Evidence map›Paper›PMID 38482890›Full record

ArticleJournal of pediatric gastroenterology and nutrition2024

Real-world effectiveness of ustekinumab and vedolizumab in TNF-exposed pediatric patients with ulcerative colitis.

Perseus V Patel, Amy Zhang, Balu Bhasuran, Vignesh G Ravindranath, Melvin B Heyman, Sofia G Verstraete, Atul J Butte, Michael J Rosen, Vivek A Rudrapatna, ImproveCareNow Pediatric IBD Learning Health System

Open access · bronzeAbstract readComparative Study
In one paragraph

Article in Journal of pediatric gastroenterology and nutrition, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 6% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Observational
  4. Article
  5. Review
  6. Article
  7. Article
  8. 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

10 authors at 2 institutions in 1 country.

Perseus V PatelDepartment of Pediatrics, University of California San Francisco, San Francisco, California, USA.
Amy ZhangQuantitative Sciences Unit, Stanford University School of Medicine, Palo Alto, California, USA.
Balu BhasuranBakar Computational Health Sciences Institute, University of California San Francisco, San Francisco, California, USA.
Vignesh G RavindranathBakar Computational Health Sciences Institute, University of California San Francisco, San Francisco, California, USA.
Melvin B HeymanDepartment of Pediatrics, University of California San Francisco, San Francisco, California, USA.
Sofia G VerstraeteDepartment of Pediatrics, University of California San Francisco, San Francisco, California, USA.
Atul J ButteDepartment of Pediatrics, University of California San Francisco, San Francisco, California, USA.
Michael J RosenDivision of Pediatric Gastroenterology, Stanford University School of Medicine, Palo Alto, California, USA.
Vivek A RudrapatnaBakar Computational Health Sciences Institute, University of California San Francisco, San Francisco, California, USA.
ImproveCareNow Pediatric IBD Learning Health System
University of California, San Francisco · USStanford University · US

Funding

NRSA Training CoreTL1TR001883 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ALEX BUI, Nina Thawata Harawa · 2016 to 2026
$8.6M
TRAINING PROGRAM IN PEDIATRIC GASTROENTEROLOGY/NUTRITIONT32DK007762 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI James Bayrer · 1998 to 2026
$7.3M
A data science framework for transforming electronic health records into real-world evidenceK99LM014099 · NLM · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI RUDRAPATNA, VIVEK ASHOK · 2023 to 2024
$178k
NCATS NIH HHS TL1 TR001883NIDDK NIH HHS T32 DK007762NIH HHS T32 DK007762NLM NIH HHS K99 LM014099
6 · The paper itself

Abstract

objectivesVedolizumab (VDZ) and ustekinumab (UST) are second-line treatments in pediatric patients with ulcerative colitis (UC) refractory to antitumor necrosis factor (anti-TNF) therapy. Pediatric studies comparing the effectiveness of these medications are lacking. Using a registry from ImproveCareNow (ICN), a global research network in pediatric inflammatory bowel disease, we compared the effectiveness of UST and VDZ in anti-TNF refractory UC.

methodsWe performed a propensity-score weighted regression analysis to compare corticosteroid-free clinical remission (CFCR) at 6 months from starting second-line therapy. Sensitivity analyses tested the robustness of our findings to different ways of handling missing outcome data. Secondary analyses evaluated alternative proxies of response and infection risk.

resultsOur cohort included 262 patients on VDZ and 74 patients on UST. At baseline, the two groups differed on their mean pediatric UC activity index (PUCAI) (p = 0.03) but were otherwise similar. At Month 6, 28.3% of patients on VDZ and 25.8% of those on UST achieved CFCR (p = 0.76). Our primary model showed no difference in CFCR (odds ratio: 0.81; 95% confidence interval [CI]: 0.41-1.59) (p = 0.54). The time to biologic discontinuation was similar in both groups (hazard ratio: 1.26; 95% CI: 0.76-2.08) (p = 0.36), with the reference group being VDZ, and we found no differences in clinical response, growth parameters, hospitalizations, surgeries, infections, or malignancy risk. Sensitivity analyses supported these findings of similar effectiveness.

conclusionsUST and VDZ are similarly effective for inducing clinical remission in anti-TNF refractory UC in pediatric patients. Providers should consider safety, tolerability, cost, and comorbidities when deciding between these therapies.

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeGastrointestinal AgentsUstekinumabAdolescentChildFemaleHumansMalePropensity ScoreRegistriesRemission InductionTreatment OutcomeTumor Necrosis Factor-alphaAntibodies, Monoclonal, HumanizedGastrointestinal AgentsTumor Necrosis Factor-alphaUstekinumabvedolizumabbiologic therapychildrenclinical data sciencecomparative effectivenessinflammatory bowel disease

Identifiers

PMID38482890
PMCPMC11065561
OpenAlexW4392807237

What OpenQuestion holds

Textmetadata
LicenceTDM
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.