Apremilast (trade name: Otezla) has been approved in Germany since January 2015 for the treatment of psoriasis in adults. It is a treatment option for two types of psoriasis:
- For people with moderate to severe chronic plaque psoriasis who did not benefit enough from or who cannot have systemic therapy, such as treatments using ciclosporin or methotrexate, or photochemotherapy
- For people with psoriatic arthritis who did not benefit enough from or who did not tolerate antirheumatic medication. Here apremilast is used alone in monotherapy or in combination with antirheumatic drugs
Psoriasis is a non-contagious inflammatory skin disease. The main symptoms include clearly defined red patches, scaly skin and often itching too. It comes and goes in bouts: The skin can get better on its own, but it may also suddenly get worse. Psoriasis is a chronic (long-lasting) condition that cannot be cured so far.
The most common form, affecting about 85% of people with psoriasis, is called plaque psoriasis or psoriasis vulgaris. Psoriatic arthritis (arthritis psoriatica) is less common. It also involves swelling, inflammation and pain in various joints.
Psoriasis is usually treated topically, for instance using creams or ointments. Phototherapy is an option for people with more severe psoriasis. There are also drugs designed to slow down or stop the inflammatory process in different ways. These drugs are often used in combination with each other. Methotrexate and ciclosporin are examples of two drugs commonly used in systemic therapy.
Apremilast is supposed to decrease the inflammatory reaction of the skin by inhibiting a protein and affecting several chemical messengers that increase or inhibit inflammatory processes.
Apremilast is taken in tablet form. The recommended dose is 30 mg of apremilast twice a day. Doses should be taken about twelve hours apart.
A dose of 10 mg of apremilast is used at first. This is then gradually increased to 30 mg over a period of five days.
For people with moderate to severe chronic plaque psoriasis who cannot have systemic therapy, treatment with a tumor necrosis factor (TNF) α inhibitor(adalimumab or infliximab) is an option. Alternatively, ustekinumab is also available.
For people who did not benefit enough from or who cannot tolerate therapy with antirheumatic medication, a TNFα inhibitor is an option. It can also be combined with methotrexate.
In the spring of 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of apremilast in adults with moderate to severe chronic plaque psoriasis or psoriatic arthritis compared with the standard therapies.
The manufacturer did not provide any suitable data to answer this question. It was therefore not possible to determine whether apremilast is able to provide any added benefit when compared with the standard therapies for either of the clinical forms.
This text summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of these reviews and the hearings received, the G-BA passed a resolution on the added benefit of apremilast (Otezla).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Apremilast – Benefit assessment according to §35a Social Code Book V. Dossier assessment A15-09. Cologne: IQWiG. May 13, 2015.
IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.
Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. We do not offer individual consultations.
Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.