Evidence map›Paper›PMID 34683880›Full record

ArticlePharmaceutics2021

Ustekinumab Dosing Individualization in Crohn's Disease Guided by a Population Pharmacokinetic-Pharmacodynamic Model.

Jurij Aguiar Zdovc, Jurij Hanžel, Tina Kurent, Nejc Sever, Matic Koželj, Nataša Smrekar, Gregor Novak, Borut Štabuc, Erwin Dreesen, Debby Thomas and 4 more

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.9field-weighted citation impact, top 8% 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

7 citing papers in PubMed, 24 citations in OpenAlex.

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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

14 authors at 4 institutions in 3 countries.

Jurij Aguiar ZdovcDepartment of Biopharmaceutics and Pharmacokinetics, Faculty of Pharmacy, University of Ljubljana, 1000 Ljubljana, Slovenia.
Jurij HanželDepartment of Gastroenterology, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.ORCID 0000-0003-3158-8014
Tina KurentDepartment of Gastroenterology, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.
Nejc SeverDepartment of Gastroenterology, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.
Matic KoželjDepartment of Gastroenterology, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.
Nataša SmrekarDepartment of Gastroenterology, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.ORCID 0000-0003-0208-5629
Gregor NovakDepartment of Gastroenterology, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.ORCID 0000-0002-9110-9188
Borut ŠtabucDepartment of Gastroenterology, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.
Erwin DreesenDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.ORCID 0000-0002-0785-2930
Debby ThomasDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.ORCID 0000-0003-3075-9846
Tomaž VovkDepartment of Biopharmaceutics and Pharmacokinetics, Faculty of Pharmacy, University of Ljubljana, 1000 Ljubljana, Slovenia.ORCID 0000-0002-3322-4807
Barbara OstanekDepartment of Clinical Biochemistry, Faculty of Pharmacy, University of Ljubljana, 1000 Ljubljana, Slovenia.
David DrobneDepartment of Gastroenterology, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.ORCID 0000-0003-2734-675X
Iztok GrabnarDepartment of Biopharmaceutics and Pharmacokinetics, Faculty of Pharmacy, University of Ljubljana, 1000 Ljubljana, Slovenia.ORCID 0000-0003-3452-1499
University of Ljubljana · SILjubljana University Medical Centre · SIKU Leuven · BEUppsala University · SE

Funding

Slovenian Research Agency P1-0189
6 · The paper itself

Abstract

Ustekinumab is a monoclonal antibody used in Crohn's disease (CD). Dose optimization in case of non-response and the role of pharmacokinetic-pharmacodynamic (PK-PD) monitoring remain unresolved dilemmas in clinical practice. We aimed to develop a population PK-PD model for ustekinumab in CD and simulate efficacy of alternative dosing regimens. We included 57 patients and recorded their characteristics during 32 weeks after starting with ustekinumab therapy. Serum ustekinumab concentration was prospectively measured and fecal calprotectin (FC) concentration was used to monitor the disease activity. Ustekinumab PK-PD was described by a two-compartment target-mediated drug disposition model linked to an indirect response model. Lower fat-free mass, higher serum albumin, previous non-exposure to biologics,

Indexed as

fecal calprotectininflammatory bowel diseasepharmacokinetics-pharmacodynamicstherapeutic drug monitoringustekinumab

Identifiers

PMID34683880
PMCPMC8538292
OpenAlexW3204717716

What OpenQuestion holds

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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.