Evidence map›Paper›PMID 24473673›Full record

Trial reportAnnals of the rheumatic diseases2014

Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis: the ACT-RAY study.

Maxime Dougados, Karsten Kissel, Philip G Conaghan, Emilio Martin Mola, Georg Schett, Roberto Gerli, Michael Sejer Hansen, Howard Amital, Ricardo M Xavier, Orrin Troum and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00810199 (Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab), which is not on this map. Cited by 65 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 9 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
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  4. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017
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5 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 DougadosRheumatology B Department, Paris-Descartes University, Cochin Hospital, , Paris, France.
Karsten Kissel
Philip G Conaghan
Emilio Martin Mola
Georg Schett
Roberto Gerli
Michael Sejer Hansen
Howard Amital
Ricardo M Xavier
Orrin Troum
Corrado Bernasconi
T W J Huizinga

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the 1-year efficacy and safety of a regimen of tocilizumab plus methotrexate or placebo, which was augmented by a treat-to-target strategy from week 24.

methodsACT-RAY was a double-blind, 3-year trial. Adults with active rheumatoid arthritis despite methotrexate were randomised to add tocilizumab to ongoing methotrexate (add-on strategy) or to switch to tocilizumab plus placebo (switch strategy). Tocilizumab 8 mg/kg was administered every 4 weeks. Conventional open-label disease-modifying antirheumatic drugs (DMARDs) other than methotrexate were added at week 24 or later in patients with DAS28>3.2.

results556 patients were randomised; 85% completed 52 weeks. The proportion of patients receiving open-label DMARDs was comparable in the add-on (29%) and switch (33%) arms. Overall, week 24 results were maintained or further improved at week 52 in both arms. Some endpoints favoured the add-on strategy. Mean changes in Genant-modified Sharp scores were small; more add-on (92.8%) than switch patients (86.1%) had no radiographic progression. At week 52, comparable numbers of patients had antidrug antibodies (ADAs; 1.5% and 2.2% of add-on and switch patients, respectively) and neutralising ADAs (0.7% and 1.8%). Rates of serious adverse events and serious infections per 100 patient-year (PY) were 11.3 and 4.5 in add-on and 16.8 and 5.5 in switch patients. In patients with normal baseline values, alanine aminotransferase elevations >3× upper limit of normal were observed in 11% of add-on and 3% of switch patients.

conclusionsDespite a trend favouring the add-on strategy, these data suggest that both tocilizumab add-on and switch strategies led to meaningful clinical and radiographic responses.

Indexed as

Antibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntibody FormationAntirheumatic AgentsArthritis, RheumatoidDisease ProgressionDouble-Blind MethodFemaleHumansMaleMethotrexateMiddle AgedRadiographyTreatment OutcomeAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntirheumatic AgentsMethotrexatetocilizumabDMARDs (biologic)MethotrexateRheumatoid Arthritis

Identifiers

PMID24473673
PMCPMC3995223

What OpenQuestion holds

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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.