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.
| Original language | English |
|---|---|
| Article number | 71 |
| Journal | Arthritis Research and Therapy |
| Volume | 22 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Apr 7 2020 |
Keywords
- Biologics
- Immunosuppressive therapy
- Infections
- Juvenile idiopathic arthritis
- Opportunistic
ASJC Scopus subject areas
- Rheumatology
- Immunology and Allergy
- Immunology
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Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis : Analysis by the Pharmachild Safety Adjudication Committee. / Giancane, Gabriella; 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; Pistorio, Angela; Martini, Alberto; Wulffraat, Nico; Ruperto, Nicolino; Cuttica, Ruben; Garay, Stella Maris; Brunner, Jurgen; Emminger, Wolfgang; Appenzeller, Simone; Len, Claudio; Saad Magalhaes, Claudia; Telcharova-Mihaylovska, Albena; Harjacek, Miroslav; Jelusic, Marija; Estmann, Anne; Nielsen, Susan; Herrera Mora, Cristina; Gervais, Elisabeth; Koné-Paut, Isabelle; Quartier, Pierre; Foeldvari, Ivan; Horneff, Gerd; Lutz, Thomas; Minden, Kirsten; Tzaribachev, Nikolay; Trachana, Maria; Tsitsami, Elena; Vougiouka, Olga; Orban, Ilonka; Harel, Liora; Hashkes, Philip; Uziel, Yosef; Cimaz, Rolando; Civino, Adele; Consolini, Rita; D'Angelo, Gianfranco; De Benedetti, Fabrizio; Filocamo, Giovanni; Fueri, Elena; Gallizzi, Romina; Maggio, Maria Cristina; Magnolia, Maria Greca; Miniaci, Angela; Montin, Davide; Olivieri, Alma Nunzia; Pastore, Serena; Rigante, Donato; Zulian, Francesco; Rumba-Rozenfelde, Ingrida; Stanevicha, Valda; Panaviene, Violeta; Rodriguez Lozano, Ana Luisa; Rubio-Perez, Nadina; Vega Cornejo, Gabriel; Hoppenreijs, Esther; Kamphuis, Sylvia; Flato, Berit; Nordal, Ellen Berit; Abdwani, Reem; Miraval, Tatiana; Paz Gastanaga, Maria Eliana; Smolewska, Elzbieta; Ailioaie, Constantin; Cochino, Alexis Virgil; Laday, Matilda; Lazar, Calin; Alexeeva, Ekaterina; Chasnyk, Vyacheslav; Keltsev, Vladimir; Suwairi, Wafaa Mohammed Saad; Vijatov-Djuric, Gordana; Vojinovic, Jelena; Arkachaisri, Thaschawee; Koskova, Elena; Avcin, Tadej; Ally, Mahmood; Van Rensburg, Christa Janse; Louw, Ingrid; Lopez, Jordi Anton; Boteanu, Alina Lucica; Calvo Penades, Inmaculada; De Inocencio, Jaime; Mesa-Del-Castillo, Pablo; Moreno, Estefania; Remesal, Agustin; Hofer, Michael; Gok, Faysal; Ozen, Seza; Ramanan, Athimalaipet; Pallotti, Chiara; Villa, Luca.
In: Arthritis Research and Therapy, Vol. 22, No. 1, 71, 07.04.2020.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis
T2 - Analysis by the Pharmachild Safety Adjudication Committee
AU - Giancane, Gabriella
AU - Swart, Joost F.
AU - Castagnola, Elio
AU - Groll, Andreas H.
AU - Horneff, Gerd
AU - Huppertz, Hans Iko
AU - Lovell, Daniel J.
AU - Wolfs, Tom
AU - Herlin, Troels
AU - Dolezalova, Pavla
AU - Sanner, Helga
AU - Susic, Gordana
AU - Sztajnbok, Flavio
AU - Maritsi, Despoina
AU - Constantin, Tamas
AU - Vargova, Veronika
AU - Sawhney, Sujata
AU - Rygg, Marite
AU - Oliveira, Sheila K.
AU - Cattalini, Marco
AU - Bovis, Francesca
AU - Bagnasco, Francesca
AU - Pistorio, Angela
AU - Martini, Alberto
AU - Wulffraat, Nico
AU - Ruperto, Nicolino
AU - Cuttica, Ruben
AU - Garay, Stella Maris
AU - Brunner, Jurgen
AU - Emminger, Wolfgang
AU - Appenzeller, Simone
AU - Len, Claudio
AU - Saad Magalhaes, Claudia
AU - Telcharova-Mihaylovska, Albena
AU - Harjacek, Miroslav
AU - Jelusic, Marija
AU - Estmann, Anne
AU - Nielsen, Susan
AU - Herrera Mora, Cristina
AU - Gervais, Elisabeth
AU - Koné-Paut, Isabelle
AU - Quartier, Pierre
AU - Foeldvari, Ivan
AU - Horneff, Gerd
AU - Lutz, Thomas
AU - Minden, Kirsten
AU - Tzaribachev, Nikolay
AU - Trachana, Maria
AU - Tsitsami, Elena
AU - Vougiouka, Olga
AU - Orban, Ilonka
AU - Harel, Liora
AU - Hashkes, Philip
AU - Uziel, Yosef
AU - Cimaz, Rolando
AU - Civino, Adele
AU - Consolini, Rita
AU - D'Angelo, Gianfranco
AU - De Benedetti, Fabrizio
AU - Filocamo, Giovanni
AU - Fueri, Elena
AU - Gallizzi, Romina
AU - Maggio, Maria Cristina
AU - Magnolia, Maria Greca
AU - Miniaci, Angela
AU - Montin, Davide
AU - Olivieri, Alma Nunzia
AU - Pastore, Serena
AU - Rigante, Donato
AU - Zulian, Francesco
AU - Rumba-Rozenfelde, Ingrida
AU - Stanevicha, Valda
AU - Panaviene, Violeta
AU - Rodriguez Lozano, Ana Luisa
AU - Rubio-Perez, Nadina
AU - Vega Cornejo, Gabriel
AU - Hoppenreijs, Esther
AU - Kamphuis, Sylvia
AU - Flato, Berit
AU - Nordal, Ellen Berit
AU - Abdwani, Reem
AU - Miraval, Tatiana
AU - Paz Gastanaga, Maria Eliana
AU - Smolewska, Elzbieta
AU - Ailioaie, Constantin
AU - Cochino, Alexis Virgil
AU - Laday, Matilda
AU - Lazar, Calin
AU - Alexeeva, Ekaterina
AU - Chasnyk, Vyacheslav
AU - Keltsev, Vladimir
AU - Suwairi, Wafaa Mohammed Saad
AU - Vijatov-Djuric, Gordana
AU - Vojinovic, Jelena
AU - Arkachaisri, Thaschawee
AU - Koskova, Elena
AU - Avcin, Tadej
AU - Ally, Mahmood
AU - Van Rensburg, Christa Janse
AU - Louw, Ingrid
AU - Lopez, Jordi Anton
AU - Boteanu, Alina Lucica
AU - Calvo Penades, Inmaculada
AU - De Inocencio, Jaime
AU - Mesa-Del-Castillo, Pablo
AU - Moreno, Estefania
AU - Remesal, Agustin
AU - Hofer, Michael
AU - Gok, Faysal
AU - Ozen, Seza
AU - Ramanan, Athimalaipet
AU - Pallotti, Chiara
AU - Villa, Luca
N1 - Publisher Copyright: © 2020 The Author(s).
PY - 2020/4/7
Y1 - 2020/4/7
N2 - 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.
AB - 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.
KW - Biologics
KW - Immunosuppressive therapy
KW - Infections
KW - Juvenile idiopathic arthritis
KW - Opportunistic
UR - http://www.scopus.com/inward/record.url?scp=85083071972&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85083071972&partnerID=8YFLogxK
U2 - 10.1186/s13075-020-02167-2
DO - 10.1186/s13075-020-02167-2
M3 - Article
C2 - 32264969
AN - SCOPUS:85083071972
VL - 22
JO - Arthritis Research and Therapy
JF - Arthritis Research and Therapy
SN - 1478-6354
IS - 1
M1 - 71
ER -