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.(Continued on next page)

Comparative risk of infections among real-world users of biologics for juvenile idiopathic arthritis: data from the German BIKER registry

“…According to an analysis on opportunistic infections in patients with JIA using data from the Pharmachild registry, the three most common opportunistic infections are Herpes zoster, tuberculosis and candidiasis. In a total of 8274 patients, 66 cases of Herpes zoster, 10 cases of tuberculosis and 4 cases of oral candidiasis occurred [ 29 ]. The rates of Herpes zoster and oral candidiasis are quite in line with the rates we found, while the rate of tuberculosis in the Pharmachild registry seems to be higher.…”

SARS-CoV-2 infections in children and young people

“…Generally, CYP with systemic inflammatory conditions are at an increased risk for infections, which is caused by general immune dysregulation and immune modulating/suppressive treatments [ [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] , [55] , [56] , [57] ]. Frequently, immune responses to virus infections and vaccinations are reduced and prolonged viral shedding is common [ [58] , [59] , [60] , [61] , [62] , [63] , [64] , [65] , [66] , [67] ].…”

Correlation of Age, Sex, and Symptoms to Number of Problematic Joints in Children with Idiopathic Juvenile Arthritis

“…Inflammation can also cause fatigue. Physical examination shows a limp, hesitates to use an arm or leg, or, in younger children, has problems with fine motor skills (1,18) .…”