Adalimumab for Crohn`s Disease

Adalimumab for Crohn’s Disease
Digestive Disease Centre
How does it work?
Adalimumab (Humira) works with your body’s immune system to
block the action of an inflammatory agent, TNF-alpha (Tumour
necrosis factor- alpha) found in the blood. As part of the immune
response, your body naturally produces chemicals, such as TNF-alpha,
to help fight infections, temporarily causing inflammation in the
affected areas. In Crohn’s disease the body produces too much TNFalpha. This high concentration of TNF-alpha found in the lining of the
inflamed intestine is believed to be one of the key drivers of chronic
inflammation. Adalimumab is a fully human monoclonal antibody.
This means that it does not contain any components from other
animals. It recognises and binds specifically to TNF-alpha and
neutralises its biological function. It also lessens the movement of
inflammatory cells, directed by TNF-alpha, into inflamed areas of the
intestines by altering your body’s inappropriate immune response.
Adalimumab is not a cure but can help reduce inflammation and
relieve the symptoms of Crohn’s disease.
How quickly does it work?
For those people who respond to Adalimumab they will notice
some improvement in 4 weeks. The largest study looking at the
effectiveness of Adalimumab found that 40% of patients were in
remission and off steroids at 6 months and of these 81% remained
in remission at 1 year. In some people however, no significant
improvement was seen. If there is no improvement after 12 weeks
treatment it is likely that Adalimumab will be discontinued.
How will my treatment be given?
Adalimumab is given as a subcutaneous injection (just under the
skin) either using a pre-filled pen or syringe (see information on
administration for more details). The injections will be delivered to
your home and you will be taught how to give the injection yourself.
The first dose is 160mg as indicated, the second dose of 80mg is
given 2 weeks later, with maintenance doses of 40mg being
administered every 2 weeks
How long will I take it for?
Treatment will be given for one year in those patients who
respond. If it helps keep your symptoms under control this may be
a long term treatment. However, we will evaluate your response
after you have been on the treatment for 12 months to decide if it
should be continued.
Does Adalimumab have any risks or side effects?
Like all medicines, Adalimumab can have side effects. Most side
effects are mild to moderate. However some may be serious and
require treatment. Side effects may occur up to 5 months after the
last treatment. Adalimumab is a new drug for the treatment of
Crohn’s disease but has been used for other conditions such as
joint problems for some time.
Adalimumab is an immunosuppressant, this means that it weakens
your immune system and may make you more susceptible to
picking up infections. It is important that you take sensible
precautions to prevent infections whenever you can. These
include checking that your vaccinations are up to date (10 yearly
Tetanus/Diptheria/inactivated Polio, yearly flu vaccination and 10
yearly Pneumovax) as well as washing your hands regularly and
avoiding people with known contagious infections wherever
possible.
There have been reports of serious infections, including TB
occurring during and after treatment with this type of drug, which
can be fatal.
Female patients should also ensure that their smear tests are up to
date as this includes a check for the Human Papilloma Virus (that
also causes genital warts) which can be made worse by
Adalimumab.
The following list describes side effects/risks according to their
frequency, ie very common, common, uncommon and rare.
Very common more than 1 in 10 patients experience problems with
❊ pain, swelling, redness or itching at the injection site
Common (less that 1 in 10 patients)
❊ Lower and upper respiratory tract infections (such as bronchitis,
pneumonia, cold, runny nose, sinus infections)
❊ Urinary tract infection, cold sores, shingles
❊ Dizziness including vertigo, headache
❊ Eye inflammation
❊ Nausea, diarrhoea, abdominal pain, mouth ulcers
❊ Raised liver blood tests
❊ Rash, itching , hair loss
❊ Fatigue
❊ Fever
Uncommon (less than 1 in 100)
❊ Serious infections (such as sepsis (blood poisoning) joint
infection, fungal infections). In a small number of patients this
could be fatal.
❊ Anaemia, low white blood counts
❊ Allergic reaction
❊ Increased blood fats ie Cholesterol, appetite disorders
❊ Anxiety, depression, feeling sleepy and difficulty sleeping
❊ Nerve disorders (such as multiple sclerosis) and eye nerve
inflammation, taste disturbances, Muscle weakness
❊ Vision disturbances, Ear discomfort
❊ Sensation of heart beating rapidly, high blood pressure
❊ Asthma, shortness of breath
❊ Abdominal symptoms (such as vomiting, indigestion,
constipation, rectal bleeding)
❊ Skin disorders (such as psoriasis, eczema or infections) itchy
rash, slow wound healing, warts
❊ Urinary disturbances (such as blood in urine, increased urinary
frequency)
❊ Increased menstrual bleeding
❊ Flu like symptoms, chest pain, swelling of the feet
Rare (less than 1 in 1000)
❊ Glaucoma
❊ Skin cancer
❊ Thyroid disorders
❊ Protein in urine
It is important that you contact the Inflammatory Bowel
Disease (IBD) Nurses/Doctor if you are worried that you may
be experiencing any side effects.
After reading this you may feel very anxious about taking this drug.
Please remember that most people do not experience any side
effects, but you should take them into account when deciding
whether or not to have this treatment. If you have any concerns
please contact the IBD team.
Pregnancy/Breast Feeding (written by Crohns & Colitis UK)
There have been several reports of successful pregnancies in
women with Crohn’s on adalimumab before conception or during
pregnancy. Because the drug is relatively new the clinical evidence
is limited. Therefore, the manufacturers recommend that if you are
a woman of childbearing age and are prescribed adalimumab, you
should use adequate contraception to prevent pregnancy and
continue to use it for at least 5 months after stopping taking
adalimumab. However, in many cases the risks of active Crohn’s
disease outweigh the risks of the drug, even during pregnancy.
If you are thinking of trying for a baby, you should discuss this with
your doctor. For example, if your Crohn’s has previously been
severe and you do not want to wait before trying for a baby, your
doctor may help you to weigh up the risk of stopping against the
benefits of continuing with your treatment. If you become
pregnant while using adalimumab there may be reasons why your
doctor will advise you to continue with your treatment throughout
the first 6 months of pregnancy, and it is not advisable to stop the
drug without consulting your doctor. In the last 3 months of
pregnancy adalimumab should only be used with caution, and on
advice from your doctor, as it will cross the placenta and might
affect the immune system of your baby.
If you are considering pregnancy or find out you are pregnant,
please let us know at the first opportunity so you can discuss your
options with your consultant.
Please let your Midwife, Obstetrician and other healthcare
professionals know that you are taking adalimumab.
The safety evidence for breast feeding is limited but European
guidelines suggest that breast feeding is probably safe but you
should discuss this with your Consultant or IBD Nurse to ensure
that the latest evidence is taken into account before you make this
important decision.
If you have had adalimumab during your pregnancy, your
baby should not be given any live vaccines (ie BCG, MMR)
for the first 6 months.
Is Adalimumab safe for everyone to take?
Although it is safe for the majority of people, there are some cases
where Adalimumab may not be given or is given with extreme
caution:
❊ High risk of active infection ie chronic leg ulcers, recurrent chest
infections, Tuberculosis (TB)
❊ Heart Failure
❊ Cancer within the previous 10 years
❊ Multiple Sclerosis
We discuss the risks and benefits of individual cases in patients
who are high risk.
Everyone who is to be treated with Adalimumab will have a chest x
ray and, if you have not had a BCG injection as a child, you may
also have a blood test to rule out TB infection before treatment is
started. In addition if you have a history of personal or close family
history of TB, the pros and cons of treatment with Adalimumab
will need to be discussed with your consultant.
People born outside the UK in Countries where TB is common,
may have to take a 3-6 month course of anti TB medicine.
Immunosuppressant drugs can cause problems in people with
Hepatitis or HIV. You will therefore have a blood test to check that
you don’t have either of these conditions before starting this drug.
Please tell your doctor if you have lived in a region where
histoplasmosis (a disease caused by a type of fungus) is common
(eg parts of USA, South America and Africa).
Are there times when I should not give myself the
injection?
YES It is very IMPORTANT that you do not have your injection if
you think that you may have any type of infection. Giving your
treatment whilst you have any infection could make it a lot more
serious and difficult to treat. We suggest that you ask yourself the
following questions before giving your treatment.
❊ Do I have a temperature, cold or flu, cold sore, sore throat, skin
infection, thrush, urine infection, abscess or pus leaking from
fistulae?
❊ Have I been in contact with chicken pox or exposed to any live
vaccines?
❊ Could I be pregnant?
❊ Is it possible that I have any other type of infection?
If the answer is yes to any of the above you should not have your
injection until you have spoken to the IBD Nurses. They will advise
you on what action to take.
Following your treatment
Although you are having your treatment at home, we will still
need to review you regularly in the out patient clinic as usual and
you should attend these as requested. You should also have your
blood tested every 2-3 months to monitor for signs of adverse
effects.
Can I take other medicines along with Adalimumab?
Yes, you can take other medicines with Adalimumab. The only
drug that you cannot take with Adalimumab is called Anakinra
(Kineret), this is used in Rheumatoid Arthritis. It is important
however, that your doctor is aware of any medication you are
taking. This includes any over the counter medicines, supplements
and herbal medicines. Tell your doctor or Pharmacist that you are
receiving treatment with Adalimumab whenever you are
prescribed or buy other medicines
Patient Alert Card
You will be given a patient alert card. Adalimumab stays in your
body for 5 months and if you need any medical attention during
that time it is important that medical staff are aware you have
taken this drug. You should therefore keep this card with you at
all times.
It is very important that you tell any doctors involved in your
treatment that you have been given Adalimumab.
If you are worried about any new or unusual symptoms, please
ring the IBD Nurses for advice.
Can I have vaccines while on Adalimumab?
If you are taking immunosuppressant drugs (ie Steroids,
Azathioprine, Methotrexate, Infliximab or Adalimumab) your
immune system may not be as strong as it would be without them.
This means that you should not be given certain live vaccinations
(see table).
It should also be remembered that immunisation may not be as
effective in immunocompromised people.
Annual Flu vaccine and 10 yearly Pneumovax are safe and
recommended. It is also recommended that you keep your
10 yearly Tetanus/Diptheria/ Polio vaccination programme
up to date.
Show this leaflet to your Practice Nurse before having any
vaccinations or seek advice from your Consultant or IBD Nurse.
Vaccination of people taking immunosuppressant drugs
Live Vaccines
Bacille Calmette Guerin (BCG
MMR (Measles/Mumps/Rubella)
Oral Typhoid
X
X
Varicella (Adults)
Killed (Inactivated) Vaccines
Haemophilus influenzae( Hib)
Hepatitis A
Hepatitis B
Influenza (inactivated)
Japanese encephalitis
Meningococcal
Pneumococcal polysaccharide
Polio (injection)
Rabies
Tetanus & Diptheria
Pertussis (whooping cough)
Typhoid (injection)
Key
X
X
Oral Polio *
Yellow Fever
X
X = Not to be used
✓ = Recommended for all
U = Use if needed as indicated
for person not taking
immunosuppressant drugs.
X
U
U
U
✓
U
U
✓
U
U
✓
U
U
Smoking: Bradford Teaching Hospitals NHS Foundation Trust is a
smoke-free organisation. You are not permitted to smoke in any of
the hospital buildings or grounds, with the exception of the
smoking shelters which are provided for visitors and patients only.
Wristbands: When you are in hospital it is essential to wear a
wristband at all times to ensure your safety during your stay. The
wristband will contain accurate details about you on it including all
of the essential information that staff need to identify you correctly
and give you the right care. All hospital patients including babies,
children and older people should wear the wristband at all times.
Where can I get more information?
If you would like more information about Adalimumab or would
like to discuss the treatment in more detail please contact the
Inflammatory Bowel Disease Nurses on 01274 364822 Monday to
Friday 0800 to 1530 or e-mail us at Ibd.Nurse@bthft.nhs.uk or
leave a message on the answer phone.
You are also advised to read the manufacturers advice leaflet on
Adalimumab.
By Textphone: We use the BT Text Relay service for patients who
are deaf or have hearing difficulties. To contact us ring 18001
01274 364627
NHS 111
Useful websites:
IBD Bradford: www.ibd.bthft.nhs.uk
Abbvie (Manufacturers of Adalimumab) http://www.abbvie.com
Crohns & Colitis UK www.crohnsandcolitis.org.uk
This leaflet has been created & printed by the Medical Illustration Dept.
© Bradford Teaching Hospitals NHS Foundation Trust.
Author: Jane Healey / Deborah Patterson
Review date: April 2016 MID Ref: 14031320