Quantification of longitudinal patient-reported burden of adverse drug reactions attributed to the use of TNF-α inhibitors in inflammatory rheumatic diseases: an observational prospective cohort study

被引:0
|
作者
Konig, Benthe H. [1 ]
Gosselt, Helen R. [1 ]
van Lint, Jette A. [1 ]
Kosse, Leanne J. [1 ]
van den Bemt, Bart J. F. [2 ,3 ]
ten Klooster, Peter M. [4 ]
Vonkeman, Harald E. [4 ,5 ]
Jessurun, Naomi T. [1 ]
机构
[1] Netherlands Pharmacovigilance Ctr Lareb, Dutch Biol Monitor, Goudsbloemvallei 7, NL-5237 MH sHertogenbosch, Netherlands
[2] Sint Maartenskliniek, Dept Pharm, Nijmegen, Netherlands
[3] Radboudumc, Dept Pharm, Nijmegen, Netherlands
[4] Univ Twente, Dept Psychol Hlth & Technol, Enschede, Netherlands
[5] Med Spectrum Twente, Dept Rheumatol & Clin Immunol, Enschede, Netherlands
关键词
Biologics; adverse drug reactions; inflammatory rheumatism; longitudinal study; burden of ADRs; ARTHRITIS; RISK;
D O I
10.1080/14740338.2024.2383697
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
BackgroundThere is a lack of knowledge on patient perspectives on adverse drug reactions (ADRs) attributed to the use of biologics. The aim of this study is to quantify the burden over time of ADRs attributed to TNF-alpha inhibitors in patients with inflammatory rheumatic diseases (IRDs) and investigate whether the burden over time differs between different types of ADRs.Research design and methodsData were used from the Dutch Biologic Monitor (DBM), an observational prospective cohort study for patient-reported ADRs attributed to biologics. Patients with an IRD using a TNF-alpha inhibitor reporting an ADR, lasting for three consecutive questionnaires, were included. Questionnaires were sent every 2 months and the burden was scored on a 5-point Likert-type scale. Burden scores were analyzed using linear mixed models.ResultsData from 166 unique patients reporting 274 ADRs were included. The burden score decreased every month by 0.29 points (95% CI -0.34 - -0.24) on average on a 5-point Likert-type scale. The burden score for infections and infestations decreased significantly faster than the burden score for injection site reactions.ConclusionsPatient-reported burden of ADRs attributed to the use of a TNF-alpha inhibitor in patients with IRDs decreased significantly over time, especially for infections and infestations.
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页数:6
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