• Gabriella Giancane, Joost F Swart, Elio Castagnola, Andreas H Groll, Gerd Horneff, Hans-Iko Huppertz, Daniel J Lovell, Tom Wolfs, Troels Herlin, Pavla Dolezalova, Helga Sanner, Gordana Susic, Flavio Sztajnbok, Despoina Maritsi, Tamas Constantin, Veronika Vargova, Sujata Sawhney, Marite Rygg, K Oliveira Sheila S Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil., Marco Cattalini, Francesca Bovis, Francesca Bagnasco, Angela Pistorio, Alberto Martini, Nico Wulffraat, Nicolino Ruperto, and Paediatric Rheumatology International Trials Organisation (PRINTO).
• IRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Genoa, Italy.
• Arthritis Res. Ther. 2020 Apr 7; 22 (1): 71.

BackgroundTo 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).MethodsThe 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.ResultsA 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.ConclusionsWe 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 RegistrationClinicaltrials.gov NCT01399281; ENCePP seal: awarded on 25 November 2011.

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