Publications

Authors:

Bellitto, Chiara; Ingrasciotta, Ylenia; Soardo, Federica; Spini, Andrea; L'Abbate, Luca; Pellegrini, Giorgia; Mathieu, Clément; Carollo, Massimo; Tuccori, Marco; Leoni, Olivia; Mazzone, Arianna; Ancona, Domenica; Stella, Paolo; Cavazzana, Anna; Scapin, Angela; Lopes, Sara; Belleudi, Valeria; Ledda, Stefano; Carta, Paolo; Rossi, Paola; Ejlli, Lucian; Sapigni, Ester; Puccini, Aurora; Scarpelli, Rita Francesca; De Sarro, Giovambattista; Gini, Rosa; Allotta, Alessandra; Pollina, Sebastiano Addario; Bucaneve, Giampaolo; Mangano, Antea Maria Pia; Balducci, Francesco; Sorrentino, Carla; Senesi, Ilenia; Trama, Ugo; Bernardi, Francesca Futura; Da Cas, Roberto; Costa, Giorgio; Urru, Silvana Anna Maria; Campomori, Annalisa; Spila Alegiani, Stefania; Massari, Marco; Gallizzi, Romina; Trifirò, Gianluca

Title:

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

Year:

2025

Type of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Format:

Elettronico

Referee:

No

Name of journal:

Pharmacological Research

ISSN of journal:

1043-6618

N° Volume:

218

Page numbers:

1-12

Keyword:

Biological drugs; Drug utilization; Immune-mediated inflammatory diseases; Pediatrics; Persistence; Pharmacoepidemiology

Short description of contents:

: 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.

Note:

Available online 28 June 2025

Product ID:

146610

Handle IRIS:

11562/1166170

Last Modified:

August 20, 2025

Bibliographic citation:

Bellitto, Chiara; Ingrasciotta, Ylenia; Soardo, Federica; Spini, Andrea; L'Abbate, Luca; Pellegrini, Giorgia; Mathieu, Clément; Carollo, Massimo; Tuccori, Marco; Leoni, Olivia; Mazzone, Arianna; Ancona, Domenica; Stella, Paolo; Cavazzana, Anna; Scapin, Angela; Lopes, Sara; Belleudi, Valeria; Ledda, Stefano; Carta, Paolo; Rossi, Paola; Ejlli, Lucian; Sapigni, Ester; Puccini, Aurora; Scarpelli, Rita Francesca; De Sarro, Giovambattista; Gini, Rosa; Allotta, Alessandra; Pollina, Sebastiano Addario; Bucaneve, Giampaolo; Mangano, Antea Maria Pia; Balducci, Francesco; Sorrentino, Carla; Senesi, Ilenia; Trama, Ugo; Bernardi, Francesca Futura; Da Cas, Roberto; Costa, Giorgio; Urru, Silvana Anna Maria; Campomori, Annalisa; Spila Alegiani, Stefania; Massari, Marco; Gallizzi, Romina; Trifirò, Gianluca, Trend in the use of biological drugs in pediatric patients with immune-mediated inflammatory diseases: Insight from the large-scale Italian VALORE project «Pharmacological Research» , vol. 218 , 2025 , pp. 1-12

Consulta la scheda completa presente nel repository istituzionale della Ricerca di Ateneo