The National Institute for Health and Care Excellence (NICE) has recommended vedolizumab (Entyvio) in final draft guidance for use on the NHS for adults with moderately to severely active ulcerative colitis (UC) across its full licenced indication.1 NICE recognised that vedolizumab is an innovative, cost effective option, which represents a step change in treatment because of its novel mode of action,1 providing long-term remission from symptoms and improved quality of life with a safety profile similar to placebo.1, 2, 5

Vedolizumab is a 30-minute intravenous infusion given every eight weeks after induction.6 It works selectively in the gut to help block the entry of white blood cells,6 reducing inflammation and associated symptoms,5 such as urgent bloody diarrhoea, rectal bleeding and extreme fatigue.4 These distressing symptoms can leave people house-bound, having a profound impact on everyday life.3 The goal of treatment is to achieve and maintain remission - a period of good health with no symptoms.11, 12

Chris Probert, Professor of Gastroenterology at the University of Liverpool, chair of the IBD Section for the British Society of Gastroenterology and vice-chair of the Clinical Advisers Committee for Crohn's and Colitis UK, commented "We are delighted that NICE has approved the use of vedolizumab for patients with ulcerative colitis. This is the first new class of treatment in over a decade and the data are very exciting, as vedolizumab provides a real step change in treatment. For our patients, achieving long-lasting remission with minimal side-effects is the goal of treatment and this has been proven in clinical trials for vedolizumab. This is a landmark day for many patients with tough ulcerative colitis, especially those whose quality of life has been impaired by their disease and may have been contemplating surgery or a limited range of drug options."

In clinical trials, 47% of people responded to vedolizumab within six weeks.5 Of those patients that responded, 42% were in remission at one year, compared to 16% on baseline therapies and placebo.5 73% of vedolizumab-treated patients who completed the main one year trial remained in remission at year two (the extension trial).2 Health-related quality of life was measured in the clinical trials at weeks 6, 30 and 52. Improvements in quality of life were greater with vedolizumab than placebo at all time points.1

Many current UC treatments come with serious safety concerns (including serious infections and increased risk of cancer) because they suppress the body's entire immune system.13 Vedolizumab selectively targets the immune system in the gut, so the rest of the body's immune system remains unaffected.1, 6 In clinical trials in UC, the frequency of side-effects with vedolizumab was similar to placebo.5 NICE recognised this difference as a step change in the management of UC.1

UC is a life-long condition characterised by chronic inflammation of the large intestine (colon).3 It affects 146,000 people in the UK,3 23,000 of which are under 30.14 It is a relapsing condition, usually diagnosed in the late teens or early twenties and often leaves young adults dealing with unpredictable, debilitating symptoms when they are studying, finding their first job and establishing their adult lives.4

The UK has the highest incidence of UC in the EU5 (France, Germany, Italy, Spain, UK)15 and inflammatory bowel disease (UC and Crohn's) costs the NHS £470 million per year.4 Current treatments include corticosteroids, 5-aminosalicylates, immunosuppressants and anti-TNFα biologics.16 While effective in some people, these treatments do not work for all patients and can stop working over time:

  • 40% of people fail to respond to biologic therapy and of those that do, 40% lose response over time7
  • Anti-TNF adalimumab has a 72% failure rate for maintaining remission at two years in UC7

UK hospital admissions and surgery rates remain high as many medical treatments fail to achieve long- term remission.10 78% of emergency surgical admissions for UC in 2013 resulted from failure of medical therapy.10 Up to one third of people will undergo surgery to remove their colon,4 which can often result in physical and psychological problems including sexual dysfunction, female infertility and infections.17

Three UK centres (Barts and the London NHS Trust, Cambridge University Hospitals NHS Foundation Trust and University Hospital of Wales, Cardiff) were involved in clinical trials of vedolizumab.

The final decision is contingent upon Takeda UK providing vedolizumab to the NHS within the terms of an agreed patient access scheme.1

About Vedolizumab (www.entyvio.co.uk)

Vedolizumab is licensed for the treatment of adults (≥18 years old) with moderately to severely active UC and adults (≥18 years old) with moderately to severely active Crohns Disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or an anti-TNFα biologic.6

Vedolizumab works by binding exclusively to the α4β7 integrin which is expressed on a sub-group of lymphocytes (a type of white blood cell) that bind to the MAdCam-1 receptor, expressed preferentially in the gut.6 By blocking the α4β7 integrin, vedolizumab selectively reduces the influx of inflammatory cells to the gut.6 In clinical trials in adults with moderately to severely active UC and CD, vedolizumab was generally well tolerated and showed statistically significantly better efficacy compared to placebo across a range of endpoints.5, 18

The safety and efficacy of vedolizumab was evaluated in the GEMINITM Studies, the largest Phase 3 clinical trial programme to date evaluating both UC and CD patients in parallel.19, 20, 21 In UC studies, vedolizumab has been shown to induce clinical response, remission and mucosal healing in patients with no prior anti- TNFα biological therapy exposure, as well as in those who have not responded or become intolerant to anti- TNFα therapy.5 In CD studies, vedolizumab has been shown to induce clinical remission and to produce an enhanced clinical response and a corticosteroid-free clinical remission (at week 52) in patients with no prior anti-TNFα biological therapy exposure, as well as in those who have not responded or become intolerant to prior anti-TNFα therapy.18 The most common side-effects were nausea, nasopharyngitis (common cold), upper respiratory tract infection, arthralgia (joint pain), pyrexia (fever), fatigue, headache, cough and infusion-related reactions.5, 18 As with other biologic treatments, there is an increased risk of infection and patients should be issued with a Patient Alert Card.6