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

Autor: Vyzhga Y; IRCCS Istituto Giannina Gaslini, UOC Reumatologia E Malattie Autoinfiammatorie, Genoa, Italy. yulia_tokarchuk@yahoo.com., Frenkel J; Department of Pediatric Immunology and Rheumatology, Wilhelmina Kinderziekenhuis, Utrecht, Netherlands., Insalaco A; Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy., Anton J; Hospital Sant Joan de Déu, Department of Pediatric Rheumatology, Universitat de Barcelona. Institut de Recerca Sant Joan de Deu, Barcelona, Spain., Koné-Paut I; Department of Pediatric Rheumatology, National Referral Centre of Auto-Inflammatory Diseases and Inflammatory Amyloidosis, CEREMAIA, CHU de Biĉetre, APHP, University of Paris Sud, Le Kremlin Biĉetre, Paris, France., Legger GE; Department of Pediatric Rheumatology, University Groningen, University Medical Center Groningen, Groningen, The Netherlands., Fabio G; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Dipartimento Di Medicina Interna, UOS Malattie Rare, Milan, Italy., Cattalini M; Clinica Pediatrica Dell'Universita' Di Brescia, Unita' Di Immunologia E Reumatologia Pediatrica, Spedali Civili, Brescia, Italy., Kamphuis S; Department of Paediatric Rheumatology, Sophia Children's Hospital, Erasmus University Medical Centre, Rotterdam, The Netherlands., Hachulla E; Service Medecine Interne, CHRU de Lille- Hospital Claude, Huriez - 4 Étage EST, Lille, France., Krause K; Dpt. of Dermatology and Allergy, Charite University Hospital Berlin, Berlin, Germany., Ekinci Z; Department of Pediatric Rheumatology, Başkent University İstanbul Hospital, Istanbul, Turkey., Sanchez-Manubens J; Hospital Parc Taulí de Sabadell, Reumatologia Pediàtrica - Servei de Medicina Pediàtrica, Barcelona, Spain., Van den Berg JM; Emma Children Hospital, Department of Pediatric Immunology, Rheumatology and Infectious Disease, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands., Mora CH; Hospital de Niños Roberto Gilbert Elizalde, Reumatology, Guayaquil, Ecuador., Brinkman D; Department of Pediatrics, Division of Pediatric Rheumatology, Willem-Alexander Children`S Hospital, Leiden University Medical Center, Leiden, Netherlands., Labrador E; San Pedro Hospital, Rheumatology, Logroño, Spain., Potjewijd J; Department of Internal Medicine, Section Clinical Immunology, Maastricht University Medical Center, Maastricht, Netherlands., Carlini L; Gaslini Trial Centre/Servizio Di Sperimentazioni Cliniche Pediatriche, IRCCS Istituto Giannina Gaslini, PRINTO, Genoa, Italy., Bustaffa M; IRCCS Istituto Giannina Gaslini, UOC Reumatologia E Malattie Autoinfiammatorie, Genoa, Italy., Caorsi R; IRCCS Istituto Giannina Gaslini, UOC Reumatologia E Malattie Autoinfiammatorie, Genoa, Italy., Ruperto N; Gaslini Trial Centre/Servizio Di Sperimentazioni Cliniche Pediatriche, IRCCS Istituto Giannina Gaslini, PRINTO, Genoa, Italy., Gattorno M; IRCCS Istituto Giannina Gaslini, UOC Reumatologia E Malattie Autoinfiammatorie, Genoa, Italy.
Jazyk: angličtina
Zdroj: Journal of clinical immunology [J Clin Immunol] 2024 May 17; Vol. 44 (5), pp. 119. Date of Electronic Publication: 2024 May 17.
DOI: 10.1007/s10875-024-01719-4
Abstrakt: 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.
(© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE
Externí odkaz: