Sirolimus and Mycophenolate as Combination Prophylaxis in Corneal Transplant Recipients at High Rejection Risk

PURPOSE: To examine efficacy and safety of dual sirolimus and mycophenolate mofetil systemic immunosuppression as allograft rejection prophylaxis after penetrating keratoplasty in patients at high rejection risk. DESIGN: Prospective, interventional case series. METHODS: SETTINGS: Single-center subspecialty clinic. PATIENTS: Six penetrating transplant recipients at high rejection risk and with no confounding additional cause for high risk of graft failure. All transplant recipient eyes had good visual potential. INTERVENTION: Treatment with oral mycophenolate mofetil in combination with sirolimus for 1 year, and sirolimus alone for 2 further years after keratoplasty at doses used in prophylaxis after cadaveric kidney transplantation. MAIN OUTCOMES MEASURES: Interval to first rejection episode, transplant survival, and significant drug adverse effects. Minimum follow-up interval was 13 months after transplantation. RESULTS: Rejection episodes occurred in 3 patients, one of which led to transplant failure. Of the 6 transplants, 5 remained clear at latest follow-up. Hepatotoxicity required discontinuation of mycophenolate in 1 patient, and both drugs were otherwise free of significant adverse effects. CONCLUSIONS: Sirolimus and mycophenolate mofetil in combination are effective in extending corneal transplant survival in most but not all high rejection risk patients and generally are well tolerated. Results justify further evaluation of this regimen in a larger controlled study. (Am J Ophthalmol 2010;150:179-184. (C) 2010 by Elsevier Inc. All rights reserved.)