A Novel Management Strategy of Steroid-Free Immunosuppression After Liver Transplantation: Efficacy and Safety of Tacrolimus and Mycophenolate Mofetil

Ringe, Burckhardt; Braun, Felix; Schütz, Ekkehard; Füzesi, L.; Lorf, Thomas; Canelo, Rubén; Oellerich, Michael; Ramadori, G.

doi:10.1097/00007890-200102270-00005

Cited by 82 publications

(57 citation statements)

References 26 publications

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“…Ringe et al 8 treated 30 nonrandomized patients with tacrolimus and MMF with intraoperative steroids, but no post-OLT steroids. 8 The incidence of rejection in this trial was 26%, and all these patients were administered steroids. Only 43%, or 13 of the patients in their series, were never administered steroids post-OLT.…”

Section: Discussionmentioning

confidence: 79%

“…[14][15][16] Previous attempts at complete steroid abstinence in OLT have had mixed results, with a significant number of patients subsequently requiring steroid treatment for rejection. [5][6][7][8] Tisone et al 6 randomized 45 patients to the administration of cyclosporine and azathioprine with or without steroids. The incidence of rejection was 60% in each group, with 10% of patients in each group subsequently being administered steroids for rejection.…”

Section: Discussionmentioning

confidence: 99%

“…[1][2][3][4] Previous attempts at complete avoidance of steroid use in OLT have had mixed results, and none was able to maintain patients completely without steroids. [5][6][7][8] Thymoglobulin (Sangstat, Freemont, CA) is a polyclonal rabbit antithymocyte globulin (RATG) previously shown to be an effective immunosuppressive agent in OLT. [9][10][11] RATG in conjunction with steroids has been shown to effectively reduce the incidence of rejection in OLT without an increased incidence of infectious complications or malignancy.…”

mentioning

confidence: 99%

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Steroid-free liver transplantation using rabbit antithymocyte globulin induction: Results of a prospective randomized trial

Eason

Loss

Blazek

et al. 2001

Liver Transplantation

121

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Steroids have been 1 of the primary modes of immunosuppression since the inception of transplantation and have been credited with both the prevention and treatment of rejection. Steroids also have been held responsible for increased infections, posttransplantation diabetes, and recurrent hepatitis after orthotopic liver transplantation (OLT). The purpose of this ongoing prospective randomized trial is to eliminate steroid use in OLT through induction with rabbit antithymocyte globulin (RATG). This is the first report of a prospective randomized trial in OLT achieving complete absence of steroids. Seventy-one adult patients were prospectively randomized to administration of RATG or steroids. Thirty-six patients were randomized to the administration of RATG induction at a dose of 1.5 mg/kg intravenously (IV) beginning during the anhepatic phase. No steroids were administered. Patients were administered a second 1.5-mg/kg dose of RATG post-OLT day 1. Thirty-five patients were randomized to the administration of methylprednisolone, which had been our standard immunosuppressive protocol. These patients were administered methylprednisolone, 1,000 mg IV, initiated during the anhepatic phase and followed by steroid taper. Maintenance immunosuppression consisted of tacrolimus and mycophenolate, with or without prednisone. Three patients died in each group, for an overall survival rate of 91% in each group. One patient in each group required re-OLT, for a graft survival rate of 89% in each group. Seven patients administered RATG had biopsy-proven rejection (20.5%), all of whom were successfully treated by increasing tacrolimus doses. Eleven patients administered steroid had biopsy-proven rejection (32%), 7 (64%) of whom required additional steroids for treatment, whereas 4 patients (36%) were successfully treated by increasing tacrolimus doses. The incidence of rejection was not statistically significant; however, there was a significant difference in the incidence of steroid-requiring rejection (P ‫؍‬ .01). The incidence of recurrent hepatitis C was 50% in RATG patients and 71% in steroid patients (P ‫؍‬ not significant). The incidence and severity of infectious complications were slightly lower in RATG patients, accounted for by a greater incidence of cytomegalovirus (CMV) infection in the steroid patients. RATG induction enables complete avoidance of steroid use in OLT with a trend toward a lower rejection rate, decreased incidence of post-OLT diabetes and recurrent hepatitis C, and decreased CMV infection. This prospective randomized trial gives encouraging support that steroids can be safely eliminated in OLT. (Liver Transpl 2001;7: 693-697.) S teroids have been a cornerstone of immunosuppression since the inception of transplantation and are credited with both the prevention and treatment of rejection. However, steroids have also been shown to increase infectious complications, bone disease, and posttransplantation diabetes and possibly increase the incidence and severity of recurrent hepatitis C virus (HCV) infecti...

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Section: Discussionmentioning

confidence: 79%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Steroid-free liver transplantation using rabbit antithymocyte globulin induction: Results of a prospective randomized trial

Eason

Loss

Blazek

et al. 2001

Liver Transplantation

121

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“…The detailed characteristics have been previously described [13] . The indications for LTx included hepatitis C virus related cirrhosis in seven recipients.…”

Section: Materials and Methods Patientsmentioning

confidence: 99%

“…Recently, we published a series of 30 patients receiving steroid-free immunosuppression that consisted of tacrolimus and mycophenolate mofetil (MMF) [13] . Since the hypothesis that steroid-free immunosuppression might be particularly beneficial in HCV infected liver recipients, we analyzed this subgroup of liver recipients with regard to the risk of acute rejection, and development of serious HCV related liver disease in the graft.…”

Section: Introductionmentioning

confidence: 99%

Initial steroid-free immunosuppression after liver transplantation in recipients with hepatitis c virus related cirrhosis

Wietzke‐Braun¹,

Braun²,

Sattler³

et al. 2004

WJG

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AIM: Steroids can increase hepatitis C virus (HCV) replication. After liver transplantation (LTx), steroids are commonly used for immunosuppression and acute rejection is usually treated by high steroid dosages. Steroids can worsen the outcome of recurrent HCV infection. Therefore, we evaluated the outcome of HCV infected liver recipients receiving initial steroid-free immunosuppression. METHODS:Thirty patients undergoing LTx received initial steroid-free immunosuppression. Indication for LTx included 7 patients with HCV related cirrhosis. Initial immunosuppression consisted of tacrolimus 2×0.05 mg/kg·d po and mycophenolate mofetil (MMF) 2×15 mg/kg·d po. The tacrolimus dosage was adjusted to trough levels in the target range of 10-15 µg/L during the first 3 mo and 5-10 µg/L thereafter. Manifestations of acute rejection were verified histologically.

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Excellent Short-term Results With Steroid-Free Maintenance Immunosuppression in Low-Risk Simultaneous Pancreas-Kidney Transplantation

Freise

Kang²,

Feng³

et al. 2003

Arch Surg

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Hypothesis:Steroid avoidance is possible in simultaneous pancreas-kidney transplantation with the use of newer immunosuppressive agents and induction therapy.Design: A retrospective consecutive case review.Setting: A university tertiary referral center.Patients: Medical records of 40 consecutive patients who underwent pancreas-kidney transplantation from November 2000 to July 2002 were reviewed. Intervention:The immunosuppression protocol used in this series of patients consisted of Thymoglobulin induction combined with mycophenolate mofetil, tacrolimus, and sirolimus for maintenance immunosuppression. Steroids were used as pretreatment only, given with Thymoglobulin, and were typically discontinued by postoperative week 1.Main Outcome Measures: Graft and patient survival rates, rejection rates of the kidney or pancreas, infection rates, and surgical complication rates.Results: Patient, kidney, and pancreas survival rates were 95.0%, 92.5%, and 87.5%, respectively. Biopsy-proven pancreas rejection rates at 1 and 3 months' posttransplantation were 2.5%. Kidney rejection rates at 1 and 3 months were 2.5%. Steroids were given only to patients with documented transplant rejection. Surgical and medical complications were no different from earlier protocols.Conclusions: Immunosuppression protocols that do not include maintenance steroids have shown minimal rejection in the first 3 months and equivalent patient and graft survival rates compared with protocols that use steroids. The potential beneficial long-term impact of steroid avoidance will require further study.

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A Novel Management Strategy of Steroid-Free Immunosuppression After Liver Transplantation: Efficacy and Safety of Tacrolimus and Mycophenolate Mofetil

Cited by 82 publications

References 26 publications

Steroid-free liver transplantation using rabbit antithymocyte globulin induction: Results of a prospective randomized trial

Steroid-free liver transplantation using rabbit antithymocyte globulin induction: Results of a prospective randomized trial

Initial steroid-free immunosuppression after liver transplantation in recipients with hepatitis c virus related cirrhosis

Excellent Short-term Results With Steroid-Free Maintenance Immunosuppression in Low-Risk Simultaneous Pancreas-Kidney Transplantation

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