Trend in the use of biological drugs in pediatric patients with immune-mediated inflammatory diseases: Insight from the large-scale Italian VALORE project

Trend in the use of biological drugs in pediatric patients with immune-mediated inflammatory diseases: Insight from the large-scale Italian VALORE project

Real-world data on biological drug use in pediatric patients with immune-mediated inflammatory diseases (IMIDs) are scarce. This retrospective, population-based, cohort study aimed to provide an overview of biological drug use among children and adolescents with IMIDs from 2010 to 2023 using the Ita...

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Main Authors: Chiara Bellitto, Ylenia Ingrasciotta, Federica Soardo, Andrea Spini, Luca L’Abbate, Giorgia Pellegrini, Clément Mathieu, Massimo Carollo, Marco Tuccori, Olivia Leoni, Arianna Mazzone, Domenica Ancona, Paolo Stella, Anna Cavazzana, Angela Scapin, Sara Lopes, Valeria Belleudi, Stefano Ledda, Paolo Carta, Paola Rossi, Lucian Ejlli, Ester Sapigni, Aurora Puccini, Rita Francesca Scarpelli, Giovambattista De Sarro, Rosa Gini, Alessandra Allotta, Sebastiano Addario Pollina, Giampaolo Bucaneve, Antea Maria Pia Mangano, Francesco Balducci, Carla Sorrentino, Ilenia Senesi, Ugo Trama, Francesca Futura Bernardi, Roberto Da Cas, Giorgio Costa, Silvana Anna Maria Urru, Annalisa Campomori, Stefania Spila Alegiani, Marco Massari, Romina Gallizzi, Gianluca Trifirò
Format: Article
Language:English
Published: Elsevier 2025-08-01
Series:Pharmacological Research
Subjects:
Drug utilization
Pediatrics
Pharmacoepidemiology
Immune-mediated inflammatory diseases
Biological drugs
Persistence
Online Access:http://www.sciencedirect.com/science/article/pii/S1043661825002683
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Summary:Real-world data on biological drug use in pediatric patients with immune-mediated inflammatory diseases (IMIDs) are scarce. This retrospective, population-based, cohort study aimed to provide an overview of biological drug use among children and adolescents with IMIDs from 2010 to 2023 using the Italian VALORE distributed database network. As secondary aim, potential of such a network for evaluating the risk of serious infections related to biological drugs in pediatrics was investigated. The yearly prevalence of use of biological drugs in IMID pediatric patients was calculated. Among incident users, persistence to adalimumab, etanercept, infliximab, golimumab, tocilizumab, secukinumab, and abatacept was measured. A sample power analysis to estimate the person-years of exposure required to investigate the association with the risk of serious infection and individual biological drug was performed. The yearly prevalence of biological drug use increased over time (+427.3 %), and it was consistently higher among females than males and among 12–17-year-olds than younger children. A total of 6222 incident biological drug users were identified, with a median follow-up of 3.8 years, and juvenile idiopathic arthritis (JIA, 35.9 %) and inflammatory bowel diseases (IBDs, 35.9 %) were the most common indications for use. After one year from the treatment start, more than 70 % of JIA patients using either adalimumab or etanercept were still on treatment, while persistence rates in IBDs were lower (ranging from 57.4 % to 65.0 %). Findings of this study show the potential of the VALORE network to provide enough exposure data to investigate the risk of serious infections for adalimumab, etanercept, and infliximab.
ISSN:1096-1186

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