Evidence map›Paper›PMID 34718434›Full record

Trial reportRheumatology (Oxford, England)2022

New-onset versus relapsing giant cell arteritis treated with tocilizumab: 3-year results from a randomized controlled trial and extension.

John H Stone, Helen Spotswood, Sebastian H Unizony, Martin Aringer, Daniel Blockmans, Elisabeth Brouwer, Maria C Cid, Bhaskar Dasgupta, Juergen Rech, Carlo Salvarani and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01791153 (A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
6.3field-weighted citation impact, top 3% 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.

NCT01791153 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis

TypeinterventionalSponsorHoffmann-La RocheRan2013 to 2018Enrolled251ConditionsGiant Cell ArteritisArmsTocilizumab, Prednisone, Tocilizumab Placebo, Prednisone Placebo, Corticosteroids
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Observational
  6. Article
  7. Review
  8. Article
  9. Advances and challenges in management of large vessel vasculitis.Rheumatology and immunology research · 2023
    Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Treatment of Giant Cell Arteritis (GCA).Journal of clinical medicine · 2022
    Review
  15. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 6 countries.

John H StoneMassachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA, USA.ORCID 0000-0001-6588-9435
Helen SpotswoodRoche Products Ltd, Welwyn Garden City, UK.
Sebastian H UnizonyMassachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA, USA.
Martin AringerUniversity Medical Center and Faculty of Medicine, TU Dresden, Dresden, Germany.ORCID 0000-0003-4471-8375
Daniel BlockmansDepartment of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium.
Elisabeth BrouwerDepartment of Rheumatology and Clinical Immunology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Maria C CidDepartment of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
Bhaskar DasguptaMid and South Essex NHS Foundation Trust, Southend University Hospital, Westcliff-on-Sea, UK.
Juergen RechDepartment of Internal Medicine 3-Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg, Universitätsklinikum Erlangen, Erlangen, Germany.
Carlo SalvaraniDivision of Rheumatology, AUSL IRCCS Reggio Emilia and University of Modena and Reggio Emilia, Reggio Emilia, Italy.
Robert SpieraDepartment of Medicine, Hospital for Special Surgery, New York, NY.
Min BaoGenentech, South San Francisco, CA, USA.
Harvard University · USFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHospital for Special Surgery · USRoche (United Kingdom) · GBSouthend University Hospital NHS Foundation Trust · GBTechnische Universität Dresden · DEUniversitat de Barcelona · ESUniversity Medical Center Groningen · NLUniversity of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTocilizumab plus prednisone induces sustained glucocorticoid-free remission in patients with GCA. However, its long-term benefits in new-onset vs relapsing disease are uncertain, and the value of weekly vs every-other-week dosing has not been evaluated.

methodsIn Giant-Cell Arteritis Actemra (GiACTA) part 1, patients with new-onset or relapsing GCA received blinded tocilizumab weekly (TCZ QW), tocilizumab every-other-week (TCZ Q2W) or placebo for 52 weeks, with a prednisone taper. In part 2 (open-label), patients were treated at investigator discretion for 104 weeks. In this analysis, patients were evaluated according to their original treatment assignments, and outcomes beyond 52 weeks were assessed. Outcomes of interest included time to first flare and cumulative glucocorticoid exposure over 3 years according to baseline disease status.

resultsPart 1 enrolled 250 patients; 215 entered part 2. At baseline, 48% had new-onset disease and 52% had relapsing disease. In patients with new-onset and relapsing disease, the median time to first flare in the TCZ QW group was 577 and 575 days, respectively, vs 479 and 428 days with TCZ Q2W and 179 and 224 days with placebo; the median cumulative glucocorticoid dose was 3068 mg and 2191 mg with TCZ QW, 4080 mg and 2353 mg with TCZ Q2W, and 4639 mg and 6178 mg with placebo.

conclusionTCZ QW delayed the time to flare and reduced the cumulative glucocorticoid dose in patients with relapsing GCA and new-onset GCA. These data support initiating TCZ QW as part of first-line therapy in all patients with active GCA.

trial registrationClinicalTrials.gov, https://clinicaltrials.gov, NCT01791153.

Indexed as

Giant Cell ArteritisAntibodies, Monoclonal, HumanizedGlucocorticoidsHumansPrednisoneTreatment OutcomeAntibodies, Monoclonal, HumanizedGlucocorticoidsPrednisonetocilizumabbiologic therapiescardiovascularclinical trials and methodsgiant cell arteritisinflammation

Identifiers

PMID34718434
PMCPMC9258533
OpenAlexW3211287668

What OpenQuestion holds

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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.