The National Institute for Health and Care Excellence (NICE) has issued final Technology Appraisal Guidance (TAG) recommending SKYRIZI® (risankizumab) as a treatment option for adults with moderately to severely active ulcerative colitis (UC).
Risankizumab is recommended when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or has lost response to treatment, only if a TNF-alpha inhibitor has not worked or a TNF-alpha inhibitor cannot be tolerated or is not suitable.1
This recommendation closely follows the Medicines and Healthcare products Regulatory Agency (MHRA) approval of risankizumab for the treatment of adult patients with moderately to severely active UC who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.2
According to a report by Crohn’s & Colitis UK, UC has a higher prevalence than Crohn’s disease (CD) or unclassified inflammatory bowel disease (IBD) in the UK.3
With at least 1 in every 227 people diagnosed, 296,000 people are estimated to be living with UC today in the UK.4
The severity of symptoms and unpredictability of flares can lead to a substantial burden and often cause disability for those living with the disease.5,6 More than 1 in 3 people with CD or UC identify as disabled.6
The NICE recommendation is supported by data from two Phase 3 clinical trials – the INSPIRE induction trial and the COMMAND maintenance trial.2,7
The INSPIRE trial evaluated 1200mg of intravenous (IV) risankizumab administered as an induction dose at 0, 4 and 8 weeks in patients with moderately to severely active UC.2,7
In the COMMAND trial, patients who responded to induction treatment in INSPIRE were re-randomised to receive 180mg or 360mg of subcutaneous (SC) risankizumab as maintenance doses for an additional 52 weeks.2,7
The safety profile of risankizumab in both trials was consistent with the safety profile observed in previous trials across other indications, with no new safety risks observed.
The most frequently reported adverse reactions were upper respiratory infections.2,7 The recommended induction dose is 1200mg IV, followed by a maintenance dose of 180mg or 360mg SC.2,7
Dr Gareth Parkes, Consultant Gastroenterologist, Barts Health NHS Trust said: “The unpredictable and potentially debilitating nature of ulcerative colitis can cause significant emotional stress for patients. With ulcerative colitis 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.”1,7,8
References:
1. NICE. Technology Appraisal Guidance. Risankizumab. ID6209. Available at: https://www.nice.org.uk/guidance/ta998. [Last accessed: August 2024].
2. Skyrizi 360 mg solution for injection in cartridge. Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/15011/smpc#. [Last accessed: July 2024].
3. Crohn’s & Colitis UK. Epidemiology Summary: Incidence and Prevalence of IBD in the United Kingdom. Available at: https://crohnsandcolitis.org.uk/media/4e5ccomz/epidemiology-summary-final.pdf. [Last accessed: July 2024].
4. NHS. Overview Ulcerative colitis. Available from: https://www.nhs.uk/conditions/ulcerative-colitis/#:~:text=The%20UK%20Crohn’s%20%26%20Colitis%20UK,amounts%20to%20around%20296%2C000%20people. [Last accessed: July 2024].
5. Mehta F, et al. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60
6. Crohn’s & Colitis UK. Ulcerative Colitis: Your Guide. Available at: https://crohnsandcolitis.org.uk/media/sw5fmsjq/uc-ed-10-with-links.pdf. [Last accessed: July 2024].
7. Louis E, et al. Risankizumab for Ulcerative Colitis Two Randomized Clinical Trials. JAMA. Published online July 22, 2024. doi:10.1001/jama.2024.12414.
8. Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn’s and Colitis. 2013 Volume 7, Issue 4, Pages 322–337, https://doi.org/10.1016/j.crohns.2013.01.010
