None listed
Conditions
Brief summary
This study aims to assess the cardiovascular risk in people with acute gout treated with anakinra through performing imaging the heart at baseline and at 9 months. We will determine the impact of having an acute flare of gout on the scans, which is a surrogate of cardiovascular risk. We will also determine the impact of a drug (anakinra), which is increasingly being used in acute gout, on its effect on these heart scans. This will help us understand the effect of acute inflammation on cardiovascular risk in gout. The use of anakinra for acute gout will also be assessed in terms of its effectiveness, safety and tolerability.
Interventions
The exposure is an attack of acute gout. Patients will randomised to receive anakinra plus allopurinol escalation therapy versus standard care alone. Standard care involves usual acute gout management (colchicine 500mcg daily for duration of flare) plus allopurinol escalation. Allopurinol dose will be increased according to published protocols starting at 50-100mg daily and increased 50-100mg every 2-4 weeks until target uric acid levels are achieved. Target uric level is either 0.30 or 0.36umol
The exposure is an attack of acute gout. Patients will randomised to receive anakinra plus allopurinol escalation therapy versus standard care alone. Standard care involves usual acute gout management (colchicine 500mcg daily for duration of flare) plus allopurinol escalation. Allopurinol dose will be increased according to published protocols starting at 50-100mg daily and increased 50-100mg every 2-4 weeks until target uric acid levels are achieved. Target uric level is either 0.30 or 0.36umol/L depending on patient factors (ACR 2020 and EULAR 2016 gout management guidelines). The dose of anakinra will be 100mg daily for 3 days administered subcutaneously and will be administered in clinic. At baseline, all patients will undergo a Coronary CT Angiogram to assess for plaque burden in coronary arteries which will be repeated at 9 months. We undertake also patient questionnaires, metrology(swollen and tender joint count) and blood tests. The total duration of follow-up for each patient is 9 months. Patients will be assessed monthly (initial and final visit may last one hour where as other visits approximately 20 mins)
Sponsors
Fiona Stanley Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A diagnosis of gout according to 2015 ACR criteria and defined clinically as requiring initiation or currently on allopurinol therapy. 45 years and a minimum of 2 risk factors, i.e. controlled hypertension, controlled diabetes, controlled dyslipidemia, obesity, age >55 years, smoker <65 years and first degree relative with evidence of atherosclerosis <65 years will be recruited. The above cardiac risk factors ensure patients that are likely to have coronary atherosclerotic plaque on CCTA.
Exclusion criteria
1. Other forms of inflammatory arthritis (especially rheumatoid arthritis and psoriasis). 2. Moderate to severe hepatic impairment 3. Contra indication to allopurinol, especially azathioprine or 6-mercaptopurine use. 4. Contra indication to anti IL-1 therapy, including active infection (HIV, tuberculosis, hepatitis B or C). 5. Pregnancy or breastfeeding. 6. Presence of any serious medical illness that may preclude follow up. 7. Inability to provide informed consent. 8. eGFR less than 50. 9. Cardiac stents in situ or coronary artery bypass grafts (CABG). 10. Poorly controlled diabetes. 11. Current malignancy.
Outcome results
None listed