Evidence map›Paper›PMID 38229916›Full record

Observational studyDrug design, development and therapy2024

Immunosuppression with Generics in Liver and Kidney Transplantation: A Real-World Evidence Study.

Marco Finocchietti, Maria Lucia Marino, Alessandro C Rosa, Arianna Bellini, Lucia Masiero, Massimo Cardillo, Marco Massari, Stefania Spila Alegiani, Silvia Pierobon, Eliana Ferroni and 8 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Drug design, development and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. A Retrospective Post-Marketing Surveillance Study on TGlobulin25Iranian journal of medical sciences · 2026
    Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 5 institutions in 1 country.

Marco Finocchietti *Department of Epidemiology, Lazio Regional Health Service-ASL Roma 1, Rome, Italy.
Maria Lucia Marino *Department of Epidemiology, Lazio Regional Health Service-ASL Roma 1, Rome, Italy.
Alessandro C RosaDepartment of Epidemiology, Lazio Regional Health Service-ASL Roma 1, Rome, Italy.
Arianna BelliniDepartment of Epidemiology, Lazio Regional Health Service-ASL Roma 1, Rome, Italy.ORCID 0000-0002-4558-0921
Lucia MasieroItalian National Transplant Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0002-6552-6228
Massimo CardilloItalian National Transplant Center, Istituto Superiore di Sanità, Rome, Italy.
Marco MassariNational Center for Drug Research and Evaluation, Istituto Superiore Di Sanità, Rome, Italy.ORCID 0000-0001-8442-4238
Stefania Spila AlegianiNational Center for Drug Research and Evaluation, Istituto Superiore Di Sanità, Rome, Italy.ORCID 0000-0003-0656-1346
Silvia PierobonAzienda Zero, Veneto Region, Padua, Italy.ORCID 0000-0001-9028-6580
Eliana FerroniAzienda Zero, Veneto Region, Padua, Italy.ORCID 0000-0003-4803-2004
Martina ZanforliniThe innovation and procurement regional company, A.R.I.A. S.p.A.-Lombardy Region, Milan, Italy.
Olivia LeoniRegional Epidemiological Observatory, Lombardy Region, Milan, Italy.
Stefano LeddaGeneral Directorate for Health, Sardinia Region, Cagliari, Italy.
Donatella GarauGeneral Directorate for Health, Sardinia Region, Cagliari, Italy.
Marina DavoliDepartment of Epidemiology, Lazio Regional Health Service-ASL Roma 1, Rome, Italy.
Antonio AddisDepartment of Epidemiology, Lazio Regional Health Service-ASL Roma 1, Rome, Italy.ORCID 0000-0003-0962-9959
Valeria BelleudiDepartment of Epidemiology, Lazio Regional Health Service-ASL Roma 1, Rome, Italy.ORCID 0000-0002-8286-443X
CESIT Study Group
ASL Roma · ITIstituto Superiore di Sanità · ITRegione Autonoma della SardegnaRegione del Veneto · ITRegione Lombardia

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: This study evaluates the use, benefit-risk profile, and economic impact of generic immunosuppressants (tacrolimus-TAC, cyclosporine-CsA, and mycophenolate-MYC) in kidney and liver transplant recipients compared to brand-name drugs. Patients and Methods: A retrospective multicentre observational study, involving four Italian regions, was conducted based on the national transplant Information system and regional healthcare claims data. The analysis focused on incident patients who received kidney and liver transplants between 2013 and 2019 and evaluated the use of generic of CsA, TAC, and MYC during the 30-day period following discharge. For each type of transplant and immunosuppressive agent, the benefit-risk profile of generic vs branded drugs in a two-year window was estimated by multivariate Cox models (HR; 95% CI). Furthermore, the potential cost savings per person associated with one year of treatment using generics were calculated. Results: The utilization of generic drugs showed a significant increase; over the study years, the proportion of users among kidney recipients ranged from 14.2% to 40.5% for TAC, from 36.9% to 56.7% for MYC, and from 18.2% to 94.7% for CsA. A great variability in generic uptake for region was found. A comparable risk-benefit profile between generic and branded formulations was shown for all immunosuppressors considered. Choosing generic immunosuppressants during maintenance could result in yearly savings of around 2000 euros per person for each therapy ingredient. Conclusion: The study shows an increasing proportion of patients using generic immunosuppressive drugs over time suggesting a growing acceptance of generics within the transplant community and reveals comparable risk-benefit profiles between the generic and branded formulations of TAC, CsA, and MYC. A significant variability in the use of generics immunosuppressive agents was found both at the regional level and among transplant centers and future research should delve into regional prescribing variations.

Indexed as

Kidney TransplantationCyclosporineDrugs, GenericGraft RejectionHumansImmunosuppression TherapyImmunosuppressive AgentsLiverRetrospective StudiesTacrolimusCyclosporineDrugs, GenericImmunosuppressive AgentsTacrolimuscyclosporinemaintenance therapymycophenolaterisk-benefit profilesustainabilitytacrolimustransplantuptake generics

Identifiers

PMID38229916
PMCPMC10790661
OpenAlexW4390807302

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.