What is apremilast?

Apremilast (Otezla™) is a type of disease-modifying anti-rheumatic drug (DMARD). It works by targeting enzymes involved in the inflammatory processes that cause the symptoms of psoriatic arthritis. It’s a long-term treatment, so it may be up to four months before you start to notice the benefits. It can be used alone or with methotrexate.

Unlike some other therapies for psoriatic arthritis, apremilast is taken as a tablet.

Apremilast can be prescribed by a consultant or other clinical specialist in rheumatology for adults with psoriatic arthritis.

Are there any reasons I won't be prescribed apremilast?

Apremilast won’t be started if:

  • your arthritis isn’t active
  • you haven’t tried other treatments appropriate for your condition first
  • you’re pregnant or planning to try for a baby.

Your doctor may decide not to prescribe this treatment if:

  • you’re underweight
  • you have symptoms of depression.

Your doctor may decide to do some tests, for example kidney function tests, before starting treatment. Before starting treatment, tell your doctor if you’re lactose intolerant.

How is it taken?

Apremilast is taken as tablets. They can be taken with or without food − one in the morning and one in the evening. You start off on a low dose of 10mg and work up to the maximum (30mg twice a day) over six days. You will then remain on this dose. If you have kidney problems your specialist may reduce your dose to one a day.

When you start taking apremilast, you’ll be given a special starter pack which contains all the doses for the first six days. It’s clearly labelled to make sure you take the correct tablet at the correct time. You only need to go through this ‘initiation’ period once − even if you stop and restart the treatment.

If you miss a dose, contact your specialist team immediately for advice on when to take the next one.

If your symptoms haven’t improved sufficiently after four months, your doctor may decide to stop the treatment.

Because it’s a long-term treatment, it’s important to keep taking apremilast (unless you have severe side-effects):

  • even if it doesn’t seem to be working at first
  • even when your symptoms improve (to help keep the disease under control).

Side-effects and risks

Like any medicine, apremilast can cause side-effects. Common side-effects include nausea, diarrhoea, headaches and insomnia. In most people these occur within two weeks of starting the treatment and go away over time. Some people may have coughs and colds, lack of appetite or problems with their digestive system.

You should discuss any side-effects with your doctor, but in particular:

  • feelings of depression or suicidal thoughts – these are very rare side-effects but the consequences can be very serious, so contact your doctor immediately
  • weight loss – tell your doctor if you have unexplained or significant weight loss after starting apremilast; it may be best for you not to continue the treatment if .

Reducing the risk of infection

Try to avoid close contact with people with severe active infections.

For advice on avoiding infection from food, visit NHS Choices - 10 ways to stop food poisoning.

If you pick up an infection while you’re on apremilast, speak to your doctor. If the infection is serious, you may need to stop taking apremilast until you’re better.

Effects on other treatment

You may be taking other disease-modifying drugs as well as apremilast. However, apremilast can interact with some medicines, so check with your doctor before starting any new medicines, and remember to mention you’re on apremilast if you’re treated by anyone other than your usual rheumatology team.

  • You can carry on taking non-steroidal anti-inflammatory drugs (NSAIDs) or painkillers, if needed, unless your doctor advises otherwise.
  • Don’t take over-the-counter or herbal medicines without discussing it first with your doctor. Some of these, including St John’s Wort, contain agents which can interfere with the treatment.

Vaccinations

It’s best to discuss with your doctor any vaccinations you might need before you start treatment with apremilast. It’s usually recommended that you avoid live vaccines, such as yellow fever, if you’re on apremilast. However, sometimes a live vaccine may be necessary.

If you’re offered shingles vaccination (Zostavax), you should discuss with your rheumatology team whether you should have this.

Pneumococcal vaccine (which protects against the most common cause of pneumonia) and yearly flu vaccines are recommended.

Having an operation

If you’re thinking about having surgery, talk this over first with your rheumatology team. In some cases they may suggest that you stop taking apremilast for a time before and after surgery.

Alcohol

There’s no known interaction between apremilast and alcohol. However, if you’re also taking methotrexate, you should keep well within the recommended limits of no more than 14 units of alcohol per week for adults because methotrexate and alcohol can interact and affect your liver. In some circumstances your doctor may advise lower limits.

Fertility, pregnancy and breastfeeding

There’s limited information available about the possible effects of apremilast in pregnancy. Women who could become pregnant should use effective contraception while being treated with apremilast. If you’re planning to try for a baby or if you’re already pregnant, your doctor won’t prescribe it.

Similarly, because we don’t yet know if the drug can pass into human milk, you shouldn’t take apremilast if you’re breastfeeding.

There’s currently no information on whether apremilast might affect male or female fertility.