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Arthritis Research & Therapy
Published in: Arthritis Research & Therapy 1/2020

01-12-2020 | Herpes Virus | Research article

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

Authors: 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, Sheila K. Oliveira, Marco Cattalini, Francesca Bovis, Francesca Bagnasco, Angela Pistorio, Alberto Martini, Nico Wulffraat, Nicolino Ruperto, for the Paediatric Rheumatology International Trials Organisation (PRINTO)

Published in: Arthritis Research & Therapy | Issue 1/2020

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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.
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Metadata
Title
Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Authors
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
Sheila K. Oliveira
Marco Cattalini
Francesca Bovis
Francesca Bagnasco
Angela Pistorio
Alberto Martini
Nico Wulffraat
Nicolino Ruperto
for the Paediatric Rheumatology International Trials Organisation (PRINTO)
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Arthritis Research & Therapy / Issue 1/2020
Electronic ISSN: 1478-6362
DOI
https://doi.org/10.1186/s13075-020-02167-2

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