Real-world clinical effectiveness of ustekinumab in the treatment of Crohn’s disease in the East Midlands UK

White, Jonathan Richard; Ahmad, Saqib; Ashraf, Fahad; Foley, Stephen; Din, Said; Das, Ronit Kumar; Charles, Nina Mary; Pinheiro, João; Palejwala, Altaf; Wright, Pamela; Andiappan, Manoharan; Alexander, Myriam; Uddin, Burhan; Hoshen, Deloar; Elphick, David; Qamar, Tufail; Rezwan, Nivin; Hamza, Mohammad Viquaruddin; Glover, John; Robinson, Richard; Gopakumar, Veena; Sajjad, Aamir; Shahzad, Muhammad; Moran, Gordon

Abstract

Objectives: To evaluate the effectiveness of ustekinumab in treating Crohn’s disease (CD) in a UK real-world setting.

Design: This was a multicentre, retrospective observational study of patients (aged ≥18 years) with CD or inflammatory bowel disease of unclassified type (IBDU) starting ustekinumab between 11 November 2016 and 1 August 2020 across eight English hospitals. The primary objective was to determine the proportion of patients achieving corticosteroid-free remission at week 52 for patients with CD/IBDU following initiation with ustekinumab. Corticosteroid-free remission was defined as achieving a clinical Harvey-Bradshaw Index (HBI) score of ≤4 and corticosteroid-free status.

Results: The analysis included 422 patients with CD/IBDU. Corticosteroid-free remission was 41% (68/166) at week 16, 41% (47/115) at week 30 and 48% (38/80) at week 52. Clinical remission was 51% (85/166) at week 16 and 50% (40/80) at week 52. Clinical response was 34% (43/125) at week 16 and 32% (17/53) at week 52. Objective remission was 40% (4/10) at week 16 and 70% (7/10) at week 52. Corticosteroid-free remission at week 52 was achieved in patients with previous exposure to 1–2 biologics and/or small oral molecules (56%; 35/63), those without surgical history (64%; 16/25), and those without penetrating disease (54%; 29/54). Patients who achieved clinical remission at week 16 were more likely to achieve corticosteroid-free remission at week 52 (70%; 14/20) versus those who did not (20%; 4/20). In total, 37 adverse events occurred in 21 patients.

Conclusion: This multicentre study provides real-world experience of ustekinumab in patients with CD/IBDU in England.

Citation

White, J. R., Ahmad, S., Ashraf, F., Foley, S., Din, S., Das, R. K., …Moran, G. (in press). Real-world clinical effectiveness of ustekinumab in the treatment of Crohn’s disease in the East Midlands UK. Frontline Gastroenterology, flgastro-2024-102718. https://doi.org/10.1136/flgastro-2024-102718

• Journal Article Type: Article
• Acceptance Date: Jun 7, 2024
• Online Publication Date: Jun 14, 2024
• Deposit Date: Jun 19, 2024
• Publicly Available Date: Jun 21, 2024
• Journal: Frontline Gastroenterology
• Print ISSN: 2041-4137
• Electronic ISSN: 2041-4145
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Pages: flgastro-2024-102718
• DOI: https://doi.org/10.1136/flgastro-2024-102718
• Publisher URL: https://fg.bmj.com/content/early/2024/06/14/flgastro-2024-102718