Evidence map›Paper›PMID 37010772›Full record

ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2023

Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor.

Jette A van Lint, Naomi T Jessurun, Sander W Tas, Harald E Vonkeman, Martijn B A van Doorn, Frank Hoentjen, Michael T Nurmohamed, Eugene P van Puijenbroek, Bart J F van den Bemt

Abstract read
In one paragraph

Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

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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

2 citing papers in PubMed.

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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

9 authors.

Jette A van LintNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands. Jette.vanlint@radboudumc.nl.ORCID http://orcid.org/0000-0003-2303-6199
Naomi T JessurunNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
Sander W TasDepartment of Rheumatology and Clinical Immunology, Amsterdam Infection and Immunity Institute and Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam University Medical Center (AMC), Amsterdam, The Netherlands.
Harald E VonkemanDepartment of Rheumatology, Medisch Spectrum Twente, Enschede, The Netherlands.
Martijn B A van DoornDepartment of Dermatology, Erasmus Medical Center, Rotterdam, The Netherlands.
Frank HoentjenInflammatory Bowel Disease Center, Department of Gastroenterology, Radboud University Medical Center, Nijmegen, The Netherlands.
Michael T NurmohamedAmsterdam Rheumatology Immunology Center, Location Reade, Amsterdam, The Netherlands.
Eugene P van PuijenbroekNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
Bart J F van den BemtDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.

Funding

ZonMw 848050005
6 · The paper itself

Abstract

backgroundFatigue is a common problem in immune-mediated inflammatory disease (IMID) patients, significantly impacting their quality of life.

objectivesIn this study, we describe the pattern and characteristics of fatigue as a patient-reported adverse drug reaction (ADR) of biologics, and compared patient and treatment characteristics with patients reporting other ADRs or no ADRs.

methodsIn this cohort event monitoring study, the description and characteristics of fatigue reported as a possible ADR in the Dutch Biologic Monitor were assessed and analysed for commonly recurring themes or patterns. Baseline and treatment characteristics of patients with fatigue and patients reporting other ADRs or no ADRs were compared.

resultsOf 1382 participating patients, 108 patients (8%) reported fatigue as an ADR of a biologic. Almost half of these patients (50 patients, 46%) described episodes of fatigue during or shortly after biologic injection, which often recurred following subsequent injections. Patients with fatigue were significantly younger than patients with other ADRs or patients without ADRs (median age for patients with fatigue, 52 years; median age for patients with other ADRs, 56 years; and median age for patients without ADRs, 58 years); significantly more often smoked (25% vs. 16% and 15%); used infliximab (22% vs. 9% and 13%), rituximab (9% vs. 3% and 1%) or vedolizumab (6% vs. 2% and 1%); and significantly more often had Crohn's disease (28% vs. 13% and 13%) and other comorbidities (31% vs. 20% and 15%). Patients with fatigue significantly less frequently used etanercept (12% vs. 29% and 34%) or had rheumatoid arthritis (30% vs. 45% and 43%).

conclusionsIMID patients may experience fatigue as a postdosing effect of biologics.

Indexed as

Arthritis, RheumatoidBiological ProductsDrug-Related Side Effects and Adverse ReactionsAdverse Drug Reaction Reporting SystemsFatigueHumansMiddle AgedPatient Reported Outcome MeasuresQuality of LifeBiological Products

Identifiers

PMID37010772
PMCPMC10287789

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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.