Evidence map›Paper›PMID 26359449›Full record

Trial reportAnnals of the rheumatic diseases2016

Impact of baseline anti-cyclic citrullinated peptide-2 antibody concentration on efficacy outcomes following treatment with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial.

Jeremy Sokolove, Michael Schiff, Roy Fleischmann, Michael E Weinblatt, Sean E Connolly, Alyssa Johnsen, Jin Zhu, Michael A Maldonado, Salil Patel, William H Robinson

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00929864 (A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis), which is not on this map. Cited by 103 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 2 pooled it
10.7field-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.

NCT00929864 phase3completednot on this map

A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis

TypeinterventionalSponsorBristol-Myers SquibbRan2009 to 2012Enrolled869ConditionsRheumatoid ArthritisArmsAbatacept, Adalimumab
3 · Its place in the literature

Who cites it

103 citing papers in PubMed, 2 syntheses or guidelines pooled it, 189 citations in OpenAlex.

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43 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

10 authors at 5 institutions in 1 country.

Jeremy SokoloveVA Palo Alto Health Care System and Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA.
Michael SchiffDepartment of Rheumatology, University of Colorado, Denver, Colorado, USA.
Roy FleischmannDepartment of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Michael E WeinblattDepartment of Rheumatology & Immunology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Sean E ConnollyImmunoscience, Bristol-Myers Squibb, Princeton, New Jersey, USA.
Alyssa JohnsenImmunoscience, Bristol-Myers Squibb, Princeton, New Jersey, USA.
Jin ZhuGlobal Biometric Sciences, Bristol-Myers Squibb, Princeton, New Jersey, USA.
Michael A MaldonadoImmunoscience, Bristol-Myers Squibb, Princeton, New Jersey, USA.
Salil PatelImmunoscience, Bristol-Myers Squibb, Princeton, New Jersey, USA.
William H RobinsonVA Palo Alto Health Care System and Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA.
Bristol-Myers Squibb (United States) · USVA Palo Alto Health Care System · USBrigham and Women's Hospital · USThe University of Texas Southwestern Medical Center · USUniversity of Colorado Denver · US

Funding

Training Program in Adult and Pediatric RheumatologyT32AR050942 · NIAMS · STANFORD UNIVERSITY · PI LEWIS, DAVID BRAM, ROBINSON, WILLIAM H · 2005 to 2025
$6.6M
NIAMS NIH HHS T32 AR050942
6 · The paper itself

Abstract

objectivesTo examine whether baseline anti-cyclic citrullinated peptide-2 (CCP2) antibody status and concentration correlated with clinical outcomes in patients treated with abatacept or adalimumab on background methotrexate (MTX) in the 2-year AMPLE (Abatacept versus adaliMumab comParison in bioLogic-naïvE rheumatoid arthritis subjects with background MTX) study.

methodsIn this exploratory analysis, anti-CCP2 antibody concentration was measured at baseline, and antibody-positive patients were divided into equal quartiles, Q1-Q4, representing increasing antibody concentrations. Clinical outcomes analysed by baseline anti-CCP2 status and quartile included change from baseline in disease activity and disability and remission rates.

resultsBaseline characteristics were generally comparable across quartiles and treatment groups. In both treatment groups, anti-CCP2 antibody-negative patients responded less well than antibody-positive patients. At year 2, improvements in disease activity and disability and remission rates were similar across Q1-Q3, but were numerically higher in Q4 in the abatacept group; in contrast, treatment effects were similar across all quartiles in the adalimumab group.

conclusionsIn AMPLE, baseline anti-CCP2 positivity was associated with a better response for abatacept and adalimumab. Patients with the highest baseline anti-CCP2 antibody concentrations had better clinical response with abatacept than patients with lower concentrations, an association that was not observed with adalimumab. TRIAL REGISTRATION NUMBER: NCT00929864.

Indexed as

AbataceptAdalimumabAdultAgedAged, 80 and overAntirheumatic AgentsArthritis, RheumatoidAutoantibodiesDrug Therapy, CombinationFemaleHumansImmunoglobulin GInjections, SubcutaneousMaleMethotrexateMiddle AgedAbataceptAdalimumabAntirheumatic AgentsAutoantibodiescyclic citrullinated peptideImmunoglobulin GMethotrexatePeptides, CyclicAnt-CCPAutoantibodiesDMARDs (biologic)Rheumatoid Arthritis

Identifiers

PMID26359449
PMCPMC4819608
OpenAlexW1660699958

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.