Background Tacrolimus is a potent immunosuppressive agent that provides hig
her freedom from acute and chronic rejection than cyclosporine after liver
transplantation (LTx). Initially, a steroid-free state was observed in abou
t 70% of patients at 1 year; this did not change over the next 5 years. The
present study identifies the various reasons why the remaining 30% of adul
t patients still require steroids even after 5 years after successful LTx.
Method. Eight hundred thirty-four consecutive patients who underwent LTx be
tween August 1989 and December 1992 were included in this study. Four hundr
ed ninety-nine patients were alive in January 1999 and were available for t
his study. The dose of steroid and the reason for steroid use were retrospe
ctively determined from the clinical records.
Results. Three hundred sixty-five patients (73.1%) were off steroid, wherea
s 134 patients (26.9%) were receiving prednisone (mean dose was 6.4 +/-3.7
mg/day) at the time of the study. Four hundred and eight-four patients (97%
) were off prednisone at some time after LTx; however, in 119 (23.8%) patie
nts, steroids were reintroduced. Fifteen patients (3%) continued to receive
prednisone; eight receive prednisone due to reluctance of the local physic
ian to withdraw the medication; in five patients, the prednisone was not wi
thdrawn because these patients were on cyclosporine; in the remaining two p
atients, repeated attempts to withdraw steroid resulted in a rise in liver
function test. In the 49 (36.6%) of 119 patients in whom the steroid was re
introduced, it was restarted secondary to pathologically proven or clinical
ly suspected rejection (group I). In five patients steroid was reintroduced
for abnormal liver function after being off immunosuppression for treatmen
t of a posttransplantation lymphoproliferative disorder. Six patients were
noncompliant with their immunosuppressive medication, and the steroid was r
eintroduced to control rejection. Steroids were reintroduced in 30 patients
(22.4%) for recurrence of original disease: primary biliary cirrhosis (n=1
9), sclerosing cholangitis (n=6), and autoimmune hepatitis (n=5) (group II)
. In 24 patients (20.2%), steroids were reintroduced to lower the dose of t
acrolimus secondary to nephrotoxicity. Six of these patients received kidne
y transplantation (group III). In 16 patients (13.4%) the steroid was reint
roduced for concomitant medical problems, consisting of ulcerative/Crohn's
colitis (n=6), adrenal insufficiency (n=5), hematological disorders (n=3),
dermatitis (n=1), and rheumatoid arthritis (n=1) (group IV).
Conclusion. Ninety-seven percent of patients under tacrolimus were weaned o
ff steroid; however, 23.8% required steroid reintroduction for late rejecti
on, recurrence of autoimmune process(es), renal impairment, or the concomit
ant presence of other medical conditions, Although the use of other immunos
uppressive agents may reduce the rate of reintroduction of steroid, long-te
rm sustained freedom from steroid may not be possible in all patients under
tacrolimus secondary to these conditions.