Can Mycophenolate be Stopped in Stable SLE? Save

In patients with clinically stable systemic lupus erythematosus (SLE) and lupus nephritis, the withdrawal of mycophenolate mofetil was not significantly inferior to mycophenolate maintenance, but MMF withdrawal had numerically more reactivations, while MMF maintenance had more infections.

Because of its teratogenicity, cost and side effects it is unknown if disease quiescence is reason enough to withdraw mycophenolate.

A US multicenter, open-label, randomised trial (funded by NIAID/NIAMS) included 102 adults meeting 1997 ACR SLE criteria, with a SLEDAI score < 4 and on stable or decreasing Mycophenolate mofetil therapy for 2 years or more for renal indications, or for 1 year or more for non-renal indications. The primary outcome was clinically significant disease reactivation by week 60 following random allocation, requiring increased doses or new immunosuppressive therapy.

Of the 102, 49 were on MMF maintenance and 51 MMF withdrawal. The average age was 42.  Lupus reactivation by week 60 was seen in:

• Maintenance MMF:  10%
• Withdrawal MMF: 18%

Clinically significant disease reactivation was 7% with mycophenolate mofetil withdrawal (one-sided upper 85% confidence limit 15%).

Adverse events were similar between groups (90% vs 88%), but infections were more frequent in the MMF maintenance group (64% vs 46%).

These estimates can help in making informed decisions on withdrawing mycophenolate mofetil in patients with stable SLE.