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. 2023 Jan 16:1:1060621.
doi: 10.3389/frtra.2022.1060621. eCollection 2022.

Temporal and spatial variability of immunosuppressive therapies in transplant patients: An observational study in Italy

Maria Lucia Marino  1 , Alessandro C Rosa  1 , Marco Finocchietti  1 , Arianna Bellini  1 , Francesca R Poggi  1 , Marco Massari  2 , Stefania Spila Alegiani  2 , Lucia Masiero  3 , Andrea Ricci  3 , Gaia Bedeschi  3 , Francesca Puoti  3 , Massimo Cardillo  3 , Silvia Pierobon  4 , Maurizio Nordio  4 , Eliana Ferroni  4 , Martina Zanforlini  5 , Giuseppe Piccolo  6 , Olivia Leoni  7 , Stefano Ledda  8 , Paolo Carta  8 , Donatella Garau  8 , Ersilia Lucenteforte  9 , Marina Davoli  1 , Antonio Addis  1 , Valeria Belleudi  1
Affiliations

Temporal and spatial variability of immunosuppressive therapies in transplant patients: An observational study in Italy

Maria Lucia Marino et al. Front Transplant. .

Abstract

Background: In immunosuppression after transplantation, several multi-drug approaches are used, involving calcineurin inhibitors (CNI: tacrolimus-TAC or cyclosporine-CsA), antimetabolites (antiMs), mammalian target of rapamycin inhibitors (mTORis), and corticosteroids. However, data on immunosuppressive therapy by organ and its space-time variability are lacking.

Methods: An Italian multicentre observational cohort study was conducted using health information systems. Patients with incident transplant during 2009-2019 and resident in four regions (Veneto, Lombardy, Lazio, and Sardinia) were enrolled. The post-transplant immunosuppressive regimen was evaluated by organ, region, and year.

Results: The most dispensed regimen was triple-drug therapy for the kidneys [tacrolimus (TAC) + antiM + corticosteroids = 41.5%] and heart [cyclosporin + antiM + corticosteroids = 36.6%] and double-drug therapy for liver recipients (TAC + corticosteroids = 35.4%). Several differences between regions and years emerged with regard to agents and the number of drugs used.

Conclusion: A high heterogeneity in immunosuppressive therapy post-transplant was found. Further studies are needed in order to investigate the reasons for this variability and to evaluate the risk-benefit profile of treatment schemes adopted in clinical practice.

Keywords: drug utilization; immunosuppressive therapy; real-world evidence; solid organ transplant; space–time variability.

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Conflict of interest statement

MZ was employed by ARIA, S.p.a. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Pattern of immunosuppressive therapy by type of transplant and regions.
Figure 2
Figure 2
Variability by discharge facility of the main drug therapy by organ.
Figure 3
Figure 3
Immunosuppressive therapeutic combination over the years in kidney, liver, and heart transplantations. The analysis has been limited since 2013, when data for all regions were available.
See this image and copyright information in PMC

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