Evidence map›Paper›PMID 28389552›Full record

Trial reportAnnals of the rheumatic diseases2017

Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial.

Gerd R Burmester, William F Rigby, Ronald F van Vollenhoven, Jonathan Kay, Andrea Rubbert-Roth, Ricardo Blanco, Alysha Kadva, Sophie Dimonaco

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01007435 (A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab), which is not on this map. Cited by 49 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 8 pooled it
10.4field-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.

NCT01007435 phase3completednot on this map

A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis

TypeinterventionalSponsorHoffmann-La RocheRan2009 to 2014Enrolled1,162ConditionsRheumatoid ArthritisArmsTocilizumab, Placebo to tocilizumab, Methotrexate, Placebo to methotrexate
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 8 syntheses or guidelines pooled it, 81 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. Guideline
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. 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

8 authors at 7 institutions in 5 countries.

Gerd R BurmesterCharité-Universitätsmedizin Berlin, Free University and Humboldt University of Berlin, Berlin, Germany.
William F RigbyGeisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA.
Ronald F van VollenhovenKarolinska Institute, Stockholm, Sweden.
Jonathan KayUMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, Massachusetts, USA.ORCID http://orcid.org/0000-0002-8970-4260
Andrea Rubbert-RothUniversity of Cologne, Cologne, Germany.
Ricardo BlancoHospital Universitario Marqués de Valdecilla, Santander, Spain.
Alysha KadvaGenentech, South San Francisco, California, USA.
Sophie DimonacoRoche Products Ltd., Welwyn Garden City, UK.
Dartmouth College · USHumboldt-Universität zu Berlin · DEKarolinska Institutet · SEMarqués de Valdecilla University Hospital · ESRoche (United Kingdom) · GBUniversity of Cologne · DEUniversity of Massachusetts Chan Medical School · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveInvestigate whether the efficacy and safety of intravenous tocilizumab (TCZ) demonstrated at week 52 in patients with early rheumatoid arthritis (RA) are maintained to week 104.

methodsMethotrexate (MTX)-naive patients with early progressive RA were randomly assigned to double-blind 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo or placebo+MTX for 104 weeks. Patients not receiving 8 mg/kg TCZ and not achieving Disease Activity Score-28 joints (DAS28-erythrocyte sedimentation rate (ESR)) ≤3.2 at week 52 switched to escape therapy (8 mg/kg TCZ+MTX). Analyses were exploratory.

resultsIntent-to-treat and safety populations included 1157 and 1153 patients, respectively. DAS28-ESR remission (<2.6) rates were maintained from weeks 52 to 104 (eg, 8 mg/kg TCZ+MTX, 49.3% to 47.6%). Placebo+MTX and 4 mg/kg TCZ+MTX escape patients' week 104 response rates were 51.4% and 30.5%, respectively. Inhibition of radiographic progression was maintained with 8 mg/kg TCZ (eg, 8 mg/kg TCZ+MTX mean (SD) change from baseline in modified total Sharp score: 0.13 (1.28), week 52; 0.19 (2.08), week 104). The safety profile of TCZ was consistent with that of previous reports.

conclusionsPatients with early RA treated with TCZ monotherapy or TCZ+MTX maintained clinical benefits during their second year of treatment with no new safety signals. TRIAL REGISTRATION NUMBER: NCT01007435; Results.

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDisease ProgressionDouble-Blind MethodFemaleHumansJointsMaleMedication Therapy ManagementMethotrexateMiddle AgedRadiographyRemission InductionTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatetocilizumabDMARDs (biologic)Early Rheumatoid ArthritisMethotrexate

Identifiers

PMID28389552
PMCPMC5530348
OpenAlexW2605002490

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.