HODDESDON, England, October 14, 2014 /PRNewswire/ --

NICE draft guidance says no to biologic treatments for patients with moderate-to-severe ulcerative colitis - potentially missing the opportunity to provide an alternative to surgery for patients if conventional therapies fail

New research shows that the majority of patients with the challenging inflammatory bowel disease, ulcerative colitis (UC), state that the three biggest impacts of the disease on their lives are on their emotional state (in terms of depression, anger or anxiety levels) (76%), ability to get adequate rest/sleep (75%), and taking sick days off work (70%).^[1] Those who have had a colectomy (removal of the colon) were more likely to suffer from these impacts.^[1]

Patients who have had a colectomy continue to experience UC symptoms, with fatigue, abdominal pain and diarrhoea reported as their most common symptoms (74%, 54% and 33%, respectively).^[1]More than half (53%) agreed that fatigue was the hardest consequence to live with.^[1] The most commonly reported post-surgery complications included infections (43%), followed by pouch leakage (31%) and pouchitis (23%).^[1] If they could go back in time, nearly half (46%) of those that had the surgery said they would ask for more information on the treatment choices available.

The research was commissioned and funded by MSD with the co-operation of Crohn's and Colitis UK (CCUK), who provided a link to the survey via its website and social media channels.The online survey considered the level of disease control, impact on quality of life, treatment satisfaction and experiences of surgery among 684 people with UC.^[1]

Just under half (46%) of all respondents were aged 25-39, 29% were aged 40-54 and 18% were aged 24 and under; nearly three-quarters (74%) were female.^[1] Almost one in 10 (9%) of all respondents had undergone a colectomy, of whom more than half (56%) were aged 25-39 and over three-quarters (77%) were female.^[1] Just one in 10 said they felt they had control over the choice of having surgery or its timing.^[1]

The new research comes at a time when the NICE Multiple Technology Appraisal (MTA) of biologics for moderate-to-severe UC is underway.^[2] This represents an opportunity to improve access for patients with this disease as current NICE guidance restricts use of biologics only for those hospitalised with severe UC, leaving those with moderate-to-severe UC no option other than surgery if they fail conventional therapies. Last month, NICE issued the draft guidance not recommending the use of biologics for moderate-to-severe UC; the consultation on this draft is open until 15 October, with final guidance expected early next year.

Chris Probert, Professor of Gastroenterology at the University of Liverpool, Honorary Consultant Gastroenterologist at Royal Liverpool Hospital, chair of the IBD Committee for the British Society of Gastroenterology and vice-chair of the Clinical Advisers Committee for Crohn's and Colitis UK, says: 'Although many people with ulcerative colitis will respond well to conventional therapies, there will always be a subset of those who fail to respond to these treatments and alternative choices to surgery are needed. Biologics could offer a life-transforming opportunity for these patients, who are often young adults, and may even help delay the need for a colectomy.'

Only a third (35%) of all respondents (n=684) say they are completely satisfied with their current treatment when it comes to reducing symptoms and keeping the disease under control, with many experiencing regular flare-ups and hospitalisation.^[1] Additionally, nearly half (46%) those who have had a colectomy (n=61) have experienced more than six flare ups in the past two years compared with those who have not had this surgery (19%).^[1]

'Helen Terry, Director of Policy and Research at patient charity Crohn's and Colitis UK, explains: 'Biological therapies offer hope to people with ulcerative colitis for whom conventional therapies are failing to control symptoms, not only so that surgery may be avoided but so they can resume their lives.'

Nearly half of all respondents (47%) had been hospitalised in the past five years, with the average number of days spent in hospital being 16 days over this period.^[1] One in five (19%) of those hospitalised went on to have a colectomy.^[1]

Currently, in the UK, conventional medications, such as corticosteroids, aminosalicylates (5-ASA), and thiopurine immunomodulators (AZA and 6-MP) are prescribed for UC, but if they do not control the disease, surgery to remove the affected colon (colectomy) may be considered.^[3] Surgery is not without potential complications, and may not necessarily be successful in the long term^{[4],[ 5]}, so there is a need for additional treatment options when conventional therapies fail.

Notes to editors: 

About the survey^[1]

The Ulcerative Colitis Patient Survey was commissioned and funded by MSD.

The anonymous survey, which was available via the Crohn's and Colitis UK website and social media channels, explored adult patients' views of the impact of ulcerative colitis on their lives, and their expectations and experiences of treatments and surgery.

The research was conducted by Kantar Health, a market research agency, during 15-24 September 2014. The survey evaluated results from 684 adults with ulcerative colitis.

All of Kantar Health's activities are in line with the Market Research Society (MRS) code of conduct.

About UC 

Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD), that causes inflammation and ulceration in the inner lining of the large intestine (colon) or rectum (proctitis).^[3] The most common symptoms of UC include abdominal pain and bloody diarrhoea. Patients also may experience fatigue, weight loss, loss of appetite and rectal bleeding.^[3]When conventional medications do not control the disease, surgery may be considered as an option to remove the affected colon (colectomy). About one in five (20%) people with UC will undergo a colectomy at some point.^[4]

About MSD 

We believe the most important thing we make is a difference. We operate in more than 140 countries and through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products we work with customers to bring innovative healthcare solutions to those who need them the most. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programmes and partnerships. For more information visit http://www.msd-uk.com. MSD is a trade name of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A.

References 

1. MSD Data on File. Survey of patients with ulcerative colitis. September 2014. GAST-1132487-0000.
2. National Institute for Health and Care Excellence (NICE). Ulcerative colitis (moderate, severe) - infliximab (review TA140), adalimumab (review TA262) & golimumab (2^nd line) [ID695]: Guidance consultation. Available at: http://www.nice.org.uk/guidance/indevelopment/gid-tag357/consultation. Last accessed: September 2014.
3. Crohn's and Colitis UK. Ulcerative Colitis. Available at: http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Booklets/living-with-ibd.pdf. Last accessed: September 2014.
4. Crohn's and Colitis UK. Surgery for Ulcerative Colitis (UC). Available at: http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Info-Sheets/surgery-for-ulcerative-colitis.pdf. Last accessed: September 2014.
5. Pemberton J.H. et al. Long term results with ileoanal pouch. In: Bayless TM, Hanauer SB, editors. Advanced Therapy of Inflammatory Bowel Disease. Hamilton, Ontario: B.C. Decker; 2001.

For further information please contact

Funda Suleyman (MSD)
+44(0)1992-455389
funda.suleyman@merck.com

Yasmin Ghariani (Pegasus)
+44(0)1273-712045
yghariani@thisispegasus.co.uk

SOURCE Merck Sharp & Dohme