Evidence map›Paper›PMID 19074911›Full record

Trial reportAnnals of the rheumatic diseases2009

The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial.

M Schiff, C Pritchard, J E Huffstutter, V Rodriguez-Valverde, P Durez, X Zhou, T Li, K Bahrt, S Kelly, M Le Bars and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00124982 (A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept), which is not on this map. Cited by 66 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 5 pooled it
–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.

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
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  20. Biologics' switching: new insights toward establishing practice norms.United European gastroenterology journal · 2019
    Article

6 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

11 authors.

M SchiffUniversity of Colorado, Greenwood Village, CO 80111, USA. Lmschiff@aol.com
C Pritchard
J E Huffstutter
V Rodriguez-Valverde
P Durez
X Zhou
T Li
K Bahrt
S Kelly
M Le Bars
M C Genovese

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the safety, tolerability and efficacy of abatacept in patients with rheumatoid arthritis (RA) who had failed anti-tumour necrosis factor (TNF) therapy and were switched to abatacept directly or after completing washout.

methodsIn this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for 3 months or longer and a disease activity score in 28 joints (DAS28 (C-reactive protein; CRP) of 5.1 or greater. "Washout" patients discontinued anti-TNF therapy 2 months or longer pre-screening; "direct-switch" patients began abatacept ( approximately 10 mg/kg) at their next scheduled anti-TNF therapy dose.

results1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events (AE; 78.0% vs 79.2%), serious AE (11.1% vs 9.9%) and discontinuations due to AE (3.8% vs 4.0%) and serious AE (2.0% vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (> or =1.2 unit improvement, 59.5% vs 53.6%, respectively; low disease activity state, 22.5% vs 22.3%; DAS28-defined remission, 12.0% vs 13.7%), physical function (health assessment questionnaire disability index > or =0.22 improvement; 46.3% vs 47.1%) and health-related quality of life (mean change in short-form 36 scores: physical component summary, 5.5 vs 6.1; mental component summary, 4.8 vs 5.4).

conclusionAbatacept demonstrated acceptable safety and tolerability and clinically meaningful efficacy over 6 months in patients with inadequate response to anti-TNF therapy. Results were comparable with or without a washout, supporting direct switching from anti-TNF therapy to abatacept as an option in clinical practice. TRIAL REGISTRATION NUMBER: NCT00124982.

Indexed as

AbataceptAdultAgedAntirheumatic AgentsArthritis, RheumatoidAutoimmune DiseasesBiomarkersC-Reactive ProteinFemaleHumansImmunoconjugatesMaleMiddle AgedNeoplasmsOpportunistic InfectionsQuality of LifeAbataceptAntirheumatic AgentsBiomarkersC-Reactive ProteinImmunoconjugatesTumor Necrosis Factor-alpha

Identifiers

PMID19074911
PMCPMC2756956

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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.