Ulcerative colitis control: an interview with Dr Paul Robinson, Medical Director, MSD UK

Published on March 26, 2014 at 9:29 AM · No Comments

Interview conducted by , BA Hons (Cantab)

Paul Robinson ARTICLE IMAGE

Please can you give a brief introduction to ulcerative colitis and the varying levels of severity?

Ulcerative colitis (UC) is an inflammatory bowel disease (IBD), which means there is chronic inflammation and ulceration in the lining of the digestive tract, usually in the large intestine.

Patients with IBD tend to get abdominal pain and diarrhea, which is often bloody diarrhea. They can become anemic and fatigued, feel sick, lose weight, lose their appetite, and in addition they can have rectal bleeding.

From a symptom point of view, it's quite a distressing, debilitating, and sometimes embarrassing condition to have.

The condition affects about 1 in 500 people in the UK and there are two main peaks in the age people are affected at. One peak is the late teens to early twenties. 15-25 years is a very typical age for people to first present with abdominal pain and weight loss.

There is a smaller peak that occurs at around 55-65 years, with these individuals developing a sudden but often less aggressive, more “groaning” form of the disease.

Predominantly, I think it's a condition that affects people at university or those just starting out at work, for example, and it can be quite debilitating for them.

A lot of people get confused between IBD and IBS. Please could you explain the difference?

In inflammatory bowel disease, there's a very obvious pathology. If a patient underwent endoscopy and the bowel was examined, there would be ulceration, there would be inflammation and there would be blood.

If a patient had a biopsy taken that was looked at under the microscope, there would be pus. It is a clear, physical disease.

Irritable bowel syndrome, on the other hand, is a group of symptoms. There is often abdominal pain and bloating, but no objective evidence of an inflammatory process.

There's quite a bit of overlap in terms of some of the symptomatology, but some patients with inflammatory bowel disease do have irritable bowel syndrome as well. They can coexist.

What are the standard therapies for this condition? Do they differ for patients with moderate to severe UC and those at the acute end of the disease spectrum?

In terms of the disease’s spectrum, symptoms range from a relatively mild bowel frequency and abdominal pain through to symptoms requiring hospitalization, abdominal surgery and possibly even intensive care. The complications of the condition range from very mild to effectively life threatening and treatments differ accordingly.

At the milder end of the spectrum, we are probably talking about the use of anti-inflammatory medications based on amino salicylates, which are similar to aspirin and can be taken by mouth or in an enema.

Steroids are often also used, which may be taken as tablets but also as enemas, since the disease tends to affect the rectum and the lower colon. Often, these treatments are actually injected in the form of foams or suppositories to try and decrease the inflammation down at the very lower end of the bowel.

The next step would be to use drugs that suppress the inflammatory process, such as cyclosporine or azathioprine.

For those patients with moderate to severe or acute severe cases of ulcerative colitis biologic medicines can be used which interfere with the inflammatory process.

The drug we make, Remicade (infliximab), is an example and there are others being used and also being developed that interfere with the inflammatory process.

The ultimate aim of treatment is a) to improve the patients' symptoms and b) to prevent them having to go to surgery and have part or all of their colon removed.

Could you please outline the aims of the recent Ulcerative Colitis Condition, Attitude, Resources and Educational Study (UC CARES) study?

I think there were three objectives. The first was to describe how many symptoms patients had and in particular, what impact the symptoms were having on their quality of life by interfering with their work productivity and social life, for example.

The second aim was to assess how well their disease was being controlled and whether or not their symptoms were actually under control with the treatment they were receiving.

The third aim was to understand how much the patients knew about the disease and whether they were satisfied that the treatment they were receiving was suppressing their symptoms to the extent that they would like.

It was very much a case of asking patients with moderate or severe ulcerative colitis whether they were happy with the level of care and the level of symptom control that they were receiving, to help clarify whether medicine was being applied effectively and in a way that would render as many people as symptom free as possible.

What were the main findings of this research?

About 250 patients were surveyed from 11 countries across Europe and the main findings were that 87.2% of those patients did not have well controlled disease.

By well controlled, we mean scoring two or less on a scale of 1 to 12 or 1 to 9. The rating scale was 1 to 12 if patients had undergone a colonoscopy and 1 to 9 if they had not, but essentially, we were looking for an extremely low score on a commonly used scale developed by the Mayo Clinic.

The questionnaire asked about stool frequency and rectal bleeding, and also included an item where the doctor is asked how well they think the disease is controlled. Patients needed to score two or less without being on steroids because ideally, patients would want to avoid long-term steroid use and its complications.

By these criteria, 87.2% were not well controlled.

Were you surprised by this figure?

I think that's probably higher than would be expected. That is quite a high percentage of patients who are not in remission without steroids.

We think it indicates room for improvement, certainly. Just under half (46.8%) of patients weren't satisfied with their level of symptom control, which presumably means their symptoms are interfering with their daily life to some extent and they would be much happier if their symptoms were better controlled.

What needs to be done to increase patients’ satisfaction with their treatments?

Firstly, patients should always speak to their doctor because all patients are different and it may be that they need to speak to their doctor to have their treatment reviewed.

I think that patients need to understand what level of control they can reasonably expect. Many of these patients should be rendered almost symptom free for most of the time if the treatment they receive is appropriate and I think patients are putting up with symptoms that they probably do not need to.

Helping patients to understand what they can reasonably expect and then speaking to their doctor about trying to achieve that is, I think, what they can do.

NICE has issued guidance on what can be expected from the NHS treatment of ulcerative colitis and some of the guidance is relatively patient friendly to read. I think if patients realize what they can reasonably expect, then hopefully more of them will then receive it.

What do you think the future holds for UC treatments?

There's a lot of research going on into new types of treatments. Many of these are biologic and interfere with the inflammatory pathways that cause the disease in the first place.

What we would like to see is these medicines being used earlier on in the disease course. Very often, these medicines are reserved until the patients are in a severe and acute situation, possibly even in hospital, which is probably leaving it too late.

I think we'll see earlier and better use of the more potent biologic therapies and that improved biologic therapies will be made available. If that does happen, then I hope we'll see fewer patients being on long-term steroids and I hope we'll see fewer patients having had their colons removed.

Where can readers find more information?

The three places I would point people to are firstly, their doctor.

Secondly, there is a patient group called the Crohns and Colitis UK, which has a website: www.nacc.org.uk. They produce a lot of useful patient-centered material that is both explanatory and advisory.

Thirdly, there’s the NICE website. NICE have issued guidelines on how ulcerative colitis should be managed in the NHS. The guidelines help patients understand whether they are getting the treatment that they should reasonably expect.

About Dr Paul Robinson, Medical Director, MSD

Paul Robinson BIG IMAGEQualified in Medicine from London University.

20 years’ experience in development of new medicines across a variety of disease areas.

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