Evidence map›Paper›PMID 24550168›Full record

Trial reportAnnals of the rheumatic diseases2015

Efficacy and safety of ascending methotrexate dose in combination with adalimumab: the randomised CONCERTO trial.

Gerd-Rűdiger Burmester, Alan J Kivitz, Hartmut Kupper, Udayasankar Arulmani, Stefan Florentinus, Sandra L Goss, Suchitrita S Rathmann, Roy M Fleischmann

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 99 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 11 pooled it
23.7field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 11 syntheses or guidelines pooled it, 228 citations in OpenAlex.

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39 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 6 institutions in 3 countries.

Gerd-Rűdiger BurmesterDepartment of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany.
Alan J KivitzAltoona Center for Clinical Research, Duncansville, Pennsylvania, USA.
Hartmut KupperAbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.
Udayasankar ArulmaniAbbVie Inc, North Chicago, Illinois, USA.
Stefan FlorentinusAbbVie, Rungis, France.
Sandra L GossAbbVie Inc, North Chicago, Illinois, USA.
Suchitrita S RathmannAbbVie Inc, North Chicago, Illinois, USA.
Roy M FleischmannUniversity of Texas Southwestern, Dallas, Texas, USA.
AbbVie (United States) · USAbbott (France) · FRAbbVie (Germany) · DEAltoona Center for Clinical Research · USCharité - Universitätsmedizin Berlin · DEThe University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveCONCERTO was a randomised, double-blind, parallel-armed study of methotrexate (MTX) in combination with adalimumab to assess whether an increasing trend of efficacy and decreased safety exists when increasing MTX dose in patients with early rheumatoid arthritis (RA).

methodsEarly, biologic and MTX-naive RA patients (N=395) were evenly randomised to open-label adalimumab (40 mg every other week) plus weekly blinded 2.5, 5, 10 or 20 mg MTX for 26 weeks. Clinical, radiographic and functional outcomes were analysed using two-sided linear trend tests or one-way analysis of covariance.

resultsStatistically significant increasing trends were observed in the proportion of patients achieving the primary endpoint, 28-joint count disease activity score with C reactive protein (DAS28(CRP)) <3.2 (42.9%, 44.0%, 56.6% and 60.2% for 2.5, 5, 10 or 20 mg/week MTX, respectively), DAS28(CRP) <2.6 and American College of Rheumatology 50/70/90 responses with increasing doses of MTX in combination with adalimumab. No statistical differences in minimal clinically important differences in physical function were detected. Statistically significant trends for achieving low disease activity and remission were demonstrated with increasing MTX dose by validated clinical indices; differences comparing 10 and 20 mg MTX were minimal. Adalimumab serum concentrations increased with ascending dose up to 10 mg MTX. More patients experienced infectious adverse events with increasing MTX dose.

conclusionsIncreasing doses of MTX in combination with adalimumab demonstrated a statistically significant trend in improved clinical outcomes that mimicked the adalimumab pharmacokinetic profile. In early RA patients initiating adalimumab combination therapy, efficacy of 10 and 20 mg/week MTX appeared equivalent.

Indexed as

AdalimumabAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedTreatment OutcomeAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexate

Identifiers

PMID24550168
PMCPMC4431334
OpenAlexW2110345763

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Registered trials

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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.