Evidence map›Paper›PMID 34911811›Full record

Observational studyRMD open2021

Serum etanercept concentrations in relation to disease activity and treatment response assessed by ultrasound, biomarkers and clinical disease activity scores: results from a prospective observational study of patients with rheumatoid arthritis.

Johanna Elin Gehin, Silje Watterdal Syversen, David John Warren, Guro Løvik Goll, Joseph Sexton, Nils Bolstad, Hilde Berner Hammer

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in RMD open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 25% 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

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Observational
  5. Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Review
  6. 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

7 authors at 3 institutions in 1 country.

Johanna Elin GehinDepartment of Medical Biochemistry, Oslo University Hospital, Oslo, Norway johgeh@ous-hf.no.ORCID 0000-0002-9896-0223
Silje Watterdal SyversenDivision of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.
David John WarrenDepartment of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.
Guro Løvik GollDivision of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.
Joseph SextonDivision of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.
Nils Bolstad *Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.
Hilde Berner Hammer *Faculty of Medicine, University of Oslo, Oslo, Norway.ORCID 0000-0001-7317-8991
Diakonhjemmet Hospital · NOOslo University Hospital · NOUniversity of Oslo · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo identify the therapeutic range for etanercept and to assess the incidence of anti-etanercept antibody formation.

methodsAssociations between etanercept serum concentration and disease activity as well as treatment response were examined in a longitudinal observational study of rheumatoid arthritis patients starting etanercept. Disease activity was assessed by ultrasound (grey scale and power Doppler), 28-joint Disease Activity Score (DAS28), Simplified Disease Activity Index, plasma calprotectin and C reactive protein. Etanercept concentration and anti-etanercept antibodies were analysed using automated in-house fluorescence assays.

resultsA total of 89 patients were included, whereof 66% were biological disease-modifying antirheumatic drug (DMARD) naïve and 91% used concomitant synthetic DMARD. At 3 months, the median etanercept concentration was 1.8 (IQR 1.1-2.5) mg/L. Longitudinal associations were found between etanercept concentration and disease activity assessed by plasma calprotectin, C reactive protein and DAS28, but not between etanercept concentration and improvement in disease activity by any of the parameters at 3, 6 or 12 months of treatment. Etanercept concentrations were not significantly different among patients who achieved response or remission, compared with non-response or non-remission. Hence, no therapeutic range could be identified. None of the patients developed anti-etanercept antibodies.

conclusionDespite the use of sensitive and objective markers of inflammation, a therapeutic range could not be identified for etanercept. Hence, this study suggests that proactive therapeutic drug monitoring is unlikely to benefit rheumatoid arthritis patients treated with etanercept, but a potential benefit in certain clinical situations cannot be excluded.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBiomarkersEtanerceptHumansUltrasonography, DopplerAntirheumatic AgentsBiomarkersEtanerceptetanerceptpharmacokineticsrheumatoid arthritistumor necrosis factor inhibitors

Identifiers

PMID34911811
PMCPMC8679136
OpenAlexW4200156511

What OpenQuestion holds

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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.