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., Charles, N. M., Pinheiro, J., Palejwala, A., Wright, P., Andiappan, M., Alexander, M., Uddin, B., Hoshen, D., Elphick, D., Qamar, T., Rezwan, N., Hamza, M. V., Glover, J., Robinson, R., …Moran, G. (2024). Real-world clinical effectiveness of ustekinumab in the treatment of Crohn’s disease in the East Midlands UK. Frontline Gastroenterology, 15(5), 359-365. https://doi.org/10.1136/flgastro-2024-102718

• Journal Article Type: Article
• Acceptance Date: Jun 7, 2024
• Online Publication Date: Jun 14, 2024
• Publication Date: 2024-09
• 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
• Volume: 15
• Issue: 5
• Pages: 359-365
• DOI: https://doi.org/10.1136/flgastro-2024-102718
• Public URL: https://nottingham-repository.worktribe.com/output/36296111
• Publisher URL: https://fg.bmj.com/content/early/2024/06/14/flgastro-2024-102718