ObjectiveTo understand the effectiveness of ustekinumab in treating Crohn’s disease (CD) in a UK real-world setting.DesignRetrospective cohort study using prospectively maintained clinical records.SettingSingle UK inflammatory bowel disease centre.PatientsAdult patients with an established diagnosis of CD prescribed ustekinumab outside of clinical trials at University Hospital Southampton (UHS).InterventionsUstekinumab, a monoclonal antibody to the shared p40 subunit of interleukin (IL) 12 and IL-23 as part of routine clinical care.Main outcome measuresEffectiveness as measured by an improvement in physician’s global assessment, drug persistence and improvement in biomarkers (C-reactive protein (CRP), albumin and calprotectin).Results84 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.ConclusionsUstekinumab 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.
BackgroundGlucocorticosteroids (GC) are long-established, widely used agents for induction of remission in inflammatory bowel disease (IBD). Hyperglycaemia is a known complication of GC treatment with implications for morbidity and mortality. Published data on prevalence and risk factors for GC-induced hyperglycaemia in the IBD population are limited. We prospectively characterise this complication in our cohort, employing machine-learning methods to identify key predictors of risk.MethodsWe conducted a prospective observational study of IBD patients receiving intravenous hydrocortisone (IVH). Electronically triggered three times daily capillary blood glucose (CBG) monitoring was recorded alongside diabetes mellitus (DM) history, IBD biomarkers, nutritional and IBD clinical activity scores. Hyperglycaemia was defined as CBG ≥11.1 mmol/L and undiagnosed DM as glycated haemoglobin ≥48 mmol/mol. Random forest (RF) regression models were used to extract predictor-patterns present within the dataset.Results94 consecutive IBD patients treated with IVH were included. 60% (56/94) of the cohort recorded an episode of hyperglycaemia, including 57% (50/88) of those with no history of DM, of which 19% (17/88) and 5% (4/88) recorded a CBG ≥14 mmol/L and ≥20 mmol/L, respectively. The RF models identified increased C-reactive protein (CRP) followed by a longer IBD duration as leading risk predictors for significant hyperglycaemia.ConclusionHyperglycaemia is common in IBD patients treated with intravenous GC. Therefore, CBG monitoring should be included in routine clinical practice. Machine learning methods can identify key risk factors for clinical complications. Steroid-sparing treatment strategies may be considered for those IBD patients with higher admission CRP and greater disease duration, who appear to be at the greatest risk of hyperglycaemia.
<46 mg/g. Median time (IQR) to repeat 35d (22-74.) 70 results 100-249 mg/g indicated routine referral; median wait for review 83d (54-160.) 130 results !250 mg/g indicated urgent referral; median wait 59d (40-105.) 18% had endoscopy directly ('straight to test.') 16% of results <46 ug/g still referred.Conclusions This is the largest analysis of UK primary care FC testing to date that considers IBD specifically, as opposed to any organic intestinal disease, versus IBS. Comparing favourably to other published work, the assay platform and clinical pathway are fit for purpose in safely and effectively ruling out IBD. A 100mg/g cut-off is optimal based on the sensitivity×specificity product. Those with significantly raised results access secondary care more quickly; direct endoscopy rates appear low but data were incomplete. Repeat tests often normalize and repeats should be mandated for all positive tests. Sensitivity drops precipitously without an appropriate age limit; educating clinical users about pretest probability should minimize false negatives, streamline test workload and reduce unnecessary clinic utilization.
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