Evidence map›Paper›PMID 30092827›Full record

Trial reportArthritis research & therapy2018

Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial.

Tanja Alexandra Stamm, Klaus Peter Machold, Daniel Aletaha, Farideh Alasti, Peter Lipsky, David Pisetsky, Robert Landewe, Desiree van der Heijde, Alexandre Sepriano, Martin Aringer and 12 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 4 pooled it
2.8field-weighted citation impact, top 10% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 4 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Efficacy of methotrexate in reducing the risk of bone erosion in patients with rheumatoid arthritis: a systematic review of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Observational
  7. Targeting Therapeutic Windows for Rheumatoid Arthritis Prevention.Chinese journal of integrative medicine · 2024
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. 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

22 authors at 17 institutions in 9 countries.

Tanja Alexandra StammSection for Outcomes Research, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.
Klaus Peter MacholdDepartment of Medicine III, Division of Rheumatology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Daniel AletahaDepartment of Medicine III, Division of Rheumatology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Farideh AlastiDepartment of Medicine III, Division of Rheumatology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Peter LipskyRILITE Research Institute, 250 W Main Street, Charlottesville, Virginia, 22902, USA.
David PisetskyMedical Research Service Durham VA Medical Center, and Duke University Medical Center, 151G Durham VA Medical Center, 508 Fulton Street, Durham, North Carolina, 27705, USA.
Robert LandeweDepartment of Medicine, Division of Rheumatology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
Desiree van der HeijdeDepartment of Rheumatology, Leiden University Medical Centre, Albinusdreef 2, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Alexandre SeprianoDepartment of Rheumatology, Leiden University Medical Centre, Albinusdreef 2, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Martin AringerDivision of Rheumatology, Department of Medicine III, University Medical Center and Faculty of Medicine Carl Gustav Carus at the TU Dresden, Fetscherstrasse 74, 01309, Dresden, Germany.
Dimitri BoumpasRheumatology Medical School University of Crete, Heraklion and Joint Rheumatology Program, National and Kapodestrian University of Athens, Athens, Greece.
Gerd BurmesterDepartment of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany.
Maurizio CutoloResearch Laboratory and Division of Rheumatology, Department of Internal Medicine, University of Genova, Viale Benedetto XV, 6, 16132, Genoa, Italy.
Wolfgang EbnerDepartment of Internal Medicine, Centre for Rheumatic Diseases, Hietzing Hospital, Wolkersbergenstraße 1, 1130, Vienna, Austria.
Winfried GraningerDepartment of Rheumatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Styria, Austria.
Tom HuizingaDepartment of Rheumatology, Leiden University Medical Centre, Albinusdreef 2, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Georg SchettDepartment of Internal Medicine 3, Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.
Hendrik Schulze-KoopsDivision of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig Maximilians University of Munich, Pettenkoferstraße 8a, 80336, Munich, Germany.
Paul-Peter TakAmsterdam Rheumatology and Immunology Center, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
Emilio Martin-MolaHospital Universitario La Paz, Paseo de la Castellana 261, 28046, Madrid, Spain.
Ferdinand BreedveldLeiden University Medical Center, Albinusdreef 2, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Josef SmolenDepartment of Medicine III, Division of Rheumatology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. josef.smolen@meduniwien.ac.at.
Leiden University · NLMedical University of Vienna · ATKlinik Hietzing · ATAcademic Medical Center · NLAge UK · GBAmpel BioSolutions (United States) · USDurham VA Medical Center · USFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHospital Universitario La Paz · ESHumboldt-Universität zu Berlin · DELeiden University Medical Center · NLLudwig-Maximilians-Universität München · DEMedical University of Graz · ATStatistics Austria · ATUniversity Hospital Carl Gustav Carus · DEUniversity of Crete · GRUniversity of Genoa · IT

Funding

Strategies for Evaluating and Treating Early SynovitisR21AR050880 · NIAMS · DUKE UNIVERSITY · PI PISETSKY, DAVID STEPHEN · 2003 to 2004
$154k
Planing an Early RA Prevention TrialR34AR052465 · NIAMS · DUKE UNIVERSITY · PI PISETSKY, DAVID STEPHEN · 2005 to 2005
$154k
NIAMS NIH HHS R21 AR050880NIAMS NIH HHS R34 AR052465NIH HHS AR050880NIH HHS AR052465
6 · The paper itself

Abstract

backgroundIn the present study, we explored the effects of immediate induction therapy with the anti-tumour necrosis factor (TNF)α antibody infliximab (IFX) plus methotrexate (MTX) compared with MTX alone and with placebo (PL) in patients with very early inflammatory arthritis.

methodsIn an investigator-initiated, double-blind, randomised, placebo-controlled, multi-centre trial (ISRCTN21272423, http://www.isrctn.com/ISRCTN21272423 ), patients with synovitis of 12 weeks duration in at least two joints underwent 1 year of treatment with IFX in combination with MTX, MTX monotherapy, or PL randomised in a 2:2:1 ratio. The primary endpoint was clinical remission after 1 year (sustained for at least two consecutive visits 8 weeks apart) with remission defined as no swollen joints, 0-2 tender joints, and an acute-phase reactant within the normal range.

resultsNinety patients participated in the present study. At week 54 (primary endpoint), 32% of the patients in the IFX + MTX group achieved sustained remission compared with 14% on MTX alone and 0% on PL. This difference (p < 0.05 over all three groups) was statistically significant for IFX + MTX vs PL (p < 0.05), but not for IFX + MTX vs MTX (p = 0.10), nor for MTX vs PL (p = 0.31). Remission was maintained during the second year on no therapy in 75% of the IFX + MTX patients compared with 20% of the MTX-only patients.

conclusionsThese results indicate that patients with early arthritis can benefit from induction therapy with anti-TNF plus MTX compared with MTX alone, suggesting that intensive treatment can alter the disease evolution.

trial registrationThe trial was registered at http://www.isrctn.com/ISRCTN21272423 on 4 October 2007 (date applied)/12 December 2007 (date assigned). The first patient was included on 24 October 2007.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationFemaleHumansInfliximabMaleMethotrexateMiddle AgedRemission InductionTreatment OutcomeAntirheumatic AgentsInfliximabMethotrexateClinical remissionEarly arthritisRheumatoid arthritis

Identifiers

PMID30092827
PMCPMC6085639
OpenAlexW2887352503

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.