the general population. The excess CVD risk in SLE is believed to be primarily driven by vascular inflammation. However, it is not known whether SLE treatments that target the immune system may also reduce inflammation in blood vessels, or whether these therapies could potentially reduce CVD risk.
The AISLE study will examine whether a targeted anti-inflammatory drug used to treat SLE disease activity (called anifrolumab) can reduce inflammation in blood vessels. Inflammation within the cardiovascular system will be identified and tracked using Positron Emission Tomography (PET) imaging with a radio-labelled tracer (called DOTATATE). Our research at the University of Cambridge has shown this imaging method to be an effective way to detect inflammation in blood vessels and the heart across a range of cardiovascular conditions. Unlike other PET tracers, this method does not require individuals to fast prior scanning and can be reliably used in the coronary arteries.
In this study, patients with active SLE symptoms despite conventional treatments who meet clinical criteria for anifrolumab, will be enrolled. These individuals will receive anifrolumab for 4 months, with DOTATATE PET imaging before and after therapy. Imaging will be performed using a combined PET and MRI scanner, and a CT coronary scan will also be performed to examine for atherosclerosis. Blood samples will be analysed for associated changes in markers of systemic inflammation.
This research will improve our understanding of whether a targeted inflammation lowering therapy used for SLE could also improve vessel wall inflammation that is known to be associated with CVD risk.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
25/EE/0121
Date of REC Opinion
7 Jul 2025
REC opinion
Further Information Favourable Opinion