Evidence map›Paper›PMID 37087459›Full record

Trial reportArthritis research & therapy2023

The trajectory of clinical responses in patients with early rheumatoid arthritis who achieve sustained remission in response to abatacept: subanalysis of AVERT-2, a randomized phase IIIb study.

Paul Emery, Yoshiya Tanaka, Vivian P Bykerk, Clifton O Bingham, Thomas W J Huizinga, Gustavo Citera, Kuan-Hsiang Gary Huang, Chun Wu, Sean E Connolly, Yedid Elbez and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Trial
  2. Trial
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

13 authors at 8 institutions in 5 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.
Yoshiya TanakaUniversity of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Vivian P BykerkHospital for Special Surgery, New York, NY, USA.
Clifton O BinghamJohns Hopkins University, Baltimore, MD, USA.
Thomas W J HuizingaLeiden University Medical Center, Leiden, the Netherlands.
Gustavo CiteraInstituto de Rehabilitación Psicofísica, Buenos Aires, Argentina.
Kuan-Hsiang Gary HuangBristol Myers Squibb, Princeton, NJ, USA.
Chun WuBristol Myers Squibb, Princeton, NJ, USA.
Sean E ConnollyBristol Myers Squibb, Princeton, NJ, USA.
Yedid ElbezSignifience, Puteaux, France.
Robert WongBristol Myers Squibb, Princeton, NJ, USA.
Karissa LozenskiBristol Myers Squibb, Princeton, NJ, USA.
Roy FleischmannUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Bristol-Myers Squibb (United States) · USHospital for Special Surgery · USInstituto Nacional de Rehabilitación Psicofísica · ARJohns Hopkins University · USLeiden University Medical Center · NLNIHR Leeds Musculoskeletal Biomedical Research Unit · GBThe University of Texas Southwestern Medical Center · USUniversity 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
Department of HealthNIAMS NIH HHS UH2 AR067691
6 · The paper itself

Abstract

backgroundAVERT-2 (a phase IIIb, two-stage study) evaluated abatacept + methotrexate versus methotrexate alone, in methotrexate-naive, anti-citrullinated protein antibody-positive patients with early (≤ 6 months), active RA. This subanalysis investigated whether individual patients who achieved the week 24 Simplified Disease Activity Index (SDAI) remission primary endpoint could sustain remission to 1 year and then maintain it following changes in therapy.

methodsDuring the 56-week induction period (IP), patients were randomized to weekly subcutaneous abatacept 125 mg + methotrexate or abatacept placebo + methotrexate. Patients completing the IP who achieved SDAI remission (≤ 3.3) at weeks 40 and 52 entered a 48-week de-escalation (DE) period. Patients treated with abatacept + methotrexate were re-randomized to continue weekly abatacept + methotrexate, or de-escalate and then withdraw abatacept (after 24 weeks), or receive abatacept monotherapy. Proportions of patients achieving sustained SDAI and Boolean remission, and Disease Activity Score in 28 joints using C-reactive protein (DAS28 [CRP]) < 2.6, were assessed. For patients achieving early sustained SDAI remission at weeks 24/40/52, flow between disease activity categories and individual trajectories was evaluated; flow was also evaluated for later remitters (weeks 40/52 but not week 24).

resultsAmong patients treated with abatacept + methotrexate (n/N = 451/752) at IP week 24, 22% achieved SDAI remission, 17% achieved Boolean remission, and 42% achieved DAS28 (CRP) < 2.6; of these, 56%, 58%, and 74%, respectively, sustained a response throughout IP weeks 40/52. Among patients with a sustained response at IP weeks 24/40/52, 82% (14/17) on weekly abatacept + methotrexate, 81% (13/16) on abatacept monotherapy, 63% (12/19) who de-escalated/withdrew abatacept, and 65% (11/17) on abatacept placebo + methotrexate were in SDAI remission at end of the DE period; rates were higher than for later remitters in all arms except abatacept placebo + methotrexate.

conclusionsA high proportion of individual patients achieving clinical endpoints at IP week 24 with abatacept + methotrexate sustained their responses through week 52. Of patients achieving early and sustained SDAI remission through 52 weeks, numerically more maintained remission during the DE period if weekly abatacept treatment continued.

trial registrationNCT02504268 (ClinicalTrials.gov), registered July 21, 2015.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAbataceptDrug Therapy, CombinationHumansMethotrexateRemission InductionTreatment OutcomeAbataceptAntirheumatic AgentsMethotrexateAbataceptAnti-citrullinated protein antibodyRheumatoid arthritisSustained remission

Identifiers

PMID37087459
PMCPMC10122306
OpenAlexW4366769947

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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.