Everolimus versus MMF in maintenance immunosuppression after lung transplantation, interim analysis of a prospective randomized trial

This study was designed to compare Everolimus with Mycophenolatemofetil (MMF) in maintenance immunosuppression after lung transplantation (LTX).

Methods: In a prospective randomized trial patients, four weeks after successful LTX, were treated either with Everolimus or MMF in combination with Cyclosporin A and corticosteroids. An interims analysis was carried out after inclusion of 100 patients to compare effect and adverse events during the first year after LTX.

Results: In the MMF group 4 of 50 recipients expired. No mortality occurred in the Everolimus group. The study was terminated in 12 (Everolimus) and 13 (MMF) patients due to severe side effects or repeated acute rejection episodes. The total number of acute rejections was comparable (60 versus 52), as well as incidence of BOS (one case per group). The incidence of CMV-Antigenemia was lower in the Everolimus group (3 versus 15, p<0.05). The number of pneumonias (5 versus 3) and non specific broncholpulmonary infections (23 versus 31) were comparable. A higher number of bacterial infections was found in the Everolimus group (23 versus 10, p<0.05). During follow up lung function increased in a comparable fashion (best-FeV1 77±18 versus 83±20%). The glomerular filtration rate decreased from 103ml/min to 54ml/min (Everolimus) and from 96ml/min to 48ml/min (MMF).

Conclusions: The further follow up will show if the survival benefit in the Everolimus group is valid. CMV reactivation is less with admistration of Everolimus; however, the incidence of bacterial infections is increased. The nephrotoxicity in both groups was comparable and intolerable high.