Evidence map›Paper›PMID 27037326›Full record

ReviewAnnals of the rheumatic diseases2016

Clinical trials of new drugs for the treatment of rheumatoid arthritis: focus on early disease.

Josef S Smolen, Sabine Collaud Basset, Maarten Boers, Ferdinand Breedveld, Christopher J Edwards, Tore K Kvien, Pierre Miossec, Tuulikki Sokka-Isler, Ronald F van Vollenhoven, Eric C Abadie and 7 more

Open access · hybridAbstract readReview
In one paragraph

Review in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 5% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Simulation-Based Research on Phytoconstituents ofLife (Basel, Switzerland) · 2023
    Article
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  6. Observational
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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

17 authors at 13 institutions in 11 countries.

Josef S SmolenDepartment of Internal Medicine III, Hietzing Hospital, Vienna, Austria Division of Rheumatology, Medical University Vienna, Vienna, Austria.ORCID 0000-0002-8899-9087
Sabine Collaud BassetTRB Chemedica International SA, Geneva, Switzerland.
Maarten BoersDepartment of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.
Ferdinand BreedveldLeiden University Medical Centre, Leiden, The Netherlands.
Christopher J EdwardsMusculoskeletal Research Unit, NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, Southampton, UK.
Tore K KvienDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Pierre MiossecDepartment of Clinical Immunology and Rheumatology, Immunogenomics and Inflammation Research Unit EA 4130, University of Lyon 1, Edouard Herriot Hospital, Lyon, France.
Tuulikki Sokka-IslerFaculty of Health Sciences, University of Eastern Finland, Jyvaskyla Central Hospital, Jyvaskyla, Finland.
Ronald F van VollenhovenAmsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands Department of Clinical Immunology and Rheumatology, Academic Medical Center, Amsterdam, The Netherlands Department of Rheumatology, VU University Medical Centre, Amsterdam, The Netherlands.
Eric C AbadieEuremed Consulting, Paris, France Universidade de Lisboa, Lisbon, Portugal.
Olivier BruyèreDepartment of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium.
Cyrus CooperMRC Lifecourse Epidemiology Unit, NIHR Nutrition Biomedical Research Centre, University of Southampton, Southampton, UK NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK Oxford NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, The Botnar Research Centre, University of Oxford, Oxford, UK.
Heidi MäkinenRheumatology Department, Tampere University Hospital, Tampere, Finland.
Thierry ThomasRheumatology Department, University Hospital of Saint-Etienne, Saint-Etienne, France INSERM U1059, Université de Lyon, Lyon, France.
Peter TugwellDepartment of Medicine, University of Ottawa, Ottawa, Canada.
Jean-Yves ReginsterDepartment of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium.
European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)
Université Claude Bernard Lyon 1 · FRUniversity Hospital Southampton NHS Foundation Trust · GBUniversity of Liège · BEAmsterdam UMC Location University of Amsterdam · NLDiakonhjemmet Hospital · NOKlinik Hietzing · ATLeiden University Medical Center · NLTampere University Hospital · FITRB Chemedica International (Switzerland) · CHUniversity Medical Center · USUniversity of Eastern Finland · FIUniversity of Lisbon · PTUniversity of Ottawa · CA

Funding

Medical Research Council G0400491Medical Research Council MC_U147585819Medical Research Council MC_U147585824Medical Research Council MC_U147585827Medical Research Council MC_UP_A620_1014Medical Research Council MC_UU_12011/1
6 · The paper itself

Abstract

The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases convened a task force of experts in rheumatoid arthritis (RA) and clinical trial methodology to comment on the new draft 'Guideline on clinical investigation of medicinal products for the treatment of RA' released by the European Medicines Agency (EMA). Special emphasis was placed by the group on the development of new drugs for the treatment of early RA. In the absence of a clear definition of early RA, it was suggested that clinical investigations in this condition were conducted in disease-modifying antirheumatic drugs naïve patients with no more than 1 year disease duration. The expert group recommended using an appropriate improvement in disease activity (American College of Rheumatology (ACR) or Simplified/Clinical Disease Activity Index (SDAI/CDAI) response criteria) or low disease activity (by any score) as primary endpoints, with ACR/European League Against Rheumatism remission as a secondary endpoint. Finally, as compelling evidence showed that the Disease Acrivity Score using 28-joint counts (DAS28) might not provide a reliable definition of remission, or sometimes even low disease activity, the group suggested replacing DAS28 as a measurement instrument to evaluate disease activity in RA clinical trials. Proposed alternatives included SDAI, CDAI and Boolean criteria.

Indexed as

Practice Guidelines as TopicAntirheumatic AgentsArthritis, RheumatoidClinical Trials as TopicDrugs, InvestigationalEarly DiagnosisEuropeHumansSeverity of Illness IndexAntirheumatic AgentsDrugs, InvestigationalDMARDs (biologic)DMARDs (synthetic)Early Rheumatoid ArthritisOutcomes researchTreatment

Identifiers

PMID27037326
PMCPMC4941171
OpenAlexW2328928577

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.