Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee

Abstract 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 a...

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PID https://www.doi.org/10.6084/m9.figshare.c.4929453
PID https://www.doi.org/10.1186/s13075-020-02167-2
PID https://www.doi.org/10.6084/m9.figshare.c.4929453.v1
URL https://dx.doi.org/10.6084/m9.figshare.c.4929453
URL https://dx.doi.org/10.6084/m9.figshare.c.4929453.v1
URL https://dx.doi.org/10.1186/s13075-020-02167-2
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Author Giancane, Gabriella
Author Swart, Joost F.
Author Castagnola, Elio
Author Groll, Andreas H.
Author Horneff, Gerd
Author Huppertz, Hans-Iko
Author Lovell, Daniel J.
Author Wolfs, Tom
Author Herlin, Troels
Author Dolezalova, Pavla
Author Sanner, Helga
Author Susic, Gordana
Author Sztajnbok, Flavio
Author Maritsi, Despoina
Author Constantin, Tamas
Author Vargova, Veronika
Author Sawhney, Sujata
Author Rygg, Marite
Author K. Oliveira, Sheila
Author Cattalini, Marco
Author Bovis, Francesca
Author Bagnasco, Francesca
Author Pistorio, Angela
Author Martini, Alberto
Author Wulffraat, Nico
Author Ruperto, Nicolino
Author for the Paediatric Rheumatology International Trials Organisation (PRINTO)
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Collected From Datacite
Hosted By figshare
Publication Date 2020-04-08
Publisher figshare
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Source https://science-innovation-policy.openaire.eu/search/dataset?datasetId=dedup_wf_001::7e812eb0631c4759e51c07d929dad503
Author jsonws_user
Last Updated 11 January 2021, 12:19 (CET)
Created 11 January 2021, 12:19 (CET)