FAQ

Adalimumab HUMIRA®

HOW EFFECTIVE IS IT?

Adalimumab has been widely used to treat a range of conditions including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis as well as IBD. Research has found that treatment with adalimumab can be effective in bringing about and maintaining remission in people with CD. It can help to reduce the need for hospitalization and surgery, and has also been used successfully to treat CD fistulas. In some cases, it may be effective when treatment with another similar drug, infliximab, has failed.

Adalimumab has also been used to help bring on and maintain remission in people with UC who were not responding to conventional therapy. There is some evidence that combination therapy, using adalimumab with another drug, for example, an immunosuppressant such as azathioprine or methotrexate, may also be helpful for some people with IBD by reducing the risk of developing antibodies to the drug. However, studies have suggested that combination therapies may also increase the risk of side effects, including infections and some types of cancer (see below).

It is important to talk to your IBD specialist doctor before you start your treatment with adalimumab about all the possible benefits and risks, including the potential for side effects, as some of these can be serious.

References

Steroids

ARE THERE ALTERNATIVES TO STEROIDS?

Enteral nutrition (a special liquid only diet) can be used as an alternative to steroids to induce remission. People on this diet do not need to eat ordinary food or drink because the liquid diet provides them with all the necessary nutrients they need. This approach can be especially helpful for children when there are concerns steroids could affect growth. In adults, studies show steroids work better at inducing remission than enteral therapy, but liquid diets or supplements may be used to support nutrition. If you prefer to try the liquid diet approach discuss this with our IBD team.

For people with IBD affecting the colon who cannot tolerate steroids (or wish to avoid them) 5-ASA can be considered in some circumstances, but are generally less powerful. For people who can not come off steroids (because their symptoms return when they stop treatment) biological treatments or immunosuppressants can be considered.

References

CAN I TAKE SULFASALAZINE IF I HAVE AN ALLERGY TO SULFA DRUGS?

There may be cross-reactivity if you have a sulfa allergy and therefore alternative medications to sulfasalazine should be considered instead.

CAN I TAKE 5-ASA IF I HAVE AN ASPIRIN ALLERGY?

• There are some similarities between 5-ASA and aspirin and therefore there is a concern of possible cross-reactivity

• There has been a report of successful use of 5-ASA in a patient with aspirin allergy by first using a test dose

• You will have to discuss with your IBD specialist whether to pursue a supervised test dose to assess tolerability or consider desensitization (trying to overcome the allergy by slowly introducing small doses and gradually increasing to full dose)

Steroids

CAN I TAKE OTHER MEDICATIONS ALONG WITH STEROIDS?

Before you take any new medicines, check with your IBD team or pharmacist whether there could be an interaction with steroids. This also applies to any over-the-counter medicines and any herbal, complementary or alternative medicines and treatments. You should tell any doctor or dentist treating you that you are taking steroids.

Some key drugs that interact with steroids include anticoagulants (such as warfarin), drugs for blood pressure, antiepileptics, antidiabetic drugs, antifungal drugs, bronchodilators (such as salbutamol) and diuretics.

Studies suggest taking steroids with aspirin and nonsteroidal anti inflammatory drugs (NSAIDs), such as ibuprofen, increases the risk of peptic ulcers. If you need both medications, ask your IBD team if you might benefit from taking proton pump inhibitors as well to help prevent ulcers.

References

Azathioprine and Mercaptopurine

DO THEY AFFECT FERTILITY AND PREGNANCY?

Tell your doctor if you are thinking of becoming pregnant or find you are pregnant, and either you or your partner are taking azathioprine or mercaptopurine. Manufacturers’ guidelines state azathioprine and mercaptopurine should not be given to patients who are pregnant or likely to become pregnant in the near future. But many experts now feel these drugs can be taken during pregnancy where benefits are judged to outweigh risks. Most doctors recommend women to continue with their azathioprine or mercaptopurine while pregnant as there may be a greater risk to the baby if the woman stops her treatment and as a consequence becomes unwell.

A recent study has shown that mothers taking thiopurines during pregnancy is not associated with low birth weight or birth defects, although links have been made with premature births and anaemia at birth. Long-term studies show children exposed to thiopurines in the uterus have normal mental and physical development and no increased risk of infections.

With regard to fathers taking thiopurines, one study suggests azathioprine and mercaptopurine do not reduce sperm quality, but some manufacturers say mercaptopurine may occasionally cause temporary reductions in sperm counts. However, since active IBD has been associated with abnormal sperm quality, taking medications to maintain remission may help conception.

Older studies reported a slight increase in birth defects in the children of fathers taking thiopurines. However, larger more recent studies have not found this to be the case.

For both men and women, it is important to talk to your IBD team about the risks and benefits for you, so that decisions can be made based on your own individual health.

Regarding contraception, azathioprine and mercaptopurine can reduce effectiveness of intrauterine contraceptive devices (such as the coil) so you might want to consider alternative forms of family planning.

WHAT ABOUT BREASTFEEDING AND IMMUNOSUPPRESSANTS?

If you wish to breastfeed consult your IBD team. The drug manufacturers do not recommend breast feeding by women taking azathioprine or mercaptopurine. However, many experts have suggested that mothers taking thiopurines can breastfeed so long as babies are full-term, healthy and they do not have weakened immune systems. Studies have shown very little active drug is secreted into breast milk and that the drug is not detectable in the babies’ blood.

There is no evidence of harm in children whose mothers have breastfed while on these drugs.

References

Steroids

DO STEROIDS AFFECT FERTILITY AND PREGNANCY?

Tell your doctor if you are thinking of becoming pregnant or find you are pregnant, and you are taking steroids. Because they are effective treatment, many experts now feel steroids can be taken during pregnancy as there may be a greater risk to the baby if the woman does not take effective treatment and is unwell from her IBD. Studies suggest active IBD at the time of conception and delivery may increase adverse outcomes, including spontaneous abortion and pre-term delivery, making it important to have effective treatment for active IBD.

Guidelines consider steroids taken during pregnancy to be of low risk to babies. While steroids can cross the placenta to reach the baby they rapidly become converted to less active chemicals.

Experts prefer prednisone, prednisolone, and methylprednisolone since they are more efficiently broken down by the placenta than dexamethasone or betamethasone. Maternal prednisolone doses of up to 40 mg daily are considered unlikely to affect the baby.

While some studies have shown a small increase in the risk of cleft lip and palate in babies born to women taking steroids in the first three months of pregnancy, other studies have not reported this finding. Palate formation is complete by week 12 so there are no risks of cleft lip and/or palate after this. Less is known about budesonide, but a small study of eight pregnant women did not find an increased risk of adverse outcomes.

There have been isolated reports of babies born with adrenal suppression when mothers took steroids late in pregnancy. So if you are taking steroids at the time of delivery be sure to let your health care team know as your baby may need a tapering course of steroids after birth.

In women taking steroids for other conditions (not IBD), an increase in maternal pregnancy complications (such as high blood pressure and diabetes) have occasionally been seen.

WHAT IS KNOWN ABOUT FATHERING A CHILD WHILST ON STEROIDS?

Much less is known about the effects of long-term steroids on male fertility and effects on their offspring. One study showed steroids can cause reversible decreases in sperm counts and motility, another found no link between steroid treatment and infertility.

WHAT ABOUT BREASTFEEDING AND STEROIDS?

Steroids are generally considered safe for use by breast feeding mothers. Although a small amount of the drug may pass to the baby, studies have found no harmful effects. Recommendations suggest that where possible women (especially those on high doses) should wait four hours after taking steroids before breast feeding. High doses of steroids used in other conditions have occasionally led to temporary loss of the mother’s milk supply.

For more information about pregnancy and IBD click here

References

Azathioprine and Mercaptopurine

DOES TAKING THIOPURINES INCREASE THE RISK OF CANCER?

People with IBD treated with thiopurines are at increased risk of cancer due to the drugs making the body’s tissues more susceptible and reducing the number of immune cells available to fight cancer. Studies suggest the overall risk of cancer for people taking thiopurines is increased, with the greatest risks for nonmelanoma skin cancers (which are generally not life-threatening) and lymphoma (a type of cancer affecting the lymph glands).

The skin cancer risk may persist after treatment has stopped so you will always need to use sun protection. However the risk of lymphoma appears to diminish once treatment is stopped. When weighing up these risks of cancer you should bear in mind that research shows no overall increase in mortality among people with IBD exposed to thiopurines.

References

5-ASA

HOW DO I TAKE 5-ASA?

Some 5-ASA work best in certain parts of the gut, so you may be prescribed a particular type or brand depending on where you have the inflammation. Many specialists in IBD believe that if a particular brand or type of 5-ASA is working well, you should not be switched to another without a good clinical reason.

Oral 5-ASA were previously prescribed in two or three doses during the day. However, recent evidence suggests that taking these together in a single daily dose can be just as effective. If you feel this could be helpful for you, discuss this with your doctor.

Some 5-ASA come as suppositories or enemas so may be useful if you have proctitis (inflammation of the rectum) or proctosigmoiditis (inflammation of the rectum and sigmoid colon).