Daclizumab induction and maintenance steroid-free immunosuppression with mycophenolate mofetil and tacrolimus to prevent acute rejection of hepatic allografts.
Steroid-free immunosuppressive regimens reduce corticosteroid-related side effects in liver transplant recipients although their efficacy is very variable. We evaluated the efficacy and safety of a steroid-free regimen in a 6-month, open-label, multicenter, pilot study, which involved 102 liver transplant patients treated with daclizumab (2 mg/kg within 6 h following transplant and 1 mg/kg on day 7), mycophenolate mofetil (MMF, 1 g b.i.d) and tacrolimus (trough levels of 5-15 ng/ml in the first month and 5-10 ng/ml thereafter). One intra-operative dose of methylprednisolone was administered. At 6 months, the acute rejection rate was 9.8%, and patient and graft survival rates were 96% and 95%, respectively. Acute rejection rates were similar for hepatitis C-positive patients (8.6%) and hepatitis C-negative patients (10.4%). Infections occurred in 22% of patients; most cases were considered mild or moderate. Post-transplantation hypertension and diabetes mellitus developed in 37% and 14% of patients, respectively, during the study period, but were markedly less frequent (8% and 6%, respectively) at 6 months. Hypercholesterolemia was observed in only 2% of patients. In conclusion, the steroid-free immunosuppressive regimen of daclizumab, MMF, and tacrolimus effectively prevents acute rejection after liver transplantation without decreasing safety.
Figueras
Joan
J
Hospital de Bellvitge, Barcelona, Spain.
Prieto
Martin
M
Bernardos
Angel
A
Rimola
Antoni
A
Suárez
Francisco
F
de Urbina
Jorge Ortiz
JO
Cuervas-Mons
Valentín
V
Mata
Manuel de la
Mde L
D000208:Acute Disease; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000077561:Daclizumab; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D006973:Hypertension / Q000209:etiology; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007165:Immunosuppression Therapy / Q000009:adverse effects / Q000379:methods*; D007239:Infections / Q000209:etiology; D016031:Liver Transplantation / Q000009:adverse effects / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010865:Pilot Projects; D012449:Safety; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D000077561:Daclizumab; D009173:Mycophenolic Acid; D016559:Tacrolimus