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

G. Giancane, JF. Swart, E. Castagnola, AH. Groll, G. Horneff, HI. Huppertz, DJ. Lovell, T. Wolfs, T. Herlin, P. Dolezalova, H. Sanner, G. Susic, F. Sztajnbok, D. Maritsi, T. Constantin, V. Vargova, S. Sawhney, M. Rygg, S. K Oliveira, M....

. 2020 ; 22 (1) : 71. [pub] 20200407

Jazyk angličtina Země Velká Británie

Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie, pozorovací studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc21012716

Grantová podpora
260353 Seventh Framework Programme - International

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.

1st Faculty of Medicine Department of Pediatrics and Adolescent Medicine Charles University Prague and General University Hospital Praha Czech Republic

2nd Department of Pediatrics Athens Medical School National and Kapodistrian University of Athens Athens Greece

Asklepios Clinic Sankt Augustin Department of General Paediatrics Sankt Augustin Germany

Clinic Bremen Mitte Prof Hesse Children's Hospital and Pediatric Intensive Care Medicine Bremen Germany

Clinica Pediatrica dell'Università di Brescia Spedali Civili Unità di Immunologia e Reumatologia Pediatrica Brescia Italy

Department of Clinical and Molecular Medicine Faculty of Medicine and Health Sciences NTNU Norwegian University of Science and Technology Trondheim Norway

Department of Infectious Diseases IRCCS Istituto Giannina Gaslini Genoa Italy

Department of Pediatric Immunology and Rheumatology Wilhelmina Children's Hospital University Medical Center Utrecht University Utrecht European Reference Network RITA Utrecht The Netherlands

Department of Pediatrics St Olavs University Hospital of Trondheim Trondheim Norway

Department of Rheumatology Oslo University Hospital Oslo Norway

Dipartimento di Neuroscienze Riabilitazione Oftalmologia Genetica e Scienze Materno Infantili Università degli Studi di Genova Genoa Italy

Division of Rheumatology Cincinnati Children's Hospital Medical Center Cincinnati OH USA

Faculty of Medicine Department of Paediatrics and Adolescent Medicine Pavol Jozef Šafárik University in Košice Kosice Slovakia

Hospital Universitario Pedro Ernesto Nucleo de Estudos da Saúde do Adolescente Universidade do Estado do Rio de Janeiro Rio de Janeiro Brazil

Infectious Disease Research Program Department of Pediatric Hematology and Oncology University Children's Hospital Münster Germany

Institute of Rheumatology of Belgrade Division of Pediatric Rheumatology Belgrade Serbia

Instituto de Puericultura e Pediatria Martagao Gesteira Universidade Federal do Rio de Janeiro Rio de Janeiro Brazil

IRCCS Istituto Giannina Gaslini Clinica Pediatrica e Reumatologia PRINTO Genoa Italy

IRCCS Istituto Giannina Gaslini Servizio di Epidemiologia e Biostatistica Genoa Italy

Medical Faculty Department of Paediatric and Adolescents Medicine University Hospital of Cologne Cologne Germany

Norwegian National Advisory Unit on Rheumatic Diseases in Children and Adolescents Oslo Norway

Pediatric Rheumatology Unit Aarhus University Hospital Aarhus Denmark

Sir Ganga Ram Hospital Marg Centre for Child Health Sir Ganga Ram Hospital New Delhi India

Unit of Pediatric Rheumatology Immunology 2nd Department of Pediatrics Semmelweis University Budapest Hungary

Citace poskytuje Crossref.org

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