Evidence map›Paper›PMID 38377117›Full record

Observational studyPloS one2024

Burden of non-serious infections during biological use for rheumatoid arthritis.

Barbara Bergmans, Naomi Jessurun, Jette van Lint, Jean-Luc Murk, Eugène van Puijenbroek, Esther de Vries

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 27% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
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

6 authors at 4 institutions in 1 country.

Barbara BergmansTranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.ORCID 0000-0002-9211-5504
Naomi JessurunNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Jette van LintNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Jean-Luc MurkLaboratory of Medical Microbiology and Immunology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.ORCID 0000-0003-3661-9035
Eugène van PuijenbroekNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Esther de VriesTranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.ORCID 0000-0003-4311-3550
Netherlands Pharmacovigilance Centre Lareb · NLTilburg University · NLElisabeth-TweeSteden Ziekenhuis · NLUniversity of Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBiologicals have become a cornerstone in rheumatoid arthritis (RA) treatment. The increased risk of serious infections associated with their use is well-established. Non-serious infections, however, occur more frequently and are associated with a high socioeconomic burden and impact on quality of life but have not received the same attention in the literature to date. The aim of this study was to gain insight into the various non-serious infections reported in RA patients using biologicals and their experienced burden. MATERIALS AND

methodsThe Dutch Biologic Monitor was a prospective observational study that included adults with rheumatoid arthritis and biological use who answered bimonthly questionnaires on the adverse drug reactions (ADRs) they experienced from their biological and reported the associated impact score (ranging from 1, no impact, to 5, very high impact). ADRs were assigned a MedDRA code by pharmacovigilance experts and labeled as definite, probable, possible or no infection by infectious disease professionals. Descriptive statistics were performed using medians and interquartile ranges.

resultsA total of 586 patients were included in the final analysis. Eighty-five patients (14.5%) reported a total of 421 ADRs labeled as probable or definite infections by the experts. Patient-assigned burden was ADR-specific. Upper respiratory tract infections were most frequently reported and had a high rate of recurrence or persistence, with a median impact score of 3.0 (IQR 2.0-3.0) which remained stable over time. DISCUSSION: Non-serious infections significantly outnumbered serious infections in this real-life cohort of RA patients using biologicals (77.1 non-serious infections and 1.3 serious infections per 100 patient years, respectively). Infections in the upper respiratory tract were rated as having an average burden, which remained constant over a long period of time. Awareness of the impact of recurrent and chronic non-serious infections may enable healthcare professionals to timely treat and maybe even prevent them, which would lessen the associated personal and socioeconomic burden.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAdultBiological FactorsHealth PersonnelHumansPatientsQuality of LifeAntirheumatic AgentsBiological Factors

Identifiers

PMID38377117
PMCPMC10878515
OpenAlexW4391953331

What OpenQuestion holds

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LicenceCC BY
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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.