Evidence map›Paper›PMID 38663372›Full record

GuidelineHormone research in paediatrics2025

Pediatric Endocrine Society Statement on Considerations for Use of Teplizumab (Tzield™) in Clinical Practice.

Ksenia N Tonyushkina, Shilpa Mehta, Anna Ryabets-Lienhard, Neha Patel, Emily Breidbart, Ingrid Libman, Michael J Haller, Kimber M Simmons, Emily K Sims, Linda A DiMeglio and 3 more

Abstract readPractice Guideline
PubMed Full text at PMC Publisher
In one paragraph

Guideline in Hormone research in paediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Guideline
  3. Observational
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Observational
  11. Article
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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.

Ksenia N Tonyushkina
Shilpa MehtaDivision of Pediatric Endocrinology, Department of Pediatrics, New York Medical College, Valhalla, New York, USA.
Anna Ryabets-LienhardDivision of Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles, Los Angeles, California, USA.
Neha PatelDivision of Pediatric Endocrinology and Diabetes, The Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Emily BreidbartDivision of Pediatric Endocrinology and Diabetes, Hassenfeld Children's Hospital, New York University School of Medicine, New York, New York, USA.
Ingrid LibmanDivision of Pediatric Diabetes and Endocrinology, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Michael J HallerDivision of Pediatric Endocrinology, University of Florida, Gainesville, Florida, USA.
Kimber M SimmonsDivision of Pediatrics, Barbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, Colorado, USA.
Emily K SimsDivision of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Linda A DiMeglioDivision of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Stephen E GitelmanDepartment of Pediatrics, Diabetes Center, University of California at San Francisco, San Francisco, California, USA.
Kurt J GriffinSanford Health, Sioux Falls, SD and Department of Pediatrics, Sanford School of Medicine, University of South Dakota, Sioux Falls, South Dakota, USA.
Ksenia N TonyushkinaDivision of Pediatric Endocrinology, Diabetes and Metabolism, Rainbow Babies and Children's Hospital, CWRU School of Medicine, Cleveland, Ohio, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Teplizumab (TzieldTM, Provention Bio), a monoclonal antibody directed at T-cell marker CD3, is the first medication approved by the FDA to delay progression from stage 2 to stage 3 type 1 diabetes. To date, the overwhelming majority of pediatric endocrinologists do not have experience using immunotherapeutics and seek guidance on the use of teplizumab in clinical practice. To address this need, the Pediatric Endocrine Society (PES) Diabetes Special Interest Group (Diabetes SIG) and Drug and Therapeutics Committee assembled a task force to review clinical trial data and solicit expert recommendations on the approach to teplizumab infusions. We present considerations on all aspects of teplizumab administration, utilizing evidence where possible and providing a spectrum of expert opinions on unknown aspects. We discuss patient selection and prescreening, highlighting the safety and considerations for monitoring and treatment of side effects. We propose a schedule of events, a protocol for administration, and discuss practice management aspects. We advocate for the need for further long-term systematic surveillance studies to continue evaluating the efficacy and safety of teplizumab.

Indexed as

Antibodies, Monoclonal, HumanizedDiabetes Mellitus, Type 1EndocrinologyChildHumansPediatricsSocieties, MedicalAntibodies, Monoclonal, HumanizedteplizumabBeta cell functionImmune therapyStage 2 type 1 diabetesStage 3 type 1 diabetes preventionTeplizumab

Identifiers

PMID38663372
PMCPMC12416869

What OpenQuestion holds

Textmetadata
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.