Evidence map›Paper›PMID 41069055›Full record

ArticlePharmacoepidemiology and drug safety2025

Trajectories of Adherence to Biologics in Patients With Inflammatory Bowel Diseases: A Large-Scale Multi-Regional Italian Study Through the VALORE Distributed Database.

Sabrina Giometto, Andrea Spini, Giorgia Pellegrini, Ylenia Ingrasciotta, Chiara Bellitto, Federica Soardo, Luca L'Abbate, Olivia Leoni, Arianna Mazzone, Domenica Ancona and 25 more

Abstract readMulticenter Study
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

35 authors.

Sabrina GiomettoDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Andrea SpiniDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Giorgia PellegriniDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Ylenia IngrasciottaDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Chiara BellittoDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Federica SoardoDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Luca L'AbbateDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Olivia LeoniLombardy Regional Epidemiologic Observatory, Milan, Italy.
Arianna MazzoneAzienda Regionale per l'Innovazione e gli Acquisti, S.p.A, Milan, Italy.
Domenica AnconaCentro Regionale Farmacovigilanza Regione Puglia, Bari, Italy.
Paolo StellaCentro Regionale Farmacovigilanza Regione Puglia, Bari, Italy.
Anna CavazzanaAzienda Zero, Regione Veneto, Padova, Italy.
Angela ScapinAzienda Zero, Regione Veneto, Padova, Italy.
Sara LopesDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Valeria BelleudiDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.ORCID 0000-0002-8286-443X
Stefano LeddaRegione Autonoma Della Sardegna, Cagliari, Italy.
Paolo CartaRegione Autonoma Della Sardegna, Cagliari, Italy.
Paola RossiFriuli-Venezia Giulia Regional Center of Pharmacovigilance, Trieste, Italy.
Lucian EjlliFriuli-Venezia Giulia Regional Center of Pharmacovigilance, Trieste, Italy.
Ester SapigniEmilia-Romagna Regional Center of Pharmacovigilance, Bologna, Italy.
Aurora PucciniEmilia-Romagna Regional Center of Pharmacovigilance, Bologna, Italy.
Alessandra AllottaEpidemiologic Observatory of the Sicily Regional Health Service, Palermo, Italy.
Sebastiano Addario PollinaEpidemiologic Observatory of the Sicily Regional Health Service, Palermo, Italy.
Roberto Da CasItalian National Institute of Health, Rome, Italy.
Giampaolo BucaneveUmbria Regional Centre of Pharmacovigilance, Perugia, Italy.
Antea Maria Pia ManganoAgenzia Regionale Sanitaria Della Regione Marche, Ancona, Italy.
Francesco BalducciAgenzia Regionale Sanitaria Della Regione Marche, Ancona, Italy.
Carla SorrentinoRegional Pharmaceutical Unit, Abruzzo Region, Pescara, Italy.
Ilenia SenesiAbruzzo Regional Centre of Pharmacovigilance, Teramo, Italy.
Marco TuccoriDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.ORCID 0000-0002-7979-8486
Rosa GiniAgenzia Regionale di Sanità Toscana, Firenze, Italy.ORCID 0000-0002-6250-877X
Stefania Spila AlegianiItalian National Institute of Health, Rome, Italy.
Marco MassariItalian National Institute of Health, Rome, Italy.
Gianluca TrifiròDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Ersilia LucenteforteDepartment of Statistics, Computer Science and Applications "G. Parenti", University of Florence, Florence, Italy.

Funding

Agenzia Italiana del Farmaco, Ministero della Salute
6 · The paper itself

Abstract

This study aimed to identify and describe trajectories of adherence to biologics in patients with IBDs and to identify adherence determinants in the Italian real-world setting. We conducted a retrospective cohort study across 12 Italian regions, including new users of biologics with inflammatory bowel diseases (IBDs), between 2010 and 2019 and followed them for 3 years. We assessed adherence longitudinally, and we identified trajectories using nonparametric methods. To identify determinants of adherence, we used multinomial multivariate regression models. We included 20 150 subjects in the final cohort, mostly male (56%), < 65 years old (92%), and with Crohn's disease (58%). We identified three trajectories of adherence to biologics for IBDs: one group (19% of the cohort) maintained high adherence throughout the observation period, while the largest group (46%) initially reduced adherence, stabilizing around 70%. The remaining group (35%) gradually decreased adherence over the entire follow-up, reaching 20%. Being female (odds ratio (OR) 1.52, 95% confidence interval (CI) 1.40-1.65), older (OR 1.44, 95% CI 1.21-1.70), and having adalimumab as index drug were each positively associated with low adherence compared to high adherence. In contrast, starting treatment with a biosimilar (OR 0.47, 95% CI 0.42-0.52) was negatively associated with low adherence. Our findings highlight that one in three patients with IBDs gradually reduced adherence to biologics within the first 3 years of treatment. Differences were observed according to the initial biologic dispensed and patient characteristics such as sex and age, with females and older patients positively associated with low adherence.

Indexed as

Biological ProductsInflammatory Bowel DiseasesAdultAgedAge FactorsCrohn DiseaseDatabases, FactualFemaleFollow-Up StudiesHumansItalyLongitudinal StudiesMaleMiddle AgedRetrospective StudiesSex FactorsBiological Productsadherencebiological drugsinflammatory bowel diseasespharmacoepidemiologytrajectories

Identifiers

PMID41069055
PMCPMC12511659

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Registered trials

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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.