None listed
Conditions
Brief summary
Mycophenolate is an immunosuppressant that is widely used as a treatment for systemic lupus erythematosus (SLE). Its biological effects involve a reduction in immune cell functions, which in turn reduce systemic or organ related inflammation and damage. The benefits of using mycophenolate in SLE need to be carefully balanced against unintended side effects such as increased risk of infection or blunting of vaccine responses. One strategy to counteract these effects is the temporary withdrawal of the immunosuppressant, which allows for the immune system to recover and effectively respond to a vaccine or infection. Our study will examine the effects of withdrawing mycophenolate for a short period in SLE patients. Our hypothesis is that this temporary withdrawal will result in an improvement in the immune responses to the influenza vaccination while maintaining disease control.
Interventions
Temporary withholding of mycophenolate for 2 weeks after vaccination. The dose will depend on the usual dose that patient is currently receiving, which can vary usually between 500mg twice daily to 1.5g twice daily orally. We will be relying on text messages and emails to remind participants to resume to taking their medications.
We will be offering participants the standard influenza vaccine as eligible for patients who have impaired immunity as part of the National Immunisation Program. For th
Temporary withholding of mycophenolate for 2 weeks after vaccination. The dose will depend on the usual dose that patient is currently receiving, which can vary usually between 500mg twice daily to 1.5g twice daily orally. We will be relying on text messages and emails to remind participants to resume to taking their medications. We will be offering participants the standard influenza vaccine as eligible for patients who have impaired immunity as part of the National Immunisation Program. For those who participated in 2023, we offered the Afluria Quad (CSL Sequirus) influenza vaccination. In 2024, we will offer an equally appropriate influenza vaccine of those available as part of the National Immunisation Program - the Flucelvax Quad (CSL Sequirus) influenza vaccination.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients with systemic lupus erythematosus, who are currently enrolled in the Australian Lupus Registry & Biobank. • Receiving stable doses of mycophenolate and have not experienced a flare in the last 3 months. • Combination with hydroxychloroquine will be permitted • Prednisolone must be at a dose equal or lower than 7.5mg/day.
Exclusion criteria
• Concomitant use of other biologics such as rituximab or belimumab in the last 6 months • Other targeted synthetic disease modifying anti-rheumatic drugs such as JAK inhibitors • Age >65 as a different, adjuvated vaccine is clinically recommended for this age group
Outcome results
None listed