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Corticosteroid‐free immunosuppression with tacrolimus following induction with daclizumab: A large randomized clinical study
Author(s) -
Boillot Olivier,
Mayer David A.,
Boudjema Karim,
Salizzoni Mauro,
Gridelli Bruno,
Filipponi Franco,
Trunecka Pavel,
Krawczyk Marek,
Clavien PierreAlain,
Ducerf Christian,
Margarit Carlos,
Margreiter Raimund,
Pallardo José Mir,
Hoeckerstedt Krister,
Pageaux GeorgePhillipe
Publication year - 2005
Publication title -
liver transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.814
H-Index - 150
eISSN - 1527-6473
pISSN - 1527-6465
DOI - 10.1002/lt.20307
Subject(s) - daclizumab , medicine , tacrolimus , gastroenterology , immunosuppression , regimen , urology , randomized controlled trial , corticosteroid , transplantation , surgery
This open, randomized (1 : 1), multicenter, 3‐month study compared a dual tacrolimus plus steroids (Tac / steroids) regimen with a steroid‐free immunosuppressive regimen of tacrolimus following daclizumab induction therapy (Tac / Dac) in adult liver transplant recipients. The full analysis set comprised 347 patients in the Tac / steroids group and 351 in the Tac / Dac group. Mean tacrolimus dose during month 3 was 0.11 mg/kg/day in both groups; mean whole‐blood trough levels during month 3 were 10.9 ng/mL (Tac / steroids) and 10.6 ng/mL (Tac / Dac). The incidence of biopsy‐confirmed acute rejection that required treatment was similar in both groups: 26.5% in the Tac / steroids group and 25.4% in the Tac / Dac group ( P = .727). However, the incidence of biopsy‐confirmed corticosteroid‐resistant acute rejection was higher in the Tac / steroids group than in the Tac / Dac group (6.3 vs. 2.8%; P = .027). Kaplan‐Meier estimates of graft survival (92.2 vs. 90.5%) and patient survival (94.5 vs. 93.7%) were similar in both groups. While also the overall adverse event profiles were similar, the incidences of diabetes mellitus (15.3 vs. 5.7%, respectively; P < .001) and cytomegalovirus infection (11.5 vs. 5.1%, respectively; P = .002) were higher in the Tac / steroids group compared with the Tac / Dac group. Mean cholesterol levels increased by 16% in the Tac / steroids group, but were unchanged in the Tac / Dac group during the study. In conclusion, tacrolimus monotherapy following daclizumab induction is an effective and safe regimen, with an advantage over concomitant steroid‐maintenance therapy in terms of a lower incidence of diabetes and viral infection, and a lower incidence of steroid‐resistant acute rejection. (Liver Transpl 2005;11:61–67.)