Evidence map›Paper›PMID 34117737›Full record

Trial reportRheumatology (Oxford, England)2021

Quantitative ultrasound to monitor the vascular response to tocilizumab in giant cell arteritis.

Luca Seitz, Lisa Christ, Fabian Lötscher, Godehard Scholz, Adela-Cristina Sarbu, Lukas Bütikofer, Florian Kollert, Wolfgang A Schmidt, Stephan Reichenbach, Peter M Villiger

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03745586 (Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
6.8field-weighted citation impact, top 2% 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.

NCT03745586 phase1 / phase2completednot on this map

Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2018 to 2021Enrolled18ConditionsGiant Cell ArteritisArmsTocilizumab, Glucocorticoids
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. Pooled it
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  3. Review
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  12. Observational
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  15. Review
  16. Diagnosing vasculitis with ultrasound: findings and pitfalls.Therapeutic advances in musculoskeletal disease · 2024
    Review
  17. Article
  18. Review
  19. 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

10 authors at 3 institutions in 2 countries.

Luca SeitzDepartment of Rheumatology and Immunology, Inselspital, Bern University Hospital.ORCID 0000-0002-5051-1445
Lisa ChristDepartment of Rheumatology and Immunology, Inselspital, Bern University Hospital.
Fabian LötscherDepartment of Rheumatology and Immunology, Inselspital, Bern University Hospital.
Godehard ScholzDepartment of Rheumatology and Immunology, Inselspital, Bern University Hospital.
Adela-Cristina SarbuDepartment of Rheumatology and Immunology, Inselspital, Bern University Hospital.
Lukas BütikoferCTU Bern, University of Bern, Bern, Switzerland.
Florian KollertDepartment of Rheumatology and Immunology, Inselspital, Bern University Hospital.ORCID 0000-0002-8172-1285
Wolfgang A SchmidtMedical Centre for Rheumatology, Immanuel Krankenhaus Berlin, Berlin-Buch, Germany.
Stephan ReichenbachDepartment of Rheumatology and Immunology, Inselspital, Bern University Hospital.ORCID 0000-0001-8098-6567
Peter M VilligerDepartment of Rheumatology and Immunology, Inselspital, Bern University Hospital.ORCID 0000-0002-8859-9964
University Hospital of Bern · CHImmanuel Krankenhaus · DEUniversity of Bern · CH

Funding

Research Funds of the Department of Rheumatology, Immunology and Allergology, University Hospital
6 · The paper itself

Abstract

objectivesTo characterize the effect of ultra-short glucocorticoids followed by Tocilizumab monotherapy on the intima-media thickness (IMT) in GCA.

methodsEighteen GCA patients received 500 mg for 3 consecutive days (total of 1500mg) i.v. methylprednisolone on days 0-2, followed by i.v. Tocilizumab (8 mg/kg) on day 3 and thereafter weekly s.c. Tocilizumab injections (162 mg) over 52 weeks. US of temporal (TAs), axillary (AAs) and subclavian (SAs) arteries was performed at baseline, on days 2-3, and at weeks 4, 8, 12, 24 and 52. The largest IMT of all segments and IMT at landmarks of AA/SA were recorded. IMT was scaled by mean normal values and averaged. Each segment was classified according to diagnostic cut-offs.

resultsOf the 18 GCA patients, 16 patients had TA and 6 had extracranial large artery involvement. The IMT showed a sharp decline on day 2/3 in the TAs and AAs/SAs. In TAs, this was followed by an increase to baseline levels at week 4 and a subsequent slow decrease, which was paralleled by decreasing symptoms and achievement of clinical remission. The AAs/SAs showed a new signal of vasculitis at week 4 in three patients, with an IMT increase up to week 8.

conclusionGlucocorticoid pulse therapy induced a transient decrease of the IMT in TAs and AAs/SAs. Tocilizumab monotherapy resulted in a slow and steady decrease in IMT of the TAs and a smaller and delayed effect on the AAs/SAs. The data strongly support a remission-inducing effect of Tocilizumab and argue the case for US having an important role in monitoring disease activity in GCA.

trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT03745586.

Indexed as

AgedAntibodies, Monoclonal, HumanizedArteriesFemaleGiant Cell ArteritisGlucocorticoidsHumansMaleProof of Concept StudyTunica IntimaUltrasonographyAntibodies, Monoclonal, HumanizedGlucocorticoidstocilizumabgiant cell arteritisglucocorticoidstocilizumabultrasoundvascular responsevasculitis

Identifiers

PMID34117737
PMCPMC8566271
OpenAlexW3170644935

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.