P575 Real-world effectiveness and safety of ustekinumab for the treatment of refractory Crohn’s disease: The Scottish ustekinumab cohort
N. PLEVRIS1, A. Robertson2, J. Fulforth1, R. Hall3, I. Campbell4, C. Kane5, J. Veryan6, W. Lam6, J. Saunders2, P. Jenkinson1, C. Chuah7, C. Kelly8, D. Watts8, D. Gaya6, J. Macdonald9, H. Jafferbhoy7, J.P. Seenan9, C. Mowat3, D. Sutherland2, G. Naismith10, G. Bain5, I. Arnott1, G. Jones1, C. Lees1
1Department of Gastroenterology, Western General Hospital, The Edinburgh IBD Unit, Edinburgh, UK, 2Department of Gastroenterology, University Hospital Hairmyres, Glasgow, UK, 3Department of Gastroenterology, Ninewells Hospital, Dundee, UK, 4Department of Gastroenterology, Royal Alexandra Hospital, Glasgow, UK, 5Department of Gastroenterology, Aberdeen Royal Infirmary, Aberdeen, UK, 6Department of Gastroenterology, Glasgow Royal Infirmary,Glasgow, UK, 7Department of Gastroenterology, Victoria Hospital, Kirkcaldy, UK, 8Department of Gastroenterology, Forth Valley Royal Hospital, Larbert, UK, 9Department of Gastroenterology, Queen Elizabeth University Hospital, Glasgow, UK, 10Department of Gastroenterology, Royal Alexandra Hospital, Paisley, UK
Background
Ustekinumab (UST) is an anti-IL12/23 biologic licensed for the treatment of moderate to severe Crohn’s disease (CD). The aims of this study were to establish the long-term real-world effectiveness and safety of UST for the treatment of CD in a large UK cohort.
Methods
This was a multicentre retrospective cohort study , including 7 NHS health-boards in Scotland. Patients treated with UST between November 2015 and June 2019 were identified. Inclusion criteria included: a diagnosis of CD; active symptoms attributed to CD with objective evidence of mucosal inflammation (CRP >5mg/l or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/ MRI); and completion of induction with a minimum of 8 weeks follow-up. Clinical assessments were performed based on physician global assessment (response was defined as ≥50% reduction in CD-related symptoms and remission defined as complete resolution of all CD-related symptoms). Mucosal healing was defined as the absence of ulceration/erosions on ileo-colonoscopy or no inflammation on MRI if ileo-colonoscopy was not possible (eg. B2 disease). Deep remission was defined as clinical remission plus mucosal healing. Rates of serious adverse events (discontinuation of UST, hospitalisation or death) during follow-up were described quantitively.
Results
A total of 207 patients (43% male; median age 39.2 years, IQR 28.9–51.4; median disease duration 10.0 years, IQR 5.7–16.6) with a median follow-up of 34.6 weeks (IQR 16.9–52.1) were included. The majority of patients had ileocolonic disease (L1, 19.3%; L2, 23.7%; L3, 57%) and an inflammatory phenotype (B1, 43.0%; B2, 41.1%; B3, 15.9%). A total of 98.6% of patients had previously been exposed to a biologic and 55.1 % had undergone previous surgery. Seventy-one per cent of patients received Q8 maintenance dosing, whilst 25.6% and 42.0% of patients were also receiving an immunomodulator (IMM) and steroids at initiation, respectively. At week 8, clinical response and remission rates were 51.7% and 5.8%, respectively. Twelve-month cumulative rates of clinical remission, mucosal healing (
Conclusion
We have shown in a large real-world cohort of complex, treatment-refractory CD patients that UST is a safe and effective treatment option.