Evidence map›Paper›PMID 25367713›Full record

Trial reportAnnals of the rheumatic diseases2015

Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period.

Paul Emery, Gerd R Burmester, Vivian P Bykerk, Bernard G Combe, Daniel E Furst, Emilie Barré, Chetan S Karyekar, Dennis A Wong, Tom W J Huizinga

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter 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 2 registered trials, which are not on this map. Cited by 130 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 13 pooled it
19.9field-weighted citation impact, top 1% 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.

NCT01142726 phase3completednot on this map

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA

TypeinterventionalSponsorBristol-Myers SquibbRan2010 to 2014Enrolled511ConditionsRheumatoid ArthritisArmsAbatacept, Methotrexate, Abatacept placebo, Methotrexate placebo
NCT03652961 phase4completednot on this mapstarted 2019, after this paper: background citation

Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA)

TypeinterventionalSponsorNYU Langone HealthRan2019 to 2021Enrolled25ConditionsRheumatoid ArthritisArmsAbatacept, DMARDs
3 · Its place in the literature

Who cites it

130 citing papers in PubMed, 13 syntheses or guidelines pooled it, 236 citations in OpenAlex.

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70 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

9 authors at 6 institutions in 4 countries.

Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Gerd R BurmesterDepartment of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany.
Vivian P BykerkDepartment of Rheumatology, Hospital for Special Surgery, New York, New York, USA.
Bernard G CombeDepartment of Rheumatology, Lapeyronie Hospital, Montpellier I University, Montpellier, France.
Daniel E FurstDepartment of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Emilie BarréBristol-Myers Squibb, Braine-L'Alleud, Belgium.
Chetan S KaryekarBristol-Myers Squibb, Princeton, New Jersey, USA.
Dennis A WongBristol-Myers Squibb, Princeton, New Jersey, USA.
Tom W J HuizingaDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Bristol-Myers Squibb (United States) · USBristol-Myers Squibb (Belgium) · BECharité - Universitätsmedizin Berlin · DEHospital for Special Surgery · USLeiden University Medical Center · NLUniversity of California, Los Angeles · US

Funding

Versus Arthritis 18475
6 · The paper itself

Abstract

objectivesTo evaluate clinical remission with subcutaneous abatacept plus methotrexate (MTX) and abatacept monotherapy at 12 months in patients with early rheumatoid arthritis (RA), and maintenance of remission following the rapid withdrawal of all RA treatment.

methodsIn the Assessing Very Early Rheumatoid arthritis Treatment phase 3b trial, patients with early active RA were randomised to double-blind, weekly, subcutaneous abatacept 125 mg plus MTX, abatacept 125 mg monotherapy, or MTX for 12 months. Patients with low disease activity (Disease Activity Score (DAS)28 (C reactive protein (CRP)) <3.2) at month 12 entered a 12-month period of withdrawal of all RA therapy. The coprimary endpoints were the proportion of patients with DAS28 (CRP) <2.6 at month 12 and both months 12 and 18, for abatacept plus MTX versus MTX.

resultsPatients had <2 years of RA symptoms, DAS28 (CRP) ≥3.2, anticitrullinated peptide-2 antibody positivity and 95.2% were rheumatoid factor positive. For abatacept plus MTX versus MTX, DAS28 (CRP) <2.6 was achieved in 60.9% versus 45.2% (p=0.010) at 12 months, and following treatment withdrawal, in 14.8% versus 7.8% (p=0.045) at both 12 and 18 months. DAS28 (CRP) <2.6 was achieved for abatacept monotherapy in 42.5% (month 12) and 12.4% (both months 12 and 18). Both abatacept arms had a safety profile comparable with MTX alone.

conclusionsAbatacept plus MTX demonstrated robust efficacy compared with MTX alone in early RA, with a good safety profile. The achievement of sustained remission following withdrawal of all RA therapy suggests an effect of abatacept's mechanism on autoimmune processes. TRIAL REGISTRATION NUMBER: NCT01142726.

Indexed as

AbataceptAdultAntirheumatic AgentsArthritis, RheumatoidC-Reactive ProteinDouble-Blind MethodDrug Therapy, CombinationEarly Medical InterventionFemaleHumansImmunoconjugatesMaleMethotrexateMiddle AgedRemission InductionTreatment OutcomeAbataceptAntirheumatic AgentsC-Reactive ProteinImmunoconjugatesMethotrexateDisease ActivityDMARDs (biological)MethotrexateRheumatoid Arthritis

Identifiers

PMID25367713
PMCPMC4283672
OpenAlexW2140082616

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.