{
  "abstract": "Objective Risankizumab is an interleukin-23 p19 subunit inhibitor which received approval for Crohn’s disease (CD) by UK licensing authorities in May 2023. Our aim was to evaluate the real-world outcomes of risankizumab in the UK.Design We conducted a retrospective, multicentre, cohort study of patients with CD treated with risankizumab across 25 health boards in the UK between 1 January 2021 and 1 November 2024. Our primary outcome was treatment persistence at 6 months. Our secondary endpoints were steroid-free clinical remission (Harvey-Bradshaw index <5), C-reactive protein (CRP) remission (CRP ≤5 mg) and faecal calprotectin (FCAL) remission (FCAL <250 µg/g).Results We included 763 patients with a median follow-up time of 27 weeks (IQR 18–41 weeks) with a total of 432 and 110 patients having 6-month and 12-month data available. The median number of advanced therapy exposures was 3 (2–4), with 92% (704/763) having failed anti-tumour necrosis factor therapy and 72% (548/763) having failed ustekinumab. Treatment persistence at 6 and 12 months was 95.4% and 89.2%, respectively. Unadjusted persistence rates for ustekinumab-naive versus ustekinumab-exposed patients were 92.7% vs 95.3% and 89.0% vs 74.2% at 6 and 12 months, respectively (p=0.62). Rates of clinical, CRP and FCAL remission were 52% (123/236), 53% (169/319) and 44% (69/156) at 6 months. Rates of clinical remission for ustekinumab naive versus exposed were 57% (29/51) vs 51% (94/185) (p=0.54) 6 months. Adverse events occurred in 17% (n=127) of the cohort, of which 12% (n=92) were serious.Conclusion Risankizumab was effective in a large, real-world, medically refractory CD cohort with excellent persistence and good clinical and biochemical remission rates.",
  "authors": [
    {
      "affiliations": [
        "Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK",
        "Faculty of Medicine, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia"
      ],
      "name": "Alexander Thomas Elford"
    },
    {
      "affiliations": [
        "The University of Edinburgh Centre for Genomic and Experimental Medicine, Edinburgh, UK",
        "The University of Edinburgh MRC Human Genetics Unit, Edinburgh, UK"
      ],
      "name": "Nathan Constantine-Cooke"
    },
    {
      "affiliations": [
        "Gastroenterology, Barts Health NHS trust, London, London, UK"
      ],
      "name": "Krishna Shah"
    },
    {
      "affiliations": [
        "Gastroenterology, Barts Health NHS trust, London, London, UK"
      ],
      "name": "Sarah C Faloon"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, St Mark’s Hospital and Academic Institute, London, UK"
      ],
      "name": "Magdalini Manti"
    },
    {
      "affiliations": [
        "IBD Centre, Guy’s and St Thomas’ NHS Foundation Trust, London, London, UK"
      ],
      "name": "Benjamin Zare"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, St George’s University Hospitals NHS Foundation Trust, London, UK"
      ],
      "name": "Michael Colwill"
    },
    {
      "affiliations": [
        "University College London Hospitals NHS Foundation Trust, London, UK"
      ],
      "name": "Jie Han Yeo"
    },
    {
      "affiliations": [
        "Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK"
      ],
      "name": "Umair Akbani"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Northern Care Alliance NHS Foundation Trust, Salford, UK"
      ],
      "name": "Hannah Morgan"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK"
      ],
      "name": "Robert J Mulligan"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, King’s College Hospital NHS Foundation Trust, London, UK"
      ],
      "name": "Chandni Radia"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK"
      ],
      "name": "David Young"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK"
      ],
      "name": "Fakhirah Badrulhisham"
    },
    {
      "affiliations": [
        "Gastroenterology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"
      ],
      "name": "Sean Morris"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK"
      ],
      "name": "Zoheb Anwar-Hashim"
    },
    {
      "affiliations": [
        "Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK"
      ],
      "name": "James Henry Arthur Hassall"
    },
    {
      "affiliations": [
        "IBD Unit, Hull University Teaching Hospitals NHS Trust, Hull, UK"
      ],
      "name": "Mithun Thomas"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Imperial College London, London, UK"
      ],
      "name": "Lovesh Dyall"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Kingston Hospital NHS Foundation Trust, London, UK"
      ],
      "name": "Jennie Clough"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Chelsea and Westminster Hospitals NHS Foundation Trust, MiddlesexUK"
      ],
      "name": "Taha Mahmood"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, NHS Glasgow and Clyde South Glasgow University Hospitals NHS Trust, Glasgow, Scotland, UK"
      ],
      "name": "Aboalgasim Mohammed"
    },
    {
      "affiliations": [
        "Department of Digestive Diseases, Kettering General Hospital Department of Gastroenterology, Kettering, UK"
      ],
      "name": "Vikram Mohanan"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK"
      ],
      "name": "Emily Brownson"
    },
    {
      "affiliations": [
        "Mid Yorkshire Hospitals NHS Trust, Wakefield, UK"
      ],
      "name": "Sarah Hancox"
    },
    {
      "affiliations": [
        "Gastroenterology, Coventry and Warwickshire Partnership Trust, Coventry, UK"
      ],
      "name": "Benjamin Disney"
    },
    {
      "affiliations": [
        "Department of Digestive Diseases, Kettering General Hospital Department of Gastroenterology, Kettering, UK"
      ],
      "name": "Ajay M Verma"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, NHS Glasgow and Clyde South Glasgow University Hospitals NHS Trust, Glasgow, Scotland, UK"
      ],
      "name": "John P Seenan"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Chelsea and Westminster Hospitals NHS Foundation Trust, MiddlesexUK"
      ],
      "name": "Emma Johnston"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Kingston Hospital NHS Foundation Trust, London, UK"
      ],
      "name": "Rishi Goel"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Imperial College London, London, UK"
      ],
      "name": "Lucy C Hicks"
    },
    {
      "affiliations": [
        "IBD Unit, Hull University Teaching Hospitals NHS Trust, Hull, UK",
        "Hull York Medical School, Hull, UK"
      ],
      "name": "Shaji Sebastian"
    },
    {
      "affiliations": [
        "Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK"
      ],
      "name": "Melissa Hale"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK"
      ],
      "name": "Philip Harvey"
    },
    {
      "affiliations": [
        "Gastroenterology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"
      ],
      "name": "Rachel Cooney"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK"
      ],
      "name": "Tariq Ahmad"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK"
      ],
      "name": "Fraser Cummings"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, King’s College Hospital NHS Foundation Trust, London, UK"
      ],
      "name": "Alexandra Kent"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK"
      ],
      "name": "Andrew King"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Northern Care Alliance NHS Foundation Trust, Salford, UK",
        "Gastroenterology, University of Manchester Institute of Science and Technology Department of Biomolecular Science, Manchester, UK"
      ],
      "name": "Jimmy K Limdi"
    },
    {
      "affiliations": [
        "Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK"
      ],
      "name": "Christian Selinger"
    },
    {
      "affiliations": [
        "University College London Hospitals NHS Foundation Trust, London, UK"
      ],
      "name": "Sara McCartney"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, St George’s University Hospitals NHS Foundation Trust, London, UK"
      ],
      "name": "Richard Pollok"
    },
    {
      "affiliations": [
        "IBD Centre, Guy’s and St Thomas’ NHS Foundation Trust, London, London, UK"
      ],
      "name": "Peter M Irving"
    },
    {
      "affiliations": [
        "IBD Centre, Guy’s and St Thomas’ NHS Foundation Trust, London, London, UK"
      ],
      "name": "Mark A Samaan"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, St Mark’s Hospital and Academic Institute, London, UK",
        "Department of Gastroenterology, Imperial College London, London, UK"
      ],
      "name": "Naila Arebi"
    },
    {
      "affiliations": [
        "Gastroenterology, Barts Health NHS trust, London, London, UK"
      ],
      "name": "Gareth Parkes"
    },
    {
      "affiliations": [
        "Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK"
      ],
      "name": "The UK experience of Risankizumab in Crohn’s disease"
    },
    {
      "affiliations": [
        "Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK",
        "The University of Edinburgh Centre for Genomic and Experimental Medicine, Edinburgh, UK"
      ],
      "name": "Charlie W Lees"
    },
    {
      "affiliations": [
        "Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK",
        "The University of Edinburgh Centre for Genomic and Experimental Medicine, Edinburgh, UK"
      ],
      "name": "Nikolas Plevris"
    }
  ],
  "title": "Real-world effectiveness of risankizumab in Crohn’s disease: a pan UK retrospective cohort study",
  "uid": "35360c3f-91f7-5e88-8a52-56ffef1269e2"
}