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

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dc.contributor.authorGiancane, Gabriella
dc.contributor.authorPaediatric Rheumatology International Trials Organisation (PRINTO)
dc.contributor.authorStaņēviča, Valda
dc.date.accessioned2021-08-27T13:10:05Z
dc.date.available2021-08-27T13:10:05Z
dc.date.issued2020-04-07
dc.descriptionPublisher Copyright: © 2020 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
dc.description.abstractBackground: 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.en
dc.description.statusPeer reviewed
dc.format.extent717405
dc.identifier.citationGiancane, G, Paediatric Rheumatology International Trials Organisation (PRINTO) & Staņēviča, V 2020, 'Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis : Analysis by the Pharmachild Safety Adjudication Committee', Arthritis Research and Therapy, vol. 22, no. 1, 71. https://doi.org/10.1186/s13075-020-02167-2
dc.identifier.doi10.1186/s13075-020-02167-2
dc.identifier.issn1478-6354
dc.identifier.urihttps://dspace.rsu.lv/jspui/handle/123456789/6116
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85083071972&partnerID=8YFLogxK
dc.language.isoeng
dc.relation.ispartofArthritis Research and Therapy
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectBiologics
dc.subjectImmunosuppressive therapy
dc.subjectInfections
dc.subjectJuvenile idiopathic arthritis
dc.subjectOpportunistic
dc.subject3.2 Clinical medicine
dc.subject1.1. Scientific article indexed in Web of Science and/or Scopus database
dc.subjectRheumatology
dc.subjectImmunology and Allergy
dc.subjectImmunology
dc.subjectSDG 3 - Good Health and Well-being
dc.titleOpportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis : Analysis by the Pharmachild Safety Adjudication Committeeen
dc.type/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article

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