Evidence map›Paper›PMID 35301512›Full record

Trial reportJournal of Crohn's & colitis2022

Pharmacokinetics, Safety and Efficacy of Intravenous Vedolizumab in Paediatric Patients with Ulcerative Colitis or Crohn's Disease: Results from the Phase 2 HUBBLE Study.

Jeffrey S Hyams, Dan Turner, Stanley A Cohen, Erzsébet Szakos, Kinga Kowalska-Duplaga, Frank Ruemmele, Nicholas M Croft, Bartosz Korczowski, Promise Lawrence, Siddharth Bhatia and 8 more

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Crohn's & colitis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 4 pooled it
7.5field-weighted citation impact, top 2% 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

24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 42 citations in OpenAlex.

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  18. The Role of Therapeutic Drug Monitoring in Children.Gastroenterology clinics of North America · 2023
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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

18 authors at 9 institutions in 6 countries.

Jeffrey S HyamsConnecticut Children's Medical Center, Hartford, CT, USA.
Dan TurnerShaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel.
Stanley A CohenChildren's Center for Digestive Health Care, Atlanta, GA, USA.
Erzsébet SzakosBorsod-A-Z County Central University Teaching Hospital, Velkey Laszlo Paediatric Health Centre, University of Miskolc, Miskolc, Hungary.
Kinga Kowalska-DuplagaDepartment of Paediatrics, Gastroenterology and Nutrition, Jagiellonian University Medical College, Kraków, Poland.
Frank RuemmeleUniversité de Paris, APHP, Hôpital Necker Enfants Malades, Paediatric Gastroenterology, Paris, France.
Nicholas M CroftCentre for Immunobiology, Blizard Institute, Barts and the London School of Medicine, Queen Mary University of London and The Royal London Children's Hospital, Barts Health NHS Trust, London, UK.
Bartosz KorczowskiDepartment of Paediatrics and Paediatric Gastroenterology, University of Rzeszów, Rzeszów, Poland.
Promise LawrenceTakeda, Cambridge, MA, USA.
Siddharth BhatiaTakeda, Cambridge, MA, USA.
Harisha KadaliTakeda, Cambridge, MA, USA.
Chunlin ChenTakeda, Cambridge, MA, USA.
Wan SunTakeda, Cambridge, MA, USA.
Maria RosarioTakeda, Cambridge, MA, USA.
Senthil KabilanTakeda, Cambridge, MA, USA.
William TreemTakeda, Cambridge, MA, USA.
Guillermo RossiterTakeda, Cambridge, MA, USA.
Richard A LirioTakeda, Cambridge, MA, USA.
Takeda (United States) · USAssistance Publique – Hôpitaux de Paris · FRConnecticut Children's Medical Center · USJagiellonian University · PLQueen Mary University of London · GBRzeszów University · PLShaare Zedek Medical Center · ILTroy Gastroenterology · USUniversity of Miskolc · HU

Funding

Takeda Foundation
6 · The paper itself

Abstract

BACKGROUND AND

aimsTo date, there are no systematic pharmacokinetic [PK] data on vedolizumab in paediatric inflammatory bowel disease [IBD]. We report results from HUBBLE, a dose-ranging, phase 2 trial evaluating the PK, safety and efficacy of intravenous vedolizumab for paediatric IBD.

methodsEnrolled patients [aged 2-17 years] with moderate to severe ulcerative colitis [UC] or Crohn's disease [CD] and body weight ≥10 kg were randomized by weight to receive low- or high-dose vedolizumab [≥30 kg, 150 or 300 mg; <30 kg, 100 or 200 mg] on Day 1 and Weeks 2, 6 and 14. Week 14 assessments included PK, clinical response and exposure-response relationship. Safety and immunogenicity were assessed.

resultsRandomized patients weighing ≥30 kg [UC, n = 25; CD, n = 24] and <30 kg [UC, n = 19; CD, n = 21] had a baseline mean [standard deviation] age of 13.5 [2.5] and 7.6 [3.2] years, respectively. In almost all indication and weight groups, area under the concentration curve and average concentration increased ~2-fold from low to high dose; the trough concentration was higher in each high-dose arm compared with the low-dose arms. At Week 14, clinical response occurred in 40.0-69.2% of patients with UC and 33.3-63.6% with CD in both weight groups. Clinical responders with UC generally had higher trough concentration vs non-responders, while this trend was not observed in CD. Fourteen per cent [12/88] of patients had treatment-related adverse events and 6.8% [6/88] had anti-drug antibodies.

conclusionsVedolizumab exposure increased in an approximate dose-proportional manner. No clear dose-response relationship was observed in this limited cohort. No new safety signals were identified.

Indexed as

Colitis, UlcerativeCrohn DiseaseInflammatory Bowel DiseasesAntibodies, Monoclonal, HumanizedChildGastrointestinal AgentsHumansTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal Agentsvedolizumabclinical trialsEndoscopypaediatrics

Identifiers

PMID35301512
PMCPMC9426668
OpenAlexW4220957505

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.