Evidence map›Paper›PMID 23962455›Full record

Trial reportAnnals of the rheumatic diseases2014

Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial.

Michael Schiff, Michael E Weinblatt, Robert Valente, Désirée van der Heijde, Gustavo Citera, Ayanbola Elegbe, Michael Maldonado, Roy Fleischmann

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05353829 (Efficacy, Tolerability and Preferences of Per Oral or Subcutaneous Methotrexate in Patients with Early Rheumatoid Arthritis - a Randomised Register Based Multicentre Study), which is not on this map. Cited by 131 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
131citing papers in PubMed, 11 pooled it
21.2field-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.

NCT05353829 phase4active not recruitingnot on this mapstarted 2022, after this paper: background citation

Efficacy, Tolerability and Preferences of Per Oral or Subcutaneous Methotrexate in Patients with Early Rheumatoid Arthritis - a Randomised Register Based Multicentre Study

TypeinterventionalSponsorRegion VästerbottenRan2022 to 2026Enrolled212ConditionsRheumatoid ArthritisArmsMethotrexate
3 · Its place in the literature

Who cites it

131 citing papers in PubMed, 11 syntheses or guidelines pooled it, 292 citations in OpenAlex.

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71 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

8 authors at 7 institutions in 4 countries.

Michael SchiffDepartment of Rheumatology, University of Colorado, , Denver, Colorado, USA.
Michael E Weinblatt
Robert Valente
Désirée van der Heijde
Gustavo Citera
Ayanbola Elegbe
Michael Maldonado
Roy Fleischmann
Brigham and Women's Hospital · USBristol-Myers Squibb (Germany) · DEBristol-Myers Squibb (United States) · USInstituto Nacional de Rehabilitación Psicofísica · ARLeiden University Medical Center · NLThe University of Texas Southwestern Medical Center · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA).

methodsAMPLE is a phase IIIb, 2-year, randomised, investigator-blinded study with a 1-year primary endpoint. Biologic-naive patients with active RA and an inadequate response to MTX were randomised to 125 mg abatacept weekly or 40 mg adalimumab bi-weekly, both with a stable dose of MTX.

resultsOf 646 patients randomised, 79.2% abatacept and 74.7% adalimumab patients completed year 2. At year 2, efficacy outcomes, including radiographic, remained comparable between groups and with year 1 results. The American College Rheumatology 20, 50 and 70 responses at year 2 were 59.7%, 44.7% and 31.1% for abatacept and 60.1%, 46.6% and 29.3% for adalimumab. There were similar rates of adverse events (AEs) and serious adverse events (SAEs). More serious infections occurred with adalimumab (3.8% vs 5.8%) including two cases of tuberculosis with adalimumab. There were fewer discontinuations due to AEs (3.8% vs 9.5%), SAEs (1.6% vs 4.9%) and serious infections (0/12 vs 9/19 patients) in the abatacept group. Injection site reactions (ISRs) occurred less frequently with abatacept (4.1% vs 10.4%).

conclusionsThrough 2 years of blinded treatment in this first head-to-head study between biologic disease-modifying antirheumatic drugs in RA patients with an inadequate response to MTX, subcutaneous abatacept and adalimumab were similarly efficacious based on clinical, functional and radiographic outcomes. Overall, AE frequency was similar in both groups but there were less discontinuations due to AEs, SAEs, serious infections and fewer local ISRs with abatacept.

Indexed as

AbataceptAdalimumabAdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDrug Therapy, CombinationFemaleHumansImmunoconjugatesInjections, SubcutaneousMaleMethotrexateMiddle AgedTreatment OutcomeAbataceptAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsImmunoconjugatesMethotrexateDMARDs (Biologic)MethotrexateRheumatoid Arthritis

Identifiers

PMID23962455
PMCPMC3888617
OpenAlexW2139323151

What OpenQuestion holds

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LicenceCC BY-NC
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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.