Evidence map›Paper›PMID 31783773›Full record

Trial reportArthritis research & therapy2019

Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study.

Johanna Elin Gehin, Guro Løvik Goll, David John Warren, Silje Watterdal Syversen, Joseph Sexton, Eldri Kveine Strand, Tore Kristian Kvien, Nils Bolstad, Elisabeth Lie

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01581294 (Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% 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.

NCT01581294 recruitingnot on this map

Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study

TypeobservationalSponsorDiakonhjemmet HospitalRan2012 to 2050Enrolled15,000ConditionsInflammatory Joint Diseases
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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

9 authors at 3 institutions in 1 country.

Johanna Elin GehinDepartment of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Nydalen, Box 4953, 0424, Oslo, Norway. johgeh@ous-hf.no.ORCID 0000-0002-9896-0223
Guro Løvik GollDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
David John WarrenDepartment of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Nydalen, Box 4953, 0424, Oslo, Norway.
Silje Watterdal SyversenDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Joseph SextonDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Eldri Kveine StrandLillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway.
Tore Kristian KvienFaculty of Medicine, University of Oslo, Oslo, Norway.
Nils BolstadDepartment of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Nydalen, Box 4953, 0424, Oslo, Norway.
Elisabeth LieDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
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 a therapeutic target interval for certolizumab pegol drug levels and examine the influence of anti-drug antibodies in patients with inflammatory joint diseases.

methodsCertolizumab pegol and anti-drug antibody levels were measured in serum samples collected after 3 months of certolizumab pegol treatment in 268 patients with inflammatory joint diseases (116 axial spondyloarthritis, 91 rheumatoid arthritis and 61 psoriatic arthritis) in the NOR-DMARD study. Treatment response was defined by Ankylosing Spondylitis Disease Activity Score Clinically important improvement in axial spondyloarthritis, European League Against Rheumatism good/moderate response in rheumatoid arthritis, and improvement in 28-joint Disease Activity Score of ≥ 0.6 in PsA. Serum drug levels and anti-drug antibodies were analysed using automated in-house assays.

resultsCertolizumab pegol serum levels varied considerably between individuals (median (IQR) 32.9 (17.3-43.9) mg/L). Certolizumab pegol level ≥ 20 mg/L was associated with treatment response for the total inflammatory joint disease population, with odds ratio (OR) 2.3 (95% CI 1.2-4.5, P = 0.01) and OR 1.9 (95% CI 1.0-3.5, P = 0.05) after 3 and 6 months of treatment, respectively. For individual diagnoses, this association was most consistent for axial spondyloarthritis, with OR 3.4 (95% CI 1.0-11.1, P < 0.05) and OR 3.3 (95% CI 1.0-10.8, P < 0.05), respectively. Certolizumab pegol level > 40 mg/L was not associated with any additional benefit for any of the diagnoses. Anti-drug antibodies were detected in 6.1% (19/310) of samples and were associated with low certolizumab pegol levels (P < 0.01).

conclusionsSerum certolizumab pegol levels 20-40 mg/L were associated with treatment response in inflammatory joint diseases. Our study is the first to show this association in axial spondyloarthritis and psoriatic arthritis patients. The results suggest a possible benefit of therapeutic drug monitoring in patients with inflammatory joint disease on certolizumab pegol treatment.

trial registrationNCT01581294, April 2012.

Indexed as

AdultAntibodiesAntirheumatic AgentsArthritis, PsoriaticArthritis, RheumatoidCertolizumab PegolFemaleHumansLongitudinal StudiesMaleMiddle AgedSpondylarthritisSpondylitis, AnkylosingTreatment OutcomeAntibodiesAntirheumatic AgentsCertolizumab PegolAnti-drug antibodiesAxial spondyloarthritisCertolizumab pegolInflammatory joint diseasesPsoriatic arthritisRheumatoid arthritisSerum drug levelsTNF-inhibitors

Identifiers

PMID31783773
PMCPMC6883678
OpenAlexW2990715705

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.