The National Institute for Health and Care Excellence announce technology appraisal guidance recommending risankizumab for adult patients with moderate to severe ulcerative colitis
Natalia Elliot | August 29, 2024 | News story | Research and Development | AbbVie, Crohns, Gastrointestinal tract, Immunology, NICE, approval, ulcerative colitis
The National Institute for Health and Care Excellence (NICE) have recommended adult patients in England or Wales with moderately or severely active ulcerative colitis (UC) who have not responded well to or cannot tolerate conventional or biological therapy including a tumour necrosis factor (TNF) alpha inhibitor will now have the option of skyrizi (risankizumab).
UC patients who lost or have had inadequate response, or were intolerant to, conventional and/or biologic therapy also had risankizumab approved by the Medicines and healthcare Products Regulatory Agency (MHRA) a week prior.
UC has a higher prevalence than Crohn’s disease (CD) or unclassified inflammatory bowel disease (IBD) in the UK, according to a report by Crohn’s & Colitis UK, with 296,000 people estimated to be living with UC today in the UK, and at least 1 in every 227 people diagnosed. The severity of symptoms and unpredictability of flares can lead to a substantial burden and often cause disability for those living with the disease. More than 1 in 3 people with CD or UC identify as disabled.
The recommendation from NICE is based on results from two phase 3 clinical trials. The introduction trial, INSPIRE, evaluated intravenous risankizumab at a dose of 1200mg, administered as an introduction dose to adult patients with moderately to severely active UC at zero, four and finally eight weeks. Patients who responded to the introduction treatment were re-randomised for the second trial, COMMAND. In this trial, patients received a subcutaneous (SC) injection of risankizumab as a maintenance dose, at a dosage of either 180mg or 360mg. The maintenance doses were administered over a period of 52 weeks.
Dr Gareth Parkes, consultant gastroenterologist, Barts Health NHS Trust UK stated: “The unpredictable and potentially debilitating nature of UC can cause significant emotional stress for patients. With UC becoming increasingly more common, I’m pleased that we now have another treatment option to offer eligible patients in England and Wales, which may help them to gain long-term control of their condition.”
Natalia Elliot
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