Evidence map›Paper›PMID 22562983›Full record

Trial reportAnnals of the rheumatic diseases2013

Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY).

Maxime Dougados, Karsten Kissel, Tom Sheeran, Paul P Tak, Philip G Conaghan, Emilio Martín Mola, Georg Schett, Howard Amital, Federico Navarro-Sarabia, Antony Hou and 2 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2013. 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 122 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
122citing papers in PubMed, 13 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.

NCT00810199 phase3completednot on this map

Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...

TypeinterventionalSponsorHoffmann-La RocheRan2009 to 2013Enrolled556ConditionsRheumatoid ArthritisArmstocilizumab [RoActemra/Actemra], methotrexate, placebo
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
3 · Its place in the literature

Who cites it

122 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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62 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

12 authors.

Maxime DougadosDepartment of Rheumatology, Cochin Hospital, Paris, France. maxime.dougados@cch.aphp.fr
Karsten Kissel
Tom Sheeran
Paul P Tak
Philip G Conaghan
Emilio Martín Mola
Georg Schett
Howard Amital
Federico Navarro-Sarabia
Antony Hou
Corrado Bernasconi
T W J Huizinga

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIn patients with active rheumatoid arthritis (RA) despite methotrexate, to compare the efficacy of adding tocilizumab to that of switching to tocilizumab monotherapy.

methodsDouble-blind, 2-year study in which adults with active RA (DAS28 >4.4) despite methotrexate were randomly assigned either to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 8 mg/kg every 4 weeks or switch to tocilizumab and placebo (TCZ+PBO). The primary endpoint was the DAS28-erythrocyte sedimentation rate (ESR) remission rate at week 24. Secondary objectives included other symptomatic outcomes, quality of life and progression of structural damage.

resultsOf 556 randomly assigned patients, 512 (92%) completed 24 weeks. DAS28-ESR remission rates were 40.4% for TCZ+MTX and 34.8% for TCZ+PBO (p=0.19); American College of Rheumatology 20/50/70/90 rates were 71.5%/45.5%/24.5%/5.8% (TCZ+MTX) and 70.3%/40.2%/25.4%/5.1% (TCZ+PBO; differences not significant). A significant difference between groups was seen for low DAS28 (61.7% vs 51.4%). Radiographic progression was small and not different between groups (Genant-Sharp score progression ≤ smallest detectable change in 91% (TCZ+MTX) and 87% (TCZ+PBO)). Rates per 100 patient-years of serious adverse events and serious infections were 21 and six, respectively, for TCZ+MTX and 18 and six, respectively, for TCZ+PBO. Alanine aminotransferase elevations greater than threefold the upper limit of normal occurred in 7.8% and 1.2% of TCZ+MTX and TCZ+PBO patients, respectively.

conclusionNo clinically relevant superiority of the TCZ+MTX add-on strategy over the switch to tocilizumab monotherapy strategy was observed. The combination was more commonly associated with transaminase increases. Meaningful clinical and radiographic responses were achieved with both strategies, suggesting that tocilizumab monotherapy might be a valuable treatment strategy in suitable RA patients.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidBlood SedimentationDouble-Blind MethodFemaleHumansMethotrexateMiddle AgedRadiographyAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatetocilizumab

Identifiers

PMID22562983
PMCPMC3551223

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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.