Evidence map›Paper›PMID 24217983›Full record

ArticleClinical drug investigation2014

Pharmacokinetics, pharmacodynamics, and immunogenicity of belatacept in adult kidney transplant recipients.

Jinshan Shen, Robert Townsend, Xiaoli You, Yun Shen, Ping Zhan, Zexun Zhou, Dong Geng, Dianna Wu, Nadia McGirr, Kathleen Soucek and 3 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical drug investigation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.3field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 40 citations in OpenAlex.

  1. Obesity is associated with a higher incidence of rejection in patients on belatacept: A pooled analysis from the BENEFIT/BENEFIT-EXT clinical trials.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2024
    Trial
  2. Every 2-month belatacept maintenance therapy in kidney transplant recipients greater than 1-year posttransplant: A randomized, noninferiority trial.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021
    Trial
  3. Article
  4. Biologics in Kidney Transplantation: Why and How Should We Personalize Their Dosage?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  5. Article
  6. The obese transplant organ recipient: experimental and clinical evidence for tailored immunosuppression.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Review
  7. Article
  8. Article
  9. A Quantitative Prediction Method for the Human Pharmacokinetics of Fc-Fusion Proteins.European journal of drug metabolism and pharmacokinetics · 2023
    Article
  10. Article
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  12. TIGIT regulates apoptosis of risky memory T cell subsets implicated in belatacept-resistant rejection.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021
    Article
  13. Phase I study of single-dose pharmacokinetics and pharmacodynamics of belatacept in adolescent kidney transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2019
    Article
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  15. Review
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  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 2 countries.

Jinshan ShenClinical Pharmacology and Pharmacometrics, Oncology-Immunology, Bristol-Myers Squibb, P.O. Box 4000, E1.409, Princeton, NJ 08543-4000, USA.
Robert Townsend
Xiaoli You
Yun Shen
Ping Zhan
Zexun Zhou
Dong Geng
Dianna Wu
Nadia McGirr
Kathleen Soucek
Elizabeth Proszynski
Janice Pursley
Eric Masson
Bristol-Myers Squibb (Germany) · DEBristol-Myers Squibb (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesBelatacept is a first-in-class, selective co-stimulation blocker recently approved for the prophylaxis of organ rejection in adult kidney transplant recipients. The objective of this study was to report the pharmacokinetics, pharmacodynamics, and immunogenicity of belatacept.

methodsThe pharmacokinetics, pharmacodynamics (CD86 receptor occupancy), and immunogenicity of belatacept were studied in de novo adult kidney transplant recipients in phase II and III clinical studies.

resultsFollowing multiple doses of 5 or 10 mg/kg, the geometric mean (percentage coefficient of variation) maximum serum concentration and area under the serum concentration-time curve over one dosing interval of belatacept were 136 (20%) and 238 (27%) μg/mL, and 13,587 (27%) and 21,241 (35%) μg·h/mL, respectively. The median belatacept elimination half-life was 8-9 days. Belatacept exhibited concentration-dependent binding to CD86 receptors. The pre-dose CD86 receptor occupancy by belatacept decreased from 94 to 65% between day 5 and 1 year post-transplant, with corresponding pre-dose trough serum concentrations of belatacept decreasing from ~35 to 4 μg/mL during this period. The cumulative incidence of developing anti-belatacept antibodies was 5.3% up to 3 years post-transplant and had no impact on belatacept exposure.

conclusionsBelatacept in adult kidney transplant demonstrated linear pharmacokinetics with low variability, concentration-dependent pharmacodynamics, and a low incidence of anti-drug antibodies.

Indexed as

AbataceptAdultAntibodiesArea Under CurveB7-2 AntigenClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDose-Response Relationship, DrugHalf-LifeHumansImmunoconjugatesImmunosuppressive AgentsKidney TransplantationTime FactorsAbataceptAntibodiesB7-2 AntigenCD86 protein, humanImmunoconjugatesImmunosuppressive Agents

Identifiers

PMID24217983
PMCPMC3899455
OpenAlexW2065095349

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.