Evidence map›Paper›PMID 25550337›Full record

Trial reportAnnals of the rheumatic diseases2015

Maintenance of remission following 2 years of standard treatment then dose reduction with abatacept in patients with early rheumatoid arthritis and poor prognosis.

Rene Westhovens, Manuel Robles, Antonio Carlos Ximenes, Jurgen Wollenhaupt, Patrick Durez, Juan Gomez-Reino, Walter Grassi, Boulos Haraoui, William Shergy, Sung-Hwan Park and 4 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00989235 (A Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study), which is not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 4 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT00989235 phase3completednot on this map

A Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study

TypeinterventionalSponsorBristol-Myers SquibbRan2007 to 2009Enrolled108ConditionsRheumatoid ArthritisArmsAbatacept
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Observational
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Co-stimulation Therapy in Rheumatoid Arthritis: Today and Tomorrow.Current treatment options in rheumatology · 2015
    Review
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

14 authors at 12 institutions in 8 countries.

Rene WesthovensSkeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven, Rheumatology, University Hospitals Leuven, Leuven, Belgium.
Manuel RoblesCentro Médico Toluca, Metepec, México.
Antonio Carlos XimenesHospital Geral de Goiânia, Goiânia, Brazil.
Jurgen WollenhauptSchoen Klinik Hamburg Eilbek, Hamburg, Germany.
Patrick DurezService et Pôle de Rhumatologie, Cliniques Universitaires Saint-Luc, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.
Juan Gomez-ReinoHospital Clinico Universidad De Santiago, A Coruna, Spain.
Walter GrassiClinica Reumatologica, Università Politecnica delle Marche, Ancona, Italy.
Boulos HaraouiInstitut de Rhumatologie de Montréal, Montréal, Quebec, Canada.
William ShergyUniversity of Alabama, Huntsville, Alabama, USA.
Sung-Hwan ParkThe Catholic University of Korea, Seoul, South Korea.
Harry GenantUniversity of California, San Francisco/Synarc, San Francisco, California, USA.
Charles PeterfySpire Sciences, Inc., Boca Raton, Florida, USA.
Jean-Claude BeckerBecker Clinical Research Consulting LLC, New York, New York, USA.
Bindu MurthyBristol-Myers Squibb, Princeton, New Jersey, USA.
Bristol-Myers Squibb (United States) · USCatholic University of Korea · KRClinical Research Consulting · USCliniques Universitaires Saint-Luc · BEComplejo Hospitalario Universitario de Santiago · ESInstituto Tecnológico de Toluca · MXKU Leuven · BEMarche Polytechnic University · ITMontreal Clinical Research Institute · CASchön Klinik Hamburg Eilbek · DEUniversity of Alabama in Huntsville · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate maintenance of response while reducing intravenous abatacept dose from ~10 mg/kg to ~5 mg/kg in patients with early rheumatoid arthritis (RA) who achieved disease activity score (DAS)28 (erythrocyte sedimentation rate, ESR) <2.6.

methodsThis 1-year, multinational, randomised, double-blind substudy evaluated the efficacy and safety of ~10 mg/kg and ~5 mg/kg abatacept in patients with early RA with poor prognosis who had reached DAS28 (ESR) <2.6 at year 2 of the AGREE study. The primary outcome was time to disease relapse (defined as additional disease-modifying antirheumatic drugs, ≥2 courses high-dose steroids, return to open-label abatacept ~10 mg/kg, or DAS28 (C reactive protein) ≥3.2 at two consecutive visits).

results108 patients were randomised (~10 mg/kg, n=58; ~5 mg/kg, n=50). Three and five patients, respectively, discontinued, and four per group returned to open-label abatacept. Relapse over time and the proportion of patients relapsing were similar in both groups (31% (~10 mg/kg) vs 34% (~5 mg/kg); HR: 0.87 (95% CI 0.45 to 1.69)). Mean steady-state trough serum concentration for the ~10 mg/kg group was 20.3-24.1 µg/mL, compared with 8.8-12.0 µg/mL for the ~5 mg/kg group.

conclusionsThis exploratory study suggests that abatacept dose reduction may be an option in patients with poor prognosis early RA who achieve DAS28 (ESR) <2.6 after ≥1 year on abatacept (~10 mg/kg). TRIAL REGISTRATION NUMBER: NCT00989235.

Indexed as

AbataceptAdultAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodFemaleHumansImmunoconjugatesInduction ChemotherapyKaplan-Meier EstimateMaintenance ChemotherapyMaleMiddle AgedPrognosisRecurrenceRemission InductionAbataceptAntirheumatic AgentsImmunoconjugatesDisease ActivityDMARDs (biologic)Early Rheumatoid ArthritisRheumatoid ArthritisTreatment

Identifiers

PMID25550337
PMCPMC4345907
OpenAlexW2168536859

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.