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).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.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.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.Clinicaltrials.gov
NCT01399281; ENCePP seal: awarded on 25 November 2011.
