Evidence map›Paper›PMID 30835950›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2019

Glucocorticoid Dosages and Acute-Phase Reactant Levels at Giant Cell Arteritis Flare in a Randomized Trial of Tocilizumab.

John H Stone, Katie Tuckwell, Sophie Dimonaco, Micki Klearman, Martin Aringer, Daniel Blockmans, Elisabeth Brouwer, Maria C Cid, Bhaskar Dasgupta, Juergen Rech and 6 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 6 pooled it
–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

46 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Tocilizumab for giant cell arteritis.The Cochrane database of systematic reviews · 2022
    Pooled it
  6. Tocilizumab for giant cell arteritis.The Cochrane database of systematic reviews · 2021
    Pooled it
  7. Trial
  8. Trial
  9. Treatment failure in giant cell arteritis.Annals of the rheumatic diseases · 2021
    Trial
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Observational
  17. Review
  18. Article
  19. Article
  20. Nature communications · 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

16 authors.

John H StoneMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Katie TuckwellGenentech, San Francisco, California.
Sophie DimonacoRoche Products Ltd., Welwyn Garden City, UK.
Micki KlearmanGenentech, San Francisco, California.
Martin AringerUniversity Medical Center and Technische Universität Dresden, Dresden, Germany.
Daniel BlockmansUniversity Hospitals Gasthuisberg, Leuven, Belgium.ORCID 0000-0001-9783-1780
Elisabeth BrouwerUniversity of Groningen and University Medical Center Groningen, Groningen, The Netherlands.
Maria C CidUniversity Hospital Clínic de Barcelona and University of Barcelona, Barcelona, Spain.
Bhaskar DasguptaSouthend University Hospital, NHS Foundation Trust, Southend, UK.
Juergen RechUniversitätsklinikum Erlangen, Erlangen, Germany.
Carlo SalvaraniAzienda USL-IRCCS di Reggio Emilia and Università di Modena and Reggio Emilia, Reggio Emilia, Italy.
Hendrik Schulze-KoopsUniversity of Munich, Munich, Germany.
Georg SchettUniversitätsklinikum Erlangen, Erlangen, Germany.
Robert SpieraHospital for Special Surgery, New York, New York.
Sebastian H UnizonyMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Neil CollinsonRoche Products Ltd., Welwyn Garden City, UK.

Funding

F. Hoffmann-La Roche
6 · The paper itself

Abstract

objectiveThis study was undertaken to evaluate glucocorticoid dosages and serologic findings in patients with giant cell arteritis (GCA) flares.

methodsPatients with GCA were randomly assigned to receive double-blind dosing with either subcutaneous tocilizumab (TCZ) 162 mg weekly plus 26-week prednisone taper (TCZ-QW + Pred-26), every-other-week TCZ plus 26-week prednisone taper (TCZ-Q2W + Pred-26), placebo plus 26-week prednisone taper (PBO + Pred-26), or placebo plus 52-week prednisone taper (PBO + Pred-52). Outcome measures were prednisone dosage, C-reactive protein (CRP) level, and erythrocyte sedimentation rate (ESR) at the time of flare.

resultsOne hundred patients received TCZ-QW + Pred-26, 49 received TCZ-Q2W + Pred-26, 50 received PBO + Pred-26, and 51 received PBO + Pred-52. Of the 149 TCZ-treated patients, 36 (24%) experienced flare, 23 (64%) of whom were still receiving prednisone (median dosage 2.0 mg/day). Among 101 PBO + Pred-treated patients, 59 (58%) experienced flare, 45 (76%) of whom were receiving prednisone (median dosage 5.0 mg/day). Many flares occurred while patients were taking >10 mg/day prednisone: 9 (25%) in the TCZ groups and 13 (22%) in the placebo groups. Thirty-three flares (92%) in TCZ-treated groups and 20 (34%) in PBO + Pred-treated groups occurred with normal CRP levels. More than half of the PBO + Pred-treated patients had elevated CRP levels without flares. Benefits of the TCZ and prednisone combination over prednisone alone for remission induction were apparent by 8 weeks.

conclusionMost GCA flares occurred while patients were still receiving prednisone. Acute-phase reactant levels were not reliable indicators of flare in patients treated with TCZ plus prednisone or with prednisone alone. The addition of TCZ to prednisone facilitates earlier GCA control.

Indexed as

Acute-Phase ProteinsAntibodies, Monoclonal, HumanizedBlood SedimentationC-Reactive ProteinDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleGiant Cell ArteritisGlucocorticoidsHumansInduction ChemotherapyMaleMiddle AgedPrednisoneSymptom Flare UpAcute-Phase ProteinsAntibodies, Monoclonal, HumanizedC-Reactive ProteinGlucocorticoidsPrednisonetocilizumab

Identifiers

PMID30835950
PMCPMC6772126

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LicenceCC BY-NC-ND
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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.