A retrospective analysis of treatment patterns, drug discontinuation and healthcare costs in Crohn's disease patients treated with biologics.


Journal

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385

Informations de publication

Date de publication:
09 2023
Historique:
received: 20 02 2023
revised: 07 04 2023
accepted: 07 04 2023
medline: 28 8 2023
pubmed: 27 4 2023
entrez: 26 4 2023
Statut: ppublish

Résumé

This real-world analysis evaluated the persistence and direct healthcare costs of Crohn's Disease (CD) patients treated with biologics in Italy. A retrospective analysis on administrative databases of Italian healthcare entities, covering 10.4 million residents, was performed. Adult CD patients under biologics between 2015 and 2020 were included and attributed to first/second treatment line based on absence/presence of biologic prescriptions 5-years before index-date (first biologic prescription). Of 16,374 CD patients identified, 1,398 (8.5%) were biologic-treated: 1,256 (89.8%) in first line and 135 (9.7%) in second line. Kaplan-Meier curves estimated a higher persistence for ustekinumab-treated patients followed by vedolizumab, infliximab and adalimumab, in both lines. Considering baseline variables and adalimumab as reference, infliximab in first line (HR: 0.537) and ustekinumab in first (HR: 0.057) and second line (HR: 0.213) were associated with significantly reduced risk of drug-discontinuation. First line total/average healthcare direct-costs were €13,637, €11,201, €17,104 and €18,340 in patients persistent on adalimumab, infliximab, ustekinumab and vedolizumab, respectively. This real-world analysis showed differences in persistence over 12-months between biologic treatments, being higher in ustekinumab-treated group, followed by vedolizumab, infliximab and adalimumab. Patients' management was associated with comparable direct healthcare costs among treatment lines, mainly driven by drug-related expenses.

Sections du résumé

BACKGROUND/AIMS
This real-world analysis evaluated the persistence and direct healthcare costs of Crohn's Disease (CD) patients treated with biologics in Italy.
METHODS
A retrospective analysis on administrative databases of Italian healthcare entities, covering 10.4 million residents, was performed. Adult CD patients under biologics between 2015 and 2020 were included and attributed to first/second treatment line based on absence/presence of biologic prescriptions 5-years before index-date (first biologic prescription).
RESULTS
Of 16,374 CD patients identified, 1,398 (8.5%) were biologic-treated: 1,256 (89.8%) in first line and 135 (9.7%) in second line. Kaplan-Meier curves estimated a higher persistence for ustekinumab-treated patients followed by vedolizumab, infliximab and adalimumab, in both lines. Considering baseline variables and adalimumab as reference, infliximab in first line (HR: 0.537) and ustekinumab in first (HR: 0.057) and second line (HR: 0.213) were associated with significantly reduced risk of drug-discontinuation. First line total/average healthcare direct-costs were €13,637, €11,201, €17,104 and €18,340 in patients persistent on adalimumab, infliximab, ustekinumab and vedolizumab, respectively.
CONCLUSIONS
This real-world analysis showed differences in persistence over 12-months between biologic treatments, being higher in ustekinumab-treated group, followed by vedolizumab, infliximab and adalimumab. Patients' management was associated with comparable direct healthcare costs among treatment lines, mainly driven by drug-related expenses.

Identifiants

pubmed: 37100708
pii: S1590-8658(23)00568-6
doi: 10.1016/j.dld.2023.04.010
pii:
doi:

Substances chimiques

Adalimumab FYS6T7F842
Infliximab B72HH48FLU
Ustekinumab FU77B4U5Z0
Biological Products 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1214-1220

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of Interest Janssen-Cilag SpA purchased the study report that is the basis for this manuscript. This manuscript was developed with Janssen-Cilag SpA and CliCon S.r.l. Società Benefit. The views expressed here are those of the authors and not necessarily those of the supporters. The agreement signed by CliCon S.r.l. and Janssen-Cilag SpA does not create any entity, joint venture or any similar relationship between parties. CliCon S.r.l. is an independent company. Neither CliCon S.r.l. nor any of their representatives are employees of Janssen-Cilag SpA for any purpose. Andrea Franchi, Ottavio Secchi and Andrea Serra are employees of Janssen-Cilag SpA. Marco Daperno served as member of boards, lecturer and/or received grants for participation to congresses from Abbvie, Takeda, Jannsen, Pfizer, Celltrion, Galapagos, SOFAR, Chiesi, Zambon, Ferring; he acts as consultant for Bioclinica-Clario. Edoardo Vincenzo Savarino has served as speaker for Abbvie, AGPharma, Alfasigma, Dr Falk, EG Stada Group, Fresenius Kabi, Grifols, Janssen, Innovamedica, Malesci, Pfizer, Reckitt Benckiser, Sandoz, SILA, Sofar, Takeda, Unifarco; has served as consultant for Alfasigma, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Diadema Farmaceutici, Dr. Falk, Fresenius Kabi, Janssen, Merck & Co, Reckitt Benckiser, Regeneron, Sanofi, Shire, SILA, Sofar, Synformulas GmbH, Takeda, Unifarco; he received research support from Pfizer, Reckitt Benckiser, SILA, Sofar, Unifarco. Franco Scaldaferri received fees for consultancy or other activities form MSD, Janseen, Takeda, Sandoz, Ferring, Pfizer. or other activities. Alessandro Armuzzi has received consulting fees from: AbbVie, Allergan, Amgen, Arena, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda; speaker's fees from: AbbVie, Amgen, Arena, Biogen, Bristol-Myers Squibb, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Tigenix; research support from: MSD, Takeda, Pfizer, Biogen. All the other authors have no competing interest to disclose.

Auteurs

Luca Degli Esposti (L)

CliCon S.r.l., Società Benefit, Health, Economics & Outcomes Research, 40137 Bologna, Italy. Electronic address: luca.degliesposti@clicon.it.

Marco Daperno (M)

SC Gastroenterologia AO Ordine Mauriziano di Torino, 10128 Torino, Italy.

Melania Dovizio (M)

CliCon S.r.l., Società Benefit, Health, Economics & Outcomes Research, 40137 Bologna, Italy.

Andrea Franchi (A)

Janssen Cilag Spa, 20093 Cologno Monzese, Milano, Italy.

Diego Sangiorgi (D)

CliCon S.r.l., Società Benefit, Health, Economics & Outcomes Research, 40137 Bologna, Italy.

Edoardo Vicenzo Savarino (EV)

Università Degli Studi di Padova, 35131 Padova, Italy.

Franco Scaldaferri (F)

CEMAD (Centro Malattie Apparato Digerente) - UOS Malattie Infiammatorie Croniche Intestinali, IBD UNIT, Fondazione Policlinico A. Gemelli IRCSS - Università Cattolica del Sacro Cuore, 00168 Roma, Italy.

Ottavio Secchi (O)

Janssen Cilag Spa, 20093 Cologno Monzese, Milano, Italy.

Andrea Serra (A)

Janssen Cilag Spa, 20093 Cologno Monzese, Milano, Italy.

Valentina Perrone (V)

CliCon S.r.l., Società Benefit, Health, Economics & Outcomes Research, 40137 Bologna, Italy.

Alessandro Armuzzi (A)

IBD Center, IRCCS Humanitas Research Hospital, 20089 Rozzano, Milano, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20090 Milan, Italy.

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Classifications MeSH