Effectiveness, safety, and cost of combination advanced therapies in inflammatory bowel disease.

Biologic therapy Clinical trials Combination advanced therapies Inflammatory bowel disease Small molecule therapy

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:
21 Sep 2024
Historique:
received: 24 05 2024
revised: 20 08 2024
accepted: 22 08 2024
medline: 23 9 2024
pubmed: 23 9 2024
entrez: 22 9 2024
Statut: aheadofprint

Résumé

A significant proportion of inflammatory bowel disease (IBD) patients fail to respond to advanced therapies. Combining advanced therapies may improve treatment outcome. This study aimed to assess the effectiveness, adverse events, and costs associated with combining advanced therapies in IBD patients. Combination advanced therapy was defined as the concurrent use of two biological agents or one biological agent with a small molecule therapy. Clinical data, including disease characteristics, treatment regimens, and adverse events, were collected from electronic patient records. Clinical response rates, biochemical markers, and treatment costs were evaluated. The study included 109 IBD patients receiving combination advanced therapies from 9 academic centers in Ireland. Corticosteroid-free clinical response rates at 12 weeks and 52 weeks were 39 % and 38 %, respectively. Adverse events occurred in 26 % of therapeutic trials, with disease-related events being the most common. Notably, there were 3 cases of non-melanomatous skin cancer and 10 infectious complications. The annual cost of maintenance therapy for combination advanced therapies ranged from €17,560 to €30,724 per patient. Combination advanced therapies demonstrated effectiveness and acceptable safety profiles in a cohort of treatment-refractory IBD patients. Further large, prospective trials are required to definitively evaluate the role of combination advanced therapies in IBD.

Sections du résumé

BACKGROUND BACKGROUND
A significant proportion of inflammatory bowel disease (IBD) patients fail to respond to advanced therapies. Combining advanced therapies may improve treatment outcome. This study aimed to assess the effectiveness, adverse events, and costs associated with combining advanced therapies in IBD patients.
METHODS METHODS
Combination advanced therapy was defined as the concurrent use of two biological agents or one biological agent with a small molecule therapy. Clinical data, including disease characteristics, treatment regimens, and adverse events, were collected from electronic patient records. Clinical response rates, biochemical markers, and treatment costs were evaluated.
RESULTS RESULTS
The study included 109 IBD patients receiving combination advanced therapies from 9 academic centers in Ireland. Corticosteroid-free clinical response rates at 12 weeks and 52 weeks were 39 % and 38 %, respectively. Adverse events occurred in 26 % of therapeutic trials, with disease-related events being the most common. Notably, there were 3 cases of non-melanomatous skin cancer and 10 infectious complications. The annual cost of maintenance therapy for combination advanced therapies ranged from €17,560 to €30,724 per patient.
CONCLUSION CONCLUSIONS
Combination advanced therapies demonstrated effectiveness and acceptable safety profiles in a cohort of treatment-refractory IBD patients. Further large, prospective trials are required to definitively evaluate the role of combination advanced therapies in IBD.

Identifiants

DOI: 10.1016/j.dld.2024.08.055 PMID: 39307602
pubmed: 39307602
pii: S1590-8658(24)00973-3
doi: 10.1016/j.dld.2024.08.055
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Conflicts of interest There are no conflicts of interest pertaining to this paper.

Auteurs

Cathy McShane (C)

Department of Gastroenterology, St. James's Hospital, Dublin, Ireland; Wellcome - HRB Clinical Research Facility, St. James's Hospital, James's Street, Dublin, Ireland; Trinity Academic Gastroenterology Group, Trinity College Dublin, Ireland. Electronic address: mcshanca@tcd.ie.

Rachel Varley (R)

Mercy University Hospital, Cork, Ireland.

Anne Fennessy (A)

St Vincent's University Hospital Center for Colorectal Disease, Dublin, Ireland.

Clodagh Byron (C)

Cork University Hospital, Cork, Ireland.

John Richard Campion (JR)

Galway University Hospital, Galway, Ireland.

Karl Hazel (K)

Beaumont Hospital, Dublin, Ireland.

Conor Costigan (C)

Tallaght University Hospital, Dublin, Ireland; Trinity Academic Gastroenterology Group, Trinity College Dublin, Ireland.

Eabha Ring (E)

Connolly Hospital Blanchardstown, Dublin, Ireland.

Alan Marrinan (A)

Mater Misericordiae University Hospital, Dublin, Ireland.

Ciaran Judge (C)

Mercy University Hospital, Cork, Ireland.

Kathleen Sugrue (K)

Mercy University Hospital, Cork, Ireland.

Garret Cullen (G)

St Vincent's University Hospital Center for Colorectal Disease, Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Cara Dunne (C)

Department of Gastroenterology, St. James's Hospital, Dublin, Ireland; Trinity Academic Gastroenterology Group, Trinity College Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Karen Hartery (K)

Department of Gastroenterology, St. James's Hospital, Dublin, Ireland; Trinity Academic Gastroenterology Group, Trinity College Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Marietta Iacucci (M)

Mercy University Hospital, Cork, Ireland; College of Medicine and Health, University College Cork, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Orlaith Kelly (O)

Connolly Hospital Blanchardstown, Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Jan Leyden (J)

Mater Misericordiae University Hospital, Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Susan McKiernan (S)

Department of Gastroenterology, St. James's Hospital, Dublin, Ireland; Trinity Academic Gastroenterology Group, Trinity College Dublin, Ireland.

Aoibhlinn O'Toole (A)

Beaumont Hospital, Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Juliette Sheridan (J)

St Vincent's University Hospital Center for Colorectal Disease, Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Eoin Slattery (E)

Galway University Hospital, Galway, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Karen Boland (K)

Beaumont Hospital, Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Deirdre McNamara (D)

Tallaght University Hospital, Dublin, Ireland; Trinity Academic Gastroenterology Group, Trinity College Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Laurence Egan (L)

Galway University Hospital, Galway, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Subrata Ghosh (S)

Cork University Hospital, Cork, Ireland; College of Medicine and Health, University College Cork, Ireland.

Glen Doherty (G)

St Vincent's University Hospital Center for Colorectal Disease, Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Jane McCarthy (J)

Mercy University Hospital, Cork, Ireland; Initiative IBD Research Network, Dublin, Ireland.

David Kevans (D)

Department of Gastroenterology, St. James's Hospital, Dublin, Ireland; Wellcome - HRB Clinical Research Facility, St. James's Hospital, James's Street, Dublin, Ireland; Trinity Academic Gastroenterology Group, Trinity College Dublin, Ireland; Initiative IBD Research Network, Dublin, Ireland.

Classifications MeSH