Evidence map›Paper›PMID 19297346›Full record

Trial reportAnnals of the rheumatic diseases2010

Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study.

G Jones, A Sebba, J Gu, M B Lowenstein, A Calvo, J J Gomez-Reino, D A Siri, M Tomsic, E Alecock, T Woodworth and 1 more

2 registry-linked trialsOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 310 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
310citing papers in PubMed, 13 pooled it
39.9field-weighted citation impact, top 1% 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.

NCT02087696 phase4unknown statusnot on this mapstarted 2014, after this paper: background citation

Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis and Candidates With a Biological Monotherapy

TypeinterventionalSponsorSpanish Foundation of RheumatologyRan2014 to 2016Enrolled122ConditionsArthritis, RheumatoidArmsTocilizumab
NCT04335071 phase2terminatednot on this mapstarted 2020, after this paper: background citation

CORON-ACT - a Multicenter, Double-blind, Randomized Controlled Phase II Trial on the Efficacy and Safety of Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2020 to 2020Enrolled5ConditionsSARS-CoV-2 InfectionArmsTocilizumab (TCZ), Placebo
3 · Its place in the literature

Who cites it

310 citing papers in PubMed, 13 syntheses or guidelines pooled it, 804 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

250 more citing papers are in PubMed but not listed here.

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 8 institutions in 8 countries.

G JonesMenzies Research Institute, University of Tasmania, Hobart, TAS 7001, Australia. g.jones@utas.edu.au
A Sebba
J Gu
M B Lowenstein
A Calvo
J J Gomez-Reino
D A Siri
M Tomsic
E Alecock
T Woodworth
M C Genovese
Roche (United Kingdom) · GBCentro Peruano de Estudios Sociales · PEInstitute of Physics Rosario · ARLjubljana University Medical Centre · SIStanford University · USSun Yat-sen University · CNUniversidade de Santiago de Compostela · ESUniversity of Tasmania · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe anti-interleukin (IL) 6 receptor antibody tocilizumab inhibits signalling of IL6, a key cytokine in rheumatoid arthritis (RA) pathogenesis.

objectiveTo evaluate through the AMBITION study the efficacy and safety of tocilizumab monotherapy versus methotrexate in patients with active RA for whom previous treatment with methotrexate/biological agents had not failed.

methodsThis 24-week, double-blind, double-dummy, parallel-group study, randomised 673 patients to either tocilizumab 8 mg/kg every 4 weeks, or methotrexate, starting at 7.5 mg/week and titrated to 20 mg/week within 8 weeks, or placebo for 8 weeks followed by tocilizumab 8 mg/kg. The primary end point was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 24.

resultsThe intention-to-treat analysis demonstrated that tocilizumab was better than methotrexate treatment with a higher ACR20 response (69.9 vs 52.5%; p<0.001), and 28-joint Disease Activity Score (DAS28) <2.6 rate (33.6 vs 12.1%) at week 24. Mean high-sensitivity C-reactive protein was within the normal range from week 12 with tocilizumab, whereas levels remained elevated with methotrexate. The incidence of serious adverse events with tocilizumab was 3.8% versus 2.8% with methotrexate (p = 0.50), and of serious infections, 1.4% versus 0.7%, respectively. There was a higher incidence of reversible grade 3 neutropenia (3.1% vs 0.4%) and increased total cholesterol > or =240 mg/dl (13.2% vs 0.4%), and a lower incidence of alanine aminotransferase elevations >3x-<5x upper limit of normal (1.0% vs 2.5%), respectively.

conclusionTocilizumab monotherapy is better than methotrexate monotherapy, with rapid improvement in RA signs and symptoms, and a favourable benefit-risk, in patients for whom treatment with methotrexate or biological agents has not previously failed.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidBiomarkersC-Reactive ProteinDouble-Blind MethodFemaleHumansImmunosuppressive AgentsMaleMethotrexateMiddle AgedReceptors, Interleukin-6Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsBiomarkersC-Reactive ProteinImmunosuppressive AgentsMethotrexateReceptors, Interleukin-6tocilizumab

Identifiers

PMID19297346
PMCPMC3747519
OpenAlexW2096862304

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.