Otezla
Authorised
This medicine is authorised for use in the European Union
apremilast
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Otezla is a medicine used to treat adults with:
- moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in patients who have not responded to or cannot use other systemic (affecting the whole body) treatments for psoriasis, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen’ before being exposed to ultraviolet light
- active psoriatic arthritis (inflammation of the joints associated with psoriasis) in patients who cannot take or who have not responded well enough to other treatments called disease-modifying antirheumatic drugs (DMARDs). Otezla may be used alone or combined with other DMARDs.
- Ulcers in the mouth caused by Behçet’s disease, an inflammatory disease that may affect many parts of the body.
Otezla contains the active substance apremilast.
Otezla can only be obtained with a prescription and treatment should only be started by a doctor experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis.
The medicine is available as tablets (10, 20 and 30 mg). Treatment is started with a dose of 10 mg on day 1 and gradually increased over a week to the recommended dose of 30 mg twice a day. Lower doses should be given to patients with severe impairment of kidney function. Response to treatment should be evaluated regularly and use of Otezla should be reconsidered if there is no improvement after six months.
For more information about using Otezla, see the package leaflet or contact your doctor or pharmacist.
The active substance in Otezla, apremilast, blocks the action of an enzyme inside cells called phosphodiesterase 4 (PDE4). This enzyme plays a role in triggering the production of messenger molecules in the immune system (the body’s natural defences) called cytokines, which are involved in the inflammation and other processes that cause psoriasis and psoriatic arthritis. By blocking PDE4, apremilast reduces the level of these cytokines in the body, and so reduces the inflammation and other symptoms of psoriasis, psoriatic arthritis and Behçet’s disease.
Psoriasis
In psoriasis, Otezla has been investigated in 2 main studies involving a total of 1,257 patients with moderate to severe plaque psoriasis, in which treatment with Otezla was compared with placebo (a dummy treatment). The main measure of effectiveness in both studies was the proportion of patients who ‘responded’ to treatment after 16 weeks. Response to treatment was defined as patients having a 75% or more reduction in a symptom score known as Psoriasis Area Severity Index (PASI-75). Of the patients given Otezla in these two studies, 33% (168 of 562) and 29% (79 of 274) responded to treatment. This compared with 5% (15 of 282) and 6% (8 of 137) given placebo.
Psoriatic arthritis
For psoriatic arthritis, Otezla has been compared with placebo in 3 main studies, involving 1,493 patients with active disease despite prior treatment. Patients who were already taking other so-called ‘small-molecule DMARDs’ such as the medicine methotrexate continued this treatment during the study. The main measure of effectiveness was a 20% improvement in a score measuring symptoms such as tender and swollen joints (ACR-20) after 16 weeks of treatment. This was achieved in between 32 and 41% of patients given the approved dose of Otezla in the three studies, compared with 18 to 19% of those given placebo. Benefit was seen both in patients taking Otezla alone and those also taking other DMARDs.
For both psoriasis and psoriatic arthritis benefit there was evidence of maintained benefit when treatment was extended (to 32 and 52 weeks respectively).
Behçet’s disease
For Behçet’s disease, a study in 207 patients with mouth ulcers caused by this condition compared Otezla with placebo. In this study, after 3 months, 53% of patients who took Otezla no longer had mouth ulcers compared with 22% of those who took placebo.
The most common side effects with Otezla (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), upper respiratory tract infections (colds) and headaches.
Otezla must not be used during pregnancy, and women who can become pregnant should use an effective means of contraception during treatment. For the full list of all side effects and restrictions with Otezla, see the package leaflet.
The European Medicines Agency decided that Otezla’s benefits are greater than its risks and it can be authorised for use in the EU.
Main studies showed that benefits of Otezla in reducing symptoms of psoriasis and psoriatic arthritis. Although the medicine had not been compared with other authorised treatments, and for psoriatic arthritis X-ray evidence of an effect on the progress of the disease was not available, the mostly mild or moderate side effects and the fact that the medicine could be taken by mouth might make it more acceptable to patients.
With respect to Behçet’s disease, Otezla’s was shown to be effective at reducing the number of patients’ mouth ulcers, which are common in patients with this condition and can be painful and difficult to treat.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Otezla have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Otezla are continuously monitored. Side effects reported with Otezla are carefully evaluated and any necessary action taken to protect patients.
Otezla received a marketing authorisation valid throughout the EU on on 15 January 2015.
This overview was last updated in 03-2020.
Product information
Latest procedure affecting product information:
II/0044/G
21/10/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Otezla
- Active substance
- apremilast
- International non-proprietary name (INN) or common name
- apremilast
- Therapeutic area (MeSH)
- Arthritis, Psoriatic
- Psoriasis
- Behcet Syndrome
- Anatomical therapeutic chemical (ATC) code
- L04AA32
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Psoriatic arthritis
Otezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
Psoriasis
Otezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
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