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Cited by 135Renal Transplantation Outcomes and TreatmentsTransplantation: Methods and OutcomesOrgan and Tissue Transplantation Research

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Polyclonal and monoclonal antibodies for induction therapy in kidney transplant recipients

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Hill, Penny, Cross, Nicholas B, Barnett, A Nicholas R, Palmer, Suetonia C, Webster, Angela C·2017·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd004759.pub2PMC PMC6464766
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Abstract

BACKGROUND: Prolonging kidney transplant survival is an important clinical priority. Induction immunosuppression with antibody therapy is recommended at transplantation and non-depleting interleukin-2 receptor monoclonal antibodies (IL2Ra) are considered first line. It is suggested that recipients at high risk of rejection should receive lymphocyte-depleting antibodies but the relative benefits and harms of the available agents are uncertain. OBJECTIVES: We aimed to: evaluate the relative and absolute effects of different antibody preparations (except IL2Ra) when used as induction therapy in kidney transplant recipients; determine how the benefits and adverse events vary for each antibody preparation; determine how the benefits and harms vary for different formulations of antibody preparation; and determine whether the benefits and harms vary in specific subgroups of recipients (e.g. children and sensitised recipients). SEARCH METHODS: Randomised controlled trials (RCTs) comparing monoclonal or polyclonal antibodies with placebo, no treatment, or other antibody therapy in adults and children who had received a kidney transplant. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing monoclonal or polyclonal antibodies with placebo, no treatment, or other antibody therapy in adults and children who had received a kidney transplant. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed risk of bias. Dichotomous outcomes are reported as relative risk (RR) and continuous outcomes as mean difference (MD) together with their 95% confidence intervals (CI). MAIN RESULTS: We included 99 studies (269 records; 8956 participants; 33 with contemporary agents). Methodology was incompletely reported in most studies leading to lower confidence in the treatment estimates.Antithymocyte globulin (ATG) prevented acute graft rejection (17 studies: RR 0.63, 95% CI 0.51 to 0.78). The benefits of ATG on graft rejection were similar when used with (12 studies: RR 0.61, 0.49 to 0.76) or without (5 studies: RR 0.65, 0.43 to 0.98) calcineurin inhibitor (CNI) treatment. ATG (with CNI therapy) had uncertain effects on death (3 to 6 months, 3 studies: RR 0.41, 0.13 to 1.22; 1 to 2 years, 5 studies: RR 0.75, 0.27 to 2.06; 5 years, 2 studies: RR 0.94, 0.11 to 7.81) and graft loss (3 to 6 months, 4 studies: RR 0.60, 0.34 to 1.05; 1 to 2 years, 3 studies: RR 0.65, 0.36 to 1.19). The effect of ATG on death-censored graft loss was uncertain at 1 to 2 years and 5 years. In non-CNI studies, ATG had uncertain effects on death but reduced death-censored graft loss (6 studies: RR 0.55, 0.38 to 0.78). When CNI and older non-CNI studies were combined, a benefit was seen with ATG at 1 to 2 years for both all-cause graft loss (7 studies: RR 0.71, 0.53 to 0.95) and death-censored graft loss (8 studies: RR 0.55, 0.39 to 0.77) but not sustained longer term. ATG increased cytomegalovirus (CMV) infection (6 studies: RR 1.55, 1.24 to 1.95), leucopenia (4 studies: RR 3.86, 2.79 to 5.34) and thrombocytopenia (4 studies: RR 2.41, 1.61 to 3.61) but had uncertain effects on delayed graft function, malignancy, post-transplant lymphoproliferative disorder (PTLD), and new onset diabetes after transplantation (NODAT).Alemtuzumab was compared to ATG in six studies (446 patients) with early steroid withdrawal (ESW) or steroid minimisation. Alemtuzumab plus steroid minimisation reduced acute rejection compared to ATG at one year (4 studies: RR 0.57, 0.35 to 0.93). In the two studies with ESW only in the alemtuzumab arm, the effect of alemtuzumab on acute rejection at 1 year was uncertain compared to ATG (RR 1.27, 0.50 to 3.19). Alemtuzumab had uncertain effects on death (1 year, 2 studies: RR 0.39, 0.06 to 2.42; 2 to 3 years, 3 studies: RR 0.67, 95% CI 0.15 to 2.95), graft loss (1 year, 2 studies: RR 0.39, 0.13 to 1.30; 2 to 3 years, 3 studies: RR 0.98, 95% CI 0.47 to 2.06), and death-censored graft loss (1 year, 2 studies: RR 0.38, 0.08 to 1.81; 2 to 3 years, 3 studies: RR 2.45, 95% CI 0.67 to 8.97) compared to ATG. Creatinine clearance was lower with alemtuzumab plus ESW at 6 months (2 studies: MD -13.35 mL/min, -23.91 to -2.80) and 2 years (2 studies: MD -12.86 mL/min, -23.73 to -2.00) compared to ATG plus triple maintenance. Across all 6 studies, the effect of alemtuzumab versus ATG was uncertain on all-cause infection, CMV infection, BK virus infection, malignancy, and PTLD. The effect of alemtuzumab with steroid minimisation on NODAT was uncertain, compared to ATG with steroid maintenance.Alemtuzumab plus ESW compared with triple maintenance without induction therapy had uncertain effects on death and all-cause graft loss at 1 year, acute rejection at 6 months and 1 year. CMV infection was increased (2 studies: RR 2.28, 1.18 to 4.40). Treatment effects were uncertain for NODAT, thrombocytopenia, and malignancy or PTLD.Rituximab had uncertain effects on death, graft loss, acute rejection and all other adverse outcomes compar

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  • Immunosuppressive medications add to posttransplant diabetes risk by causing insulin deficiency and insulin resistance.

    “with the additive effects of immunosuppressive medications resulting in insulin deficiency as well as insulin resistance.”

    From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1578]

    In “Agreements and disagreements with other studies or reviews” (page unavailable), the review says that reducing maintenance immunosuppression could theoretically reduce new-onset diabetes requiring treatment, but that studies have not confirmed this benefit. This partly supports a link between immunosuppression and posttransplant diabetes; the review does not attribute that risk to insulin deficiency or insulin resistance. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • Risk factors for posttransplant diabetes resemble those for type 2 diabetes, especially demographics and obesity.

    “The risk factors for PTDM are similar to those for T2D, particularly with demographics, and obesity1576–1578”

    From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1578]

    The Secondary outcomes section lists new-onset diabetes after transplantation as an outcome, but does not discuss its risk factors. Searches for obesity, type 2 diabetes, and demographic risk factors found no passage comparing posttransplant diabetes with type 2 diabetes; the available copy is truncated. (LLM, conf=0.72)

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Metadata

Authors
Hill, P., Cross, N. B., Barnett, A. N. R., Palmer, S. C., & Webster, A. C.
Affiliations
  • Christchurch Hospital (NZ)
  • Guy's and St Thomas' NHS Foundation Trust; Renal & Transplant Department; London UK
  • University of Otago (NZ)
  • The University of Sydney (AU)
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2017-01-11
Volume
2017
Issue
1
Pages
CD004759-CD004759
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd004759.pub2
PMC
PMC6464766
OpenAlex
W2098874338
Cited by
135
References
1
Citations by year
2026: 3 · 2025: 9 · 2024: 16 · 2023: 13 · 2022: 17 · 2021: 17 · 2020: 21 · 2019: 11 · 2018: 15 · 2017: 12
FWCI
4.37
Type
journal article
Language
en
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • The Sydney eScholarship Repository (The University of Sydney) (submittedVersion)
Topics
  • Health Sciences › Medicine › Transplantation › Renal Transplantation Outcomes and Treatments
  • Health Sciences › Medicine › Surgery › Transplantation: Methods and Outcomes
  • Health Sciences › Medicine › Transplantation › Organ and Tissue Transplantation Research
Keywords
kidney transplantation, induction immunosuppression, monoclonal antibodies, polyclonal antibodies, antithymocyte globulin, calcineurin inhibitors, acute rejection, graft survival, transplant recipient mortality, adverse events, children, subgroup analysis, risk of bias, risk of bias assessment, risk of bias summary
MeSH terms
Alemtuzumab, Acute Disease, Antibodies, Monoclonal, Antilymphocyte Serum, Cytomegalovirus Infections, Graft Rejection, Humans, Immunosuppression Therapy, Immunosuppressive Agents, Steroids, Receptors, Interleukin-2, Kidney Transplantation, Randomized Controlled Trials as Topic, Muromonab-CD3, Antibodies, Monoclonal, Humanized, Calcineurin Inhibitors

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