Evidence map›Paper›PMID 30187153›Full record

ReviewThe AAPS journal2018

Individualized Dosing of Therapeutic Monoclonal Antibodies-a Changing Treatment Paradigm?

Anne S Strik, Yow-Ming C Wang, Laura E Ruff, William Yashar, Bradley T Messmer, Diane R Mould

Open access · hybridAbstract readReview
In one paragraph

Review 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 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
3.4field-weighted citation impact, top 7% 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

15 citing papers in PubMed, 33 citations in OpenAlex.

  1. Review
  2. Article
  3. Clinical pharmacology-how it shapes the drug development journey.European journal of clinical pharmacology · 2025
    Review
  4. Article
  5. Review
  6. Article
  7. Observational
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  9. Review
  10. Article
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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

6 authors at 4 institutions in 2 countries.

Anne S StrikAcademic Medical Center Division of Gastroenterology, Amsterdam, Netherlands.ORCID 0000-0002-8908-0136
Yow-Ming C WangTherapeutic Biologics Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Laura E RuffAbreos Biosciences, San Diego, California, USA.
William YasharAbreos Biosciences, San Diego, California, USA.
Bradley T MessmerAbreos Biosciences, San Diego, California, USA.
Diane R MouldProjections Research Inc., 535 Springview Lane, Phoenixville, Pennsylvania, 19460, USA. drmould@pri-home.net.
Abreos Biosciences (United States) · USAmsterdam UMC Location University of Amsterdam · NLCenter for Drug Evaluation and Research · USSpringhouse · US

Funding

Personalized precision dosing of anti-TNF biologic therapiesR44AI138838 · NIAID · ABREOS BIOSCIENCES, INC. · PI MESSMER, BRADLEY T · 2018 to 2020
$1.9M
NIAID NIH HHS R44 AI138838
6 · The paper itself

Abstract

The introduction of monoclonal antibodies (mAbs) to the treatment of inflammatory bowel disease (IBD) was an important medical milestone. MAbs have been demonstrated as safe and efficacious treatments of IBD. However, a large percentage of patients either fail to respond initially or lose response to therapy after a period of treatment. Although there are factors associated with poor treatment outcomes in IBD, one cause for treatment failure may be low mAb exposure. Consequently, gastroenterologists have begun using therapeutic drug monitoring (TDM) to guide dose adjustment. However, while beneficial, TDM does not provide sufficient information to effectively adjust doses. The pharmacokinetics (PK) and pharmacodynamics (PD) of mAbs are complex, with numerous factors impacting on mAb PK and PD. The concept of dashboard-guided dosing based on Bayesian PK models allows physicians to combine TDM with factors influencing mAb PK to individualize therapy more effectively. One issue with TDM has been the slow turnaround of assay results, either necessitating an additional clinic visit for a sample or reacting to TDM results at a subsequent, rather than the current, dose. New point-of-care (POC) assays for mAbs are being developed that would potentially allow physicians to determine drug concentration quickly. However, work remains to understand how to determine what target exposure is needed for an individual patient, and whether the combination of POC assays and dashboards presents a safe approach with substantial outcome benefit over the current standard of care.

Indexed as

Antibodies, MonoclonalBayes TheoremBiological ProductsDose-Response Relationship, DrugDrug MonitoringDrug ResistanceHumansImmunoassayInflammatory Bowel DiseasesPoint-of-Care TestingTreatment FailureTumor Necrosis Factor-alphaAntibodies, MonoclonalBiological ProductsTumor Necrosis Factor-alphadashboardinflammatory bowel diseasemonoclonal antibodiespoint of caretherapeutic drug monitoring

Identifiers

PMID30187153
PMCPMC8364290
OpenAlexW2891870805

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.