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

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; Ruben Cuttica; Stella Maris Garay; Jurgen Brunner; Wolfgang Emminger; Simone Appenzeller; Claudio Len; Claudia Saad Magalhaes; Albena Telcharova-Mihaylovska; Miroslav Harjacek; Marija Jelusic; Anne Estmann; Susan Nielsen; Cristina Herrera Mora; Elisabeth Gervais; Isabelle Koné-Paut; Pierre Quartier; Ivan Foeldvari; Gerd Horneff; Thomas Lutz; Kirsten Minden; Nikolay Tzaribachev; Maria Trachana; Elena Tsitsami; Olga Vougiouka; Ilonka Orban; Liora Harel; Philip Hashkes; Yosef Uziel; Rolando Cimaz; Adele Civino; Rita Consolini; Gianfranco D'Angelo; Fabrizio De Benedetti; Giovanni Filocamo; Elena Fueri; Romina Gallizzi; Maria Cristina Maggio; Maria Greca Magnolia; Angela Miniaci; Davide Montin; Alma Nunzia Olivieri; Serena Pastore; Donato Rigante; Francesco Zulian; Ingrida Rumba-Rozenfelde; Valda Stanevicha; Violeta Panaviene; Ana Luisa Rodriguez Lozano; Nadina Rubio-Perez; Gabriel Vega Cornejo; Esther Hoppenreijs; Sylvia Kamphuis; Berit Flato; Ellen Berit Nordal; Reem Abdwani; Tatiana Miraval; Maria Eliana Paz Gastanaga; Elzbieta Smolewska; Constantin Ailioaie; Alexis Virgil Cochino; Matilda Laday; Calin Lazar; Ekaterina Alexeeva; Vyacheslav Chasnyk; Vladimir Keltsev; Wafaa Mohammed Saad Suwairi; Gordana Vijatov-Djuric; Jelena Vojinovic; Thaschawee Arkachaisri; Elena Koskova; Tadej Avcin; Mahmood Ally; Christa Janse Van Rensburg; Ingrid Louw; Jordi Anton Lopez; Alina Lucica Boteanu; Inmaculada Calvo Penades; Jaime De Inocencio; Pablo Mesa-Del-Castillo; Estefania Moreno; Agustin Remesal; Michael Hofer; Faysal Gok; Seza Ozen; Athimalaipet Ramanan; Chiara Pallotti; Luca Villa

doi:10.1186/s13075-020-02167-2

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

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 CattaliniFrancesca Bovis, Francesca Bagnasco, Angela Pistorio, Alberto Martini, Nico Wulffraat, Nicolino Ruperto^*, Ruben Cuttica, Stella Maris Garay, Jurgen Brunner, Wolfgang Emminger, Simone Appenzeller, Claudio Len, Claudia Saad Magalhaes, Albena Telcharova-Mihaylovska, Miroslav Harjacek, Marija Jelusic, Anne Estmann, Susan Nielsen, Cristina Herrera Mora, Elisabeth Gervais, Isabelle Koné-Paut, Pierre Quartier, Ivan Foeldvari, Gerd Horneff, Thomas Lutz, Kirsten Minden, Nikolay Tzaribachev, Maria Trachana, Elena Tsitsami, Olga Vougiouka, Ilonka Orban, Liora Harel, Philip Hashkes, Yosef Uziel, Rolando Cimaz, Adele Civino, Rita Consolini, Gianfranco D'Angelo, Fabrizio De Benedetti, Giovanni Filocamo, Elena Fueri, Romina Gallizzi, Maria Cristina Maggio, Maria Greca Magnolia, Angela Miniaci, Davide Montin, Alma Nunzia Olivieri, Serena Pastore, Donato Rigante, Francesco Zulian, Ingrida Rumba-Rozenfelde, Valda Stanevicha, Violeta Panaviene, Ana Luisa Rodriguez Lozano, Nadina Rubio-Perez, Gabriel Vega Cornejo, Esther Hoppenreijs, Sylvia Kamphuis, Berit Flato, Ellen Berit Nordal, Reem Abdwani, Tatiana Miraval, Maria Eliana Paz Gastanaga, Elzbieta Smolewska, Constantin Ailioaie, Alexis Virgil Cochino, Matilda Laday, Calin Lazar, Ekaterina Alexeeva, Vyacheslav Chasnyk, Vladimir Keltsev, Wafaa Mohammed Saad Suwairi, Gordana Vijatov-Djuric, Jelena Vojinovic, Thaschawee Arkachaisri, Elena Koskova, Tadej Avcin, Mahmood Ally, Christa Janse Van Rensburg, Ingrid Louw, Jordi Anton Lopez, Alina Lucica Boteanu, Inmaculada Calvo Penades, Jaime De Inocencio, Pablo Mesa-Del-Castillo, Estefania Moreno, Agustin Remesal, Michael Hofer, Faysal Gok, Seza Ozen, Athimalaipet Ramanan, Chiara Pallotti, Luca Villa

^*Corresponding author for this work

Child Health

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	71
Journal	Arthritis Research and Therapy
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13075-020-02167-2
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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10.1186/s13075-020-02167-2

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Giancane, G., Swart, J. F., Castagnola, E., Groll, A. H., Horneff, G., Huppertz, H. I., Lovell, D. J., Wolfs, T., Herlin, T., Dolezalova, P., Sanner, H., Susic, G., Sztajnbok, F., Maritsi, D., Constantin, T., Vargova, V., Sawhney, S., Rygg, M., Oliveira, S. K., ... Villa, L. (2020). Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: Analysis by the Pharmachild Safety Adjudication Committee. Arthritis Research and Therapy, 22(1), [71]. https://doi.org/10.1186/s13075-020-02167-2

Giancane, G, Swart, JF, Castagnola, E, Groll, AH, Horneff, G, Huppertz, HI, Lovell, DJ, Wolfs, T, Herlin, T, Dolezalova, P, Sanner, H, Susic, G, Sztajnbok, F, Maritsi, D, Constantin, T, Vargova, V, Sawhney, S, Rygg, M, Oliveira, SK, Cattalini, M, Bovis, F, Bagnasco, F, Pistorio, A, Martini, A, Wulffraat, N, Ruperto, N, Cuttica, R, Garay, SM, Brunner, J, Emminger, W, Appenzeller, S, Len, C, Saad Magalhaes, C, Telcharova-Mihaylovska, A, Harjacek, M, Jelusic, M, Estmann, A, Nielsen, S, Herrera Mora, C, Gervais, E, Koné-Paut, I, Quartier, P, Foeldvari, I, Horneff, G, Lutz, T, Minden, K, Tzaribachev, N, Trachana, M, Tsitsami, E, Vougiouka, O, Orban, I, Harel, L, Hashkes, P, Uziel, Y, Cimaz, R, Civino, A, Consolini, R, D'Angelo, G, De Benedetti, F, Filocamo, G, Fueri, E, Gallizzi, R, Maggio, MC, Magnolia, MG, Miniaci, A, Montin, D, Olivieri, AN, Pastore, S, Rigante, D, Zulian, F, Rumba-Rozenfelde, I, Stanevicha, V, Panaviene, V, Rodriguez Lozano, AL, Rubio-Perez, N, Vega Cornejo, G, Hoppenreijs, E, Kamphuis, S, Flato, B, Nordal, EB, Abdwani, R, Miraval, T, Paz Gastanaga, ME, Smolewska, E, Ailioaie, C, Cochino, AV, Laday, M, Lazar, C, Alexeeva, E, Chasnyk, V, Keltsev, V, Suwairi, WMS, Vijatov-Djuric, G, Vojinovic, J, Arkachaisri, T, Koskova, E, Avcin, T, Ally, M, Van Rensburg, CJ, Louw, I, Lopez, JA, Boteanu, AL, Calvo Penades, I, De Inocencio, J, Mesa-Del-Castillo, P, Moreno, E, Remesal, A, Hofer, M, Gok, F, Ozen, S, Ramanan, A, Pallotti, C & Villa, L 2020, 'Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: Analysis by the Pharmachild Safety Adjudication Committee', Arthritis Research and Therapy, vol. 22, no. 1, 71. https://doi.org/10.1186/s13075-020-02167-2

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title = "Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: Analysis by the Pharmachild Safety Adjudication Committee",

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.",

keywords = "Biologics, Immunosuppressive therapy, Infections, Juvenile idiopathic arthritis, Opportunistic",

author = "Gabriella Giancane and Swart, {Joost F.} and Elio Castagnola and Groll, {Andreas H.} and Gerd Horneff and Huppertz, {Hans Iko} and Lovell, {Daniel J.} and Tom Wolfs and Troels Herlin and Pavla Dolezalova and Helga Sanner and Gordana Susic and Flavio Sztajnbok and Despoina Maritsi and Tamas Constantin and Veronika Vargova and Sujata Sawhney and Marite Rygg and Oliveira, {Sheila K.} and Marco Cattalini and Francesca Bovis and Francesca Bagnasco and Angela Pistorio and Alberto Martini and Nico Wulffraat and Nicolino Ruperto and Ruben Cuttica and Garay, {Stella Maris} and Jurgen Brunner and Wolfgang Emminger and Simone Appenzeller and Claudio Len and {Saad Magalhaes}, Claudia and Albena Telcharova-Mihaylovska and Miroslav Harjacek and Marija Jelusic and Anne Estmann and Susan Nielsen and {Herrera Mora}, Cristina and Elisabeth Gervais and Isabelle Kon{\'e}-Paut and Pierre Quartier and Ivan Foeldvari and Gerd Horneff and Thomas Lutz and Kirsten Minden and Nikolay Tzaribachev and Maria Trachana and Elena Tsitsami and Olga Vougiouka and Ilonka Orban and Liora Harel and Philip Hashkes and Yosef Uziel and Rolando Cimaz and Adele Civino and Rita Consolini and Gianfranco D'Angelo and {De Benedetti}, Fabrizio and Giovanni Filocamo and Elena Fueri and Romina Gallizzi and Maggio, {Maria Cristina} and Magnolia, {Maria Greca} and Angela Miniaci and Davide Montin and Olivieri, {Alma Nunzia} and Serena Pastore and Donato Rigante and Francesco Zulian and Ingrida Rumba-Rozenfelde and Valda Stanevicha and Violeta Panaviene and {Rodriguez Lozano}, {Ana Luisa} and Nadina Rubio-Perez and {Vega Cornejo}, Gabriel and Esther Hoppenreijs and Sylvia Kamphuis and Berit Flato and Nordal, {Ellen Berit} and Reem Abdwani and Tatiana Miraval and {Paz Gastanaga}, {Maria Eliana} and Elzbieta Smolewska and Constantin Ailioaie and Cochino, {Alexis Virgil} and Matilda Laday and Calin Lazar and Ekaterina Alexeeva and Vyacheslav Chasnyk and Vladimir Keltsev and Suwairi, {Wafaa Mohammed Saad} and Gordana Vijatov-Djuric and Jelena Vojinovic and Thaschawee Arkachaisri and Elena Koskova and Tadej Avcin and Mahmood Ally and {Van Rensburg}, {Christa Janse} and Ingrid Louw and Lopez, {Jordi Anton} and Boteanu, {Alina Lucica} and {Calvo Penades}, Inmaculada and {De Inocencio}, Jaime and Pablo Mesa-Del-Castillo and Estefania Moreno and Agustin Remesal and Michael Hofer and Faysal Gok and Seza Ozen and Athimalaipet Ramanan and Chiara Pallotti and Luca Villa",

note = "Publisher Copyright: {\textcopyright} 2020 The Author(s).",

year = "2020",

month = apr,

day = "7",

doi = "10.1186/s13075-020-02167-2",

language = "English",

volume = "22",

journal = "Arthritis Research and Therapy",

issn = "1478-6354",

publisher = "BioMed Central",

number = "1",

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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

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

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DO - 10.1186/s13075-020-02167-2

M3 - Article

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SN - 1478-6354

VL - 22

JO - Arthritis Research and Therapy

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ER -

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

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