Evidence map›Paper›PMID 37626399›Full record

ArticleArthritis research & therapy2023

Extracellular matrix turnover biomarkers reflect pharmacodynamic effects and treatment response of adalimumab in patients with axial spondyloarthritis-results from two randomized controlled trials.

Helena Port, Signe Holm Nielsen, Peder Frederiksen, Sofie Falkenløve Madsen, Anne-Christine Bay-Jensen, Inge Juul Sørensen, Bente Jensen, Anne Gitte Loft, Ole Rintek Madsen, Mikkel Østergaard and 1 more

Open access · goldAbstract read
In one paragraph

Article in Arthritis research & therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 22% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Biomarkers of Extracellular Matrix Fragments in Patients with Psoriasis.International journal of molecular sciences · 2024
    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 at 5 institutions in 1 country.

Helena PortDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. hep@nordicbio.com.
Signe Holm NielsenNordic Bioscience A/S, Immunoscience, Herlev, Denmark.
Peder FrederiksenNordic Bioscience A/S, Immunoscience, Herlev, Denmark.
Sofie Falkenløve MadsenNordic Bioscience A/S, Immunoscience, Herlev, Denmark.
Anne-Christine Bay-JensenNordic Bioscience A/S, Immunoscience, Herlev, Denmark.
Inge Juul SørensenDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Bente JensenDepartment of Rheumatology and Spine Diseases, Righospitalet, Copenhagen, Denmark.
Anne Gitte LoftDepartment of Rheumatology, Aarhus University Hospital, Aarhus, Denmark.
Ole Rintek MadsenDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Mikkel ØstergaardDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Susanne Juhl PedersenDepartment of Rheumatology and Spine Diseases, Righospitalet, Copenhagen, Denmark.
Rigshospitalet · DKUniversity of Copenhagen · DKNordic Bioscience (Denmark) · DKAarhus University · DKTechnical University of Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate if extracellular matrix (ECM) blood-based biomarkers reflect the pharmacodynamic effect and response to TNF-α inhibitor therapy (adalimumab, ADA), in patients with axial spondyloarthritis (axSpA).

methodsWe investigated ECM biomarkers in two randomized, double-blind, placebo-controlled trials of axSpA patients (DANISH and ASIM, n = 52 and n = 49, respectively) receiving ADA 40 mg or placebo every other week for 12 and 6 weeks, respectively, and thereafter ADA to week 48. Serum concentrations of degraded type I (C1M), II (C2M, T2CM), III (C3M), IV (C4M), VI (C6M), type X (C10C) collagen; metabolite of C-reactive protein (CRPM), prolargin (PROM), citrullinated vimentin (VICM), calprotectin (CPa9-HNE); and formation of type II (PRO‑C2), III (PRO‑C3), and VI (PRO‑C6) turnover of type IV collagen (PRO-C4) were measured at baseline and weeks 6 or 12, 24, and 48. The pharmacodynamic effect and treatment response to ADA was evaluated by linear mixed models, and correlations between biomarkers and clinical scores were assessed by Spearman's correlation.

resultsC1M, C3M, C4M, C6M, CRP, PRO-C4, and CPa9-HNE levels declined after 6 or 12 weeks in patients receiving ADA compared to placebo (all p < 0.05). Patients with AS Disease Activity Score C-reactive protein (ASDAS CRP) major improvement and/or clinically important improvement had significantly higher C1M, C3M, C4M, C6M, and PRO-C4 levels than patients with no/low improvement at baseline (all p < 0.05). Baseline levels of biomarkers showed weak to moderate correlations with ASDAS and structural damage scores.

conclusionECM metabolites showed a pharmacodynamic effect and were associated with ASDAS response during TNF-α inhibitor treatment in patients with axSpA.

Indexed as

Axial SpondyloarthritisC-Reactive ProteinAdalimumabBiomarkersComplement C4Extracellular MatrixHumansRandomized Controlled Trials as TopicTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsAdalimumabBiomarkersComplement C4C-Reactive ProteinTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsAdalimumabAxial spondyloarthritisBiomarkersExtracellular matrix

Identifiers

PMID37626399
PMCPMC10463764
OpenAlexW4386164339

What OpenQuestion holds

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LicenceCC BY
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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.