AbbVie’s SKYRIZI[®] (risankizumab) Is Recommended by NICE as an Option for Use in Adults with Moderately to Severely Active Ulcerative Colitis
For UK consumer, medical and trade media only
- In final guidance published today, adults in England and Wales with moderately to severely active ulcerative colitis (UC) who cannot tolerate, or have not responded well or lost response to conventional or biological therapy including a tumour necrosis factor (TNF)-alpha inhibitor, will have an additional treatment option.1
- UC, a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD), is estimated to affect around 296,000 people across the UK and may lead to reduced quality of life, inability to work and disability due to the severity of symptoms.2-4
- This recommendation closely follows the UK Medicines and Healthcare Products Regulatory Agency (MHRA) approval on 21st August 2024.5
MAIDENHEAD, UK, 22 AUGUST 2024 – AbbVie (NYSE: ABBV) today announced that 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 UC 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 (that is the condition has not responded well enough or has lost response to treatment) or a TNF-alpha inhibitor cannot be tolerated or is not suitable, and the company provides it according to the commercial arrangement.1 This recommendation closely follows the 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.5
According to a report by Crohn's & Colitis UK, UC has a higher prevalence than Crohn’s disease (CD) or unclassified IBD in the UK.6 With at least 1 in every 227 people diagnosed, 296,000 people are estimated to be living with UC today in the UK.2 The severity of symptoms and unpredictability of flares can lead to a substantial burden and often cause disability for those living with the disease.3,4 More than 1 in 3 people with CD or UC identify as disabled.4
“The unpredictable and potentially debilitating nature of ulcerative colitis can cause significant emotional stress for patients,” said Dr Gareth Parkes, Consultant Gastroenterologist, Barts Health NHS Trust. “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
The NICE recommendation is supported by data from two Phase 3 clinical trials: the INSPIRE induction trial and the COMMAND maintenance trial.5,8 The INSPIRE trial evaluated 1200 mg of intravenous (IV) risankizumab administered as an induction dose at 0, 4 and 8 weeks in patients with moderately to severely active UC.5,8 In the COMMAND trial, patients who responded to induction treatment in INSPIRE were re-randomised to receive 180 mg or 360 mg of subcutaneous (SC) risankizumab as maintenance doses for an additional 52 weeks.5,8 In both trials, the primary endpoint of clinical remission (per Adapted Mayo score*) and key secondary endpoints, including endoscopic improvement** and histologic-endoscopic mucosal improvement (HEMI),† were met.5,8 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.5,8 The recommended induction dose is 1200 mg IV, followed by a maintenance dose of 180 mg or 360 mg SC.5,8
“AbbVie is committed to addressing the unmet needs of patients living with IBD”, said Rachael Millward, Medical Director, AbbVie UK. “We are delighted that following NICE recommendation, risankizumab will be made available for suitable UC patients.”1,5
-Ends-
UK media contacts:
Helen Brown Kathryn Smith
AbbVie UK GCI Health
T: +44 (0)7929 087878 T: +44 (0)7825 678469
E: Helen.Brown@abbvie.com E: Kathryn.Smith@gcihealth.com
NOTES TO EDITORS:
*Adapted Mayo score is based on stool frequency subscore (SFS), rectal bleeding subscore (RBS), and endoscopic subscore (ES).
**Endoscopic improvement is defined as endoscopic subscore ≤1 without evidence of friability.
†Histologic Endoscopic Mucosal Improvement (HEMI) is defined as an endoscopic subscore of ≤1 without evidence of friability and Geboes score ≤3.1.
About ulcerative colitis (UC)
UC is a chronic, immune-mediated IBD of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the large intestine.9 The exact cause of UC is not entirely understood. The hallmark signs and symptoms of UC include rectal bleeding, abdominal pain, bloody diarrhoea, tenesmus (a sense of pressure), urgency and faecal incontinence.9 The disease course of UC varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or life-threatening complications.9
About risankizumab
Risankizumab is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.5 IL-23 is a cytokine involved in inflammatory processes linked to a number of chronic immune-mediated diseases.5
Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.
About INSPIRE phase 3 clinical trial5,8
INSPIRE is a Phase 3, multicentre, randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of IV risankizumab 1200 mg administered at 0, 4 and 8 weeks as induction therapy in patients with moderately to severely active UC. The primary endpoint of the trial is clinical remission (per Adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and ES ≤1 without friability) at week 12. Key secondary endpoints include clinical response (decrease from baseline in the Adapted Mayo Score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1), endoscopic improvement (ES ≤1 without friability) and HEMI (ES of 0 or 1 without friability and Geboes score ≤3.1) at week 12.
More information can be found on www.clinicaltrials.gov (NCT03398148).
About COMMAND Maintenance phase 3 clinical trial5,8
COMMAND is a Phase 3, multicentre, randomised, double-blind, controlled, 52-week maintenance trial designed to evaluate the efficacy and safety of SC risankizumab 180 mg or 360 mg in adults with moderately to severely active UC. This study had a re-randomised withdrawal design in which all patients received risankizumab IV induction, and those who responded to risankizumab IV were re-randomised to receive SC risankizumab 180 mg or 360 mg or withdrawal from risankizumab treatment (induction-only control group). For those patients randomised to withdraw from risankizumab treatment (induction-only control group), the rest of the study duration was a risankizumab washout. The objective of the Phase 3 trial is to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderately to severely active UC who responded to risankizumab IV induction in the INSPIRE trial.
The primary endpoint of the trial is clinical remission (per Adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and ES ≤1 without evidence of friability) at week 52. Key secondary endpoints include endoscopic improvement (ES ≤1 without evidence of friability), HEMI (ES of ≤1 without evidence of friability and Geboes score ≤3.1), and steroid-free clinical remission at week 52 (defined as clinical remission per Adapted Mayo Score at week 52 and corticosteroid free for ≥90 days prior to week 52).
More information can be found on www.clinicaltrials.gov (NCT03398135).
About AbbVie in gastroenterology
For more than 20 years, AbbVie has been dedicated to improving care for people living with immune disorders. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with inflammatory conditions reach their treatment goals.
AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information, please visit www.abbvie.co.uk.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on Twitter or YouTube.
References
Clicking the links below will take you to external websites that are not managed or owned by AbbVie.
1. NICE. Technology Appraisal Guidance. Risankizumab. ID6209. Available at: https://www.nice.org.uk/guidance/gid-ta11184/documents/html-content-3. [Last accessed: August 2024].
2. 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].
3. 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
4. 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].
5. 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].
6. 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].
7. 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
8. Louis E, et al. Risankizumab for Ulcerative Colitis Two Randomized Clinical Trials. JAMA. Published online July 22, 2024. doi:10.1001/jama.2024.12414.
9. Gajendran M, et al. A Comprehensive Review and Update on Ulcerative Colitis. Dis Mon. 2019. 65(12):100851. doi:10.1016/j.disamonth.2019.02.004.
UK-IMMG-240176 | August 2024