Evidence map›Paper›PMID 15082469›Full record

Trial reportAnnals of the rheumatic diseases2004

A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate.

S B Cohen, L W Moreland, J J Cush, M W Greenwald, S Block, W J Shergy, P S Hanrahan, M M Kraishi, A Patel, G Sun and 2 more

Open access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 118 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
118citing papers in PubMed, 18 pooled it
13.3field-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

118 citing papers in PubMed, 18 syntheses or guidelines pooled it, 299 citations in OpenAlex.

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  15. Adverse effects of biologics: a network meta-analysis and Cochrane overview.The Cochrane database of systematic reviews · 2011
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  16. Anakinra for rheumatoid arthritis.The Cochrane database of systematic reviews · 2009
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  18. Rheumatoid arthritis.BMJ clinical evidence · 2007
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58 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

12 authors at 9 institutions in 2 countries.

S B CohenDepartment of Rheumatology, St Paul Medical Center, Dallas, Texas 75235, USA. stanleycohen@radiantresearch.net
L W Moreland
J J Cush
M W Greenwald
S Block
W J Shergy
P S Hanrahan
M M Kraishi
A Patel
G Sun
M B Bear
990145 Study Group
Amgen (United States) · USEastern Maine Medical Center · USFoundation for the Advancement in Research in Medicine · USMercy Medical Center · USRheumatology Consultants · USSt. John Medical Center · USTexas Health Dallas · USTropical Population Health Unit · AUUniversity of Alabama at Birmingham · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of 100 mg daily anakinra (Kineret), a recombinant form of the naturally occurring interleukin 1 receptor antagonist, plus methotrexate (MTX) in reducing the signs and symptoms of rheumatoid arthritis (RA).

methodsPatients with active RA (n = 506) despite current treatment with MTX were enrolled in this multicentre, double blind, randomised, placebo controlled study. Patients received subcutaneous injections of anakinra 100 mg/day or placebo. They were assessed monthly for 6 months for improvement in signs and symptoms of RA and for adverse events. The primary efficacy measure was the percentage of patients attaining ACR20 response at week 24.

resultsSignificantly greater proportions of patients treated with anakinra compared with placebo achieved ACR20 (38% v 22%; p<0.001), ACR50 (17% v 8%; p<0.01), and ACR70 (6% v 2%; p<0.05) responses. The response to anakinra was rapid; the proportion of patients with an ACR20 response at the first study assessment (4 weeks) was twice as high with anakinra as with placebo (p<0.005). Clinically meaningful and statistically significant responses were also seen in individual components of the ACR response (for example, Health Assessment Questionnaire, pain, C reactive protein levels, and erythrocyte sedimentation rate). Anakinra was well tolerated, with a safety profile, similar to that of placebo with one exception: mild to moderate injection site reactions were more common with anakinra than with placebo (65% v 24%).

conclusionsThis study confirms previous observations from a dose-ranging study showing that anakinra, in combination with MTX, is an effective and safe treatment for patients with RA who have inadequate responses to MTX alone.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsInterleukin 1 Receptor Antagonist ProteinMaleMethotrexateMiddle AgedReceptors, Interleukin-1Recombinant ProteinsSeverity of Illness IndexSialoglycoproteinsAntirheumatic AgentsIL1RN protein, humanImmunosuppressive AgentsInterleukin 1 Receptor Antagonist ProteinMethotrexateReceptors, Interleukin-1Recombinant ProteinsSialoglycoproteins

Identifiers

PMID15082469
PMCPMC1755108
OpenAlexW2145249112

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.