Mycophenolate mofetil for the treatment of systemic lupus erythematosus: an open pilot trial.

OBJECTIVE

To investigate the effectiveness and safety of mycophenolate mofetil in patients with systemic lupus erythematosus who were inadequately controlled with corticosteroids, antimalarials, and other immunosuppressive agents.

METHODS

Ten patients with systemic lupus erythematosus (SLE) were treated with 1500-2000 mg mycophenolae mofetil (MMF) daily for a median observation time of 11. 2+/-2.4 (8-16) months in an open clinical trial. The effectiveness and safety of treatment were analyzed using an established disease activity score, clinical status, and laboratory parameters.

RESULTS

All patients improved under treatment with no or only minor side effects. The disease activity score (SLAM) decreased statistically significantly from a median of 15.6+/-5.5 to 9.9+/-4.1 after three months (P<0.01) and to 8.0+/-3.3 after six months (P<0.01). Hematologic parameters did not change significantly whereas a reduction of inflammatory markers was observed. Four patients with SLE-nephritis already treated with cyclophosphamide pulse therapy continuously showed a slight improvement of renal function. Prednisolone dosages could be reduced significantly from a median level of 10.0+/-5.1 mg/d before treatment to 4.6+/-3.5 mg/d after six months (P<0.01).

CONCLUSION

Mycophenolate mofetil is a promising option in immunosuppressive treatment of patients with moderate and severe systemic lupus erythematosus who did not show a satisfactory response to other immunosuppressives.