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Introduction Biologicals 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 methods The Dutch Biologic Monitor was a prospec... Mehr ...

Verfasser: Barbara Bergmans
Naomi Jessurun
Jette van Lint
Jean-Luc Murk
Eugène van Puijenbroek
Esther de Vries
Dokumenttyp: Text
Erscheinungsdatum: 2024
Schlagwörter: Medicine / Biotechnology / Ecology / Immunology / Cancer / Science Policy / Mental Health / Infectious Diseases / Virology / upper respiratory tract / performed using medians / maybe even prevent / infectious disease professionals / dutch biologic monitor / answered bimonthly questionnaires / adverse drug reactions / median impact score / xlink \ / > biologicals / prospective observational study / 0 &# 8211 / associated impact score / high socioeconomic burden / high impact ) / > non / 5 %) reported / serious infections reported / serious infections associated / 421 adrs labeled / > / serious infections / high rate / respectively ) / associated personal / would lessen / various non / timely treat / rheumatoid arthritis / remained stable / remained constant / meddra code / long period / iqr 2 / increased risk / gain insight / five patients / final analysis / descriptive statistics / chronic non / average burden / 586 patients
Sprache: unknown
Permalink: https://search.fid-benelux.de/Record/base-27064340
Datenquelle: BASE; Originalkatalog
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Link(s) : https://doi.org/10.1371/journal.pone.0296821.s001

Introduction Biologicals 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 methods The 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. Results A 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 ...