AbbVie’s SKYRIZI[®] (risankizumab) Accepted by the Scottish Medicines Consortium for Adults with Moderately to Severely Active Ulcerative Colitis
PRESS RELEASE – For UK consumer health, medical and trade media only
- Risankizumab will be available on the NHS in Scotland for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or biologic therapy.1
- UC - a chronic, idiopathic immune-mediated inflammatory bowel disease (IBD) - is a potentially debilitating condition that may substantially reduce a person’s quality of life and ability to work.2,3,4
- Scotland has the highest rates of IBD in the UK with over 50,000 people living with the condition – of which UC is the most prevalent form of the disease, according to research.5,6
- The final guidance from the Scottish Medicines Consortium (SMC) follows the recommendation by the National Institute for Health and Care Excellence (NICE) of risankizumab as an additional treatment option for this population only if a TNF-alpha inhibitor is not suitable.1,7
MAIDENHEAD, UK, 13 JANUARY 2025 – AbbVie (NYSE: ABBV) today announced that the SMC has accepted SKYRIZI® (risankizumab) for use within NHS Scotland as a treatment option for 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.1 Risankizumab offers an additional treatment choice in the therapeutic class of interleukin inhibitors.1 Risankizumab is already available on the NHS in England, Wales and Northern Ireland 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.7 The technology appraisal guidance was issued by NICE in August 2024.7
It is estimated that over 50,000 - or 1 in 103 - people in Scotland live with IBD.5 According to a report by Crohn's & Colitis UK, UC has a higher prevalence than Crohn’s disease (the other main form of IBD) or unclassified IBD.6 UC causes chronic inflammation of the colon, which may lead to symptoms such as diarrhoea and rectal bleeding, along with unpredictable flare-ups – periods of intensified symptoms.2,4 The impact of living with UC can be substantial if the condition is uncontrolled, including potentially debilitating long-term complications and a significant impact on mental health.2,3,4
“Ulcerative colitis can severely diminish a person’s quality of life and cause long-term health-related complications if it isn’t well managed,” said Professor Charlie Lees, Consultant Gastroenterologist, Western General Hospital, Edinburgh. “The treatment of ulcerative colitis is nuanced as two people with the same diagnosis may respond differently to their medication. Therefore, it is crucial that people living with this condition have a suite of treatment options to help improve both their quality of life and physical well-being. We are pleased to see the inclusion of risankizumab on the NHS in Scotland as an alternative option for people who are struggling to tolerate or benefit from their current medication.”
The SMC acceptance is supported by data from two Phase 3 clinical trials: the INSPIRE induction trial and the COMMAND maintenance trial.8,9 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.8,9 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.8,9 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.8,9 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.8,9 The recommended induction dose is 1200 mg IV, followed by a maintenance dose of 180 mg or 360 mg SC.8,9
“Improving the lives of people with inflammatory bowel disease is a major focus for us at AbbVie. The SMC’s decision to bring this treatment to those eligible in Scotland is another important milestone for the inflammatory bowel disease community,” said Rachael Millward, Medical Director, AbbVie UK.
-Ends-
UK media contacts:
Helen Brown Kathryn Smith
AbbVie UK GCI Health
T: +44 (0)7929 087878 T: +44 (0)7825 678469
E: Helen.l.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.10 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.10 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.10
About risankizumab
Risankizumab is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.8 IL-23 is a cytokine involved in inflammatory processes linked to a number of chronic immune-mediated diseases.8
Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.
About INSPIRE induction Phase 3 clinical trial8,9
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 trial8,9
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 placebo (risankizumab in induction study; placebo in maintenance study; induction-only control group). 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 placebo (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 and solutions 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 and eye care – and with products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on X (formerly Twitter) or YouTube.
References
Clicking the links below will take you to external websites that are not managed or owned by AbbVie.
1. Scottish Medicines Consortium (SMC) Final Guidance. Risankizumab. Available at: https://scottishmedicines.org.uk/medicines-advice/risankizumab-skyrizi-abb-smc2686/ [Last accessed: January 2025].
2. Gros B, Kaplan GG. Ulcerative Colitis in Adults: A Review. JAMA. 2023 Sep 12;330(10):951–965. doi: 10.1001/jama.2023.15389. PMID: 37698559.
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: January 2025].
5. Crohn’s & Colitis UK. Crohn’s & Colitis UK in Scotland. Available at: https://crohnsandcolitis.org.uk/our-work/crohns-colitis-uk-in-your-area/scotland. [Last accessed: January 2025].
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: January 2025].
7. NICE. Risankizumab for treating moderately to severely active ulcerative colitis. Available at: https://www.nice.org.uk/guidance/ta998. [Last accessed: January 2025].
8. 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: January 2025].
9. Louis E, et al. Risankizumab for Ulcerative Colitis Two Randomized Clinical Trials. JAMA. Published online July 22, 2024. doi:10.1001/jama.2024.12414.
10. 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-240232] | January 2025