Topical administration of tacrolimus and corticosteroids in tapering doses is effective in preventing immune rejection in high-risk keratoplasty: a 5-year follow-up study

Background To evaluate the efficacy of the topical administration of immunosuppressants and corticosteroids in tapering doses in the management of patients with high-risk keratoplasty. Methods One hundred and six patients treated with topical immunosuppressants (50 eyes in the FK506 group and 56 eyes in the CsA group) and corticosteroid eye drops in tapering doses were enrolled in the study. The rates of rejection episodes, irreversible rejection, graft survival, and related influential factors were evaluated. Results The mean follow-up period was 48.1 +/- 7.9 months (range, 36-60 months). The rates of rejection episodes and irreversible rejection were 14.0% and 6.00% in the FK506 group and 37.5% and 7.1% in the CsA group, respectively. Kaplan-Meier survival analysis demonstrated a significantly higher graft survival rate in the FK506 group (81.6%+/- 5.3%, 71.1%+/- 6.3%) compared with that in the CsA group (71.1%+/- 6.3%, 57.5%+/- 7.5%) at 3 and 5 years after surgery (P = 0.006). Multivariate logistic regression revealed that preoperative risk score >= 3 (P = 0.016) and endothelial immune rejection (P = 0.033) were risk factors associated with graft survival. Conclusions Topical administration of tacrolimus and corticosteroids in tapering doses is effective in decreasing the incidence of immune rejection in high-risk keratoplasty. Careful instruction of patients on the reasonable use of topical tacrolimus is critical to avoid immune rejection induced by sudden discontinuation of medication.