Evidence map›Paper›PMID 41733109›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2026

Baseline Interleukin-10 Levels as a Predictive Biomarker for Achieving Clinical Response With Abatacept in Patients Who Were Disease-Modifying Antirheumatic Drug Naive and Anti-Citrullinated Protein Antibody Positive With Early Rheumatoid Arthritis.

Jinqi Liu, Yicong Li, Kai Fu, Chun Wu, Peter Schafer, Sean E Connolly, Ian M Catlett, Michael A Maldonado, Robert Wong, Paul Emery and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2026. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Jinqi LiuBristol-Myers Squibb, Princeton, New Jersey.ORCID https://orcid.org/0000-0002-0094-9801
Yicong LiParexel International, Durham, North Carolina.
Kai FuBristol-Myers Squibb, Princeton, New Jersey.
Chun WuBristol-Myers Squibb, Princeton, New Jersey.
Peter SchaferBristol-Myers Squibb, Princeton, New Jersey.
Sean E ConnollyBristol-Myers Squibb, Princeton, New Jersey.ORCID https://orcid.org/0000-0003-4884-861X
Ian M CatlettBristol-Myers Squibb, Princeton, New Jersey.
Michael A MaldonadoBristol-Myers Squibb, Princeton, New Jersey.
Robert WongBristol-Myers Squibb, Princeton, New Jersey.
Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds NIHR Biomedical Research Centre, Leeds, United Kingdom.ORCID https://orcid.org/0000-0002-7429-8482
Yoshiya TanakaFirst Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.ORCID https://orcid.org/0000-0002-0807-7139
Vivian P BykerkDepartment of Rheumatology, Hospital for Special Surgery, New York, New York.
Clifton O BinghamDivision of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.ORCID https://orcid.org/0000-0002-4752-5029
Thomas W J HuizingaDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
Roy FleischmannDivision of Rheumatology, University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas.ORCID https://orcid.org/0000-0002-6630-1477

Funding

Bristol Myers Squibb
6 · The paper itself

Abstract

objectivePredictive biomarkers for patients with early rheumatoid arthritis (RA) are needed. This exploratory post hoc analysis investigated inflammatory biomarkers associated with baseline disease activity and biomarkers predictive of treatment response in patients who were seropositive with early RA from a phase 3 study.

methodsThe AVERT-2 study (NCT02504268) included patients who were disease-modifying antirheumatic drug naive and anti-citrullinated protein antibody positive randomized to abatacept and methotrexate (MTX) or placebo and MTX for 56 weeks. Correlations were assessed among biomarkers and disease activity, pharmacodynamic (PD) changes on disease-associated biomarkers in response to treatment, and baseline biomarkers to predict treatment response at week 52.

resultsIn the analysis, 446 patients received abatacept and MTX and 300 received placebo and MTX. Of 103 biomarkers, 47 demonstrated a significant reduction in PD changes with abatacept and MTX versus placebo and MTX, with 18 out of 47 biomarkers showing correlations with baseline disease activity. High baseline interleukin-10 (IL-10) levels were associated with greater probability of achieving efficacy measures by week 52 in patients receiving abatacept and MTX versus placebo and MTX, consistent with a significant reduction in disease activity with abatacept and MTX (P < 0.03 to P < 0.0007). Higher baseline IL-10 levels were associated with lower bone erosive development with abatacept and MTX compared with placebo and MTX.

conclusionTreatment with abatacept and MTX resulted in significantly greater reduction of biomarkers relevant to RA, and high baseline IL-10 levels predicted better treatment response with abatacept and MTX versus placebo and MTX across clinical outcomes. Findings suggest a well-suited mechanism of action for abatacept and MTX in patients with early RA and high baseline IL-10 levels.

Indexed as

AbataceptAnti-Citrullinated Protein AntibodiesAntirheumatic AgentsArthritis, RheumatoidInterleukin-10AdultBiomarkersDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedTreatment OutcomeAbataceptAnti-Citrullinated Protein AntibodiesAntirheumatic AgentsBiomarkersIL10 protein, humanInterleukin-10Methotrexate

Identifiers

PMID41733109
PMCPMC13507574

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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.