Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee.
Antirheumatic Agents
/ therapeutic use
Arthritis, Juvenile
/ complications
Child
Child, Preschool
Cohort Studies
Female
Herpes Zoster
/ diagnosis
Humans
Immunocompromised Host
Male
Opportunistic Infections
/ diagnosis
Pharmacovigilance
Registries
/ statistics & numerical data
Severity of Illness Index
Tuberculosis
/ diagnosis
Biologics
Immunosuppressive therapy
Infections
Juvenile idiopathic arthritis
Opportunistic
Journal
Arthritis research & therapy
ISSN: 1478-6362
Titre abrégé: Arthritis Res Ther
Pays: England
ID NLM: 101154438
Informations de publication
Date de publication:
07 04 2020
07 04 2020
Historique:
received:
18
11
2019
accepted:
27
03
2020
entrez:
9
4
2020
pubmed:
9
4
2020
medline:
12
1
2021
Statut:
epublish
Résumé
To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI. A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI. We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies. Clinicaltrials.gov NCT01399281; ENCePP seal: awarded on 25 November 2011.
Sections du résumé
BACKGROUND
To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC).
METHODS
The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI.
RESULTS
A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI.
CONCLUSIONS
We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies.
TRIAL REGISTRATION
Clinicaltrials.gov NCT01399281; ENCePP seal: awarded on 25 November 2011.
Identifiants
pubmed: 32264969
doi: 10.1186/s13075-020-02167-2
pii: 10.1186/s13075-020-02167-2
pmc: PMC7136994
doi:
Substances chimiques
Antirheumatic Agents
0
Banques de données
ClinicalTrials.gov
['NCT01399281']
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
71Subventions
Organisme : Seventh Framework Programme
ID : 260353
Pays : International
Investigateurs
Ruben Cuttica
(R)
Stella Maris Garay
(SM)
Jurgen Brunner
(J)
Wolfgang Emminger
(W)
Simone Appenzeller
(S)
Claudio Len
(C)
Claudia Saad Magalhaes
(C)
Albena Telcharova-Mihaylovska
(A)
Miroslav Harjacek
(M)
Marija Jelusic
(M)
Anne Estmann
(A)
Susan Nielsen
(S)
Cristina Herrera Mora
(C)
Elisabeth Gervais
(E)
Isabelle Koné-Paut
(I)
Pierre Quartier
(P)
Ivan Foeldvari
(I)
Gerd Horneff
(G)
Thomas Lutz
(T)
Kirsten Minden
(K)
Nikolay Tzaribachev
(N)
Maria Trachana
(M)
Elena Tsitsami
(E)
Olga Vougiouka
(O)
Ilonka Orban
(I)
Liora Harel
(L)
Philip Hashkes
(P)
Yosef Uziel
(Y)
Rolando Cimaz
(R)
Adele Civino
(A)
Rita Consolini
(R)
Gianfranco D'Angelo
(G)
Fabrizio De Benedetti
(F)
Giovanni Filocamo
(G)
Elena Fueri
(E)
Romina Gallizzi
(R)
Maria Cristina Maggio
(MC)
Maria Greca Magnolia
(MG)
Angela Miniaci
(A)
Davide Montin
(D)
Alma Nunzia Olivieri
(AN)
Serena Pastore
(S)
Donato Rigante
(D)
Francesco Zulian
(F)
Ingrida Rumba-Rozenfelde
(I)
Valda Stanevicha
(V)
Violeta Panaviene
(V)
Ana Luisa Rodriguez Lozano
(AL)
Nadina Rubio-Perez
(N)
Gabriel Vega Cornejo
(G)
Esther Hoppenreijs
(E)
Sylvia Kamphuis
(S)
Berit Flato
(B)
Ellen Berit Nordal
(EB)
Reem Abdwani
(R)
Tatiana Miraval
(T)
Maria Eliana Paz Gastanaga
(ME)
Elzbieta Smolewska
(E)
Constantin Ailioaie
(C)
Alexis-Virgil Cochino
(AV)
Matilda Laday
(M)
Calin Lazar
(C)
Ekaterina Alexeeva
(E)
Vyacheslav Chasnyk
(V)
Vladimir Keltsev
(V)
Wafaa Mohammed Saad Suwairi
(WMS)
Gordana Vijatov-Djuric
(G)
Jelena Vojinovic
(J)
Thaschawee Arkachaisri
(T)
Elena Koskova
(E)
Tadej Avcin
(T)
Mahmood Ally
(M)
Christa Janse Van Rensburg
(CJ)
Ingrid Louw
(I)
Jordi Anton Lopez
(JA)
Alina Lucica Boteanu
(AL)
Inmaculada Calvo Penades
(I)
Jaime De Inocencio
(J)
Pablo Mesa-Del-Castillo
(P)
Estefania Moreno
(E)
Agustin Remesal
(A)
Michael Hofer
(M)
Faysal Gok
(F)
Seza Ozen
(S)
Athimalaipet Ramanan
(A)
Chiara Pallotti
(C)
Luca Villa
(L)
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