Monitoring of Adverse Events and Safety in Autoinflammatory Diseases: Real-Life Data from the Eurofever Registry.

Humans Registries Female Male Adult Retrospective Studies Adolescent Longitudinal Studies Young Adult Middle Aged Child Child, Preschool Aged Hereditary Autoinflammatory Diseases / epidemiology Infant Drug-Related Side Effects and Adverse Reactions / epidemiology Europe / epidemiology Adverse Drug Reaction Reporting Systems / statistics & numerical data

Autoinflammatory diseases Drug-related adverse events Safety events

Journal

Journal of clinical immunology

ISSN: 1573-2592

Titre abrégé: J Clin Immunol

Pays: Netherlands

ID NLM: 8102137

Informations de publication

Date de publication:
17 May 2024

Historique:

received: 03 03 2024

accepted: 22 04 2024

medline: 17 5 2024

pubmed: 17 5 2024

entrez: 17 5 2024

Statut: epublish

Résumé

The study is aimed to evaluate the impact of safety events in the Eurofever registry for Autoinflammatory diseases. This was a retrospective and longitudinal observational multicentre study. Data were retrieved from the international registry Eurofever, starting patients' enrolment since 2009. All moderate, severe, or very severe AEs reported by treating physician in Eurofever were analyzed regardless of a possible suspected causal relationship to any therapies and according to the latest release of the Medical Dictionary for Regulatory Activities. Complete information on safety were available in 2464 patients enrolled in the registry. In 1499 of them retrospective data encompassing the period from disease onset to enrolment were available, whereas 965 consecutive patients entered in the longitudinal part of the study. A total of 479 AEs have been reported in 275 patients. Eighty-two AEs were reported as serious and 99 were drug-related according to the physicians. Infections or infestations (94; 19.6%), gastrointestinal disorders (66; 13.8%), nervous system disorders (41; 8.6%) and systemic disorders or administration site reactions (35; 7.3%) were the most frequent reported events. The highest absolute number of drug-related AEs were related to biologic DMARDs (40/99 reports, 40,4%) and colchicine (31/99 reports, 31.3%). Present study shows the importance of a longitudinal and homogeneous registration of the AEs in rare conditions, with a particular focus on the safety profile of the treatments used in these conditions.

Identifiants

DOI: 10.1007/s10875-024-01719-4 PMID: 38758228

pubmed: 38758228

doi: 10.1007/s10875-024-01719-4

pii: 10.1007/s10875-024-01719-4

doi:

Types de publication

Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

Pagination

119

Informations de copyright

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