What Is Otezla (Apremilast)?

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Otezla is the brand name for an oral medication used to treat both plaque psoriasis and active psoriatic arthritis. The active ingredient in Otezla is apremilast. It is a relatively new treatment option that was approved by the US Food and Drug Administration in 2014.

Otezla is approved for treating patients with moderate or severe plaque psoriasis who are candidates for a systemic medication or light therapy1.

Otezla is taken by mouth twice daily in the form of a tablet. The dose of the drug prescribed by your healthcare provider is gradually increased over the first 5 days of treatment until the recommended dose of 30 mg per day is reached. The gradual increase in dose is done in order to reduce possible gastrointestinal side-effects. The drug meant to be taken as a maintenance treatment, taken every day to help control symptoms2. You can take Otezla with or without eating, but you should not crush, split, or chew the tablets.

How does Otezla (apremilast) work to treat psoriasis?

Psoriasis is a chronic autoimmune condition in which a person’s immune system is overactive and produces too much inflammation in the body. This inflammation triggers the production of an excessive amount of new skin cells that are created more quickly than older skin cells can die and be shed naturally. The skin cells build up and cause plaques to form on the surface of the skin.

Otzela (apremilast) works differently than other types of oral systemic medicines for psoriasis, which affect the entire immune system. Instead, Otezla works by specifically targeting only certain molecules within immune system cells that are involved in causing inflammation, an enzyme called phosphodiesterase 4 (PDE4). By affecting the inflammatory processes within cells, Otezla can reduce the activity in the immune system that causes chronic inflammation and the formation of plaques, and thus reduce flaking and scaling of skin1.

Clinical studies were carried out to test the effectiveness of Otezla. After 4 months, around 1 in 3 patients who were treated with the medicine had a 75% reduction in symptoms such as redness, thickening, and scaliness2.

Who can take Otezla (apremilast)?

Otezla (apremilast) is approved for treating adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic medication.1 It is also approved for adult patients with active psoriatic arthritis.

Otezla is not currently approved for patients under 18 years of age. Its safety in treating women who are pregnant or breastfeeding is not yet known. People who have kidney disease may need to take a lower dose of Otezla. People who are allergic to the active ingredient, apremilast, or any other ingredients in Otezla should not take the medicine2.

What are the possible side effects of taking Otezla (apremilast)?

In the clinical studies that tested Otezla for psoriasis, the most common side effects that patients reported were:

  • diarrhea
  • nausea
  • headache, including tension headache
  • upper respiratory tract infection

These side effects were more common during the first two weeks of treatment and then tended to go away over time as patients continue to take their medication. When you first start taking Otezla, your healthcare provider may advise you to gradually increase your dose over a 5 day period in order to minimize any gastrointestinal symptoms you may experience from starting a new medication.

About 12% of the patients with psoriasis treated with Otezla experienced weight loss of between 5%-10% of their body weight during treatment. Healthcare providers should monitor patients during treatment to make sure that they maintain a healthy body weight2.

A small number (1.3%) of patients in the clinical studies who were treated with Otezla experienced depression. Patients and their caregivers should be aware of this risk and watch out for signs of depression or mood changes, and contact a healthcare provider if any of those signs of symptoms develop. Patients with a history of depression may choose to avoid treatment with Otezla.

Can Otezla (apremilast) be used with other treatments or drugs?

The studies demonstrated that Otezla is generally safe for use at the same time as1:

  • oral birth control
  • ketoconazole, an antifungal medicine
  • methotrexate

In clinical trials for Otezla, people with psoriasis were allowed to continue taking low-potency topical corticosteroids, and people with scalp psoriasis were allowed to continue to use coal tar shampoo and/or salicylic acid preparations2. Safety concerns were not reported with the use of these other medications in combination with Otezla.

Otezla may not be as effective if it is used at the same time as cytochromeP450 enzyme inducer medicines2, including:

  • rifampicin
  • phenobarbital
  • carbamazepine
  • phenytoin