Monitoring of Adverse Events and Safety in Autoinflammatory Diseases: Real-Life Data from the Eurofever Registry.
J Clin Immunol
; 44(5): 119, 2024 May 17.
Article
en En
| MEDLINE
| ID: mdl-38758228
ABSTRACT
OBJECTIVES:
The study is aimed to evaluate the impact of safety events in the Eurofever registry for Autoinflammatory diseases.METHODS:
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.RESULTS:
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%).CONCLUSIONS:
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Sistema de Registros
Límite:
Adolescent
/
Adult
/
Aged
/
Child
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Child, preschool
/
Female
/
Humans
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Infant
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Male
/
Middle aged
País/Región como asunto:
Europa
Idioma:
En
Revista:
J Clin Immunol
Año:
2024
Tipo del documento:
Article
País de afiliación:
Italia