Evidence map›Paper›PMID 20980704›Full record

Trial reportAnnals of the rheumatic diseases2011

Fcγ receptor IIIb polymorphism and use of glucocorticoids at baseline are associated with infusion reactions to infliximab in patients with rheumatoid arthritis.

Ayumi Okuyama, Hayato Nagasawa, Katsuya Suzuki, Hideto Kameda, Harumi Kondo, Kouichi Amano, Tsutomu Takeuchi

Abstract readClinical 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. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
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.

Ayumi OkuyamaRheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Hayato Nagasawa
Katsuya Suzuki
Hideto Kameda
Harumi Kondo
Kouichi Amano
Tsutomu Takeuchi

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveInfusion reaction is a major adverse event in patients with rheumatoid arthritis (RA) treated with infliximab. The possible factors including Fcγ receptor (FcγR) polymorphism associated with the development of infusion reactions in patients with RA receiving infliximab were prospectively examined.

methods96 patients with RA were enrolled and scheduled to receive infliximab at a dose of 3 mg/kg at weeks 0, 2 and 6 and every 8 weeks thereafter. Genetic polymorphisms for FcγR were examined in FCGR3A 176F/V and FCGR3B NA1/2 alleles by allele-specific PCR analysis.

resultsAn infusion reaction was observed in 17 patients (18%) during 52 weeks of treatment with infliximab. The FCGR3B NA1/NA1 genotype was found in 75% of the patients with infusion reactions and in only 37% of those without (p=0.01), whereas the FCGR3A 176F/V genotype was equally distributed in the patients with or without infusion reactions. Glucocorticoids were used in 53% of the patients who developed an infusion reaction and in 80% of those without an infusion reaction (p=0.02). A multivariable logistic regression model showed that the FCGR3B NA1/NA1 genotype and use of glucocorticoids at baseline could be used as independent predictive factors for infusion reactions (OR 6.1 (95% CI 1.9 to 24.3) and OR 0.26 (95% CI 0.08 to 0.84), respectively). The presence of anti-infliximab antibody during infliximab treatment was also associated with infusion reactions.

conclusionFCGR3B NA1/NA1 genotype, use of glucocorticoids and the presence of anti-infliximab antibody accounted for nearly all patients with RA who developed infusion reactions.

Indexed as

AdultAgedAntibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidDrug Administration ScheduleDrug Therapy, CombinationEpidemiologic MethodsFemaleGenetic Predisposition to DiseaseGlucocorticoidsGPI-Linked ProteinsHumansInfliximabInfusions, IntravenousMaleAntibodies, MonoclonalAntirheumatic AgentsFCGR3B protein, humanGlucocorticoidsGPI-Linked ProteinsInfliximabReceptors, IgGTumor Necrosis Factor-alpha

Identifiers

PMID20980704
PMCPMC3015102

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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.