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Title: | Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee |
Author: | Giancane, Gabriella Swart, Joost F. Castagnola, Elio Groll, Andreas H. Horneff, Gerd Huppertz, Hans Iko Lovell, Daniel J. Wolfs, Tom Herlin, Troels Dolezalova, Pavla Sanner, Helga Susic, Gordana Sztajnbok, Flavio Maritsi, Despoina Constantin, Tamas Vargova, Veronika Sawhney, Sujata Rygg, Marite Oliveira, Sheila Cattalini, Marco Bovis, Francesca Bagnasco, Francesca Pistorio, Angela Martini, Alberto Wulffraat, Nico Ruperto, N. Paediatric Rheumatology International Trials Organisation (PRINTO) Antón López, Jordi |
Keywords: | Infeccions oportunistes Malalts hospitalitzats Immunosupressió Artritis infecciosa Infants malalts Opportunistic infections Hospital patients Immunosuppression Infectious arthritis Sick children |
Issue Date: | 7-Apr-2020 |
Publisher: | BioMed Central |
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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1186/s13075-020-02167-2 |
It is part of: | Arthritis Research & Therapy, 2020, vol. 22, num. 71 |
URI: | http://hdl.handle.net/2445/195430 |
Related resource: | https://doi.org/10.1186/s13075-020-02167-2 |
ISSN: | 1478-6362 |
Appears in Collections: | Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques) |
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