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Meta-Analysis
. 2014 May 31;2014(5):CD010252.
doi: 10.1002/14651858.CD010252.pub2.

Antibody induction versus corticosteroid 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 corticosteroid 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 specific antibody induction compared with corticosteroid induction of immunosuppression after liver transplantation.

Objectives: To assess the benefits and harms of T-cell specific antibody induction versus corticosteroid 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) on 30 September 2013 together with reference checking, citation searching, contact with trial authors and pharmaceutical companies to identify additional trials.

Selection criteria: We included all randomised clinical trials assessing immunosuppression with T-cell specific antibody induction versus corticosteroid induction in liver transplant recipients. Our inclusion criteria stated that participants within each included trial should have received the same maintenance immunosuppressive therapy.

Data collection and analysis: We used RevMan 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 risk of systematic errors (bias) using bias risk domains with definitions. We used trial sequential analysis to control for random errors (play of chance).

Main results: We included 10 randomised trials with a total of 1589 liver transplant recipients, which studied the use of T-cell specific antibody induction versus corticosteroid induction. All trials were with high risk of bias. We compared any kind of T-cell specific antibody induction versus corticosteroid induction in 10 trials with 1589 participants, including interleukin-2 receptor antagonist induction versus corticosteroid induction in nine trials with 1470 participants, and polyclonal T-cell specific antibody induction versus corticosteroid induction in one trial with 119 participants.Our analyses showed no significant differences regarding mortality (RR 1.01, 95% CI 0.72 to 1.43), graft loss (RR 1.12, 95% CI 0.82 to 1.53) and acute rejection (RR 0.84, 95% CI 0.70 to 1.00), infection (RR 0.96, 95% CI 0.85 to 1.09), hepatitis C virus recurrence (RR 0.89, 95% CI 0.79 to 1.00), malignancy (RR 0.59, 95% CI 0.13 to 2.73), and post-transplantation lymphoproliferative disorder (RR 1.00, 95% CI 0.07 to 15.38) when any kind of T-cell specific antibody induction was compared with corticosteroid induction (all low-quality evidence). Cytomegalovirus infection was less frequent in patients receiving any kind of T-cell specific antibody induction compared with corticosteroid induction (RR 0.50, 95% CI 0.33 to 0.75; low-quality evidence). This was also observed when interleukin-2 receptor antagonist induction was compared with corticosteroid induction (RR 0.55, 95% CI 0.37 to 0.83; low-quality evidence), and when polyclonal T-cell specific antibody induction was compared with corticosteroid induction (RR 0.21, 95% CI 0.06 to 0.70; low-quality evidence). However, when trial sequential analysis regarding cytomegalovirus infection was applied, the required information size was not reached. Furthermore, diabetes mellitus occurred less frequently when T-cell specific antibody induction was compared with corticosteroid induction (RR 0.45, 95% CI 0.34 to 0.60; low-quality evidence), when interleukin-2 receptor antagonist induction was compared with corticosteroid induction (RR 0.45, 95% CI 0.35 to 0.61; low-quality evidence), and when polyclonal T-cell specific antibody induction was compared with corticosteroid induction (RR 0.12, 95% CI 0.02 to 0.95; low-quality evidence). When trial sequential analysis was applied, the trial sequential monitoring boundary for benefit was crossed. We found no subgroup differences for type of interleukin-2 receptor antagonist (basiliximab versus daclizumab). Four trials reported on adverse events. However, no differences between trial groups were noted. Limited data were available for meta-analysis on drug-specific adverse events such as haematological adverse events for antithymocyte globulin. No data were available on quality of life.

Authors' conclusions: Because of the low quality of the evidence, the effects of T-cell antibody induction remain uncertain. T-cell specific antibody induction seems to reduce diabetes mellitus and may reduce cytomegalovirus infection when compared with corticosteroid induction. No other clear benefits or harms were associated with the use of T-cell specific antibody induction compared with corticosteroid induction. For some analyses, the number of trials investigating the use of T-cell specific antibody induction after liver transplantation is small, and the numbers of participants and outcomes in these randomised trials are limited. Furthermore, the included trials are heterogeneous in nature and have applied different types of T-cell specific antibody induction therapy. All trials were at high risk of bias. Hence, additional randomised clinical trials are needed to assess the benefits and harms of T-cell specific antibody induction compared with corticosteroid induction for liver transplant recipients. Such trials ought to be conducted with low risks of systematic error and of random error.

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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
T‐cell specific antibody induction versus corticosteroid induction; acute rejection: trial sequential analysis of the effect of T‐cell specific antibody induction versus corticosteroid induction on acute rejection based on 10 trials with 1589 participants. The diversity‐adjusted required information size (DARIS) of 2082 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 (0%). The cumulative Z‐curve does not cross trial sequential monitoring boundaries and the required information size was not reached.
5
5
T‐cell specific antibody induction versus corticosteroid induction; Cytomegalovirus infection: trial sequential analysis of the effect of T‐cell specific antibody induction versus corticosteroid induction on cytomegalovirus infection based on five trials with 1164 participants. The diversity‐adjusted required information size (DARIS) of 5032 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 (3%). The cumulative Z‐curve does not cross the trial sequential monitoring boundaries and the required information size was not reached.
6
6
T‐cell specific antibody induction versus corticosteroid induction; diabetes mellitus: trial sequential analysis of the effect of T‐cell specific antibody induction versus corticosteroid induction on diabetes mellitus based on 10 trials with 1579 participants. The diversity‐adjusted required information size (DARIS) of 3083 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 (0%). The required information size was not reached but the cumulative Z‐curve crosses the trial sequential monitoring boundary for benefit.
1.1
1.1. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 1 Mortality.
1.2
1.2. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 2 Graft loss.
1.3
1.3. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 3 Acute rejection.
1.4
1.4. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 4 Adverse events.
1.5
1.5. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 5 Infection.
1.6
1.6. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 6 CMV.
1.7
1.7. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 7 Hepatitis C recurrence.
1.8
1.8. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 8 Malignancy.
1.9
1.9. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 9 Post‐transplant lymphoproliferative disorder.
1.10
1.10. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 10 Renal failure requiring dialysis.
1.11
1.11. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 11 Glomerular filtration rate.
1.12
1.12. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 12 Creatinine (mmol/L).
1.13
1.13. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 13 Diabetes mellitus.
1.14
1.14. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 14 Hyperlipidaemia.
1.15
1.15. Analysis
Comparison 1 T‐cell antibody induction versus corticosteroid induction, Outcome 15 Hypertension.
2.1
2.1. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 1 Mortality.
2.2
2.2. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 2 Graft loss.
2.3
2.3. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 3 Acute rejection.
2.4
2.4. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 4 Adverse events.
2.5
2.5. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 5 Infection.
2.6
2.6. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 6 CMV.
2.7
2.7. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 7 Hepatitis C recurrence.
2.8
2.8. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 8 Malignancy.
2.9
2.9. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 9 Post‐transplant lymphoproliferative disorder.
2.10
2.10. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 10 Renal failure requiring dialysis.
2.11
2.11. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 11 Glomerular filtration rate.
2.12
2.12. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 12 Creatinine (mmol/L).
2.13
2.13. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 13 Diabetes mellitus.
2.14
2.14. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 14 Hyperlipidaemia.
2.15
2.15. Analysis
Comparison 2 Interleukin‐2 receptor antagonist versus corticosteroid induction (type of IL2RA), Outcome 15 Hypertension.
3.1
3.1. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 1 Mortality.
3.2
3.2. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 2 Graft loss.
3.3
3.3. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 3 Acute rejection.
3.4
3.4. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 4 Adverse events.
3.5
3.5. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 5 Infection.
3.6
3.6. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 6 CMV.
3.7
3.7. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 7 Hepatitis C recurrence.
3.8
3.8. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 8 Malignancy.
3.9
3.9. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 9 Post‐transplant lymphoproliferative disorder.
3.10
3.10. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 10 Renal failure requiring dialysis.
3.11
3.11. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 11 Glomerular filtration rate.
3.12
3.12. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 12 Creatinine (mmol/L).
3.13
3.13. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 13 Diabetes mellitus.
3.14
3.14. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 14 Hyperlipidaemia.
3.15
3.15. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus corticosteroid induction (paediatric and adult), Outcome 15 Hypertension.
4.1
4.1. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 1 Mortality.
4.2
4.2. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 2 Graft loss.
4.3
4.3. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 3 Acute rejection.
4.4
4.4. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 4 Adverse events.
4.5
4.5. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 5 Infection.
4.6
4.6. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 6 CMV.
4.7
4.7. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 7 Malignancy.
4.8
4.8. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 8 Post‐transplant lymphoproliferative disorder.
4.9
4.9. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 9 Renal failure requiring dialysis.
4.10
4.10. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 10 Glomerular filtration rate.
4.11
4.11. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 11 Creatinine (mmol/L).
4.12
4.12. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 12 Diabetes mellitus.
4.13
4.13. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 13 Hyperlipidaemia.
4.14
4.14. Analysis
Comparison 4 Interleukin‐2 receptor antagonist versus corticosteroid induction (mixed transplant indications and hepatitis C virus), Outcome 14 Hypertension.
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References

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Neuhaus 2002 {published data only}
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Niemeyer 2002 {published data only}
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Ramirez 2007 {published data only}
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Strehlau 2000 {published data only}
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Yoshida 2005 {published data only}
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References to other published versions of this review

Penninga 2012a
    1. Penninga L, Wettergren A, Wilson CH, Steinbrüchel DA, Gluud C. Immunosuppressive T cell antibody induction therapy for liver transplant recipients. Cochrane Database of Systematic Reviews 2012, Issue 11, 2011 ‐ 10, 2012. [DOI: 10.1002/14651858.CD007341.pub2] - DOI
Wilson 2011
    1. Wilson CH, Asher JF, Manas DM. Immunosuppressive T cell antibodies for liver transplant recipients. Cochrane Database of Systematic Reviews 2011, Issue 3, 2008 ‐ 10, 2011. [DOI: 10.1002/14651858.CD007341] - DOI

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