V 105Systemic Mycophenolate mofetil (MMF) and Cyclosporin A (CSA) after penetrating high-risk keratoplasty results 3 years after the beginning of a prospectively randomised trial
T. Reinhard, A. Reis, M. Malinowski, E. Godehardt, R. Sundmacher
Background: In this study efficacy and safety of systemic MMF were compared with our standard immunosuppression after penetrating high-risk keratoplasty, i.e. CSA.
Patients and methods: Since March 1997 30 high-risk keratoplasty patients have been treated with 2x1 g/day MMF, another 30 high-risk keratoplasty patients have been treated with CSA aiming at trough levels of 120-150 ng/ml. Systemic immunosuppression was scheduled for 6 months. Mean patient age in the MMF group was 53 (17-88), in the CSA group 60 (29-88) years. Drug efficacy was measured by the number of patients with immune reactions and/or graft failure. Safety parameters were reported adverse side effects and laboratory controls.
Results: During a mean follow-up of 18 (6-36) months no irreversible graft failure was recorded in the MMF group, in contrast to 1 irreversible graft failure in the CSA group. 4 reversible immune reactions were documented in the MMF group (1 under immunosuppression, 3 thereafter). In the CSA group 1 irreversible (under immunosuppression) and 3 reversible (2 under immunosuppression and 1 thereafter) were observed. Premature drug withdrawal was judged to be necessary in 2 patients in both groups: In the MMF group in a patient with Hodgkin lymphoma diagnosed 1 month after the beginning of immunosuppression, and in an atopic patient with a deterioration of the skin, respectively; in the CSA group in 2 patients with an elevation of liver enzymes and gingiva hyperplasia, respectively.
Conclusions: In this study systemic MMF has shown to be an effective and safe immunosuppressive agent after high-risk penetrating keratoplasty.
Eye Hospital, Heinrich Heine University, Moorenstr. 5, D-40225 Düsseldorf