Mycophenolate mofetil (MMF) following penetrating high-risk keratoplasty: long term results of a prospective, randomised, multicentre study

• Published in: Eye (London) Vol. 23; no. 11; pp. 2063 - 2070
• Main Authors: Birnbaum, F, Mayweg, S, Reis, A, Böhringer, D, Seitz, B, Engelmann, K, Messmer, E M, Reinhard, T
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.11.2009; Nature Publishing Group
• Subjects: Adult; Aged; Analysis of Variance; Biological and medical sciences; clinical-study; Female; Graft Rejection - etiology; Graft Rejection - prevention & control; Graft Survival - drug effects; Humans; Immunosuppressive Agents - therapeutic use; Keratoplasty, Penetrating - methods; Laboratory Medicine; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Miscellaneous; Mycophenolic Acid - analogs & derivatives; Mycophenolic Acid - therapeutic use; Ophthalmology; Pharmaceutical Sciences/Technology; Prospective Studies; Surgery; Surgical Oncology; immunosuppression; high-risk keratoplasty; mycophenolate mofetil; High risk; Enzyme; IMP dehydrogenase; Enzyme inhibitor; Penetrating graft; Long term; Immunomodulator; Prospective; Immunosuppression; Treatment; Keratoplasty; Surgery; Oxidoreductases; Immunosuppressive agent; Mycophenolate mofetil; Ophthalmology
• ISSN: 0950-222X; 1476-5454
• DOI: 10.1038/eye.2008.402

Background The purpose of this prospective, randomised, multicentre study was to prove the efficacy and safety of mycophenolate mofetil (MMF) in preventing graft rejection and in improving clear graft survival following high-risk keratoplasty. Methods In all, 98 of 140 scheduled patients were included in this study (57 MMF, 41 control). Recruitment was stopped prematurely due to a statistically significant result. The patients in the MMF group received MMF orally 2 × 1 g daily for 6 months. All of the patients received fluocortolone 1 mg/kg/day tapered over 3 weeks and topical prednisolone acetate 5 × /day tapered over 5 months. Main criteria were immune reaction-free and clear graft survival, and the occurrence of side effects. Results The mean follow-up time was 34.9±16.3 (mean±SD) months. Eleven patients withdrew from the study (nine patients due to protocol deviation, two because of side effects). Six reversible and two irreversible graft rejections occurred in the MMF group, and five reversible and seven irreversible rejections in the control group. The Kaplan–Meier analysis revealed an immune reaction-free graft survival after the mean follow-up time of 83% in the MMF group and 64.5% in the control group ( P =0.044). Graft failure occurred in 10 MMF-treated patients (two due to rejection) and in nine patients in the control group (seven due to rejection). A total of 36 of 57 MMF-treated patients experienced mostly reversible adverse events. Conclusions Systemic immunosuppression with MMF over 6 months is relatively well tolerated and improves rejection-free graft survival following high-risk keratoplasty statistically significant, even in the long run.