Title: Risankizumab for previously treated moderately to severely active Crohn's disease [ID3986]
Funder: Department of Health and Social Care

Abstract: Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract (gut) that may affect any part of the gut from the mouth to the anus. People with Crohn’s disease have recurrent relapses, with acute exacerbations (‘flares’) in between periods of remission or less active disease. These flares may affect any part of the gut and are defined by location (terminal ileal, colonic, ileocolic, upper gastrointestinal), or by the pattern of the disease (inflammatory, fistulising, or stricturing). _x000D_ _x000D_ The clinical features of Crohn’s disease are variable and are determined partly by the site of the disease. Common symptoms include diarrhoea, abdominal pain, extreme tiredness, fatigue, anaemia, unintended weight loss and blood and mucus in stools. Other symptoms may include fever, nausea, vomiting, arthritis, inflammation and irritation of the eyes, mouth ulcers and areas of painful, red and swollen skin. _x000D_ _x000D_ Crohn’s disease can be complicated by the development of strictures (a narrowing of the intestine), obstructions, fistulae and perianal disease. Other complications include acute dilation, perforation and massive haemorrhage, and carcinoma of the small bowel or colon._x000D_ _x000D_ Crohn’s disease currently affects 1 in 650 people in the UK1 . It most often appears between the ages of 10 and 40, however, it may affect people of any age 2 . The condition has a debilitating impact on the daily lives and quality of life of those affected, including mental health and wellbeing, education, employment and relationships._x000D_ _x000D_ Crohn’s disease is not medically or surgically curable. Treatment aims to reduce symptoms, promote mucosal healing and maintain or improve quality of life while minimising drug-related toxicity. Clinical management depends on disease activity, site, behaviour of disease, response to previous treatments, frequency, delivery and side-effect profiles of treatments, long term safety, as well as impact on other comorbidities and extra-intestinal manifestations, such as uveitis, skin manifestations and arthritis. _x000D_ _x000D_ NICE guideline 129 recommends monotherapy with a glucocorticosteroid (prednisolone, methylprednisolone or intravenous hydrocortisone) to induce remission in people with a first presentation or a single inflammatory exacerbation of Crohn’s disease in a 12-month period. Budesonide or 5-aminosalicylates are considered for some people who decline, cannot tolerate or in whom a conventional corticosteroid is contraindicated. When 2 or more inflammatory exacerbations are experienced in a 12-month period, azathioprine, mercaptopurine and methotrexate may be considered as add-on treatments to conventional glucocorticosteroids or budesonide to induce remission of Crohn’s disease. _x000D_ _x000D_ NICE technology appraisal 187 recommends infliximab and adalimumab as treatment options for adults with severe active Crohn’s disease whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments), or who are intolerant of or have contraindications to conventional therapy. _x000D_ _x000D_ NICE technology appraisal 352 recommends vedolizumab as an option for treating moderately to severely active Crohn's disease if a tumour necrosis factor alpha inhibitor has failed, cannot be tolerated or is contraindicated. _x000D_ _x000D_ NICE technology appraisal 456 recommends ustekinumab as an option for treating moderately to severely active Crohn’s disease for adults who have had an inadequate response with, lost response to or were intolerant to either conventional therapy or a tumour necrosis factor-alpha inhibitor, or have medical contraindications to such therapies._x000D_ _x000D_ NICE guideline 129 states that in addition to pharmacological treatment, between 50 and 80% of people with Crohn’s disease will require surgery during the course of their disease. The main reasons for surgery are strictures causing obstructive symptoms, lack of response to medical therapy, and complications such as fistulae and perianal disease._x000D_ _x000D_ References_x000D_ 1) Crohn’s and Colitis UK (2019) What is Crohn’s disease? Accessed November 2021._x000D_ 2) NHS Choices. (2021) Crohn’s disease: Overview. Accessed November 2021.

Lay abstract: To appraise the clinical and cost effectiveness of risankizumab within its marketing authorisation for previously treated moderately to severely active Crohn’s disease.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: ORAL AND GASTROINTESTINAL