Evidence map›Paper›PMID 37607392›Full record

ArticleDiabetes care2023

Teplizumab: A Disease-Modifying Therapy for Type 1 Diabetes That Preserves β-Cell Function.

Kevan C Herold, Stephen E Gitelman, Peter A Gottlieb, Laura A Knecht, Ralph Raymond, Eleanor L Ramos

Open access · bronzeAbstract read
In one paragraph

Article in Diabetes care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 3 pooled it
32.6field-weighted citation impact, top 1% 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

79 citing papers in PubMed, 3 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Guideline
  4. Article
  5. Article
  6. Article
  7. Review
  8. Type 1 Diabetes Mellitus Pathogenesis: Mechanisms, Early Diagnostic Strategies, and Emerging Therapeutic Approaches.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    Review
  9. Article
  10. Article
  11. Article
  12. New and emerging therapies in type 1 diabetes mellitus.The Journal of clinical investigation · 2026
    Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Synergistic venetoclax and anti-CD3 therapy for control of alloreactive response in hematopoietic stem cell transplantation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2026
    Article
  18. Review
  19. Review
  20. Review

19 more citing papers are in PubMed but not listed here.

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

6 authors at 3 institutions in 1 country.

Kevan C HeroldDepartments of Immunobiology and Internal Medicine, School of Medicine, Yale University, New Haven, CT.
Stephen E GitelmanDepartment of Pediatrics, School of Medicine, University of California San Francisco, San Francisco, CA.
Peter A GottliebBarbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, CO.
Laura A KnechtProvention Bio, Inc., Red Bank, NJ.
Ralph RaymondProvention Bio, Inc., Red Bank, NJ.
Eleanor L RamosProvention Bio, Inc., Red Bank, NJ.ORCID 0009-0006-7163-5726
University of California, San Francisco · USUniversity of Colorado Anschutz Medical Campus · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

objectiveIn November 2022, teplizumab-mzwv became the first drug approved to delay the onset of stage 3 type 1 diabetes in adults and children age ≥8 years with stage 2 type 1 diabetes on the basis of data from the pivotal study TN-10. RESEARCH DESIGN AND

methodsTo provide confirmatory evidence of the effects of teplizumab on preserving endogenous insulin production, an integrated analysis of C-peptide data from 609 patients (n = 375 patients receiving teplizumab and n = 234 control patients) from five clinical trials in stage 3 type 1 diabetes was conducted.

resultsThe primary outcome of the integrated analysis, change from baseline in stimulated C-peptide, was significantly improved at years 1 (average increase 0.08 nmol/L; P < 0.0001) and 2 (average increase 0.12 nmol/L; P < 0.0001) after one or two courses of teplizumab. An analysis of exogenous insulin use was also conducted, showing overall reductions of 0.08 (P = 0.0001) and 0.10 units/kg/day (P < 0.0001) at years 1 and 2, respectively. An integrated safety analysis of five clinical trials that enrolled 1,018 patients with stage 2 or 3 type 1 diabetes (∼1,500 patient-years of follow-up for teplizumab-treated patients) was conducted.

conclusionsThese data confirm consistency in the preservation of β-cell function, as measured by C-peptide, across multiple clinical trials. This analysis showed that the most common adverse events included lymphopenia, rash, and headache, a majority of which occurred during and after the first few weeks of teplizumab administration and generally resolved without intervention, consistent with a safety profile characterized by self-limited adverse events after one or two courses of teplizumab treatment.

Indexed as

Diabetes Mellitus, Type 1AdultAntibodies, Monoclonal, HumanizedChildC-PeptideHumansInsulinInsulin, Regular, HumanAntibodies, Monoclonal, HumanizedC-PeptideInsulinInsulin, Regular, Humanteplizumab

Identifiers

PMID37607392
PMCPMC10545553
OpenAlexW4386055594

What OpenQuestion holds

Textmetadata
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.