Evidence map›Paper›PMID 35172859›Full record

Trial reportArthritis research & therapy2022

Prediction of flare following remission and treatment withdrawal in early rheumatoid arthritis: post hoc analysis of a phase IIIb trial with abatacept.

Harris A Ahmad, Joshua F Baker, Philip G Conaghan, Paul Emery, Thomas W J Huizinga, Yedid Elbez, Subhashis Banerjee, Mikkel Østergaard

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

Trial report in Arthritis research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01142726 (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), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.7field-weighted citation impact, top 10% 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
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. 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

8 authors at 5 institutions in 5 countries.

Harris A AhmadBristol Myers Squibb, Princeton, NJ, USA. harris.ahmad@BMS.com.ORCID 0000-0002-0890-2071
Joshua F BakerPhiladelphia Veteran's Administration Medical Center and the University of Pennsylvania, Philadelphia, PA, USA.
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.
Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.
Thomas W J HuizingaLeiden University Medical Center, Leiden, Netherlands.
Yedid ElbezDeepscover, Puteaux, France.
Subhashis BanerjeeBristol Myers Squibb, Princeton, NJ, USA.
Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Bristol-Myers Squibb (United States) · USUniversity of Leeds · GBLeiden University Medical Center · NLUniversity of Copenhagen · DKUniversity of the Sciences · US

Funding

Department of Health
6 · The paper itself

Abstract

backgroundDrug-free remission is a desirable goal in rheumatoid arthritis (RA) for both patients and clinicians. The aim of this post hoc analysis was to investigate whether clinical and magnetic resonance imaging (MRI) variables in patients with early RA who achieved remission with methotrexate and/or abatacept at 12 months could predict disease flare following treatment withdrawal.

methodsIn the AVERT study of abatacept in early RA, patients with low disease activity at month 12 entered a 12-month period with all treatment discontinued (withdrawal, WD). This post hoc analysis assessed predictors of disease flare at WD+6months (mo) and WD+12mo of patients with Disease Activity Score in 28 joints (DAS28)-defined remission (DAS28[C-reactive protein (CRP)] <2.6) at withdrawal using univariate and multivariable regression models. Predictors investigated included the Health Assessment Questionnaire-Disability Index (HAQ-DI), pain, Patient Global Assessment; MRI synovitis, erosion, bone edema, and combined (synovitis + bone edema) inflammation scores.

resultsRemission was achieved by 172 patients; 100 (58%) and 113 (66%) patients had experienced a flare at WD+6mo and WD+12mo, respectively. In univariate analyses, higher HAQ-DI and MRI synovitis, erosion, bone edema, and combined inflammation scores at WD were identified as potential predictors of flare (P ≤ 0.01). In multivariable analysis, high scores at WD for HAQ-DI and MRI erosion were confirmed as independent predictors of flare at WD+6mo and WD+12mo (P < 0.01).

conclusionIn patients with early RA achieving clinical remission, patient function (HAQ-DI), and MRI measures of bone damage (erosion) predicted disease flare 6 and 12 months after treatment withdrawal. These variables may help identify patients with early RA in clinical remission as candidates for successful treatment withdrawal.

trial registrationClinicalTrials.gov, NCT01142726 (date of registration: June 11, 2010).

Indexed as

AbataceptAntirheumatic AgentsArthritis, RheumatoidDrug Therapy, CombinationHumansRemission InductionTreatment OutcomeAbataceptAntirheumatic AgentsAbataceptDisease-modifying antirheumatic drugs (DMARDs)FlareMagnetic resonance imaging (MRI)Rheumatoid arthritis

Identifiers

PMID35172859
PMCPMC8848810
OpenAlexW4212995677

What OpenQuestion holds

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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.