Evidence map›Paper›PMID 36869251›Full record

ArticleRheumatology and therapy2023

Sustained Remission and Outcomes with Abatacept plus Methotrexate Following Stepwise Dose De-escalation in Patients with Early Rheumatoid Arthritis.

Paul Emery, Yoshiya Tanaka, Vivian P Bykerk, Thomas W J Huizinga, Gustavo Citera, Clifton O Bingham, Subhashis Banerjee, Benjamin P Soule, Marleen Nys, Sean E Connolly and 5 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02504268 (A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT02504268 phase3completednot on this map

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive

TypeinterventionalSponsorBristol-Myers SquibbRan2015 to 2020Enrolled994ConditionsRheumatoid ArthritisArmsAbatacept, Methotrexate, Abatacept Placebo, Methotrexate Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
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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

15 authors at 9 institutions in 6 countries.

Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds NIHR Biomedical Research Centre, Leeds, UK. P.Emery@leeds.ac.uk.ORCID http://orcid.org/0000-0002-7429-8482
Yoshiya TanakaFirst Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Vivian P BykerkDepartment of Rheumatology, Hospital for Special Surgery, New York City, NY, USA.
Thomas W J HuizingaDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Gustavo CiteraDepartment of Rheumatology, Instituto de Rehabilitación Psicofísca, Buenos Aires, Argentina.
Clifton O BinghamDivisions of Rheumatology and Allergy, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Subhashis BanerjeeImmunology and Fibrosis/Global Drug Development, Bristol Myers Squibb, Princeton, NJ, USA.
Benjamin P Soule *Fibrosis Business Development, Bristol Myers Squibb, Princeton, NJ, USA.
Marleen Nys *Global Biometrics and Data Science, Bristol Myers Squibb, Braine-l'Alleud, Belgium.
Sean E ConnollyImmunology and Fibrosis/Global Drug Development, Bristol Myers Squibb, Princeton, NJ, USA.
Karissa L LozenskiImmunology and Fibrosis/Global Drug Development, Bristol Myers Squibb, Princeton, NJ, USA.
Joe ZhuoWorldwide Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, NJ, USA.
Robert Wong *Immunology and Fibrosis/Global Drug Development, Bristol Myers Squibb, Princeton, NJ, USA.
Kuan-Hsiang Gary Huang *Immunology and Fibrosis/Global Drug Development, Bristol Myers Squibb, Princeton, NJ, USA.
Roy FleischmannDivision of Rheumatology, University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, TX, USA.
Bristol-Myers Squibb (United States) · USBristol-Myers Squibb (Belgium) · BEHospital for Special Surgery · USInstituto Nacional de Rehabilitación Psicofísica · ARJohns Hopkins University · USLeiden University Medical Center · NLMetroplex Clinical Research Center · USUniversity of Leeds · GBUniversity of Occupational and Environmental Health Japan · JP

Funding

Molecular Pathways in Treatment Response and Flare in RAUH2AR067691 · NIAMS · HOSPITAL FOR SPECIAL SURGERY · PI BYKERK, VIVIAN P, IVASHKIV, LIONEL B · 2014 to 2020
$2.0M
NIAMS NIH HHS UH2 AR067691
6 · The paper itself

Abstract

introductionOne target of rheumatoid arthritis (RA) treatment is to achieve early sustained remission; over the long term, patients in sustained remission have less structural joint damage and physical disability. We evaluated Simplified Disease Activity Index (SDAI) remission with abatacept + methotrexate versus abatacept placebo + methotrexate and impact of de-escalation (DE) in anti-citrullinated protein antibody (ACPA)-positive patients with early RA.

methodsThe phase IIIb, randomized, AVERT-2 two-stage study (NCT02504268) evaluated weekly abatacept + methotrexate versus abatacept placebo + methotrexate. PRIMARY ENDPOINT: SDAI remission (≤ 3.3) at week 24. Pre-planned exploratory endpoint: maintenance of remission in patients with sustained remission (weeks 40 and 52) who, from week 56 for 48 weeks (DE period), (1) continued combination abatacept + methotrexate, (2) tapered abatacept to every other week (EOW) + methotrexate for 24 weeks with subsequent abatacept withdrawal (abatacept placebo + methotrexate), or (3) withdrew methotrexate (abatacept monotherapy).

resultsPrimary study endpoint was not met: 21.3% (48/225) of patients in the combination and 16.0% (24/150) in the abatacept placebo + methotrexate arm achieved SDAI remission at week 24 (p = 0.2359). There were numerical differences favoring combination therapy in clinical assessments, patient-reported outcomes (PROs) and week 52 radiographic non-progression. After week 56, 147 patients in sustained remission with abatacept + methotrexate were randomized (combination, n = 50; DE/withdrawal, n = 50; abatacept monotherapy, n = 47) and entered DE. At DE week 48, SDAI remission (74%) and PRO improvements were mostly maintained with continued combination therapy; lower remission rates were observed with abatacept placebo + methotrexate (48.0%) and with abatacept monotherapy (57.4%). Before withdrawal, de-escalating to abatacept EOW + methotrexate preserved remission.

conclusionsThe stringent primary endpoint was not met. However, in patients achieving sustained SDAI remission, numerically more maintained remission with continued abatacept + methotrexate versus abatacept monotherapy or withdrawal.

trial registrationClinicalTrials.gov identifier, NCT02504268. Video abstract (MP4 62241 KB).

Indexed as

AbataceptAnti-citrullinated protein autoantibodies (ACPAs)Clinical trialDisease-modifying antirheumatic drugs (DMARDs)Rheumatoid arthritis

Identifiers

PMID36869251
PMCPMC10140217
OpenAlexW4323038973

What OpenQuestion holds

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LicenceCC BY-NC
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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.