Evidence map›Paper›PMID 21478189›Full record

Trial reportAnnals of the rheumatic diseases2011

Baseline tumour necrosis factor alpha levels predict the necessity for dose escalation of infliximab therapy in patients with rheumatoid arthritis.

Tsutomu Takeuchi, Nobuyuki Miyasaka, Yoshihiko Tatsuki, Toshiro Yano, Toru Yoshinari, Tohru Abe, Takao Koike

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report 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. It is linked to trial NCT01971814 (Early Serum Infliximab Levels in Severe Ulcerative Colitis), which is not on this map. Cited by 59 papers.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed
8.6field-weighted citation impact, top 2% 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.

NCT01971814 phase1completednot on this mapstarted 2013, after this paper: background citation

Early Serum Infliximab Levels in Severe Ulcerative Colitis

TypeinterventionalSponsorUniversity of California, San FranciscoRan2013 to 2015Enrolled11ConditionsUlcerative Colitis (UC), Inflammatory Bowel DiseaseArmsInfliximab
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 151 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

7 authors at 5 institutions in 1 country.

Tsutomu TakeuchiDivision of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Shinjuku-ku, Tokyo, Japan. tsutake@z5.keio.jp
Nobuyuki Miyasaka
Yoshihiko Tatsuki
Toshiro Yano
Toru Yoshinari
Tohru Abe
Takao Koike
Mitsubishi Tanabe Pharma CorporationHokkaido University · JPKeio University · JPSaitama Medical University · JPTokyo Medical and Dental University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo investigate the possible role of baseline plasma tumour necrosis factor alpha levels (baseline-TNF) on the clinical response to infliximab in patients with rheumatoid arthritis (RA).

methodsPatients with RA refractory to methotrexate received 3, 6, or 10 mg/kg of infliximab every 8 weeks, in a randomised, double-blind manner: the RISING study. Clinical response (disease activity score in 28 joints based on C-reactive protein or American College of Rheumatology core set) at week 54 and serum infliximab levels were compared in three patient groups with low, intermediate, or high baseline-TNF (TNF-low, TNF-int, or TNF-high).

resultsIn TNF-low patients, the clinical response to different doses of infliximab was comparable, whereas TNF-int patients exhibited a dose-dependent trend. In contrast, TNF-high patients (approximately 13% of the total patients) had a clinical response to 10 mg/kg significantly better than the response to 3 and 6 mg/kg of infliximab. In TNF-high patients, the median trough serum levels of infliximab were below the detection limit (<0.1 μg/ml) at 3 and 6 mg/kg but were greater than 2 μg/ml at 10 mg/kg, whereas the levels were approximately 1 μg/ml for each dosage group in TNF-low patients.

conclusionIn patients with RA, baseline-TNF is significantly associated with the clinical response to infliximab in patients with a high baseline-TNF. A higher dose of infliximab may be necessary in these patients, whereas lower doses of infliximab are sufficient for those with a low baseline-TNF. Baseline-TNF may be a useful measure for personalising the treatment of RA using infliximab.

Indexed as

AdultAntibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidBiomarkersDose-Response Relationship, DrugDrug Administration ScheduleEpidemiologic MethodsFemaleHumansInfliximabMaleMiddle AgedTreatment OutcomeTumor Necrosis Factor-alphaAntibodies, MonoclonalAntirheumatic AgentsBiomarkersInfliximabTumor Necrosis Factor-alpha

Identifiers

PMID21478189
PMCPMC3103666
OpenAlexW2128517665

What OpenQuestion holds

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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.