Evidence map›Paper›PMID 38769981›Full record

ArticleTransplantation direct2024

Long-term Safety in Epstein-Barr Virus-Seropositive Kidney-only Transplant Recipients Treated With Belatacept in Clinical Practice: Final Study Results From the ENLiST Registry.

Christian P Larsen, Flavio Vincenti, Tzuyung D Kou, Craig A Shadur, Barbara Bresnahan, Stanley C Jordan, E Steve Woodle, Nelson Goes, John Vella, David Wojciechowski and 2 more

Abstract read
In one paragraph

Article in Transplantation direct, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
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

12 authors.

Christian P LarsenDepartment of Surgery, Emory University Transplant Center, Atlanta, GA.ORCID https://orcid.org/0000-0001-6573-2649
Flavio VincentiDepartments of Medicine and Surgery, University of California, San Francisco, Transplant Center, San Francisco, CA.
Tzuyung D KouWorldwide Patient Safety, Bristol Myers Squibb, Princeton, NJ.
Craig A ShadurTransplantation Service, Iowa Kidney Physicians, Des Moines, IA.
Barbara BresnahanDivision of Nephrology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI.
Stanley C JordanComprehensive Transplant Center, Cedars Sinai, Los Angeles, CA.
E Steve WoodleDepartment of Surgery, University of Cincinnati, Cincinnati, OH.
Nelson GoesKidney Transplant Clinics, Kaiser Permanente, San Francisco, CA.
John VellaDivision of Nephrology and Transplantation, Maine Nephrology Associates, Portland, ME.
David WojciechowskiDepartment of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX.
Martin S PolinskyResearch and Development/Global Drug Development, Bristol Myers Squibb, Princeton, NJ.
Andres Gomez-CamineroWorldwide Health Economic and Outcomes Research, Bristol Myers Squibb, Princeton, NJ.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Belatacept, a selective T-cell costimulation blocker, was associated with improved survival and renal function but also with a risk of posttransplant lymphoproliferative disorder (PTLD) in adult kidney transplant recipients in phase 3 trials. This registry examined long-term safety in Epstein-Barr virus (EBV)-seropositive kidney transplant recipients treated with belatacept. Methods: This US-based, prospective, voluntary, multicenter registry (Evaluating Nulojix Long-Term Safety in Transplant [ENLiST]) included adult EBV-seropositive kidney-only transplant recipients treated de novo (within 14 d of transplantation) with belatacept. Primary objectives were to estimate incidence rates of confirmed PTLD, central nervous system (CNS) PTLD, and progressive multifocal encephalopathy (PML). The minimum follow-up was 2 y. Results: Of 985 enrolled transplant recipients, 933 EBV-seropositive patients received belatacept, with 523 (56.1%) receiving concomitant tacrolimus at transplant (for up to 12 mo). By study end, 3 cases of non-CNS PTLD (incidence rate, 0.08/100 person-years), 1 case of CNS PTLD (0.03/100 person-years), and no cases of PML had been reported. Two patients with non-CNS PTLD received concomitant belatacept and tacrolimus and 1 received belatacept and lymphocyte-depleting therapy. Incidence rates were comparable between patients who received concomitant belatacept and tacrolimus and those who did not receive tacrolimus (0.09/100 person-years and 0.07/100 person-years, respectively; Conclusions: Our results from the ENLiST registry, a large, prospective real-world study, showed that the incidence rates of PTLD and CNS PTLD in belatacept-treated EBV-seropositive transplant recipients were consistent with findings from previous phase 3 trials.

Identifiers

PMID38769981
PMCPMC11104716

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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.