Otezla (Apremilast)

Otezla (also referred to by its generic name, apremilast) is a systemic medication that can be used to treat moderate to severe psoriasis and psoriatic arthritis.

What is Otezla?

Otezla (also referred to by its generic name, apremilast) is a medication approved by the European Agency for the Evaluation of Medicinal Products (EMEA) for the treatment of moderate to severe psoriasis, and active psoriatic arthritis. The National Institute for Health and Care Excellence (NICE) recommends the use of Otezla to treat moderate to severe psoriasis and/or active psoriatic arthritis in England and Wales. The Scottish Medicines Consortium (SMC) has accepted Otezla for use within NHS Scotland in people with moderate to severe psoriasis and/or active psoriatic arthritis.

How does Otezla work?

It is not known exactly how Otezla works in psoriasis or psoriatic arthritis. However, it is known that Otezla inhibits (i.e. stops it from working as it usually does) an enzyme known as phosphodiesterase 4, or PDE4.

PDE4 controls the inflammation process in the skin for people with psoriasis, or the joints in people with psoriatic arthritis. Reducing or controlling the inflammation in the skin or joints can lead to improvement of symptoms in people with psoriasis, psoriatic arthritis or both conditions.

Who is Otezla for?

Otezla is intended for use in adults with moderate to severe chronic plaque psoriasis who have not responded to, or cannot take other systemic treatments including ciclosporin, methotrexate or PUVA for health reasons.

In Scotland, Otezla can also be used alone or in combination with another Disease-Modifying Anti-Rheumatic Drug (DMARD), for example methotrexate, sulfasalazine or leflunomide, in adults with active psoriatic arthritis, who have not had an acceptable response to at least two other DMARDs, or who cannot take another DMARD for health reasons.

In England and Wales, Otezla can be used alone or in combination with other DMARDs in adults with active psoriatic arthritis who:

  • Have peripheral arthritis (i.e. the joints of the arms and legs are affected) with three or more swollen joints and three or more tender joints
  • Have not had an acceptable response to at least two other DMARDs

How is Otezla used?

The recommended dose of Otezla is 30mg taken orally in tablet form twice daily, approximately 12 hours apart (morning and evening). The initial dose is lower and gradually increased over the first five days, until the full dose of 30mg twice daily is reached from day six onwards. Otezla can be used on its own to treat psoriasis and/or psoriatic arthritis. When used to treat psoriatic arthritis it can also be used in combination with other DMARDs.

Treatment with Otezla is usually reconsidered if the psoriasis/psoriatic arthritis has not responded adequately at 16 weeks, or by 24 weeks if in Scotland.

Who should not take Otezla?

  • People who are lactose intolerant, or who have conditions that mean they have difficulty absorbing certain sugars, should not take Otezla
  • There is little information about the effects of Otezla on fertility or in pregnancy. Pregnant or breastfeeding women should not be treated with Otezla, and women should not become pregnant whilst taking Otezla. Evidence of safety during pregnancy and in people planning pregnancy comes largely from patient registries, such as the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR), which records experiences of people taking medication in the 'real world' (e.g. not in a clinical trial). Therefore, for the most up to date advice around the use of Otezla when planning pregnancy, you should talk to your Dermatology or Rheumatology team.
  • Caution should be taken in people with severe kidney impairment, and the dose should be reduced
  • Caution should be taken in people who are underweight at the start of treatment, and their weight should be monitored regularly – this is because Otezla can cause weight loss in some individuals.

What are the side effects of Otezla?

The most common side effects reported are diarrhoea, nausea, and vomiting. These side effects are mostly mild or moderate, and most common in the first two weeks – settling down within four weeks.

Other side effects reported commonly include upper respiratory tract infections, cough, abdominal pain, back pain, headaches, and fatigue (feeling tired). Most side effects were considered to be mild or moderate in severity.

Otezla can be associated with an increased risk of insomnia and depression. Before starting Otezla, tell your doctor if you have had feelings of depression, suicidal thoughts, suicidal behaviour, or other mood changes. After starting Otezla, tell your doctor if any of these symptoms develop or worsen.

Can I have immunisations (vaccinations) whilst on Otezla?

It is important that when having vaccinations, you check with your Dermatology/Rheumatology team as to whether you need to stop or delay taking Otezla as they will have the most up-to-date advice regarding the continuing of your treatment at this time. If you are taking Otezla, you should not receive a live vaccine (e.g. chicken pox vaccine).

How do I get Otezla?

Otezla can only be prescribed by the hospital consultant (Dermatologist or Rheumatologist) who is responsible for your psoriasis or psoriatic arthritis care. Currently the recommendations are that monitoring is not required while taking Otezla, although your healthcare professional may wish to periodically take bloods to assess your general health.

Points of Note

Unlike some other tablet treatments for psoriasis, such as Methotrexate or Acitretin, there is no requirement to restrict alcohol use when taking Otezla. However, it is sensible to follow current NHS Guidance on safe alcohol limits.

Resources

The information on this page is also available in our Otezla (apremilast) information sheet

September 2022 (Review Date: September 2025)