Sirolimus and mycophenolate as combination prophylaxis in corneal transplant recipients at high rejection risk.
OBJECTIVE
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.


METHODS
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.
Chatel
Marc-Antoine
MA
Cornea & External Diseases Service, Moorfields Eye Hospital, City Road, London, United Kingdom.
Larkin
Daniel F P
DF
D000328:Adult; D000368:Aged; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015948:Keratoplasty, Penetrating; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000009:adverse effects / Q000627:therapeutic use*; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D020123:Sirolimus