Universität zu Köln

Giancane, Gabriella ORCID: 0000-0003-2558-3559, 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 K., Cattalini, Marco, Bovis, Francesca, Bagnasco, Francesca ORCID: 0000-0003-1601-9518, Pistorio, Angela, Martini, Alberto, Wulffraat, Nico and Ruperto, Nicolino ORCID: 0000-0001-8407-7782 (2020). Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee. Arthritis Res. Ther., 22 (1). LONDON: BMC. ISSN 1478-6362

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Giancane, Gabriella UNSPECIFIED orcid.org/0000-0003-2558-3559 UNSPECIFIED Swart, Joost F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Castagnola, Elio UNSPECIFIED UNSPECIFIED UNSPECIFIED Groll, Andreas H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Horneff, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Huppertz, Hans-Iko UNSPECIFIED UNSPECIFIED UNSPECIFIED Lovell, Daniel J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolfs, Tom UNSPECIFIED UNSPECIFIED UNSPECIFIED Herlin, Troels UNSPECIFIED UNSPECIFIED UNSPECIFIED Dolezalova, Pavla UNSPECIFIED UNSPECIFIED UNSPECIFIED Sanner, Helga UNSPECIFIED UNSPECIFIED UNSPECIFIED Susic, Gordana UNSPECIFIED UNSPECIFIED UNSPECIFIED Sztajnbok, Flavio UNSPECIFIED UNSPECIFIED UNSPECIFIED Maritsi, Despoina UNSPECIFIED UNSPECIFIED UNSPECIFIED Constantin, Tamas UNSPECIFIED UNSPECIFIED UNSPECIFIED Vargova, Veronika UNSPECIFIED UNSPECIFIED UNSPECIFIED Sawhney, Sujata UNSPECIFIED UNSPECIFIED UNSPECIFIED Rygg, Marite UNSPECIFIED UNSPECIFIED UNSPECIFIED Oliveira, Sheila K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cattalini, Marco UNSPECIFIED UNSPECIFIED UNSPECIFIED Bovis, Francesca UNSPECIFIED UNSPECIFIED UNSPECIFIED Bagnasco, Francesca UNSPECIFIED orcid.org/0000-0003-1601-9518 UNSPECIFIED Pistorio, Angela UNSPECIFIED UNSPECIFIED UNSPECIFIED Martini, Alberto UNSPECIFIED UNSPECIFIED UNSPECIFIED Wulffraat, Nico UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruperto, Nicolino UNSPECIFIED orcid.org/0000-0001-8407-7782 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-337433
DOI:	10.1186/s13075-020-02167-2
Journal or Publication Title:	Arthritis Res. Ther.
Volume:	22
Number:	1
Date:	2020
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1478-6362
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ENTHESITIS-RELATED ARTHRITIS; HERPES-VIRUS INFECTIONS; LONG-TERM SAFETY; PEDIATRIC-PATIENTS; BIOLOGIC THERAPIES; TREATMENT RESPONSE; ADVERSE EVENTS; ETANERCEPT; CHILDREN; EFFICACY Multiple languages Rheumatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/33743