In draft guidance published today (Thursday 3 May) for consultation, NICE, the healthcare guidance body, has made recommendations on the role of new and established treatments for the management of Crohn's disease in adults and children.

A number of new drugs have been licensed for the condition within the last decadeⁱ. Glucocorticosteroids can be offered to induce remission in people with Crohn's disease and azathioprine or mercaptopurine can be offered as maintenance treatment. The draft guidance shows the place of these new treatments in the wider care pathway for Crohn's disease.

Crohn's disease is a chronic inflammatory condition that mainly affects the gastrointestinal tract (gut). It can develop at any age but most commonly starts between the ages of 15 and 30, with around a third of patients diagnosed before the age of 21. The disease affects slightly more women than men. Its cause is unknown, but it is around twice as common than average in smokers. There are currently around 115,000 people living with Crohn's disease in the UK; between 3000 and 6000 new cases are diagnosed each year. An estimated 5% of patients have severe disease, but the proportion of people with moderate Crohn's disease is unclear. The condition can lead to possible delay of growth and puberty in children, as well as affect fertility and sexual relationships in adults.

Common symptoms of Crohn's disease include:

• recurring diarrhoea
• abdominal pain and cramping (the pain is often worse after eating)
• blood and mucus in faeces
• extreme tiredness
• weight loss

There may be long periods that last for weeks or months where there are mild or no symptoms, followed by periods where symptoms are particularly upsetting, which are known as flare-ups.

Aimed at all healthcare professionals involved in the management of Crohn's disease, draft recommendations include:

• Offer monotherapy with a conventional glucocorticosteroid (prednisolone, methylprednisolone or intravenous hydrocortisone) to induce remission in people with a first presentation or an inflammatory exacerbation of Crohn's disease.
• Discuss with people with Crohn's disease, and/or their carer if appropriate, options for managing their disease when they are in remission, including both no treatment and treatment. The discussion should include the risk of inflammatory exacerbations (with and without drug treatment) and the potential side effects of drug treatment. Record the person's views in their notes.

• Offer azathioprine or mercaptopurine as monotherapy to maintain remission when previously used with a conventional glucocorticosteroid to induce remission.
• Consider surgery as an alternative to medical treatment early in the course of the disease for people whose disease is limited to the distal ileum (small intestine), taking into account the following:
  
  - benefits and risks of medical treatment and surgery
  
  - risk of recurrence after surgery
  
  - individual preferences and any personal or cultural considerations.

Record the person's views in their notes.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE said: "Crohn's disease is a serious, life-long condition that can significantly affect a person's quality of life. We are now seeing increasing numbers of people being diagnosed with the disease, and it is particularly common in younger people. In the last ten years, there have been a number of new drugs licensed for the condition, so we are sure this new guideline will be a useful aid to all those involved in its treatment. We would urge all those registered as stakeholders in the development of this guideline to have their say on our draft recommendations, and submit their comments via the NICE website."

The draft guideline consultation runs from Thursday 3 May to Thursday 14 June at: CG152

Ends

Notes to Editors

References

i. These include drugs in the following categories: corticosteroids, immunomodulators (azathioprine, mercaptopurine and methotrexate) and aminosalicylates.

About the clinical guideline

1. The draft guideline is available for consultation on the NICE website from Thursday 3 May to Thursday 14 June.

2. Only stakeholders can comment formally on consultations, but organisations can register throughout the development process and contribute from that point onward.

3. Please see the NICE website for further details on clinical guideline development.

4. The final guideline is expected to be published in October 2012.

Related NICE guidance

Incorporated guidance

This guideline incorporates the following NICE guidance:

5. Infliximab (review) and adalimumab for the treatment of Crohn's disease. NICE technology appraisal guidance 187 (2010). Available at: www.nice.org.uk/guidance/TA187

Other related NICE guidance

6. Colonoscopic surveillance for prevention of colorectal cancer in people with ulcerative colitis, Crohn's disease or adenomas. NICE clinical guideline 118 (2011). Available at: www.nice.org.uk/guidance/CG118

7. Extracorporeal photopheresis for Crohn's disease. NICE interventional procedure guidance 288 (2009). Available at: www.nice.org.uk/guidance/IPG288

8. Medicines adherence. NICE clinical guideline 76 (2009). Available at: www.nice.org.uk/guidance/CG76

9. Irritable bowel syndrome in adults. NICE clinical guideline 61 (2008). Available at: www.nice.org.uk/guidance/CG61

10. Smoking cessation services. NICE public health guidance 10 (2008). Available at: www.nice.org.uk/guidance/PH10

11. Varenicline for smoking cessation. NICE technology appraisal guidance 123 (2007). Available at: www.nice.org.uk/guidance/TA123

12. Brief interventions and referral for smoking cessation. NICE public health guidance 1 (2006). Available at: www.nice.org.uk/guidance/PH1

13. Nutrition support in adults. NICE clinical guideline 32 (2006). Available at: www.nice.org.uk/guidance/CG32

14. Leukapheresis for inflammatory bowel disease. NICE interventional procedure guidance 26 (2005). Available at: www.nice.org.uk/guidance/IPG126

15. Fertility. NICE clinical guideline 11 (2004). Available at: www.nice.org.uk/guidance/CG11

16. Wireless capsule endoscopy for investigation of the small bowel. NICE interventional procedure guidance 101 (2004). Available at: www.nice.org.uk/guidance/IPG101

About NICE

17. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

18. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies -guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS

19. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

20. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.