Background. Mycophenolate mofetil (MMF) has been shown to have promise in s
hort-term liver transplantation graft rescue studies. The purpose of this s
tudy was to evaluate the long-term efficacy and safety of MMF in liver tran
splant patients who had failed cyclosporine (CsA)-based conventional immuno
suppression.
Methods. Nineteen orthotopic liver allograft recipients were converted from
azathioprine to MMF in combination with CsA and prednisone in this prospec
tive, open-labeled, single-center, graft rescue, pilot study. Six patients
were taken off CsA when MMF was initiated. A 4-year patient follow-up is re
ported here. Patients were considered to have failed CsA-based immunosuppre
ssion either for refractory rejection, chronic rejection, or severe CsA neu
rologic toxicity.
Results. Twelve patients had complete histologic resolution, two had partia
l resolution, and three had worsening of their rejection. Thirteen patients
had a complete biochemical response; one had a partial response and four h
ad worsening of their rejection, Two patients had no histologic and one no
biochemical follow-up. Of the six patients treated with MMF and prednisone
alone, four had complete resolution of rejection without recurrence. The ma
jority of adverse reactions were gastrointestinal [nausea and/or vomiting (
n=5); diarrhea (n=8); gastritis, duodenitis, or esophagitis (n=4); and ulce
rs (n=2)] or bone marrow suppressive [leukopenia (n=9), anemia (n=6), and t
hrombocytopenia (n=5)],
Conclusions. MMF seems to be an effective alternative immunosuppressive in
patients failing CsA-based conventional therapy. MMF may be of particular b
enefit in patients who do not tolerate CsA or tacrolimus. The long-term saf
ety profile is similar to that of other immunosuppressives.