Evidence map›Paper›PMID 28789636›Full record

ArticleBMC gastroenterology2017

Drug persistence and need for dose intensification to adalimumab therapy; the importance of therapeutic drug monitoring in inflammatory bowel diseases.

Lorant Gonczi, Zsuzsanna Kurti, Mariann Rutka, Zsuzsanna Vegh, Klaudia Farkas, Barbara D Lovasz, Petra A Golovics, Krisztina B Gecse, Balazs Szalay, Tamas Molnar and 1 more

Abstract readEvaluation Study
In one paragraph

Article in BMC gastroenterology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
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

14 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
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  10. Review
  11. Article
  12. Determination of lower cut-off levels of adalimumab associated with biochemical remission in Crohn's disease.JGH open : an open access journal of gastroenterology and hepatology · 2020
    Article
  13. Observational
  14. Accuracy of the new rapid test for monitoring adalimumab levels.Therapeutic advances in gastroenterology · 2019
    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

11 authors.

Lorant GoncziFirst Department of Medicine, Semmelweis University, Koranyi S 2A, Budapest, H-1083, Hungary.
Zsuzsanna KurtiFirst Department of Medicine, Semmelweis University, Koranyi S 2A, Budapest, H-1083, Hungary.
Mariann RutkaFirst Department of Medicine, University of Szeged, Szeged, Hungary.
Zsuzsanna VeghFirst Department of Medicine, Semmelweis University, Koranyi S 2A, Budapest, H-1083, Hungary.
Klaudia FarkasFirst Department of Medicine, University of Szeged, Szeged, Hungary.
Barbara D LovaszFirst Department of Medicine, Semmelweis University, Koranyi S 2A, Budapest, H-1083, Hungary.
Petra A GolovicsFirst Department of Medicine, Semmelweis University, Koranyi S 2A, Budapest, H-1083, Hungary.
Krisztina B GecseFirst Department of Medicine, Semmelweis University, Koranyi S 2A, Budapest, H-1083, Hungary.
Balazs SzalayDepartment of Laboratory Medicine, Semmelweis University, Budapest, Hungary.
Tamas MolnarFirst Department of Medicine, University of Szeged, Szeged, Hungary.
Peter L LakatosFirst Department of Medicine, Semmelweis University, Koranyi S 2A, Budapest, H-1083, Hungary. Peter.Lakatos@muhc.mcgill.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTherapeutic drug monitoring (TDM) aid therapeutic decision making in patients with inflammatory bowel disease (IBD) who lose response to anti-TNF therapy. Our aim was to evaluate the frequency and predictive factors of loss of response (LOR) to adalimumab using TDM in IBD patients.

methodsOne hundred twelve IBD patients (with 214 TDM measurements, CD/UC 84/28, male/female 50/62, mean age CD/UC: 36/35 years) were enrolled in this consecutive cohort from two referral centres in Hungary. Demographic data were comprehensively collected and harmonized monitoring strategy was applied. Previous and current therapy, laboratory data and clinical activity were recorded at the time of TDM. Patients were evaluated either at the time of suspected LOR or during follow-up. TDM measurements were determined by commercial ELISA (LISA TRACKER, Theradiag, France).

resultsAmong 112 IBD patients, LOR/drug persistence was 25.9%/74.1%. The cumulative ADA positivity (>10 ng/mL) and low TL (<5.0 μg/mL) was 12.1% and 17.8% after 1 year and 17.3% and 29.5% after 2 years of adalimumab therapy. Dose intensification was needed in 29.5% of the patients. Female gender and ADA positivity were associated with LOR (female gender: p < 0.001, OR:7.8 CI 95%: 2.5-24.3, ADA positivity: p = 0.007 OR:3.6 CI 95%: 1.4-9.5).

conclusionsADA development, low TL and need for dose intensification were frequent during adalimumab therapy and support the selective use of TDM in IBD patients treated with adalimumab. ADA positivity and gender were predictors of LOR.

Indexed as

AdalimumabAdultAnti-Inflammatory AgentsCohort StudiesColitis, UlcerativeCrohn DiseaseDose-Response Relationship, DrugDrug MonitoringDrug ToleranceEnzyme-Linked Immunosorbent AssayFemaleFollow-Up StudiesHumansHungaryMaleTreatment OutcomeAdalimumabAnti-Inflammatory AgentsAdalimumabInflammatory bowel diseasesLoss of responseTherapeutic drug monitoring

Identifiers

PMID28789636
PMCPMC5549364

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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.