Evidence map›Paper›PMID 32514446›Full record

ArticleJGH open : an open access journal of gastroenterology and hepatology2020

Determination of lower cut-off levels of adalimumab associated with biochemical remission in Crohn's disease.

Arne Carlsen, Roald Omdal, Lars Karlsen, Jan Terje Kvaløy, Lars Aabakken, Øyvind Steinsbø, Nils Bolstad, David Warren, Knut Erik Aslaksen Lundin, Tore Grimstad

Open access · goldAbstract read
In one paragraph

Article in JGH open : an open access journal of gastroenterology and hepatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 30% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Comparison of Timing to Develop Anti-Drug Antibodies to Infliximab and Adalimumab Between Adult and Pediatric Age Groups, Males and Females.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022
    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.

Arne CarlsenGastroenterology Unit, Department of Internal Medicine Stavanger University Hospital Stavanger Norway.ORCID https://orcid.org/0000-0002-6005-6394
Roald OmdalDepartment of Clinical Science, Faculty of Medicine University of Bergen Bergen Norway.
Lars KarlsenGastroenterology Unit, Department of Internal Medicine Stavanger University Hospital Stavanger Norway.
Jan Terje KvaløyDepartment of Mathematics and Physics University of Stavanger Stavanger Norway.
Lars AabakkenDepartment of Transplantation Medicine Oslo University Hospital Rikshospitalet Oslo Norway.
Øyvind SteinsbøGastroenterology Unit, Department of Internal Medicine Stavanger University Hospital Stavanger Norway.
Nils BolstadDepartment of Medical Biochemistry Oslo University Hospital Radiumhospitalet Oslo Norway.
David WarrenDepartment of Medical Biochemistry Oslo University Hospital Radiumhospitalet Oslo Norway.
Knut Erik Aslaksen LundinDepartment of Transplantation Medicine Oslo University Hospital Rikshospitalet Oslo Norway.
Tore GrimstadGastroenterology Unit, Department of Internal Medicine Stavanger University Hospital Stavanger Norway.ORCID https://orcid.org/0000-0001-6669-5843
Stavanger University Hospital · NOOslo University Hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimAdalimumab is administered and dosed using a standardized treatment regimen. Although therapeutic drug monitoring (TDM) may help optimize treatment efficacy, the lower cut-off concentration of adalimumab needed to retain disease remission has not been established. This cross-sectional study of patients with Crohn's disease on stable medication aimed to determine a lower therapeutic drug concentration threshold of adalimumab associated with biochemical disease remission.

methodsC-reactive protein (CRP) and fecal calprotectin were used as established markers and albumin as an explorative marker of disease activity. Time since introduction, treatment interval, drug dosage, serum drug concentration and antidrug antibodies, disease duration, age, and sex were recorded.

resultsThe study included 101 patients who were divided into "active disease" and "remission" groups for inflammatory markers based on cut-off levels of 5 mg/L for CRP and 50 mg/kg for fecal calprotectin. Cut-off levels for albumin of 36.5 and 41.5 g/L were also added as further indicatives of remission. Receiver operating characteristic analysis found optimal thresholds for adalimumab associated with remission at 6.8-7.0 mg/L for the combination of CRP and fecal calprotectin and when combining CRP, fecal calprotectin, and albumin.

conclusionsIn patients with Crohn's disease, serum adalimumab of at least 6.8 mg/L was associated with biochemical disease remission based on CRP and fecal calprotectin, supporting the use of TDM to ensure disease control. Albumin should be further tested in this setting.

Indexed as

adalimumabCrohn's diseaselower cut‐offremissiontherapeutic drug monitoring

Identifiers

PMID32514446
PMCPMC7273736
OpenAlexW2979135512

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.