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Observational Study
. 2024 May 17;44(5):119.
doi: 10.1007/s10875-024-01719-4.

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

Yulia Vyzhga  1 , Joost Frenkel  2 , Antonella Insalaco  3 , Jordi Anton  4 , Isabelle Koné-Paut  5 , G Elizabeth Legger  6 , Giovanna Fabio  7 , Marco Cattalini  8 , Sylvia Kamphuis  9 , Eric Hachulla  10 , Karoline Krause  11 , Zelal Ekinci  12 , Judith Sanchez-Manubens  13 , J Merlijn Van den Berg  14 , Cristina Herrera Mora  15 , Danielle Brinkman  16 , Eztizen Labrador  17 , Judith Potjewijd  18 , Luca Carlini  19 , Marta Bustaffa  20 , Roberta Caorsi  20 , Nicolino Ruperto  19 , Marco Gattorno  20 ; for Eurofever the Paediatric Rheumatology International Trials Organisation (PRINTO)
Affiliations
Observational Study

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

Yulia Vyzhga et al. J Clin Immunol. .

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.

Keywords: Autoinflammatory diseases; Drug-related adverse events; Safety events.

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