Psoriasis Clinical Trial
Official title:
Immune Metabolic Associations in Psoriatic Arthritis Study
To use apremilast in clinical practice as a molecular probe to evaluate the effects of PDE4 inhibition on the cardiometabolic status and immune profile in patients with PsA and psoriasis.
Psoriatic arthritis (PsA) and psoriasis are characterised by immune, metabolic, and vascular
dysfunction. There is an increase in Major Adverse Cardiovascular Events in people with PsA
and psoriasis not explained by conventional cardiovascular risk factors. Furthermore, obesity
in psoriasis is associated with increased risk of developing PsA3. Dietary interventions
leading to weight loss >5% are associated with a higher rate of achievement of minimal
disease activity in overweight/obese patients with PsA treated with TNF inhibitors.
Phosphodiesterase 4 (PDE4) inhibition with apremilast is licensed for the treatment of PsA
and psoriasis and has been noted to be associated with weight loss. There is also data from
animal models to suggest a role for PDE4 in glucose metabolism. However, the exact mechanisms
underlying this are unclear and warrant investigation in humans. PDE4 may help explain the
link between the immune and cardiometabolic dysfunction that characterises PsA and psoriasis,
with pathogenic and therapeutic implications.
This study aims to use apremilast as a clinical molecular probe to evaluate the effects of
PDE4 inhibition on metabolic, vascular, and immune status in patients with PsA and psoriasis.
The hypothesis is that PDE4 inhibition mediates profound and synergistic effects on immune
and metabolic pathways in these conditions to improve metabolic status and normalise
dysregulated immunity.
Measurement of metabolic, immunological and vascular outcomes in 60 patients (40 with PsA and
20 with psoriasis) receiving apremilast as part of their standard clinical care will be
taken. A subgroup of 20 participants with PsA will also undergo more in-depth investigations
including MRI of abdominal fat, subcutaneous fat biopsy, measurement of vascular endothelial
function using EndoPAT and more detailed deep-immunophenotyping. Patients will be recruited
from rheumatology and dermatology clinics in NHS Greater Glasgow and Clyde (primary site) and
two other recruiting sites in Scotland via the Scottish Collaborative Arthritis Research
network (SCAR).
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