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
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RJH and MM are joint first authors.
Contributors RJH, MM and JRFC were responsible for the original concept and planning of the study. RJH, MM, DY, MB, LD and LP were responsible for data collection and analysis. RJH and MM contributed equally to this work and drafted the manuscript which RF, MG and JRFC critically reviewed and revised.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests Outside the submitted work the following interests are declared. RJH: personal fees from Abbvie & Janssen; non-financial support from Falk. MM: non-financial support from Falk, MSD, Janssen & Takeda. MB: Personal fees from Abbvie, Falk, Hospira, Janssen, MSD, Napp, Takeda & Pfizer. MG: personal fees and non-financial support from Abbvie & MSD; personal fees from Takeda; non-financial support from Falk & Janssen. JRFC: grants and personal fees from Samsung, Pfizer & Biogen; personal fees and non-financial support from Janssen & Abbvie; grants, personal fees and non-financial support from Takeda; personal fees from MSD, Sandoz, Celltrion & NAPP.
Patient consent for publication Not required.
Ethics statement The Health Research Authority does not consider postmarketing surveillance, research and therefore, suggests that NHS REC approval was not necessary.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
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