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

Cathy McShane; Rachel Varley; Anne Fennessy; Clodagh Byron; John Richard Campion; Karl Hazel; Conor Costigan; Eabha Ring; Alan Marrinan; Ciaran Judge; Kathleen Sugrue; Garret Cullen; Cara Dunne; Karen Hartery; Marietta Iacucci; Orlaith Kelly; Jan Leyden; Susan McKiernan; Aoibhlinn O'Toole; Juliette Sheridan; Eoin Slattery; Karen Boland; Deirdre McNamara; Laurence Egan; Subrata Ghosh; Glen Doherty; Jane McCarthy; David Kevans

doi:10.1016/j.dld.2024.08.055

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

Cathy McShane
, Rachel Varley
, Anne Fennessy
, Clodagh Byron
, John Richard Campion
, Karl Hazel
, Conor Costigan
, Eabha Ring
, Alan Marrinan
, Ciaran Judge
, Kathleen Sugrue
, Garret Cullen
, Cara Dunne
, Karen Hartery
, Marietta Iacucci
, Orlaith Kelly
, Jan Leyden
, Susan McKiernan
, Aoibhlinn O'Toole
, Juliette Sheridan

Eoin Slattery, Karen Boland, Deirdre McNamara, Laurence Egan, Subrata Ghosh, Glen Doherty, Jane McCarthy, David Kevans

Research output: Contribution to journal › Article › peer-review

Abstract

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: 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: 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: 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.

Original language	English
Pages (from-to)	274-281
Number of pages	8
Journal	Digestive and Liver Disease
Volume	57
Issue number	1
DOIs	https://doi.org/10.1016/j.dld.2024.08.055
Publication status	Published - Jan 2025

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.dld.2024.08.055

Cite this

McShane, C., Varley, R., Fennessy, A., Byron, C., Campion, J. R., Hazel, K., Costigan, C., Ring, E., Marrinan, A., Judge, C., Sugrue, K., Cullen, G., Dunne, C., Hartery, K., Iacucci, M., Kelly, O., Leyden, J., McKiernan, S., O'Toole, A., ... Kevans, D. (2025). Effectiveness, safety, and cost of combination advanced therapies in inflammatory bowel disease. Digestive and Liver Disease, 57(1), 274-281. https://doi.org/10.1016/j.dld.2024.08.055

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title = "Effectiveness, safety, and cost of combination advanced therapies in inflammatory bowel disease",

abstract = "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: 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: 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: 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.",

keywords = "Biologic therapy, Clinical trials, Combination advanced therapies, Inflammatory bowel disease, Small molecule therapy",

author = "Cathy McShane and Rachel Varley and Anne Fennessy and Clodagh Byron and Campion, \{John Richard\} and Karl Hazel and Conor Costigan and Eabha Ring and Alan Marrinan and Ciaran Judge and Kathleen Sugrue and Garret Cullen and Cara Dunne and Karen Hartery and Marietta Iacucci and Orlaith Kelly and Jan Leyden and Susan McKiernan and Aoibhlinn O'Toole and Juliette Sheridan and Eoin Slattery and Karen Boland and Deirdre McNamara and Laurence Egan and Subrata Ghosh and Glen Doherty and Jane McCarthy and David Kevans",

note = "Publisher Copyright: {\textcopyright} 2024 Editrice Gastroenterologica Italiana S.r.l.",

year = "2025",

month = jan,

doi = "10.1016/j.dld.2024.08.055",

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McShane, C, Varley, R, Fennessy, A, Byron, C, Campion, JR, Hazel, K, Costigan, C, Ring, E, Marrinan, A, Judge, C, Sugrue, K, Cullen, G, Dunne, C, Hartery, K, Iacucci, M, Kelly, O, Leyden, J, McKiernan, S, O'Toole, A, Sheridan, J, Slattery, E, Boland, K, McNamara, D, Egan, L, Ghosh, S, Doherty, G, McCarthy, J & Kevans, D 2025, 'Effectiveness, safety, and cost of combination advanced therapies in inflammatory bowel disease', Digestive and Liver Disease, vol. 57, no. 1, pp. 274-281. https://doi.org/10.1016/j.dld.2024.08.055

TY - JOUR

T1 - Effectiveness, safety, and cost of combination advanced therapies in inflammatory bowel disease

AU - McShane, Cathy

AU - Varley, Rachel

AU - Fennessy, Anne

AU - Byron, Clodagh

AU - Campion, John Richard

AU - Hazel, Karl

AU - Costigan, Conor

AU - Ring, Eabha

AU - Marrinan, Alan

AU - Judge, Ciaran

AU - Sugrue, Kathleen

AU - Cullen, Garret

AU - Dunne, Cara

AU - Hartery, Karen

AU - Iacucci, Marietta

AU - Kelly, Orlaith

AU - Leyden, Jan

AU - McKiernan, Susan

AU - O'Toole, Aoibhlinn

AU - Sheridan, Juliette

AU - Slattery, Eoin

AU - Boland, Karen

AU - McNamara, Deirdre

AU - Egan, Laurence

AU - Ghosh, Subrata

AU - Doherty, Glen

AU - McCarthy, Jane

AU - Kevans, David

PY - 2025/1

Y1 - 2025/1

N2 - 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: 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: 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: 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.

AB - 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: 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: 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: 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.

KW - Biologic therapy

KW - Clinical trials

KW - Combination advanced therapies

KW - Inflammatory bowel disease

KW - Small molecule therapy

UR - https://www.scopus.com/pages/publications/85204500426

U2 - 10.1016/j.dld.2024.08.055

DO - 10.1016/j.dld.2024.08.055

M3 - Article

C2 - 39307602

AN - SCOPUS:85204500426

SN - 1590-8658

VL - 57

SP - 274

EP - 281

JO - Digestive and Liver Disease

JF - Digestive and Liver Disease

IS - 1

ER -

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

Abstract

Keywords

UN SDGs

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