THOUSANDS of patients with an incurable digestive disorder can be prescribed a drug found to suppresses symptoms after Scotland's medicines watchdog approved it for use on the NHS.
Sufferers of moderate to severe Crohn's disease will be able to get vedolizumab, brand name Entyvio, from their GP for the first time after the Scottish Medicines Consortium (SMC) passed the drug for routine use on the health service.
It is already available to patients with moderate to severe ulcerative colitis, a similar but distinct disorder.
It will be prescribed to adult patients who have become intolerant or unresponsive to existing treatments, known as TNF alpha inhibitors, and to those who found the current medications ineffective.
Crohn's disease is life-long, re-lapsing condition that tends to strike young people in their late teens or early twenties. There are nearly 10,380 sufferers in Scotland, one of the highest incidences in Europe.
It causes chronic inflammation of the gut wall, especially in the intestines, which can result in painful ulcers, abdominal aches and debilitating symptoms such as urgent diarrhoea, rectal bleeding and extreme fatigue. Patients also suffer malnutrition and weight loss as a result of painful flare ups which make digesting food extremely difficult.
The inflammation can lead to narrowing of the bowel and, in severe cases, potentially fatal complications such as a complete blockage or perforation of the bowel, requiring life-changing surgery at a point in life when many patients are studying, finding their first job and trying to establish their adult lives.
Famous Crohn's Disease sufferers include Sam Faiers, the former cast member of the Essex-based reality show Towie, who was hospitalised by the condition.
Clinical trials have shown vedolizumab to provide long-term relief from symptoms by suppressing the gut's immune system.
It is administered as a 30-minute intravenous infusion given every eight weeks
Dr Charlie Lees, Consultant Gastroenterologist at the Western General Hospital, Edinburgh, commented "Too many of our young patients face a lifetime of distressing symptoms and have to contemplate surgery in their 20s and 30s. Getting patients into remission and keeping them there long-term is the primary goal of treatment. Clinical trials have confirmed that vedolizumab provides long-term remission from symptoms, which is what our patients need."
In clinical trials, 28 per cent of patients who had failed to manage the disease with TNF alpha inhibitors were still in remission from Crohn's symptoms a year after being started on vedolizumab, compared to 13 per cent of patients in the control group.
It is unclear exactly what causes Crohn's Disease, but it is far more common in highly sanitised Western societies than in developing nations which has led to suggestions that a lack of exposure to bacteria has led our guts to become over-sensitive.
Some studies have also pointed to increase the Caesarean births and a decline in breastfeeding in the West for disrupting the intestinal flora, while abnormal increases and decreases of certain gut microbes have been shown in large-scale US studies to be linked to the onset of Crohn's symptoms.
In a statement, the SMC said: "Patients with Crohn's disease may experience a range of symptoms including pain due to ulceration and inflammation in the gut, and diarrhoea which can affect their self esteem and quality of life. Vedolizumab suppresses the gut immune system.
"It works differently to other treatments and potentially may have fewer side effects than other currently available treatments called TNF alpha inhibitors, which can have an effect on the whole immune system. The Committee accepted vedolizumab for the treatment of adult patients who have not responded to treatment with TNF alpha inhibitors."
Adam Zaeske, Managing Director of drug manufacturer Takeda UK and Ireland, said the decision was "an important milestone in our ambition to address high unmet need amongst patients living with Crohn's Disease in Scotland".
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