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NICE recommends use of Humira (adalimumab) on the NHS in adult patients with Ulcerative Colitis (UC)

UC is a debilitating and painful inflammatory bowel condition, which results in about 25 per cent of patients requiring surgery (removal of the large intestine)1. UC affects around 146,000 people in the UK2

The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending AbbVie’s anti-TNF treatment, HUMIRA (adalimumab), as an option for adults in England living with moderate to severely active , who have not adequately responded to or cannot take conventional therapy.3 Ulcerative Colitis can be a chronic and debilitating condition impacting on a person’s quality of life. About 1 in every 400 people in the UK develop UC, which most commonly occurs between the ages of 15 and 25.4

Dr Peter Irving, Consultant Gastroenterologist at London Digestive Health, comments: “The decision of NICE to support the funding of anti-TNF agents for patients with treatment- resistant, chronic active ulcerative colitis will be welcomed by patients and health care professionals alike. Access to these drugs for patients in the UK with ulcerative colitis has been out of sync with much of Europe and North America and this decision corrects that anomaly. For patients who respond to treatment, access to anti-TNF therapy is likely to lead to a significant improvement in quality of life as well as an opportunity to avoid surgery.”

UC is a life-long condition, although with appropriate treatment, patients can experience long periods of good health referred to as remission.4 Clinical trial results have shown that adalimumab may provide long-term sustained remission in UC. The scope of this technology appraisal was to demonstrate the clinical efficacy and cost effectiveness of the anti-TNFs licensed for treatment of moderate to severe UC after the failure of conventional therapy, NICE have concluded that these therapies should be available for treatment on the NHS.3

Helen Terry, Director of Policy at Crohn’s and Colitis UK comments: “Today’s NICE recommendation is great news for the thousands of patients whose Ulcerative Colitis is inadequately controlled by conventional therapy. For those living with extremely debilitating symptoms, personal freedom can be significantly affected. Additional treatment options are therefore vital to improve quality of life and reduce the risk of surgery, helping people with Ulcerative Colitis to gain much-needed control back over their lives.”

Anti-TNFs including adalimumab have helped thousands of patients worldwide living with auto- immune conditions such as rheumatoid arthritis, psoriasis, Crohn’s disease as well as Ulcerative Colitis. Adalimumab is approved in 10 indications in the UK and is supported by extensive efficacy, safety and real world evidence which has accumulated over 12 years since it was first introduced in 2003.5 Adalimumab has been licensed for UC since 2012.6

About Ulcerative Colitis (UC)

UC is the most common type of chronic inflammatory bowel disease which affects the inner lining of the large intestine and causes ulcers which can lead to life-threatening complications. It can be a debilitating condition that primarily affects young people and in its most severest form, may impact their future life chances, with onset typically between the ages of 15 and 25.4,7,8 UC affects about one in every 420 people in the UK. 4

About HUMIRA

HUMIRA is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.5 A list of additional indications for HUMIRA can be found on the emc website or by following this link: http://www.medicines.org.uk/emc/medicine/21201

HUMIRA is a self-injectable anti-tumour necrosis factor (TNF) for the treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to conventional therapy.9

HUMIRA is a selective immunosuppressant agent, which helps to suppress over activity of the immune system, decreasing the inflammation process and helping to reduce pain and swelling.9,10

HUMIRA is a tumour necrosis factor (TNF) blocker. This means that it binds to TNF molecules and prevents them from having an effect, which helps to reduce the perpetuated inflammation that can lead to symptoms of auto-immune diseases such as UC and Crohn’s disease.

Source

1. Patient.co.uk: Ulcerative Colitis http://www.patient.co.uk/health/ulcerative-colitis-leaflet. Accessed February 2015

2. National Institute for health and Care Excellence, Ulcerative colitis: Management in adults, children and young people (CG166), www.nice.org.uk/guidance/cg166/chapter/introduction June 2013

3. National Institute for Health and Care Excellence, Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262), February 2015

4. Crohn’s and Colitis UK, Ulcerative Colitis. Improving life for people affected by inflammatory bowel diseases Leaflet

5. For all indications: Humira Summary of Product Characteristics http://www.medicines.org.uk/emc/medicine/21201/SPC/Humira+Pre-filled+Pen,+Pre-filled+Syringe+and+Vial/

6. European medicines Agency, Summary of opinion (post authorisation), Humira (adalimumab)

7. Patient.co.uk: Ulcerative Colitis. http://www.patient.co.uk/doctor/ulcerative-colitis-pro

8. ?Huber, W. Life-threatening complications of Crohn’s disease and ulcerative colitis: a systematic analysis of ?admissions to an ICU during 18 years. Dtsch Med Wochenschr. 2010 Apr;135(14):668-74. Epub 2010 Mar 31

9. EPAR Summary for the public http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000481/WC500050865.pdf Accessed February 2015

10. NHS Choices, Adalimumab Overview http://www.nhs.uk/medicine-guides/pages/MedicineOverview.aspx?condition=Inflammatory%20skin%20conditions&medicine=Adalimumab&preparation=Adalimumab%2040mg/0.8ml%20solution%20for%20injection%20pre-filled%20syringes Accessed February 2015

Source: AbbVie