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AbbVie’s SKYRIZI® (risankizumab) Accepted by the Scottish Medicines Consortium for Adults with Moderately to Severely Active Ulcerative Colitis

January 13, 2025 – Clinical Trials, Pharmaceutical – AbbVie, IBD, NHS, Scotland, inflammatory bowel disease, ulcerative colitis

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.

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.

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.

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.

13 January 2025 – Maidenhead UK – 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. Risankizumab offers an additional treatment choice in the therapeutic class of interleukin inhibitors. 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. The technology appraisal guidance was issued by NICE in August 2024.

It is estimated that over 50,000 – or 1 in 103 – people in Scotland live with IBD. 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. 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.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.

“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. 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. 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. 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. 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. The recommended induction dose is 1200 mg IV, followed by a maintenance dose of 180 mg or 360 mg SC.

“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.

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. Visit https://www.abbvie.co.uk/