Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Posted on 2020-04-08 - 09:02
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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Giancane, Gabriella; Swart, Joost F.; Castagnola, Elio; Groll, Andreas H.; Horneff, Gerd; Huppertz, Hans-Iko; et al. (2020). Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee. figshare. Collection. https://doi.org/10.6084/m9.figshare.c.4929453.v1
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AUTHORS (26)
GG
Gabriella Giancane
JS
Joost F. Swart
EC
Elio Castagnola
AG
Andreas H. Groll
GH
Gerd Horneff
HH
Hans-Iko Huppertz
DL
Daniel J. Lovell
TW
Tom Wolfs
TH
Troels Herlin
PD
Pavla Dolezalova
HS
Helga Sanner
GS
Gordana Susic
FS
Flavio Sztajnbok
DM
Despoina Maritsi
TC
Tamas Constantin
VV
Veronika Vargova
SS
Sujata Sawhney
MR
Marite Rygg
SK
Sheila K. Oliveira
MC
Marco Cattalini