Evidence map›Paper›PMID 34049857›Full record

Trial reportAnnals of the rheumatic diseases2021

Treatment failure in giant cell arteritis.

Sebastian H Unizony, Min Bao, Jian Han, Yves Luder, Andrey Pavlov, John H Stone

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

Trial report in Annals of the rheumatic diseases, 2021. 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 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
5.0field-weighted citation impact, top 4% 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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Advances and challenges in management of large vessel vasculitis.Rheumatology and immunology research · 2023
    Article
  13. Review
  14. Observational
  15. Article
  16. Article
  17. Advances in the Treatment of Giant Cell Arteritis.Journal of clinical medicine · 2022
    Review
  18. Review
  19. Review
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

6 authors at 2 institutions in 2 countries.

Sebastian H UnizonyVasculitis and Glomerulonephritis Center, Rheumatology, Immunology and Allergy Division, Massachusetts General Hospital, Boston, Massachusetts, USA.
Min BaoGenentech Inc, South San Francisco, California, USA.
Jian HanGenentech Inc, South San Francisco, California, USA.
Yves LuderF Hoffmann-La Roche Ltd, Basel, Switzerland.
Andrey PavlovEverest Clinical Research, Markham, Ontario, Canada.
John H StoneVasculitis and Glomerulonephritis Center, Rheumatology, Immunology and Allergy Division, Massachusetts General Hospital, Boston, Massachusetts, USA JHSTONE@mgh.harvard.edu.ORCID 0000-0001-6588-9435
Massachusetts General Hospital · USRoche (Switzerland) · CH

Funding

Targeting T cell Subsets in Autoimmune DiseaseUM1AI144295 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI John H Stone · 2019 to 2026
$1.4M
NIAID NIH HHS UM1 AI144295
6 · The paper itself

Abstract

objectiveIdentify predictors of treatment failure in patients with giant cell arteritis (GCA) receiving tocilizumab in combination with glucocorticoids and in patients with GCA receiving only glucocorticoids.

methodsPosthoc analysis of the Giant-Cell Arteritis Actemra trial including 250 patients who received tocilizumab every week plus a 26-week prednisone taper (n=100), tocilizumab every-other-week plus a 26-week prednisone taper (n=49) or placebo plus a 26-week (n=50) or 52-week (n=51) prednisone taper in the intention-to-treat population. Responders for this analysis were patients who maintained remission (no GCA signs/symptoms and no erythrocyte sedimentation rate elevation) through week 52. Treatment failure was defined as inability to achieve remission by week 12 or relapse between weeks 12 and 52. Predictors investigated in univariate and multivariable analyses included patient characteristics, disease-related and treatment-related factors and patient-reported outcomes (PROs).

results149 patients received tocilizumab plus prednisone (TCZ/PDN) and 101 received placebo plus prednisone (PBO+PDN). After adjustment for confounders, treatment failure was significantly less likely in the TCZ/PDN group than the PBO/PDN group (OR, 0.2; 95% CI, 0.1 to 0.3; p<0.0001). Risk for treatment failure was significantly higher in women than men in the PBO/PDN group (OR, 5.2; 95% CI, 1.6 to 17.2; p=0.007) but not in the TCZ/PDN group. Predictors of treatment failure in the TCZ/PDN group included lower baseline prednisone doses and worse PROs at baseline.

conclusionThe strongest risk factors for treatment failure in GCA are treatment with prednisone alone and female sex. Lower starting prednisone doses and impaired PROs are associated with failure to respond to tocilizumab. TRIAL REGISTRATION NUMBER: NCT01791153.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsDrug Therapy, CombinationFemaleGiant Cell ArteritisGlucocorticoidsHumansMaleMiddle AgedPatient Reported Outcome MeasuresPrednisonePrognosisRisk FactorsSex FactorsTreatment FailureAntibodies, Monoclonal, HumanizedAntirheumatic AgentsGlucocorticoidsPrednisonetocilizumabbiological therapygiant cell arteritisglucocorticoids

Identifiers

PMID34049857
PMCPMC8522464
OpenAlexW3165270842

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.