The University of Southampton
University of Southampton Institutional Repository

Early real-world effectiveness of ustekinumab for Crohn's disease

Early real-world effectiveness of ustekinumab for Crohn's disease
Early real-world effectiveness of ustekinumab for Crohn's disease

Objective: To understand the effectiveness of ustekinumab in treating Crohn's disease (CD) in a UK real-world setting. Design: Retrospective cohort study using prospectively maintained clinical records. Setting: Single UK inflammatory bowel disease centre. Patients: Adult patients with an established diagnosis of CD prescribed ustekinumab outside of clinical trials at University Hospital Southampton (UHS). Interventions: Ustekinumab, a monoclonal antibody to the shared p40 subunit of interleukin (IL) 12 and IL-23 as part of routine clinical care. Main outcome measures: Effectiveness as measured by an improvement in physician's global assessment, drug persistence and improvement in biomarkers (C-reactive protein (CRP), albumin and calprotectin). Results: 84 patients were included, 72 had a postinduction review and 49 had 1-year data. At postinduction clinical review, clinical response occurred in 53% of patients and clinical remission occurred in 8%. For patients on ustekinumab at 1 year, clinical response occurred in 71% and remission in 14%. Adverse events included four patients with infections requiring admission, one drug-related rash, five CD surgeries and two CD exacerbations. Conclusions: Ustekinumab was well tolerated in a complex UK CD population and demonstrated benefit to patients in terms of clinical response and improvement of biomarkers and with some patients attaining clinical remission. No unexpected safety signals were seen.

crohn's disease, ibd clinical, inflammatory bowel disease
2041-4137
Harris, Richard James
f70ad114-26fa-4c01-a6b2-9687a94c4280
McDonnell, Martin
c85b3bf9-e2e7-4f64-a412-eb21363c8f98
Young, David
ac65da82-e719-4879-9aeb-5c669084e70c
Bettey, Marion
cfd008ff-26e6-450d-a537-13ad34e8e285
Downey, Louise
8e53ce81-11c4-478d-afb9-bbcecebe90f8
Pigott, Lucinda
14ff58bd-5f59-4521-b0b7-80fa8d67371a
Felwick, Richard
b19f1ab6-1de4-4df6-b149-4bc337c3fcb9
Gwiggner, Markus
af72b597-1ead-4155-a25c-0835f7e560c2
Cummings, J. R.Fraser
89e8e80c-b6e8-4387-a63c-3796b5ad7e14
Harris, Richard James
f70ad114-26fa-4c01-a6b2-9687a94c4280
McDonnell, Martin
c85b3bf9-e2e7-4f64-a412-eb21363c8f98
Young, David
ac65da82-e719-4879-9aeb-5c669084e70c
Bettey, Marion
cfd008ff-26e6-450d-a537-13ad34e8e285
Downey, Louise
8e53ce81-11c4-478d-afb9-bbcecebe90f8
Pigott, Lucinda
14ff58bd-5f59-4521-b0b7-80fa8d67371a
Felwick, Richard
b19f1ab6-1de4-4df6-b149-4bc337c3fcb9
Gwiggner, Markus
af72b597-1ead-4155-a25c-0835f7e560c2
Cummings, J. R.Fraser
89e8e80c-b6e8-4387-a63c-3796b5ad7e14

Harris, Richard James, McDonnell, Martin, Young, David, Bettey, Marion, Downey, Louise, Pigott, Lucinda, Felwick, Richard, Gwiggner, Markus and Cummings, J. R.Fraser (2019) Early real-world effectiveness of ustekinumab for Crohn's disease. Frontline Gastroenterology. (doi:10.1136/flgastro-2019-101237).

Record type: Article

Abstract

Objective: To understand the effectiveness of ustekinumab in treating Crohn's disease (CD) in a UK real-world setting. Design: Retrospective cohort study using prospectively maintained clinical records. Setting: Single UK inflammatory bowel disease centre. Patients: Adult patients with an established diagnosis of CD prescribed ustekinumab outside of clinical trials at University Hospital Southampton (UHS). Interventions: Ustekinumab, a monoclonal antibody to the shared p40 subunit of interleukin (IL) 12 and IL-23 as part of routine clinical care. Main outcome measures: Effectiveness as measured by an improvement in physician's global assessment, drug persistence and improvement in biomarkers (C-reactive protein (CRP), albumin and calprotectin). Results: 84 patients were included, 72 had a postinduction review and 49 had 1-year data. At postinduction clinical review, clinical response occurred in 53% of patients and clinical remission occurred in 8%. For patients on ustekinumab at 1 year, clinical response occurred in 71% and remission in 14%. Adverse events included four patients with infections requiring admission, one drug-related rash, five CD surgeries and two CD exacerbations. Conclusions: Ustekinumab was well tolerated in a complex UK CD population and demonstrated benefit to patients in terms of clinical response and improvement of biomarkers and with some patients attaining clinical remission. No unexpected safety signals were seen.

Full text not available from this repository.

More information

Accepted/In Press date: 14 May 2019
e-pub ahead of print date: 29 May 2019
Keywords: crohn's disease, ibd clinical, inflammatory bowel disease

Identifiers

Local EPrints ID: 433657
URI: https://eprints.soton.ac.uk/id/eprint/433657
ISSN: 2041-4137
PURE UUID: 06c22c8c-9355-47b8-99ad-37d6189eda42

Catalogue record

Date deposited: 29 Aug 2019 16:30
Last modified: 29 Aug 2019 16:30

Export record

Altmetrics

Contributors

Author: Richard James Harris
Author: Martin McDonnell
Author: David Young
Author: Marion Bettey
Author: Louise Downey
Author: Lucinda Pigott
Author: Richard Felwick
Author: Markus Gwiggner
Author: J. R.Fraser Cummings

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×