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

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About: Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Creator	Groll, Andreas Huppertz, Hans-Iko Castagnola, Elio Wolfs, Tom Oliveira, Sheila Dolezalova, Pavla Bagnasco, Francesca Bovis, Francesca Cattalini, Marco Giancane, Gabriella Herlin, Troels Horneff, Gerd Lovell, Daniel Martini, Alberto Pistorio, Angela Ruperto, Nicolino Sanner, Helga Susic, Gordana Swart, Joost Wulffraat, Nico
Source	PMC
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 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 NCT 01399281; ENCePP seal: awarded on 25 November 2011.
has issue date	2020-04-07(xsd:dateTime)
bibo:doi	10.1186/s13075-020-02167-2
bibo:pmid	32264969
has license	cc-by
sha1sum (hex)	e4bf9375734407fb8e09c5cd70feb5f693e92afe
schema:url	https://doi.org/10.1186/s13075-020-02167-2
resource representing a document's title	Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
has PubMed Central identifier	PMC7136994
has PubMed identifier	32264969
schema:publication	Arthritis Res Ther
resource representing a document's body	covid:e4bf9375734407fb8e09c5cd70feb5f693e92afe#body_text
is schema:about of	named entity 'rheumatologists' named entity 'derive' named entity 'pediatric' named entity 'Adjudication' named entity 'infections' named entity 'Organisation' named entity 'SPECIALISTS' named entity 'SEVERE' named entity 'OPPORTUNISTIC INFECTIONS' named entity 'Adjudication' named entity 'evaluated' named entity 'pediatric' named entity 'JIA' named entity 'JIA' named entity 'juvenile idiopathic arthritis' named entity 'Sanofi' named entity 'systematic review' named entity 'inter-quartile range' named entity 'Roche' named entity 'regulatory authorities' named entity 'clinical data' named entity 'Pfizer' named entity 'Descriptive statistics' named entity 'follow-up' named entity 'Italy' named entity 'pathogen' named entity 'DMARD' named entity 'MedDRA' named entity 'Squibb' named entity 'Novartis' named entity 'prednisone' named entity 'Merck' named entity 'European Union' named entity 'varicella zoster' named entity 'Novartis' named entity 'viral infections' named entity 'treatment of children' named entity 'tuberculosis' named entity 'DMARDs' named entity 'IQR' named entity 'NIH' named entity 'herpes zoster' named entity 'JIA' named entity 'tuberculosis' named entity 'immune-mediated' named entity 'ILAR' named entity 'clinical researchers' named entity 'DMARD' named entity 'glucocorticoids' named entity 'Pharmacovigilance' named entity 'glucocorticoids' named entity 'Candida infections' named entity 'rheumatoid arthritis' named entity 'prospective cohort' named entity 'herpes zoster' named entity 'JIA' named entity 'follow-up' named entity 'SAEs' named entity 'Glaxo' named entity 'Astrazeneca' named entity 'Gilead' named entity 'pathogens'

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