Evidence map›Paper›PMID 29329602›Full record

ArticleArthritis research & therapy2018

Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting.

Rieke Alten, Harald Burkhardt, Eugen Feist, Klaus Krüger, Juergen Rech, Andrea Rubbert-Roth, Reinhard E Voll, Yedid Elbez, Christiane Rauch

4 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Arthritis research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% 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.

NCT00048581 phase3completednot on this map

A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy

TypeinterventionalSponsorBristol-Myers SquibbRan2002 to 2009Enrolled738ConditionsRheumatoid ArthritisArmsAbatacept, Placebo
NCT00048932 phase3completednot on this map

A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis

TypeinterventionalSponsorBristol-Myers SquibbRan2002 to 2009Enrolled1,795ConditionsRheumatoid ArthritisArmsDouble-blind Abatacept, Double-blind Placebo, Open-label Abatacept
NCT00124982 phase3completednot on this map

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

TypeinterventionalSponsorBristol-Myers SquibbRan2005 to 2009Enrolled1,286ConditionsRheumatoid ArthritisArmsAbatacept, Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD), Anti-Tumor Necrosing Factor (TNF) Therapy
NCT02109666 completednot on this map

Long Term Experience With Abatacept in Routine Clinical Practice

TypeobservationalSponsorBristol-Myers SquibbRan2008 to 2016Enrolled2,364ConditionsRheumatoid ArthritisArmsAbatacept
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Targeting co-stimulatory molecules in autoimmune disease.Nature reviews. Drug discovery · 2020
    Review
  6. Article
  7. Article
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

9 authors at 8 institutions in 1 country.

Rieke AltenDepartment of Internal Medicine, Rheumatology, Clinical Immunology and Osteology, Schlosspark-Klinik University Medicine Berlin, Heubnerweg 2, 14059, Berlin, Germany. rieke.alten@schlosspark-klinik.de.ORCID 0000-0002-3395-4412
Harald BurkhardtUniversity Hospital Frankfurt, Goethe University, Heubnerweg 2, 14059, Frankfurt am Main, Germany.
Eugen FeistCharité Universitaetsmedizin Berlin, Berlin, Germany.
Klaus KrügerPraxiszentrum St. Bonifatius, Munich, Germany.
Juergen RechUniversity Clinic Erlangen, Erlangen, Germany.
Andrea Rubbert-RothMed Clinic I, University of Cologne, Cologne, Germany.
Reinhard E VollMedical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Yedid ElbezExcelya, Boulogne-Billancourt, France.
Christiane RauchBristol-Myers Squibb, Munich, Germany.
Bristol-Myers Squibb (Germany) · DECharité - Universitätsmedizin Berlin · DEGoethe University Frankfurt · DESchlosspark-Klinik · DESt. Bonifatius Hospital · DEUniversitätsklinikum Erlangen · DEUniversity of Cologne · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMethotrexate (MTX) remains the anchor drug in rheumatoid arthritis (RA) treatment, but is poorly tolerated or contraindicated in some patients. There is a wealth of data supporting the use of abatacept in combination with MTX, but data on alternative conventional synthetic disease-modifying antirheumatic drug (csDMARD) combinations with abatacept are scarce.

methodsIn this post-hoc exploratory analysis, efficacy and safety data were extracted from abatacept RA studies in which combination with csDMARDs other than MTX was permitted: three interventional trials (ATTAIN, ASSURE, and ARRIVE) and one real-world study (ACTION). Patients with moderate-to-severe RA received abatacept in combination with MTX, hydroxychloroquine, sulfasalazine, azathioprine, or leflunomide for 6 months to 2 years according to the study design. Change from baseline in physical function (Health Assessment Questionnaire-Disability Index (HAQ-DI); all studies) and 28-joint Disease Activity Score (C-reactive protein) (DAS28 (CRP); ATTAIN, ARRIVE, and ACTION), American College of Rheumatology response rates (ATTAIN), and safety were assessed for individual and pooled csDMARD combinations for each trial. A meta-analysis was also performed on pooled data for HAQ-DI and DAS28 (CRP) across interventional trials.

resultsAcross all four studies, 731 patients received abatacept plus one non-MTX csDMARD (hydroxychloroquine n = 152; sulfasalazine n = 123; azathioprine n = 59; and leflunomide n = 397) and 2382 patients received abatacept plus MTX. Mean changes from baseline in HAQ-DI scores for abatacept plus MTX (all csDMARDs pooled) vs abatacept plus a non-MTX csDMARD were -0.54 vs -0.44 (ATTAIN), -0.43 vs -0.43 (ASSURE), and -0.39 vs -0.36 (ARRIVE). Mean changes from baseline in DAS28 (CRP) and ACR response rates were also similar with abatacept plus MTX or non-MTX csDMARDs. Data for individual non-MTX csDMARDs (pooled across studies) and real-world data were consistent with these findings. Rates of treatment-related adverse events and serious adverse events, respectively, for abatacept plus one non-MTX csDMARD vs abatacept plus MTX were 35.7% vs 41.7% and 2.4% vs 2.3% (ATTAIN), 58.0% vs 55.9% and 4.2% vs 1.7% (ASSURE), and 38.1% vs 44.3% and 0.6% vs 2.9% (ARRIVE).

conclusionsAbatacept in combination with non-MTX csDMARDs is clinically effective and well tolerated in patients with moderate-to-severe RA, providing similar benefits to those seen with abatacept plus MTX.

trial registrationClinicalTrials.gov NCT00048581 . Registered 2 November 2002. ClinicalTrials.gov NCT00048932 . Registered 11 November 2002. ClinicalTrials.gov NCT00124982 . Registered 30 June 2005. ClinicalTrials.gov NCT02109666 . Registered 8 April 2014.

Indexed as

AbataceptAdultAgedAntirheumatic AgentsArthritis, RheumatoidClinical Trials as TopicDisability EvaluationDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedSurveys and QuestionnairesTreatment OutcomeAbataceptAntirheumatic AgentsMethotrexateAbataceptAzathioprineConventional synthetic disease-modifying antirheumatic drugHydroxychloroquineLeflunomideMethotrexateRheumatoid arthritisSulfasalazine

Identifiers

PMID29329602
PMCPMC5795278
OpenAlexW2782146274

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.