Lupus & antiphospholipid syndrome
Mycophenolate mofetil withdrawal in patients with systemic lupus erythematosus: a multicentre, open-label, randomised controlled trial
Primary result · Clinically significant disease reactivationResult — go to the resultEstimated increase in risk 7%Authors' conclusion
Mycophenolate mofetil withdrawal is not significantly inferior to mycophenolate mofetil maintenance.
Study context
- Population
- Patients aged 18–70 years with quiescent systemic lupus erythematosus (SLE) (American College of Rheumatology (ACR) 1997 criteria, clinical SLEDAI <4) on stable or decreasing long-term MMF, 19 centres in the USA100 in modified ITT analysis
- Participants
- 102 patients
- Comparison
- MMF withdrawal vs MMF maintenance at baseline dose
- Withdrawaln = 52
- Maintenancen = 50reference
- Primary endpoint
- Clinically significant disease reactivation requiring increased doses or new immunosuppressive therapy
- Follow-up
- Week 60
Methodological detailsmulticentre, open-label, non-inferiority (estimation-based), adaptive random allocation
- Multicentre
- Open-label
- Non-inferiority (estimation-based)
- Adaptive random allocation
Primary result
Clinically significant disease reactivation
Estimated increase in risk
7%
Events by treatment group
As reported in the abstract
Safety
Adverse events · similar rates
Infections · more frequent with maintenance
Original publication
Mycophenolate mofetil withdrawal in patients with systemic lupus erythematosus: a multicentre, open-label, randomised controlled trial. Lancet Rheumatol. Published 29 January 2024. doi:10.
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