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Meta-Analysis
. 2013 Nov 27;2013(11):CD008927.
doi: 10.1002/14651858.CD008927.pub2.

Antibody induction therapy for lung transplant recipients

Luit Penninga  1 , Christian H Møller, Elisabeth I Penninga, Martin Iversen, Christian Gluud, Daniel A Steinbrüchel
Affiliations
Meta-Analysis

Antibody induction therapy for lung transplant recipients

Luit Penninga et al. Cochrane Database Syst Rev. .

Abstract

Background: Lung transplantation has become a valuable and well-accepted treatment option for most end-stage lung diseases. Lung transplant recipients are at risk of transplanted organ rejection, and life-long immunosuppression is necessary. Clear evidence is essential to identify an optimal, safe and effective immunosuppressive treatment strategy for lung transplant recipients. Consensus has not yet been achieved concerning use of immunosuppressive antibodies against T-cells for induction following lung transplantation.

Objectives: We aimed to assess the benefits and harms of immunosuppressive T-cell antibody induction with ATG, ALG, IL-2RA, alemtuzumab, or muromonab-CD3 for lung transplant recipients.

Search methods: We searched the Cochrane Renal Group's Specialised Register to 4 March 2013 through contact with the Trials Search Co-ordinator using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE and EMBASE.

Selection criteria: We included all randomised controlled trials (RCTs) that compared immunosuppressive monoclonal and polyclonal T-cell antibody induction for lung transplant recipients. An inclusion criterion was that all participants must have received the same maintenance immunosuppressive therapy within each study.

Data collection and analysis: Three authors extracted data. We derived risk ratios (RR) for dichotomous data and mean differences (MD) for continuous data with 95% confidence intervals (CI). Methodological risk of bias was assessed using the Cochrane risk of bias tool and trial sequential analyses were undertaken to assess the risk of random errors (play of chance).

Main results: Our review included six RCTs (representing a total of 278 adult lung transplant recipients) that assessed the use of T-cell antibody induction. Evaluation of the included studies found all to be at high risk of bias.We conducted comparisons of polyclonal or monoclonal T-cell antibody induction versus no induction (3 studies, 140 participants); polyclonal T-cell antibody versus no induction (3 studies, 125 participants); interleukin-2 receptor antagonists (IL-2RA) versus no induction (1 study, 25 participants); polyclonal T-cell antibody versus muromonab-CD3 (1 study, 64 participants); and polyclonal T-cell antibody versus IL-2RA (3 studies, 100 participants). Overall we found no significant differences among interventions in terms of mortality, acute rejection, adverse effects, infection, pneumonia, cytomegalovirus infection, bronchiolitis obliterans syndrome, post-transplantation lymphoproliferative disease, or cancer.We found a significant outcome difference in one study that compared antithymocyte globulin versus muromonab-CD3 relating to adverse events (25/34 (74%) versus 12/30 (40%); RR 1.84, 95% CI 1.13 to 2.98). This suggested that antithymocyte globulin increased occurrence of adverse events. However, trial sequential analysis found that the required information size had not been reached, and the cumulative Z-curve did not cross the trial sequential alpha-spending monitoring boundaries.None of the studies reported quality of life or kidney injury. Trial sequential analyses indicated that none of the meta-analyses achieved required information sizes and the cumulative Z-curves did not cross the trial sequential alpha-spending monitoring boundaries, nor reached the area of futility.

Authors' conclusions: No clear benefits or harms associated with the use of T-cell antibody induction compared with no induction, or when different types of T-cell antibodies were compared were identified in this review. Few studies were identified that investigated use of antibodies against T-cells for induction after lung transplantation, and numbers of participants and outcomes were also limited. Assessment of the included studies found that all were at high risk of methodological bias.Further RCTs are needed to perform robust assessment of the benefits and harms of T-cell antibody induction for lung transplant recipients. Future studies should be designed and conducted according to methodologies to reduce risks of systematic error (bias) and random error (play of chance).

PubMed Disclaimer

Conflict of interest statement

MI received a fee for a lecture on induction therapy in Vienna, Austria in June 2008. Program by the German Transplantation Society, and the meeting was sponsored by Genzyme.

Figures

1
1
Study flow diagram
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
4
4
Any induction versus no induction; mortality: trial sequential analysis of the effect of induction versus no induction on mortality based on three studies (140 participants). The required information size of 935 patients was calculated based on type I error of 5%, type II error of 20%, risk reduction of 20%, and information size was adjusted for heterogeneity (I² = 0%)
1.1
1.1. Analysis
Comparison 1 Induction versus no induction, Outcome 1 Mortality.
1.2
1.2. Analysis
Comparison 1 Induction versus no induction, Outcome 2 Acute rejection grade II or higher.
1.3
1.3. Analysis
Comparison 1 Induction versus no induction, Outcome 3 Adverse events.
1.4
1.4. Analysis
Comparison 1 Induction versus no induction, Outcome 4 Infection.
1.5
1.5. Analysis
Comparison 1 Induction versus no induction, Outcome 5 Pneumonia.
1.6
1.6. Analysis
Comparison 1 Induction versus no induction, Outcome 6 CMV infection.
1.7
1.7. Analysis
Comparison 1 Induction versus no induction, Outcome 7 Bronchiolitis obliterans syndrome.
1.8
1.8. Analysis
Comparison 1 Induction versus no induction, Outcome 8 Post‐transplantation lymphoproliferative disease (PTLD).
1.9
1.9. Analysis
Comparison 1 Induction versus no induction, Outcome 9 Cancer.
2.1
2.1. Analysis
Comparison 2 Polyclonal antibody versus no induction, Outcome 1 Mortality.
2.2
2.2. Analysis
Comparison 2 Polyclonal antibody versus no induction, Outcome 2 Acute rejection grade II or higher.
2.3
2.3. Analysis
Comparison 2 Polyclonal antibody versus no induction, Outcome 3 Adverse events.
2.4
2.4. Analysis
Comparison 2 Polyclonal antibody versus no induction, Outcome 4 Infection.
2.5
2.5. Analysis
Comparison 2 Polyclonal antibody versus no induction, Outcome 5 Pneumonia.
2.6
2.6. Analysis
Comparison 2 Polyclonal antibody versus no induction, Outcome 6 CMV infection.
2.7
2.7. Analysis
Comparison 2 Polyclonal antibody versus no induction, Outcome 7 Bronchiolitis obliterans syndrome.
2.8
2.8. Analysis
Comparison 2 Polyclonal antibody versus no induction, Outcome 8 Post‐transplantation lymphoproliferative disease (PTLD).
2.9
2.9. Analysis
Comparison 2 Polyclonal antibody versus no induction, Outcome 9 Cancer.
3.1
3.1. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus no induction, Outcome 1 Mortality.
3.2
3.2. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus no induction, Outcome 2 Acute rejection.
3.3
3.3. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus no induction, Outcome 3 Pneumonia.
3.4
3.4. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus no induction, Outcome 4 CMV infection.
3.5
3.5. Analysis
Comparison 3 Interleukin‐2 receptor antagonist versus no induction, Outcome 5 Bronchiolitis obliterans syndrome.
4.1
4.1. Analysis
Comparison 4 Polyclonal antibody versus muromonab‐CD3, Outcome 1 Adverse events.
4.2
4.2. Analysis
Comparison 4 Polyclonal antibody versus muromonab‐CD3, Outcome 2 Infection.
4.3
4.3. Analysis
Comparison 4 Polyclonal antibody versus muromonab‐CD3, Outcome 3 Bronchiolitis obliterans syndrome.
4.4
4.4. Analysis
Comparison 4 Polyclonal antibody versus muromonab‐CD3, Outcome 4 Post‐transplantation lymphoproliferative disease (PTLD).
5.1
5.1. Analysis
Comparison 5 Polyclonal antibody versus interleukin‐2 receptor antagonist, Outcome 1 Mortality.
5.2
5.2. Analysis
Comparison 5 Polyclonal antibody versus interleukin‐2 receptor antagonist, Outcome 2 Acute rejection.
5.3
5.3. Analysis
Comparison 5 Polyclonal antibody versus interleukin‐2 receptor antagonist, Outcome 3 Adverse events.
5.4
5.4. Analysis
Comparison 5 Polyclonal antibody versus interleukin‐2 receptor antagonist, Outcome 4 Infection.
5.5
5.5. Analysis
Comparison 5 Polyclonal antibody versus interleukin‐2 receptor antagonist, Outcome 5 Pneumonia.
5.6
5.6. Analysis
Comparison 5 Polyclonal antibody versus interleukin‐2 receptor antagonist, Outcome 6 CMV infection.
5.7
5.7. Analysis
Comparison 5 Polyclonal antibody versus interleukin‐2 receptor antagonist, Outcome 7 Bronchiolitis obliterans syndrome.
5.8
5.8. Analysis
Comparison 5 Polyclonal antibody versus interleukin‐2 receptor antagonist, Outcome 8 Post‐transplantation lymphoproliferative disease (PTLD).
5.9
5.9. Analysis
Comparison 5 Polyclonal antibody versus interleukin‐2 receptor antagonist, Outcome 9 Cancer.
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Update of

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References to other published versions of this review

Penninga 2011
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