Evidence map›Paper›PMID 21708910›Full record

SynthesisAnnals of the rheumatic diseases2011

Changes in patient characteristics in anti-tumour necrosis factor clinical trials for rheumatoid arthritis: results of an analysis of the literature over the past 16 years.

Mahboob U Rahman, Jacqui Buchanan, Mittie K Doyle, Elizabeth C Hsia, Timothy Gathany, Shreekant Parasuraman, Daniel Aletaha, Eric L Matteson, Philip G Conaghan, Edward Keystone and 2 more

Open access · bronzeAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Annals of the rheumatic diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 5 pooled it
6.2field-weighted citation impact, top 3% 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

25 citing papers in PubMed, 5 syntheses or guidelines pooled it, 70 citations in OpenAlex.

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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 8 institutions in 5 countries.

Mahboob U RahmanCentocor R&D, Inc, Malvern, Pennsylvania, USA.
Jacqui Buchanan
Mittie K Doyle
Elizabeth C Hsia
Timothy Gathany
Shreekant Parasuraman
Daniel Aletaha
Eric L Matteson
Philip G Conaghan
Edward Keystone
Désireé van der Heijde
Josef S Smolen
Johnson & Johnson (United States) · USMedical University of Vienna · ATUniversity of Pennsylvania · USLeiden University Medical Center · NLMayo Clinic · USNIHR Leeds Musculoskeletal Biomedical Research Unit · GBPfizer (United States) · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate changes in baseline patient characteristics and entry criteria of randomised, controlled studies of tumour necrosis factor alpha (TNFα) inhibitors in rheumatoid arthritis (RA) patients.

methodsA systematic literature review was performed using predefined inclusion criteria to identify randomised, double-blind, controlled trials that evaluated TNFα inhibitors in adult RA patients. Entry criteria and baseline clinical characteristics were evaluated over time for methotrexate-experienced and methotrexate-naive study populations. Enrolment start date for each trial was the time metric. The anchor time was the study with the earliest identifiable enrolment start date.

results44 primary publications (reporting the primary study endpoint) from 1993 to 2008 met the inclusion criteria. Enrolment start dates of August 1993 and May 1997 were identified as time anchors for the 37 methotrexate-experienced studies and the seven methotrexate-naive studies, respectively. In methotrexate-experienced trials, no significant change was observed over the years included in this study in any inclusion criteria (including swollen joint counts and C-reactive protein (CRP)), but a significant decrease over time was observed in the baseline swollen joint count, CRP and total Sharp or van der Heijde modified Sharp score, but not in baseline tender joint counts. In the methotrexate-naive studies, significant decreases over the years were observed in swollen joint and tender joint inclusion criteria, but not in baseline tender joint count, baseline CRP, CRP inclusion criteria or baseline total Sharp or van der Heijde modified Sharp score.

conclusionInclusion criteria and baseline characteristics of RA patients enrolled in studies of TNFα inhibitors have changed, with more recent trials enrolling cohorts with lower disease activity, especially in methotrexate-experienced trials.

Indexed as

Randomized Controlled Trials as TopicAntirheumatic AgentsArthritis, RheumatoidHumansMethotrexatePatient SelectionSeverity of Illness IndexTumor Necrosis Factor-alphaAntirheumatic AgentsMethotrexateTumor Necrosis Factor-alpha

Identifiers

PMID21708910
PMCPMC3147244
OpenAlexW2132079297

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.