Evidence map›Paper›PMID 34401983›Full record

Observational studyDigestive diseases and sciences2022

Ustekinumab Therapeutic Drug Monitoring-Impact on Clinical Practice: A Multicenter Cross-Sectional Observational Trial.

Waqqas Afif, Bernie Sattin, Dorota Dajnowiec, Reena Khanna, Cynthia H Seow, Martin Williamson, Kinda Karra, Yanli Wang, Long-Long Gao, Brian Bressler

Open access · hybridAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Digestive diseases and sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 16% 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

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Clinical effectiveness and safety of ustekinumab in youth with refractory inflammatory bowel disease: A retrospective cohort study.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2025
    Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. 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 7 institutions in 3 countries.

Waqqas AfifDivision of Gastroenterology and Hepatology, Department of Medicine, McGill University, Montreal, QC, Canada.
Bernie SattinMedical Affairs, Janssen Inc, Toronto, ON, Canada.
Dorota DajnowiecMedical Affairs, Janssen Inc, Toronto, ON, Canada.
Reena KhannaDivision of Gastroenterology, University of Western Ontario, London, ON, Canada.
Cynthia H SeowDivision of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.
Martin WilliamsonMedical Affairs, Janssen Inc, Toronto, ON, Canada.
Kinda KarraMedical Affairs, Janssen Inc, Toronto, ON, Canada.
Yanli WangJanssen R&D, Spring House, PA, USA.
Long-Long GaoJanssen R&D, Spring House, PA, USA.
Brian BresslerDivision of Gastroenterology, Department of Medicine, Faculty of Medicine, University of British Columbia, 5th Floor, 2775 Laurel Street, Vancouver, BC, V5Z 1M9, Canada. brian_bressler@hotmail.com.ORCID 0000-0003-4740-8209
Janssen (United States) · USEdwards Lifesciences (United States) · USMcGill University · CAMerck Canada Inc. (Canada) · CAUniversity of British Columbia · CAUniversity of Calgary · CAWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsThe value of ustekinumab (UST) therapeutic drug monitoring (TDM) in clinical practice remains unclear. This study examined the impact of UST TDM on clinical decision making in patients with Crohn's disease (CD).

methodsA total of 110 consecutive UST-treated CD patients were enrolled in this multicenter, single-arm cross-sectional study. During a single study visit, clinical decisions, disease characteristics, and serum and fecal samples were obtained. The primary outcome was congruency of the actual and two hypothetical clinical decisions based on provision of UST TDM (with and without fecal calprotectin [FCP]) to participating clinicians. Decisions were compared against those of a review panel. A sub-study retrospectively measured the associations of clinical outcomes at the next follow-up visit with serum UST concentration [UST].

resultsNo differences in the pattern of decisions by clinicians were observed before and after provision of UST TDM (P = 1.0) or UST TDM + FCP (P = 0.86). However, 39% (TDM) and 50% (TDM + FCP) of hypothetical decisions differed from the initial decisions. The review panel's decisions differed with the addition of TDM + FCP (P = 0.0006), but not TDM alone (P = 0.16). The sub-study (n = 53) failed to detect an association between therapeutic serum [UST] at the initial study visit and clinical outcomes at the next visit.

conclusionsIn consecutive CD patients treated with UST, the addition of TDM into routine clinical practice did not significantly impact clinical decisions and there was no association between short-term clinical outcomes and serum [UST]. Further studies are warranted before clinicians routinely implement UST TDM into clinical practice.

Indexed as

Crohn DiseaseUstekinumabCross-Sectional StudiesDrug MonitoringHumansLeukocyte L1 Antigen ComplexRetrospective StudiesLeukocyte L1 Antigen ComplexUstekinumabAnti-drug antibodies to ustekinumabSerum concentrationsTreatment decision makingTreatment optimization

Identifiers

PMID34401983
PMCPMC9237009
OpenAlexW3194479823

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.