Evidence map›Paper›PMID 38758228›Full record

Observational studyJournal of clinical immunology2024

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

Yulia Vyzhga, Joost Frenkel, Antonella Insalaco, Jordi Anton, Isabelle Koné-Paut, G Elizabeth Legger, Giovanna Fabio, Marco Cattalini, Sylvia Kamphuis, Eric Hachulla and 14 more

Abstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of clinical immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Yulia VyzhgaIRCCS Istituto Giannina Gaslini, UOC Reumatologia E Malattie Autoinfiammatorie, Genoa, Italy. yulia_tokarchuk@yahoo.com.
Joost FrenkelDepartment of Pediatric Immunology and Rheumatology, Wilhelmina Kinderziekenhuis, Utrecht, Netherlands.
Antonella InsalacoDivision of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy.
Jordi AntonHospital Sant Joan de Déu, Department of Pediatric Rheumatology, Universitat de Barcelona. Institut de Recerca Sant Joan de Deu, Barcelona, Spain.
Isabelle Koné-PautDepartment 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.
G Elizabeth LeggerDepartment of Pediatric Rheumatology, University Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Giovanna FabioFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Dipartimento Di Medicina Interna, UOS Malattie Rare, Milan, Italy.
Marco CattaliniClinica Pediatrica Dell'Universita' Di Brescia, Unita' Di Immunologia E Reumatologia Pediatrica, Spedali Civili, Brescia, Italy.
Sylvia KamphuisDepartment of Paediatric Rheumatology, Sophia Children's Hospital, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Eric HachullaService Medecine Interne, CHRU de Lille- Hospital Claude, Huriez - 4 Étage EST, Lille, France.
Karoline KrauseDpt. of Dermatology and Allergy, Charite University Hospital Berlin, Berlin, Germany.
Zelal EkinciDepartment of Pediatric Rheumatology, Başkent University İstanbul Hospital, Istanbul, Turkey.
Judith Sanchez-ManubensHospital Parc Taulí de Sabadell, Reumatologia Pediàtrica - Servei de Medicina Pediàtrica, Barcelona, Spain.
J Merlijn Van den BergEmma Children Hospital, Department of Pediatric Immunology, Rheumatology and Infectious Disease, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Cristina Herrera MoraHospital de Niños Roberto Gilbert Elizalde, Reumatology, Guayaquil, Ecuador.
Danielle BrinkmanDepartment of Pediatrics, Division of Pediatric Rheumatology, Willem-Alexander Children`S Hospital, Leiden University Medical Center, Leiden, Netherlands.
Eztizen LabradorSan Pedro Hospital, Rheumatology, Logroño, Spain.
Judith PotjewijdDepartment of Internal Medicine, Section Clinical Immunology, Maastricht University Medical Center, Maastricht, Netherlands.
Luca CarliniGaslini Trial Centre/Servizio Di Sperimentazioni Cliniche Pediatriche, IRCCS Istituto Giannina Gaslini, PRINTO, Genoa, Italy.
Marta BustaffaIRCCS Istituto Giannina Gaslini, UOC Reumatologia E Malattie Autoinfiammatorie, Genoa, Italy.
Roberta CaorsiIRCCS Istituto Giannina Gaslini, UOC Reumatologia E Malattie Autoinfiammatorie, Genoa, Italy.
Nicolino RupertoGaslini Trial Centre/Servizio Di Sperimentazioni Cliniche Pediatriche, IRCCS Istituto Giannina Gaslini, PRINTO, Genoa, Italy.
Marco GattornoIRCCS Istituto Giannina Gaslini, UOC Reumatologia E Malattie Autoinfiammatorie, Genoa, Italy.
for Eurofever the Paediatric Rheumatology International Trials Organisation (PRINTO)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe study is aimed to evaluate the impact of safety events in the Eurofever registry for Autoinflammatory diseases.

methodsThis 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.

resultsComplete 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%).

conclusionsPresent 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.

Indexed as

RegistriesAdolescentAdultAdverse Drug Reaction Reporting SystemsAgedChildChild, PreschoolDrug-Related Side Effects and Adverse ReactionsEuropeFemaleHereditary Autoinflammatory DiseasesHumansInfantLongitudinal StudiesMaleMiddle AgedAutoinflammatory diseasesDrug-related adverse eventsSafety events

Identifiers

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.