Evidence map›Paper›PMID 30928454›Full record

ArticleClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2019

Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases.

Konstantinos Papamichael, Adam S Cheifetz, Gil Y Melmed, Peter M Irving, Niels Vande Casteele, Patricia L Kozuch, Laura E Raffals, Leonard Baidoo, Brian Bressler, Shane M Devlin and 6 more

Open access · greenAbstract readConsensus Statement
In one paragraph

Article in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 167 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
167citing papers in PubMed, 4 pooled it
31.5field-weighted citation impact, top 1% 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

167 citing papers in PubMed, 4 syntheses or guidelines pooled it, 321 citations in OpenAlex.

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107 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 14 institutions in 4 countries.

Konstantinos PapamichaelBeth Israel Deaconess Medical Center, Boston, Massachusetts.
Adam S CheifetzBeth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: acheifet@bidmc.harvard.edu.
Gil Y MelmedCedars-Sinai Medical Center, Los Angeles, California.
Peter M IrvingGuy's and St. Thomas' Hospitals, London, United Kingdom.
Niels Vande CasteeleUniversity of California San Diego, La Jolla, California.
Patricia L KozuchThomas Jefferson University, Philadelphia, Pennsylvania.
Laura E RaffalsMayo Clinic, Rochester, Minnesota.
Leonard BaidooNorthwestern University Feinberg School of Medicine, Chicago, Illinois.
Brian BresslerUniversity of British Columbia, Vancouver, Canada.
Shane M DevlinUniversity of Calgary, Calgary, Alberta, Canada.
Jennifer JonesDalhousie University, Halifax, Canada.
Gilaad G KaplanUniversity of Calgary, Calgary, Alberta, Canada.
Miles P SparrowAlfred Hospital, Melbourne, Australia.
Fernando S VelayosUniversity of California San Francisco, San Francisco, California.
Thomas UllmanMontefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.
Corey A SiegelDartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Beth Israel Deaconess Medical Center · USUniversity of Calgary · CACedars-Sinai Medical Center · USDalhousie University · CADartmouth–Hitchcock Medical Center · USMayo Clinic · USMontefiore Medical Center · USNorthwestern University · USSt Thomas' Hospital · GBThe Alfred Hospital · AUThomas Jefferson University · USUniversity of British Columbia · CAUniversity of California San Diego · USUniversity of California, San Francisco · US

Funding

RESEARCH TRAINING IN GASTROENTEROLOGYT32DK007760 · NIDDK · BETH ISRAEL DEACONESS MEDICAL CENTER · PI KELLY, CIARAN P · 1999 to 2019
$4.6M
NIDDK NIH HHS T32 DK007760
6 · The paper itself

Abstract

BACKGROUND &

aimsTherapeutic drug monitoring (TDM) is widely available for biologic therapies in patients with inflammatory bowel disease (IBD). We reviewed current data and provided expert opinion regarding the clinical utility of TDM for biologic therapies in IBD.

methodsWe used a modified Delphi method to establish consensus. A comprehensive literature review was performed regarding the use of TDM of biologic therapy in IBD and presented to international IBD specialists. Subsequently, 28 statements on the application of TDM in clinical practice were rated on a scale of 1 to 10 (1 = strongly disagree and 10 = strongly agree) by each of the panellists. Statements were accepted if 80% or more of the participants agreed with a score ≥7. The remaining statements were discussed and revised based on the available evidence followed by a second round of voting.

resultsThe panel agreed on 24 (86%) statements. For anti-tumor necrosis factor (anti-TNF) therapies, proactive TDM was found to be appropriate after induction and at least once during maintenance therapy, but this was not the case for the other biologics. Reactive TDM was appropriate for all agents both for primary non-response and secondary loss of response. The panellists also agreed on several statements regarding TDM and appropriate drug and anti-drug antibody (ADA) concentration thresholds for biologics in specific clinical scenarios.

conclusionConsensus was achieved towards the utility of TDM of biologics in IBD, particularly anti-TNF therapies. More data are needed especially on non-anti-TNF biologics to further define optimal drug concentration and ADA thresholds as these can vary depending on the therapeutic outcomes assessed.

Indexed as

AntibodiesAntibodies, Monoclonal, HumanizedBiological ProductsDelphi TechniqueDrug MonitoringGastrointestinal AgentsHumansImmunologic FactorsInflammatory Bowel DiseasesNatalizumabTreatment OutcomeTumor Necrosis Factor InhibitorsUstekinumabAntibodiesAntibodies, Monoclonal, HumanizedBiological ProductsGastrointestinal AgentsImmunologic FactorsNatalizumabTumor Necrosis Factor InhibitorsUstekinumabvedolizumabAnti-TNFConsensus StatementCrohn’s DiseaseImmunogenicityUlcerative ColitisUstekinumabVedolizumab

Identifiers

PMID30928454
PMCPMC6661210
OpenAlexW2923576761

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.