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Meta-Analysis
. 2014 Jun 5;2014(6):CD010253.
doi: 10.1002/14651858.CD010253.pub2.

Antibody induction versus placebo, no induction, or another type of antibody induction for liver transplant recipients

Luit Penninga  1 , André Wettergren, Colin H Wilson, An-Wen Chan, Daniel A Steinbrüchel, Christian Gluud
Affiliations
Meta-Analysis

Antibody induction versus placebo, no induction, or another type of antibody induction for liver transplant recipients

Luit Penninga et al. Cochrane Database Syst Rev. .

Abstract

Background: Liver transplantation is an established treatment option for end-stage liver failure. To date, no consensus has been reached on the use of immunosuppressive T-cell antibody induction for preventing rejection after liver transplantation.

Objectives: To assess the benefits and harms of immunosuppressive T-cell specific antibody induction compared with placebo, no induction, or another type of T-cell specific antibody induction for prevention of acute rejection in liver transplant recipients.

Search methods: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) until September 2013.

Selection criteria: Randomised clinical trials assessing immunosuppression with T-cell specific antibody induction compared with placebo, no induction, or another type of antibody induction in liver transplant recipients. Our inclusion criteria stated that participants within each included trial should have received the same maintenance immunosuppressive therapy. We planned to include trials with all of the different types of T-cell specific antibodies that are or have been used for induction (ie., polyclonal antibodies (rabbit of horse antithymocyte globulin (ATG), or antilymphocyte globulin (ALG)), monoclonal antibodies (muromonab-CD3, anti-CD2, or alemtuzumab), and interleukin-2 receptor antagonists (daclizumab, basiliximab, BT563, or Lo-Tact-1)).

Data collection and analysis: We used RevMan analysis for statistical analysis of dichotomous data with risk ratio (RR) and of continuous data with mean difference (MD), both with 95% confidence intervals (CIs). We assessed the risk of systematic errors (bias) using bias risk domains with definitions. We used trial sequential analysis to control for random errors (play of chance). We presented outcome results in a summary of findings table.

Main results: We included 19 randomised clinical trials with a total of 2067 liver transplant recipients. All 19 trials were with high risk of bias. Of the 19 trials, 16 trials were two-arm trials, and three trials were three-arm trials. Hence, we found 25 trial comparisons with antibody induction agents: interleukin-2 receptor antagonist (IL-2 RA) versus no induction (10 trials with 1454 participants); monoclonal antibody versus no induction (five trials with 398 participants); polyclonal antibody versus no induction (three trials with 145 participants); IL-2 RA versus monoclonal antibody (one trial with 87 participants); and IL-2 RA versus polyclonal antibody (two trials with 112 participants). Thus, we were able to compare T-cell specific antibody induction versus no induction (17 trials with a total of 1955 participants). Overall, no difference in mortality (RR 0.91; 95% CI 0.64 to 1.28; low-quality of evidence), graft loss including death (RR 0.92; 95% CI 0.71 to 1.19; low-quality of evidence), and adverse events ((RR 0.97; 95% CI 0.93 to 1.02; low-quality evidence) outcomes was observed between any kind of T-cell specific antibody induction compared with no induction when the T-cell specific antibody induction agents were analysed together or separately. Acute rejection seemed to be reduced when any kind of T-cell specific antibody induction was compared with no induction (RR 0.85, 95% CI 0.75 to 0.96; moderate-quality evidence), and when trial sequential analysis was applied, the trial sequential monitoring boundary for benefit was crossed before the required information size was obtained. Furthermore, serum creatinine was statistically significantly higher when T-cell specific antibody induction was compared with no induction (MD 3.77 μmol/L, 95% CI 0.33 to 7.21; low-quality evidence), as well as when polyclonal T-cell specific antibody induction was compared with no induction, but this small difference was not clinically significant. We found no statistically significant differences for any of the remaining predefined outcomes - infection, cytomegalovirus infection, hepatitis C recurrence, malignancy, post-transplant lymphoproliferative disease, renal failure requiring dialysis, hyperlipidaemia, diabetes mellitus, and hypertension - when the T-cell specific antibody induction agents were analysed together or separately. Limited data were available for meta-analysis on drug-specific adverse events such as haematological adverse events for antithymocyte globulin. No data were found on quality of life.When T-cell specific antibody induction agents were compared with another type of antibody induction, no statistically significant differences were found for mortality, graft loss, and acute rejection for the separate analyses. When interleukin-2 receptor antagonists were compared with polyclonal T-cell specific antibody induction, drug-related adverse events were less common among participants treated with interleukin-2 receptor antagonists (RR 0.23, 95% CI 0.09 to 0.63; low-quality evidence), but this was caused by the results from one trial, and trial sequential analysis could not exclude random errors. We found no statistically significant differences for any of the remaining predefined outcomes: infection, cytomegalovirus infection, hepatitis C recurrence, malignancy, post-transplant lymphoproliferative disease, renal failure requiring dialysis, hyperlipidaemia, diabetes mellitus, and hypertension. No data were found on quality of life.

Authors' conclusions: The effects of T-cell antibody induction remain uncertain because of the high risk of bias of the randomised clinical trials, the small number of randomised clinical trials reported, and the limited numbers of participants and outcomes in the trials. T-cell specific antibody induction seems to reduce acute rejection when compared with no induction. No other clear benefits or harms were associated with the use of any kind of T-cell specific antibody induction compared with no induction, or when compared with another type of T-cell specific antibody. Hence, more randomised clinical trials are needed to assess the benefits and harms of T-cell specific antibody induction compared with placebo, and compared with another type of antibody, for prevention of rejection in liver transplant recipients. Such trials ought to be conducted with low risks of systematic error (bias) and low risk of random error (play of chance).

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Conflict of interest statement

None known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Antibody induction versus no antibody induction; mortality: trial sequential analysis of the effect of antibody induction versus no antibody induction on mortality based on 16 trials with 1853 participants. The diversity adjusted required information size (DARIS) of 7684 participants was calculated on the basis of type I error of 5%, type II error of 20%, and risk reduction of 20%, and information size was adjusted for diversity (43%). The cumulative Z‐curve does not cross trial sequential monitoring boundaries, and required information size was not reached.
5
5
Antibody induction versus no antibody induction; graft loss including death: trial sequential analysis of the effect of antibody induction versus no antibody induction on graft loss including death based on 14 trials with 1749 participants. The diversity adjusted required information size (DARIS) of 4427 participants was calculated on the basis of type I error of 5%, type II error of 20%, and risk reduction of 20%, and information size was adjusted for diversity (30%). The cumulative Z‐curve does not cross trial sequential monitoring boundaries, and required information size was not reached.
6
6
Antibody induction versus no antibody induction; acute rejection: trial sequential analysis of the effect of antibody induction versus no antibody induction on acute rejection based on 16 trials with 1918 participants. The diversity adjusted required information size (DARIS) of 1272 participants was calculated on the basis of type I error of 5%, type II error of 20%, and risk reduction of 20%, and information size was adjusted for diversity (15%). The cumulative Z‐curve does cross trial sequential monitoring boundaries, and the required information size was reached.
1.1
1.1. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 1 Mortality.
1.2
1.2. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 2 Graft loss including death.
1.3
1.3. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 3 Acute rejection.
1.4
1.4. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 4 Adverse events.
1.5
1.5. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 5 Infection.
1.6
1.6. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 6 CMV.
1.7
1.7. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 7 Hepatitis C recurrence.
1.8
1.8. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 8 Malignancy.
1.9
1.9. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 9 Post‐transplant lymphoproliferative disorder.
1.10
1.10. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 10 Renal failure requiring dialysis.
1.11
1.11. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 11 Glomerular filtration rate (GFR).
1.12
1.12. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 12 Creatinine (µmol/L).
1.13
1.13. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 13 Hyperlipidaemia.
1.14
1.14. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 14 Diabetes mellitus.
1.15
1.15. Analysis
Comparison 1 T‐cell antibody induction vs placebo/no intervention, Outcome 15 Hypertension.
2.1
2.1. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 1 Mortality.
2.2
2.2. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 2 Graft loss including death.
2.3
2.3. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 3 Acute rejection.
2.4
2.4. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 4 Adverse events.
2.5
2.5. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 5 Infection.
2.6
2.6. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 6 CMV.
2.7
2.7. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 7 Hepatitis C recurrence.
2.8
2.8. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 8 Malignancy.
2.9
2.9. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 9 Post‐transplant lymphoproliferative disorder.
2.10
2.10. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 10 Renal failure requiring dialysis.
2.11
2.11. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 11 Glomerular filtration rate (GFR).
2.12
2.12. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 12 Creatinine (µmol/L).
2.13
2.13. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 13 Hyperlipidaemia.
2.14
2.14. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 14 Diabetes mellitus.
2.15
2.15. Analysis
Comparison 2 T‐cell antibody induction vs placebo/no intervention (subgroups), Outcome 15 Hypertension.
3.1
3.1. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 1 Mortality.
3.2
3.2. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 2 Graft loss including death.
3.3
3.3. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 3 Acute rejection.
3.4
3.4. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 4 Adverse events.
3.5
3.5. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 5 Infection.
3.6
3.6. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 6 CMV.
3.7
3.7. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 7 Hepatitis C recurrence.
3.8
3.8. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 8 Malignancy.
3.9
3.9. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 9 Post‐transplant lymphoproliferative disorder.
3.10
3.10. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 10 Renal failure requiring dialysis.
3.11
3.11. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 11 Glomerular filtration rate (GFR).
3.12
3.12. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 12 Creatinine (µmol/L).
3.13
3.13. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 13 Hyperlipidaemia.
3.14
3.14. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 14 Diabetes mellitus.
3.15
3.15. Analysis
Comparison 3 Interleukin‐2 receptor antagonists vs placebo/no intervention (subgroups), Outcome 15 Hypertension.
4.1
4.1. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 1 Mortality.
4.2
4.2. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 2 Graft loss including death.
4.3
4.3. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 3 Acute rejection.
4.4
4.4. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 4 Adverse events.
4.5
4.5. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 5 Infection.
4.6
4.6. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 6 CMV.
4.7
4.7. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 7 Malignancy.
4.8
4.8. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 8 Post‐transplant lymphoproliferative disorder.
4.9
4.9. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 9 Creatinine (µmol/L).
4.10
4.10. Analysis
Comparison 4 Monoclonal antibody induction vs placebo/no intervention (subgroups), Outcome 10 Renal failure requiring dialysis.
5.1
5.1. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 1 Mortality.
5.2
5.2. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 2 Graft loss including death.
5.3
5.3. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 3 Acute rejection.
5.4
5.4. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 4 Adverse events.
5.5
5.5. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 5 Infection.
5.6
5.6. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 6 CMV.
5.7
5.7. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 7 Malignancy.
5.8
5.8. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 8 Post‐transplant lymphoproliferative disorder.
5.9
5.9. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 9 Renal failure requiring dialysis.
5.10
5.10. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 10 Glomerular filtration rate (GFR).
5.11
5.11. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 11 Creatinine (µmol/L).
5.12
5.12. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 12 Hyperlipidaemia.
5.13
5.13. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 13 Diabetes mellitus.
5.14
5.14. Analysis
Comparison 5 Interleukin‐2 receptor antagonists vs placebo/no intervention (hepatitis C virus), Outcome 14 Hypertension.
6.1
6.1. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 1 Mortality.
6.2
6.2. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 2 Graft loss including death.
6.3
6.3. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 3 Acute rejection.
6.4
6.4. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 4 Adverse events.
6.5
6.5. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 5 Infection.
6.6
6.6. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 6 CMV.
6.7
6.7. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 7 Hepatitis C recurrence.
6.8
6.8. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 8 Malignancy.
6.9
6.9. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 9 Post‐transplant lymphoproliferative disorder.
6.10
6.10. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 10 Renal failure requiring dialysis.
6.11
6.11. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 11 Glomerular filtration rate (GFR).
6.12
6.12. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 12 Creatinine (µmol/L).
6.13
6.13. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 13 Hyperlipidaemia.
6.14
6.14. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 14 Diabetes mellitus.
6.15
6.15. Analysis
Comparison 6 T‐cell antibody induction vs placebo/no intervention (CNI start), Outcome 15 Hypertension.
7.1
7.1. Analysis
Comparison 7 Interleukin‐2 receptor antagonist vs monoclonal antibody induction, Outcome 1 Mortality.
7.2
7.2. Analysis
Comparison 7 Interleukin‐2 receptor antagonist vs monoclonal antibody induction, Outcome 2 Graft loss.
7.3
7.3. Analysis
Comparison 7 Interleukin‐2 receptor antagonist vs monoclonal antibody induction, Outcome 3 Acute rejection.
7.4
7.4. Analysis
Comparison 7 Interleukin‐2 receptor antagonist vs monoclonal antibody induction, Outcome 4 Infection.
7.5
7.5. Analysis
Comparison 7 Interleukin‐2 receptor antagonist vs monoclonal antibody induction, Outcome 5 CMV.
7.6
7.6. Analysis
Comparison 7 Interleukin‐2 receptor antagonist vs monoclonal antibody induction, Outcome 6 Malignancy.
7.7
7.7. Analysis
Comparison 7 Interleukin‐2 receptor antagonist vs monoclonal antibody induction, Outcome 7 Post‐transplant lymphoproliferative disorder.
8.1
8.1. Analysis
Comparison 8 Interleukin‐2 receptor antagonist vs polyclonal T‐cell specific antibody induction, Outcome 1 Mortality.
8.2
8.2. Analysis
Comparison 8 Interleukin‐2 receptor antagonist vs polyclonal T‐cell specific antibody induction, Outcome 2 Graft loss.
8.3
8.3. Analysis
Comparison 8 Interleukin‐2 receptor antagonist vs polyclonal T‐cell specific antibody induction, Outcome 3 Acute rejection.
8.4
8.4. Analysis
Comparison 8 Interleukin‐2 receptor antagonist vs polyclonal T‐cell specific antibody induction, Outcome 4 Adverse events.
8.5
8.5. Analysis
Comparison 8 Interleukin‐2 receptor antagonist vs polyclonal T‐cell specific antibody induction, Outcome 5 Infection.
8.6
8.6. Analysis
Comparison 8 Interleukin‐2 receptor antagonist vs polyclonal T‐cell specific antibody induction, Outcome 6 CMV.
8.7
8.7. Analysis
Comparison 8 Interleukin‐2 receptor antagonist vs polyclonal T‐cell specific antibody induction, Outcome 7 Malignancy.
8.8
8.8. Analysis
Comparison 8 Interleukin‐2 receptor antagonist vs polyclonal T‐cell specific antibody induction, Outcome 8 Post‐transplant lymphoproliferative disorder.
8.9
8.9. Analysis
Comparison 8 Interleukin‐2 receptor antagonist vs polyclonal T‐cell specific antibody induction, Outcome 9 Renal failure requiring dialysis.
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References

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Neuhaus 2002 {published data only}
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    1. Neuhaus P, Clavien PA, Kittur D, Salizzoni M, Rimola A, Abeywickrama K, et al. Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: results from a double‐blind randomized placebo‐controlled trial. Liver Transplantation 2002;8:132‐42. - PubMed
    1. Neuhaus P, Nashan B, Clavin PA, Kittur D, Salizzoni M, Rimola A, et al. Basiliximab (Simulect) reduces the rate and severity of acute rejection in adult liver transplant recipients [abstract]. Liver Transplantation 2000; Vol. 6, issue 3:C‐25.
Otto 1996 {published data only}
    1. Otto G, Hofmann WJ, Gaweco AS, Seelos R, Herfarth C, Meuer S. Influence of the anti‐CD25 monoclonal antibody BT563 on clinical and biological rejection after orthotopic liver transplantation. Transplantation Proceedings 1996; Vol. 28, issue 6:3210‐1. - PubMed
Reding 1996 {published data only}
    1. Reding R, Feyaerts A, Vraux H, Latinne D, De‐La Parra B, Cornet A, et al. Prophylactic immunosuppression with anti‐interleukin‐2 receptor monoclonal antibody LO‐Tact‐1 versus OKT3 in liver allografting. A two‐year follow‐up study. Transplantation 1996;61:1406‐9. - PubMed
    1. Reding R, Vraux H, Ville de Goyet J, Sokal E, Hemptinne B, Latinne D, et al. Monoclonal antibodies in prophylactic immunosuppression after liver transplantation. A randomized controlled trial comparing OKT3 and anti‐IL‐2 receptor monoclonal antibody LO‐Tact‐1. Transplantation 1993; Vol. 55, issue 3:534‐41. - PubMed
Schmeding 2007 {published data only}
    1. Schmeding M, Sauer IM, Kiessling A, Pratschke J, Neuhaus R, Neuhaus P, et al. Influence of basiliximab induction therapy on long term outcome after liver transplantation, a prospectively randomised trial. Annals of Transplantation 2007;12(3):15‐21. - PubMed
Yan 2004 {published data only}
    1. Yan LN, Wang WT, Li B, Lu SC, Wen TF. Induction with basiliximab reduces acute rejection in Chinese liver transplant recipients treated with cyclosporin, steroids and MMF. Liver Transplantation 2004;10:C‐5.
Yoshida 2005 {published data only}
    1. Yoshida EM, Marotta PJ, Greig PD, Kneteman NM, Marleau D, Cantarovich M, et al. Evaluation of renal function in liver transplant recipients receiving daclizumab (Zenapax), mycophenolate mofetil, and a delayed, low‐dose tacrolimus regimen vs. a standard‐dose tacrolimus and mycophenolate mofetil regimen: a multicenter randomized clinical trial. Liver Transplantation 2005;11(9):1064‐72. - PubMed

References to studies excluded from this review

Benitez 2010 {published data only}
    1. Benitez CE, Puig‐Pey I, Lopez M, Martinez‐Llordella M, Lozano JJ, Bohne F, et al. ATG‐Fresenius treatment and low‐dose tacrolimus: results of a randomized controlled trial in liver transplantation. American Journal of Transplantation 2010;10:2296‐304. - PubMed
Boillot 2005 {published data only}
    1. Boillot O, Mayer DA, Boudjema K, Salizzoni M, Gridelli B, Filipponi F, et al. Corticosteroid‐free immunosuppression with tacrolimus following induction with daclizumab: a large randomized clinical study. Liver Transplantation 2005; Vol. 11, issue 1:61‐7. - PubMed
De Simone 2007 {published data only}
    1. Simone P, Carlis L, Filipponi F, Grazi GL, Cuomo O, Santaniello W, et al. Results of a multicenter, randomized open‐label, controlled clinical trial comparing basiliximab versus steroids in hepatitis C positive liver transplant patients. Transplant International 2007;20(Suppl 2):33.
    1. Simone P, Carlis L, Grazi GL, Cuomo O, Calise F, Castagneto M, et al. Results of a multicenter, randomized open‐label trial comparing basiliximab vs. steroids in HCV liver transplant patients. American Journal of Transplantation 2007;7(Suppl 2):312.
Eason 2003 {published data only}
    1. Eason JD, Blazek J, Mason A, Loss GE. Steroid‐free immunosuppression through thymoglobulin induction in liver transplantation: results of a prospective randomized trial. Transplantation Proceedings 2000;32(4):208A. - PubMed
    1. Eason JD, Loss GE, Blazek J, Nair S, Mason AL. Steroid‐free liver transplantation using rabbit antithymocyte globulin induction: results of a prospective randomized trial. Liver Transplantation 2001;7(8):693‐7. - PubMed
    1. Eason JD, Nair S, Cohen AJ, Blazek JL, Loss GE Jr. Steroid‐free liver transplantation using rabbit antithymocyte globulin and early tacrolimus monotherapy. Transplantation 2003;75(8):1396‐9. - PubMed
    1. Nair S, Loss GE, Cohen AJ, Eason JD. Induction with rabbit antithymocyte globulin versus induction with corticosteroids in liver transplantation: impact on recurrent hepatitis C virus infection. Transplantation 2006;81:620‐2. - PubMed
Kato 2001 {published data only}
    1. Kato T, Gaynor JJ, Yoshida H, Montalvano M, Takahashi H, Pyrsopoulos N, et al. Randomized trial of steroid‐free induction versus corticosteroid maintenance among orthotopic liver transplant recipients with hepatitis C virus: impact on hepatic fibrosis progression at one year. Transplantation 2007;84:829‐35. - PubMed
    1. Kato T, Neff GW, Montalbano M, Hung O, Lavandera R, Levi D, et al. Steroid‐free induction with daclizumab and tacrolimus in liver transplant recipients with hepatitis C: a preliminary report [abstract]. Hepatology 2001;34:362A.
Kato 2007 {published data only}
    1. Kato T, Gaynor JJ, Yoshida H, Montalvano M, Takahashi H, Pyrsopoulos N, et al. Randomized trial of steroid‐free induction versus corticosteroid maintenance among orthotopic liver transplant recipients with hepatitis C virus: impact on hepatic fibrosis progression at one year. Transplantation 2007;84:829‐35. - PubMed
    1. Kato T, Yoshida H, Sadfar K, Martinez E, Nishida S, Moon J, et al. Steroid‐free induction and preemptive antiviral therapy for liver transplant recipients with hepatitis C: a preliminary report from a prospective randomized study. Hepatology 2005; Vol. 37, issue 2:1217‐9. - PubMed
Klintmalm 2011 {published data only}
    1. Klintmalm GB, Davis GL, Teperman L, Netto GJ, Washburn K, Rudich SM, et al. A randomized, multicenter study comparing steroid‐free immunosuppression and standard immunosuppression for liver transplant recipients with chronic hepatitis C. Liver Transplantation 2011;17(12):1394‐403. - PubMed
    1. Klintmalm GB, Washburn WK, Rudich SM, Heffron TG, Teperman LW, Fasola C, et al. Corticosteroid‐free immunosuppression with daclizumab in HCV(+) liver transplant recipients: 1‐year interim results of the HCV‐3 study. Liver Transplantation 2007;13(11):1521‐31. - PubMed
Lupo 2008 {published data only}
    1. Lupo L, Panzera P, Tandoi F, Carbotta G, Giannelli G, Santantonio T, et al. Basiliximab versus steroids in double therapy immunosuppression in liver transplantation: a prospective randomized clinical trial. Transplantation 2008;86(7):925‐31. - PubMed
    1. Lupo L, Ricci P, Caputi L, Tandoi F, Aquilino F, Palma G, et al. Basiliximab vs steroids in liver transplantation immunosuppression. A prospective randomized clinical trial. Liver Transplantation 2005;11(7):LB17.
Neumann 2012 {published data only}
    1. Neumann U, Samuel D, Trunecka P, Gugenheim J, Gerunda GE, Friman S. A randomized multicenter study comparing a tacrolimus‐based protocol with and without steroids in HCV‐positive liver allograft recipients. Journal of Transplantation 2012;2012:894215. - PMC - PubMed
Spada 2006 {published data only}
    1. Spada M, Bertani A, Petz W, Torri E, Sonzogni A, Guizzetti M, et al. A randomized trial for tacrolimus and steroids vs. tacrolimus and basiliximab in pediatric liver transplantation. Hepatology 2004; Vol. 40, issue 4 Suppl 1:473A.
    1. Spada M, Petz W, Bertani A, Riva S, Sonzogni A, Giovannelli M, et al. Randomized trial of basiliximab induction versus steroid therapy in pediatric liver allograft recipients under tacrolimus immunosuppression. American Journal of Transplantation 2006; Vol. 6, issue 8:1913‐21. - PubMed
Washburn 2001 {published data only}
    1. Washburn K, Speeg KV, Esterl R, Cigarroa F, Pollack M, Tourtellot C, et al. Steroid elimination 24 hours after liver transplantation using daclizumab, tacrolimus, and mycophenolate mofetil. Transplantation 2001;72(10):1675‐9. - PubMed

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References to other published versions of this review

Penninga 2012a
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