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An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: Framework and perspectives of the CESIT project

Authors :
Valeria Belleudi
Alessandro C. Rosa
Marco Finocchietti
Francesca R. Poggi
Maria Lucia Marino
Marco Massari
Stefania Spila Alegiani
Lucia Masiero
Andrea Ricci
Gaia Bedeschi
Francesca Puoti
Massimo Cardillo
Silvia Pierobon
Maurizio Nordio
Eliana Ferroni
Martina Zanforlini
Giuseppe Piccolo
Olivia Leone
Stefano Ledda
Paolo Carta
Donatella Garau
Ersilia Lucenteforte
Marina Davoli
Antonio Addis
CESIT Study Group
Nera Agabiti
Michele Ercolanoni
Pamela Fiaschetti
Bedeschi Gaia
Valentina Ientile
Ursula Kirchmayer
Luca L’Abbate
Lorella Leoni
Olivia Lombardozzi
Claudia Lucia Marino
Maria Marino
Arianna Mazzone
Ugo Moretti
Andrea Angelo Nisic
Alessandra Oliveti
Daniela Peritore
Andrea Rosa
Alessandro C. Ricci
Vito Sparacino
Matilde Tanaglia
Silvia Trapani
Gianluca Trifirò
Manuel Zorzi
Source :
Frontiers in Pharmacology, Vol 13 (2022)
Publication Year :
2022
Publisher :
Frontiers Media S.A., 2022.

Abstract

The goal of post-transplant immunosuppressive drug therapy is to prevent organ rejection while minimizing drug toxicities. In clinical practice, a multidrug approach is commonly used and involves drugs with different mechanisms of action, including calcineurin inhibitors (CNI) (tacrolimus or cyclosporine), antimetabolite (antimet) (mycophenolate or azathioprine), inhibitors of mechanistic target of rapamycin (mTOR) (sirolimus or everolimus), and/or steroids. Although evidence based on several randomized clinical trials is available, the optimal immunosuppressive therapy has not been established and may vary among organ transplant settings. To improve the knowledge on this topic, a multiregional research network to Compare the Effectiveness and Safety of Immunosuppressive drugs in Transplant patients (CESIT) has been created with the financial support of the Italian Medicines Agency. In this article, we describe the development of this network, the framework that was designed to perform observational studies, and we also give an overview of the preliminary results that we have obtained. A multi-database transplant cohort was enrolled using a common data model based on healthcare claims data of four Italian regions (Lombardy, Veneto, Lazio, and Sardinia). Analytical datasets were created using an open-source tool for distributed analysis. To link the National Transplant Information System to the regional transplant cohorts, a semi-deterministic record linkage procedure was performed. Overall, 6,914 transplant patients from 2009–19 were identified: 4,029 (58.3%) for kidney, 2,219 (32.1%) for liver, 434 (6.3%) for heart, and 215 (3.1%) for lung. As expected, demographic and clinical characteristics showed considerable variability among organ settings. Although the triple therapy in terms of CNI + antimet/mTOR + steroids was widely dispensed for all settings (63.7% for kidney, 33.5% for liver, 53.3% for heart, and 63.7% for lung), differences in the active agents involved were detected. The CESIT network represents a great opportunity to study several aspects related to the use, safety, and effectiveness of post-transplant maintenance immunosuppressive therapy in real practice.

Details

Language :
English
ISSN :
16639812
Volume :
13
Database :
Directory of Open Access Journals
Journal :
Frontiers in Pharmacology
Publication Type :
Academic Journal
Accession number :
edsdoj.1de07c8e2f45829a56fa78f79b76fb
Document Type :
article
Full Text :
https://doi.org/10.3389/fphar.2022.959267