Mycophenolate mofetil in high-risk penetrating keratoplasty. A pilot study

Aim. Mycophenolate mofetil (MMF,CellCept) has become a successful part of the standard immunosuppression regimes after solid organ transplantation. It was the aim of this study to compare the efficacy and the safety of MMF after penetrating high-risk keratoplasty with our standard immunosuppression, i.e. systemic cyclosporin A (CSA), in a pilot study. Patients and methods. Sixteen patients after penetrating high-risk keratoplasty were randomized to be treated either with MMF or with CSA for six months postoperatively. MMF was administered in an oral dose of two times 1 g daily whereas the CSA dose varied according to the blood trough levels of 120-150 ng/ml (monoclonal TDx) between 100 and 500 mg daily. Results. During this first follow-up period of 11.4 (5-18) months neither in the MMF- nor in the CSA-group irreversible graft failure was observed. One serious acute endothelial immune reaction was observed in the CSA-group after systemic immunomodulation had been tapered. It was treated successfully with systemic and topical corticosteroids. In one patient CSA-prophylaxis had to be stopped five months postoperatively because of elevated liver enzymes. Side-effects did not occur in the MMF-group. Conclusions. Up to now MMF has been evaluated to be as efficacious as CSA and safe. If these results are confirmed in the long run in this study MMF may become an armament to avoid immune reactions in high-risk penetrating keratoplasty patients who must not receive systemic CSA.