Starting biologic medication

What are biologic medications? 

Biologic medications are a type of treatment that work to control inflammation all over the body, including in the bowel. They are often used if other medications such as steroids or azathioprine have not been effective at controlling your disease, or if you have experienced side effects.

There are many different types of biologic medication used for a wide variety of inflammatory conditions, which include ulcerative colitis (UC) and Crohn’s disease (CD). Some biologics are only effective for treatment of UC whilst others can be used for both UC and CD. 

The biologic medications used at the Royal Free Hospital are:

Before starting your new medication 

During your clinic review you will discuss with your doctor and nurse the reasons for starting the new medication, how to take or use it, how you will be monitored and possible side effects. 

We recommend you look at the information leaflets provided with the medication you are starting, including possible side effects. You can also find more information on the Crohn’s and Colitis UK website, or by contacting the inflammatory bowel disease (IBD) advice line on 020 7830 2283 or by emailing rf.ibdnurses@nhs.net.

A member of the IBD team will call to check that you understand the changes to your new medication. This is a good time for you to ask any questions you may have, you can also email the IBD advice line at any time if you have further questions.

Tests required before your treatment 

Before you begin your new treatment, we need to do certain tests to ensure it is safe for you to start. These include blood tests and a chest X-ray. It is important that these are done and the results are checked by the IBD team before you start your treatment. If you have not had these tests done, then please contact the IBD team.

Timeline to starting treatment 

Biologic medications are a high-cost treatment and the IBD team need to apply for individual funding for you from your local authority before you can start your treatment. Depending on which medication you are starting, you will either hear from the day infusion unit (PITU) or the homecare company that will deliver your medication and teach you how to administer it. The average time for this process is approximately three weeks from the funding decision to the start of your treatment. 

If you have not heard from PITU or the homecare company within four weeks, you should contact the IBD team.

Information if you are starting biologic infusions in the hospital (Infliximab and vedolizumab) 

When you start your treatment, you will have two or three doses (depending on your needs) in a short space of time. This is known as induction and it helps to improve your symptoms as quickly as possible.

Each infusion is given over two hours but you can expect to be on the infusion unit for half a day as you must be monitored for two hours after the infusion has finished. You may want to bring something to read or an electronic device to keep you entertained. 

You are allowed to eat and drink before and during the infusion and you can drive afterwards. You may find it easier to wear a short-sleeved top for access for the IV cannula (a small tube inserted into your vein through which the medication will be administered) and to bring a warm cardigan or jacket to your appointment.

Infliximab dosing schedule
Week 0 – induction dose one
Week 2 – induction dose two
Week 6 – induction dose three then eight weekly maintenance doses thereafter.

Vedolizumab infusion dosing schedule 
Week 0 – induction dose one
Week 2 – induction dose two
Week 6 – induction dose three then eight weekly maintenance thereafter.

For patients switching to injections at home, the week 6 (induction dose three) may be given as the first injection at home via the homecare service (see below for more details on the process). We will let you know how many doses to expect via the PITU when you are starting.

You must ensure you book yourself in for the next infusion before you leave the PITU. If this is not possible, you should contact the PITU directly on the next working day to secure your next appointment. 

Information if you are starting ustekinumab (Stelara)

The first dose of Stelara is given as an infusion on the PITU. You will then have the first injection at home, eight weeks after your infusion and then every 12 weeks thereafter. The injection is given via a syringe device into the skin in either your stomach or thigh. This is usually administered by a nurse working with the homecare company. 

If you feel comfortable to do so, the homecare nurses can train you to administer the medication yourself. This will be discussed with you before you start so please let us know if this is something you would be interested in. They can also train a family member or partner to administer the injections for you if you would prefer.

Information if you are starting biologic injections at home (adalimumab, 
ustekinumab and vedolizumab)

Information if you are starting tofacitinib 

Tofacitinib is a tablet that is taken daily for ulcerative colitis. Tofacitinib is initially prescribed by the hospital and you will need to collect this from the out-patient pharmacy. Prescriptions are usually available one week after the decision is made to start the treatment. This gives us time to check your blood test and stool sample results. 

If you did not have a blood test at your last appointment or have not been given a stool sample pot, please contact the IBD team so there is no delay to starting your treatment.

The usual induction dose for tofacitinib is 10mg twice daily (morning and evening) for eight weeks, but the dose may be adjusted based on your blood results so please check your prescription carefully. You will be given an appointment seven weeks after starting treatment to check your response to the medication and to perform further blood tests and a stool sample. You will be sent a stool sample pot by the IBD team that you will need to bring with you to the appointment. 

After this appointment we will check your blood and stool sample results and decide what dose of medication you should continue to take and issue another out-patient prescription for you to collect. We may ask you to continue taking 10mg twice a day for a further eight weeks or we may reduce your dose to a maintenance dose of 5mg twice a day, depending on your symptoms. The exact dose will depend on your blood test results so please check your prescription carefully. 

If you do not have a blood test at your week seven review, this could delay your ongoing treatment so please ensure you have your blood tests taken.

If you are advised to continue on the 10mg twice daily dose, you will be reviewed again after a further seven weeks when you will need to have the same monitoring blood tests. Once you are stable on your medication, the homecare company will deliver your medication to your home each month. You will need to continue to have blood tests every three months, either from your GP or at the hospital, so we can monitor you. This is to ensure that the treatment is still right for you and that you are taking the appropriate dose.

How we monitor your response to the treatment 

You will require blood monitoring to check the safety of the medication every two to three months whilst on biologic medication. This will be done via the PITU if you are regularly attending for infusions (infliximab and vedolizumab). If you are having your treatment at home then you can have your blood monitoring tests done by the GP, if they agree. 

Please make sure results are sent to the IBD team so that they can be reviewed and monitored. Otherwise, you will need to attend the hospital to have them done. If you do not have your regular blood monitoring tests carried out it may mean we have to delay your treatment.

Your treatment will also be reviewed every 12 months from the first funding application and we will arrange investigations such as scans, blood tests, stool samples or endoscopy (a procedure to look inside the body) so that we can assess your response to the medication. This will also help us apply for a further 12 months of funding if necessary. 

You will continue to receive appointments for the IBD clinic whilst you are taking the biologic medication. This is so that we can assess your condition, perform essential blood tests and ensure you are not experiencing any side effects. The appointments may be face-to-face or via video or telephone calls with the doctor, pharmacist or IBD nurse specialist. 

It is important that you continue to attend these appointments even if you are feeling well so that we have the information required to assess whether you need to continue your treatment. 

If you have responded well to treatment or there are signs your condition is becoming less severe, we may discuss the option of stopping treatment with you. You should not stop treatment yourself without discussing this with the IBD team beforehand. Please contact the IBD team if you have not been given an appointment or any investigations three months before your annual review. 

In some cases, you may experience IBD symptoms that affect your daily life despite being on biologic medication. This may be a sign that the medication may not be working effectively, that the dose or frequency of medication needs to be reviewed or that a different treatment option should be considered. If you experience an increase in symptoms whilst receiving your treatment, please mention this at your next clinic appointment or contact the IBD advice line.

What to do if you are feeling unwell 

It is important to let the IBD team know if you have been advised to start a course of antibiotics or if you develop any signs of an infection, such as a fever. We may advise you to delay your next scheduled treatment until you are feeling better or have completed the course of antibiotics. 

If you are unable to contact us, such as over the weekend, and you are unsure if you should take your treatment, you should stop your treatment until you have spoken to a member of the IBD team. Meanwhile, you should seek alternative medical advice from your GP, by calling NHS 111, or visiting the emergency department at your local hospital.

Patient checklist 

These are some of the important things you can do to ensure your treatment goes 
smoothly:

• Contact the IBD team if you have any questions about your medication or possible side effects• Ensure you know how often you need to have blood test monitoring and keep up to date with making blood test appointments.
• Make a note of the start date of your treatment and contact the IBD team if you do not have a clinic appointment scheduled three months before your annual review is due.
• If you are receiving an infusion in hospital, always make sure you have booked the next appointment for you to attend. If not, contact the day case unit (PITU) directly.
• If you inject your biologic or take a tablet at home, the homecare company should contact you to arrange redelivery. Occasionally there may be delays with your prescription so you should check directly with the homecare company before your medication runs out. If you identify any issues with delivery of your medication, please contact the IBD team.
• If you change your GP practice, you must let the IBD team know as this may mean having to re-apply for funding for your biologic medication. Wherever possible, you should try to keep to a regular GP practice but please discuss with us if a change is unavoidable.