Efficacy and safety of systemic tacrolimus in high-risk penetrating keratoplasty after graft failure with systemic cyclosporine.

PURPOSE: The aim of this study was to investigate the efficacy and safety of systemic tacrolimus for the treatment of eyes that developed graft failure despite treatment with cyclosporine (CsA).

METHODS

Ten eyes of 10 patients who underwent high-risk penetrating keratoplasty (PKP) and developed graft failure despite treatment with systemic CsA were included in this study. The patients underwent PKP and were treated with systemic tacrolimus according to the standardized protocol.

RESULTS

Treatment with tacrolimus was continued for 18.1 ± 13.9 months. The median duration of corneal graft clarity was 34.5 months. Graft rejection occurred in 2 of 10 eyes during a mean follow-up period of 48.9 ± 22.9 months. Kaplan-Meier survival plots showed significantly fewer graft rejection episodes (P = 0.033) and longer graft survival (P = 0.042) after treatment with tacrolimus compared those with CsA. Tacrolimus was discontinued in 2 patients; 1 had renal dysfunction and the other had muscle pain and fatigue. These side effects subsided after discontinuation of tacrolimus.

CONCLUSIONS

Treatment with systemic tacrolimus is possibly safe and effective in reducing graft rejection and prolonging graft survival in patients with high-risk PKP after graft failure with systemic CsA.