Evidence map›Paper›PMID 30564993›Full record

Trial reportThe AAPS journal2018

Golimumab Dried Blood Spot Analysis (GOUDA): a Prospective Trial Showing Excellent Correlation with Venepuncture Samples and More Detailed Pharmacokinetic Information.

Iris Detrez, Ganel Schops, Jolien Lefrère, Sophie Tops, Gert Van Assche, Séverine Vermeire, Wouter Van Moerkercke, Marc Ferrante, Ann Gils

Abstract readClinical TrialMulticenter StudyValidation Study
PubMed Publisher
In one paragraph

Trial report in The AAPS journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

5 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
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

9 authors at 2 institutions in 1 country.

Iris DetrezDepartment of Pharmaceutical and Pharmacological Sciences, Laboratory for Therapeutic and Diagnostic Antibodies, KU Leuven, Leuven, Belgium. Iris.Detrez@kuleuven.be.
Ganel SchopsDepartment of Gastroenterology and Hepatology, Translational Research in Gastrointestinal Disorders, UZ Leuven, KU Leuven, Leuven, Belgium.
Jolien LefrèreDepartment of Gastroenterology and Hepatology, Translational Research in Gastrointestinal Disorders, UZ Leuven, KU Leuven, Leuven, Belgium.
Sophie TopsDepartment of Pharmaceutical and Pharmacological Sciences, Laboratory for Therapeutic and Diagnostic Antibodies, KU Leuven, Leuven, Belgium.
Gert Van AsscheDepartment of Gastroenterology and Hepatology, Translational Research in Gastrointestinal Disorders, UZ Leuven, KU Leuven, Leuven, Belgium.
Séverine VermeireDepartment of Gastroenterology and Hepatology, Translational Research in Gastrointestinal Disorders, UZ Leuven, KU Leuven, Leuven, Belgium.
Wouter Van MoerkerckeDepartment of Gastroenterology and Hepatology, Translational Research in Gastrointestinal Disorders, UZ Leuven, KU Leuven, Leuven, Belgium.
Marc FerranteDepartment of Gastroenterology and Hepatology, Translational Research in Gastrointestinal Disorders, UZ Leuven, KU Leuven, Leuven, Belgium.
Ann GilsDepartment of Pharmaceutical and Pharmacological Sciences, Laboratory for Therapeutic and Diagnostic Antibodies, KU Leuven, Leuven, Belgium.
KU Leuven · BEUniversitair Ziekenhuis Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Development of a dried blood spot (DBS) method for golimumab will facilitate sample collection in a study setting and will give a more complete insight in the total drug exposure (area under the curve, AUC). We established a DBS method and assessed its robustness, user-friendliness and clinical usefulness in 10 patients with ulcerative colitis during golimumab induction and maintenance regimens. DBS was obtained through spotting of golimumab spiked in whole citrated blood to a filter paper. Several extraction conditions were evaluated and the selected extraction condition analytically validated. In a clinical setting, DBS and serum samples were taken simultaneously through intensive sampling regimens and a conversion factor was determined. Golimumab concentrations were measured using an in-house-developed ELISA and a CE-marked ELISA kit. User-friendliness was evaluated using a questionnaire. Mucosal healing was evaluated at week 14. A total of 79 matched pairs of serum and DBS sample golimumab concentrations revealed an overall conversion factor of 3.9. DBS golimumab concentrations after conversion correlated strongly with serum golimumab concentrations (ICC = 0.984). During induction, no linear correlation was found between golimumab trough concentration (TC) and AUC (R

Indexed as

AdultAntibodies, MonoclonalAnti-Inflammatory AgentsArea Under CurveColitis, UlcerativeDried Blood Spot TestingDrug MonitoringEnzyme-Linked Immunosorbent AssayFemaleHumansMaleMiddle AgedPhlebotomyProspective StudiesRemission InductionReproducibility of ResultsAntibodies, MonoclonalAnti-Inflammatory Agentsgolimumabdried blood spotsgolimumabimmunogenicitypharmacokineticsulcerative colitis

Identifiers

PMID30564993
OpenAlexW2905446203

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.