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 - K Oliveira, Sheila
AU - Cattalini, Marco
AU - Bovis, Francesca
AU - Bagnasco, Francesca
AU - Pistorio, Angela
AU - Martini, Alberto
AU - Wulffraat, Nico
AU - Ruperto, Nicolino
AU - Paediatric Rheumatology International Trials Organisation (PRINTO)
A2 - Christensen, Anne Estmann
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 NCT01399281; 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 NCT01399281; ENCePP seal: awarded on 25 November 2011.
KW - Antirheumatic Agents/therapeutic use
KW - Arthritis, Juvenile/complications
KW - Child
KW - Child, Preschool
KW - Cohort Studies
KW - Female
KW - Herpes Zoster/diagnosis
KW - Humans
KW - Immunocompromised Host
KW - Male
KW - Opportunistic Infections/diagnosis
KW - Pharmacovigilance
KW - Registries/statistics & numerical data
KW - Severity of Illness Index
KW - Tuberculosis/diagnosis
KW - Infections
KW - Juvenile idiopathic arthritis
KW - Opportunistic
KW - Biologics
KW - Immunosuppressive therapy
U2 - 10.1186/s13075-020-02167-2
DO - 10.1186/s13075-020-02167-2
M3 - Journal article
C2 - 32264969
SN - 1478-6362
VL - 22
JO - Arthritis Research & Therapy
JF - Arthritis Research & Therapy
M1 - 71
ER -