Mycophenolate mofetil versus cyclosporin A in high risk keratoplasty patients: a prospectively randomised clinical trial

Abstract

Background/aims-The requirement for an eVective, minimally toxic immunosuppressive agent remains a major obstacle to performing high risk corneal transplantation. Although therapy with cyclosporin A (CSA) allows superior graft survival, its use is limited because of a wide range of side eVects. Mycophenolate mofetil (MMF) has been shown to be a safe and eVective immunosuppressive agent following renal transplantation. This prospective, randomised clinical trial was carried out to investigate the eYcacy and safety of MMF in preventing corneal allograft rejection. Methods-Recipients of corneal transplants who were at high risk for graft failure were randomly assigned to either CSA or MMF immunosuppressive therapy. CSA was given in doses to achieve whole blood trough levels of 120-150 ng/ml. MMF was given in a daily dose of 2 g. Both therapy groups additionally received oral corticosteroids (fluocortolone 1 mg/kg) which were tapered and discontinued within the first 3 postoperative weeks. Patients were monitored closely for evidence of corneal graft rejection and adverse side eVects. Drug eYcacy was measured, primarily, by the number of patients who experienced at least one episode of clinical graft rejection. Safety analysis focused on reported adverse side eVects and laboratory measurements. Results-41 patients were enrolled in the study. There was no statistically significant diVerence between the two groups. 20 patients received CSA and 21 patients received MMF. Two patients in each group showed evidence of acute graft rejection which could be treated eVectively by corticosteroids. All corneal grafts remained clear throughout the follow up. Conclusions-In this study it was shown that MMF is just as eVective as CSA in preventing acute rejection following high risk corneal transplantation. Mycophenolate mofetil represents a promising alternative therapeutic option in patients who are at high risk for corneal graft failure.

Systemic immunosuppression with mycophenolate mofetil to prevent corneal graft rejection after high risk penetrating keratoplasty: a 2‐year follow‐up study

“…Side effects such as nephrotoxicity, hepatotoxicity, hypertension, altered glucose metabolism, and gingival hyperplasia occur in up to 40 % of patients [8,9], but probably the most threatening complication is the increased incidence of malignancy (cancers, lymphomas) [10,11]. Reis et al [12] and Birnbaum et al [9] showed Clinical Trial Registration number if required Not required.…”

The new malononitrilamide immunosuppressant FK778 prolongs corneal allograft survival in the rat keratoplasty model

“…Side effects might lead to premature withdrawal of the immunosuppressive drug with a resulting higher risk for rejection. 12,23,24 Therefore, it is desirable to have a broader armamentarium of immunosuppressive agents offering a more favourable side effect profile and comparable efficacy in preventing graft rejection following penetrating high-risk keratoplasty.…”

Postoperative therapy of penetrating keratoplasty in herpes simplex keratitis

“…A kilökődési reakciók csökkentését jelentette a lokális kortikoszteroid alkalmazása mellett bevezetett peroralis immunmoduláns gyógyszer, amely kezdetben a cyclosporin A (CsA), majd a mycophenolat mofetil (MMF) volt [3]. Egyes klinikai vizsgálatok pedig azt mutatták, hogy a peroralisan adott antiherpeticum és az MMF erő-síti egymás hatását, a transzplantátum hosszú ideig recidívamentes marad, és kilökődési reakció sem lép fel [4].…”

“…Reis és mtsai [4] egy rövid tanulmányban felhívták a fi gyelmet, hogy MMF és AC együttes adása nullára csökkentette a recidívát és a re jectiót 15 beteg esetében 9 hónap alatt. Ugyanez a munkacsoport korábban CsA-t alkalmazott [3], de megállapították, hogy az MMF jobb hatású [13], aminek az az oka, hogy a két gyógyszer között szinergista hatás áll fenn. A peroralis antivirális és immunszuppresszív kezelés hatásosságát mások is bizonyították [11].…”