Evidence map›Paper›PMID 14644854›Full record

Trial reportAnnals of the rheumatic diseases2003

Efficacy and safety of the fully human anti-tumour necrosis factor alpha monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: a 12 week, phase II study.

L B A van de Putte, R Rau, F C Breedveld, J R Kalden, M G Malaise, P L C M van Riel, M Schattenkirchner, P Emery, G R Burmester, H Zeidler and 3 more

Open access · bronzeAbstract readClinical TrialClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 16 pooled it
10.5field-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

65 citing papers in PubMed, 16 syntheses or guidelines pooled it, 179 citations in OpenAlex.

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  10. Adverse effects of biologics: a network meta-analysis and Cochrane overview.The Cochrane database of systematic reviews · 2011
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  14. Rheumatoid arthritis.BMJ clinical evidence · 2007
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  15. Guideline
  16. Adalimumab for treating rheumatoid arthritis.The Cochrane database of systematic reviews · 2005
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5 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

13 authors at 10 institutions in 5 countries.

L B A van de PutteUniversity Hospital Nijmegen, Nijmegen, The Netherlands.
R Rau
F C Breedveld
J R Kalden
M G Malaise
P L C M van Riel
M Schattenkirchner
P Emery
G R Burmester
H Zeidler
H M Moutsopoulos
K Beck
H Kupper
Abbott (Germany) · DERadboud University Nijmegen · NLCentre Hospitalier Universitaire de Liège · BECharité - Universitätsmedizin Berlin · DEFachklinik 360° · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEFrontier Science Foundation-Hellas · GRLeiden University · NLMedizinische Hochschule Hannover · DEUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate efficacy, dose response, safety, and tolerability of adalimumab (D2E7) in disease modifying antirheumatic drug (DMARD) refractory patients with longstanding, active rheumatoid arthritis (RA).

methodsDuring a 12 week, double blind, placebo controlled study, 284 patients were randomly allocated to receive weekly subcutaneous injections of adalimumab 20 mg (n = 72), 40 mg (n = 70), or 80 mg (n = 72) or placebo (n = 70) without concomitant DMARDs.

resultsAdalimumab significantly improved the signs and symptoms of RA for all efficacy measures. ACR20 responses with adalimumab were significant at each assessment versus placebo (p</=0.01). Additionally, ACR responses with adalimumab were achieved more rapidly than with placebo, with 82/115 (71%) of the ultimate ACR20 response rate to adalimumab treatment achieved at week 2. At week 12, for adalimumab 20, 40, and 80 mg, ACR20 response rates were 50.7%, 57.1%, and 54.2%, respectively, versus 10.0% for placebo (p</=0.001 for all comparisons); ACR50 rates were 23.9%, 27.1%, and 19.4%, respectively, versus 1.4% for placebo (p</=0.001 for all comparisons); and ACR70 rates were 11.3%, 10.0%, and 8.3%, respectively, versus 0.0% for placebo (p</=0.05 for all comparisons). All adalimumab doses significantly improved all ACR core criteria at all assessments. The 40 mg and 80 mg doses provided similar benefit. Adalimumab at all doses was generally well tolerated, with only mild or moderate adverse events. Completion rates were 87% for adalimumab and 67% for placebo.

conclusionsAdalimumab given as monotreatment to patients with longstanding, severe RA refractory to traditional DMARDs produced a rapid, sustained response and was safe and well tolerated, with no dose limiting side effects.

Indexed as

AdalimumabAdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug ResistanceFemaleHumansInjections, SubcutaneousMaleMiddle AgedTreatment OutcomeAdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsTumor Necrosis Factor-alpha

Identifiers

PMID14644854
PMCPMC1754401
OpenAlexW2133604058

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.