Drugs used in inflammatory bowel disease

Information on common drugs used in inflammatory bowel disease

5-ASA drugs/mesalazine

5-ASA drugs include Pentasa, Asacol, Ipacol, Octasa, Mezavant, Salofalk, Dipentum, Balsalazide (strictly not a 5-ASA).

Most patients tolerate these drugs without any side effects and they are very safe.

They are very effective in mild-moderate ulcerative colitis but the evidence of benefit in patients with Crohn’s disease is poor.

Mezavant was the first once daily 5-ASA drug but recently several studies have shown that the majority of 5-ASAs are equally effective if given once per day and this is obviously beneficial in helping patients to remember to take all their tablets

5-ASA drugs have been shown to reduce the risk of bowel cancer in patients with IBD and for this reason most gastroenterologists would recommend continuing these drugs even when other more powerful drugs are required.

Are blood tests needed?

Blood tests for kidney function should be performed at least once per year to exclude the very rare complication of interstitial nephritis.

How are they given?

These drugs can be given by mouth or as a suppository or foam enema.

 

Steriods

-Prednisolone

-Hydrocortisone

-Predfoam

-Predsol

-Budesonide

 

How are they given?

A course of steroids by mouth (prednisolone) is commonly given to patients who fail 5-ASA drugs.

In patients with severe IBD requiring hospital admission intravenous steroids in the form of hydrocortisone are usually given.

Rectal steroids (predsol and predfoam) can be useful in patients with proctitis (disease in the last part of the bowel only), these are safe as the dose is very small and poorly absorbed.

Budesonide is a special steroid which is effective in Crohn’s disease affecting the small bowel and has the advantage that it acts locally and is poorly absorbed from the small bowel (it is not effective in ulcerative colitis) therefore it is much less likely to cause the long-term side effects that can occur in patients treating with repeated courses of prednisolone.

 

Problems and side effects

Steroids can cause many side effects if repeated courses are given, the most common problems being osteopenia and osteoporosis (thin bones), weight gain and thin skin. For this reason it is recommended that patients who need more than one course of steroids in a year (not rectal steroids) should start a steroid-sparing agent (azathioprine, mercaptopurine, methotrexate Infliximab, adalimumab).

 

Azathioprine and Mercaptopurine

Azathioprine and mercaptopurine are closely related drugs and are classified as immunomodulators. They are probably the most useful drugs in patients with inflammatory bowel disease, they are old drugs which means that the long term effects are well known and are usually well tolerated in the majority of patients. They are safe in pregnancy and breast feeding. Azathioprine and mercaptopurine are most commonly used as maintenance treatment (treatment to keep you well) in patients where 5-ASA drugs don’t work and in patients who need more than one course of steroids in a year. In patients who start taking these drugs most should continue to take them long-term.

The most common side effects of azathioprine and mercaptopurine are nausea and flu-like symptoms (muscle aches and headaches), these characteristically occur 2-3 weeks after starting treatment and importantly usually subside if treatment is continued. The most important complication is bone marrow suppression which is most likely to occur in the first few weeks of treatment and therefore weekly blood tests are needed for the first 8 weeks.

Patients should consult their GP, Consultant, or IBD nurse should they develop symptoms such as sore throat (or other signs of infection) or easy bruising which could suggest bone marrow suppression.

Azathioprine/mercaptopruine and allopurinol combination therapy

In patients who are struggling to tolerate azathioprine or mercaptopurine or who develop abnormal liver function tests, Dr McLaughlin uses combination therapy with allopurinol which allows a significantly reduced dose of azathioprine/mercaptopurine and allows the majority of patients to continue these useful drugs.

Are blood tests needed?

Yes

Weekly for 8 weeks then once every 12 weeks.

 

Methotrexate

Methotrextae is classified as an immunomodulator, it is an old drug which means that the long term effects are well known and it is usually well tolerated in the majority of patients. This drug is absolutely contraindicated in both men and women who are trying to start a family and in breast feeding mothers as it can cause harm to unborn babies (it must be stopped for 6 months first). Reliable contraception must be used whilst takin this drug.

Common side effects include nausea, vomiting, loss of appetite and diarrhoea. These symptoms usually improve with increasing folic acid supplements to 6 days per week.

The most important complication is bone marrow suppression which is most likely to occur in the first few weeks of treatment and therefore weekly blood tests are needed for the first 8 weeks.

Patients should consult their GP, Consultant, or IBD nurse should they develop symptoms such as sore throat (or other signs of infection) or easy bruising which could suggest bone marrow suppression.

How is it given?

Methotrexate is given intra-muscularly (injection into the muscle)  for at least the first 16 weeks. Following this most patients can take it by mouth, in some patients intra-muscular methotrexate needs to be continued.

Are blood tests needed?

Yes

Weekly for 8 weeks then once every 12 weeks

 

Infliximab and Adalimumab

These drugs are classified as anti-TNF drugs and are also known as ‘biologics`. Both have to be given as injections. Biologics are expensive drugs and depending on your local hospital policy your doctor may need to make an application to the local primary care trust to seek approval to use these drugs (We are fortunate at the Royal Bournemouth hospital that we do not need to seek approval). Both are NICE approved for Crohn’s disease in patients who have failed treatment with steroids or immunomodulators. The most important problem with these drugs is the development of antibodies which can lead to failure. For this reason most gastroenterologists recommend continuing azathioprine, mercaptopurine or methotrexate (even where these drugs have failed) with the aim of reducing antibodies.

Neither drug is NICE approved for ulcerative colitis patients, Infliximab has been shown to be of benefit in patients admitted to hospital with severe colitis who fail steroid treatment and may also be useful for other ulcerative colitis patients who fail immunomodulators, an application to the primary care trust to use these drugs is required in all patients.

 

Infliximab

Infliximab is given intravenously (into a vein) at time zero then repeated after 2 weeks and then repeated 6 weeks later. After this the drug is given intravenously every 8 weeks and requires coming to the hospital for this.

 

Adalimumab

Adalimumab is given as a subcutaneous injection (just below the skin), it is initially given at time zero, then repeated every 2 weeks. Patients can be taught to self-inject at home.

 

Polymeric diet

Polymeric diets are commonly used in children with small bowel Crohn’s disease where they have been shown to be as effective as steroids but they are also effective in adults. ). Patients keen to avoid steroids should consider a polymeric diet to control their disease. A polymeric diet consists of taking only special liquid food (Modulen is a common brand of polymeric diet), it should not be confused with build-up drinks such as ‘Fortisip`,  ‘Fortijuice` or ‘Ensure` etc. For a polymeric diet to be effective most gastroenterologists recommend that in addition to Modulen only black tea, black coffee or water should be taken (no food). A polymeric diet is usually taken for 2 to 4 weeks following this foods can be re-introduced using the LOFFLEX principle (low fat, fibre limited, exclusion diet) under supervision by a dietitian.

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