Background and Aim: Ustekinumab is a monoclonal antibody that targets interleukin-12/23. In Scotland, it was approved for the treatment of moderate to severe Crohn's disease in 2017. The objective of this study was to establish the real-world effectiveness and safety of ustekinumab in the treatment of Crohn's disease. Methods: We conducted a retrospective study of patients receiving ustekinumab across eight Scottish National Health Service health boards between 2017 and 2019. Inclusion criteria included a diagnosis of Crohn's disease with symptoms attributed to active disease plus objective signs of inflammation at baseline (C-reactive protein ≥ 5 mg/L or fecal calprotectin ≥ 250 μg/g or inflammation on endoscopy/magnetic resonance imaging) and completion of induction plus at least one clinical follow-up at 8 weeks. Kaplan-Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, deep remission, and perianal fistula response. Rates of serious adverse events were described quantitatively. Results: Our cohort consisted of 216 patients (female sex, 37.9%; median age, 39.0 years, interquartile range [IQR] 28.8-51.8 years; disease duration, 9.9 years, IQR 6.0-16.5 years; prior biologic, 98.6%) with a median follow-up of 35.0 weeks (IQR 17.4-52.0 weeks). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission plus mucosal healing) were 32.0%, 32.7%, and 19.3%, respectively. In patients with active perianal disease (n = 37), the 12-month cumulative perianal response rate was 53.1%. The serious adverse event rate was 13.6 per 100 patient-years of follow-up. Conclusion: Ustekinumab is a safe and effective treatment for the treatment of complex Crohn's disease.
Background and aimsSARS-CoV-2 and consequent pandemic has presented unique challenges. Beyond the direct COVID-related mortality in those with liver disease, we sought to determine the effect of lockdown on people with liver disease in Scotland. The effect of lockdown on those with alcohol-related disease is of interest; and whether there were associated implications for a change in alcohol intake and consequent presentations with decompensated disease.MethodsWe performed a retrospective analysis of patients admitted to seven Scottish hospitals with a history of liver disease between 1 April and 30 April 2020 and compared across the same time in 2017, 2018 and 2019. We also repeated an intermediate assessment based on a single centre to examine for delayed effects between 1 April and 31 July 2020.ResultsWe found that results and outcomes for patients admitted in 2020 were similar to those in previous years in terms of morbidity, mortality, and length of stay. In the Scotland-wide cohort: admission MELD (Model for End-stage Liver Disease) (16 (12–22) vs 15 (12–19); p=0.141), inpatient mortality ((10.9% vs 8.6%); p=0.499) and length of stay (8 days (4–15) vs 7 days (4–13); p=0.140). In the Edinburgh cohort: admission MELD (17 (12–23) vs 17 (13–21); p=0.805), inpatient mortality ((13.7% vs 10.1%; p=0.373) and length of stay (7 days (4–14) vs 7 days (3.5–14); p=0.525)).ConclusionThis assessment of immediate and medium-term lockdown impacts on those with chronic liver disease suggested a minimal effect on the presentation of decompensated liver disease to secondary care.
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 (n = 116) and deep remission (n = 116) were 29.8%, 35.3% and 17.9%, respectively (Figure 1). During 155 patient-years of follow-up (PYF), 11 patients experienced a serious adverse event (7.1 per 100 PYF). 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.
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