Otezla

apremilast

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This is a summary of the European public assessment report (EPAR) for Otezla. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Otezla.

For practical information about using Otezla, patients should read the package leaflet or contact their doctor or pharmacist.

What is Otezla and what is it used for?

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.

Otezla contains the active substance apremilast.

How is Otezla used?

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 further information, see the package leaflet.

How does Otezla work?

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 and psoriatic arthritis.

What benefits of Otezla have been shown in studies?

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.

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).

What are the risks associated with Otezla?

The most common side effects with Otezla (which may affect more than 1 in 10 people) are effects on the digestive system such as diarrhoea and nausea (feeling sick). These usually occur within the first two weeks of treatment, and get better within 4 weeks. The other common side effects (which may affect up to 1 in 10 people) are upper respiratory tract infections (colds) and headaches or tension 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.

Why is Otezla approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Otezla’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered thatbenefit had been shown in 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. The Committee therefore considered that it was useful as a second-line treatment in patients who do not respond to or cannot use the first-line treatments.

What measures are being taken to ensure the safe and effective use of Otezla?

A risk management plan has been developed to ensure that Otezla is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Otezla, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Otezla

The European Commission granted a marketing authorisation valid throughout the European Union for Otezla on 15 January 2015.

For more information about treatment with Otezla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Otezla : EPAR - Summary for the public BG = bălgarski 16/02/2015  
Otezla : EPAR - Summary for the public ES = español 16/02/2015  
Otezla : EPAR - Summary for the public CS = čeština 16/02/2015  
Otezla : EPAR - Summary for the public DA = dansk 16/02/2015  
Otezla : EPAR - Summary for the public DE = Deutsch 16/02/2015  
Otezla : EPAR - Summary for the public ET = eesti keel 16/02/2015  
Otezla : EPAR - Summary for the public EL = elliniká 16/02/2015  
Otezla : EPAR - Summary for the public EN = English 16/02/2015  
Otezla : EPAR - Summary for the public FR = français 16/02/2015  
Otezla : EPAR - Summary for the public IT = italiano 16/02/2015  
Otezla : EPAR - Summary for the public LV = latviešu valoda 16/02/2015  
Otezla : EPAR - Summary for the public LT = lietuvių kalba 16/02/2015  
Otezla : EPAR - Summary for the public HU = magyar 16/02/2015  
Otezla : EPAR - Summary for the public MT = Malti 16/02/2015  
Otezla : EPAR - Summary for the public NL = Nederlands 16/02/2015  
Otezla : EPAR - Summary for the public PL = polski 16/02/2015  
Otezla : EPAR - Summary for the public PT = português 16/02/2015  
Otezla : EPAR - Summary for the public RO = română 16/02/2015  
Otezla : EPAR - Summary for the public SK = slovenčina 16/02/2015  
Otezla : EPAR - Summary for the public SL = slovenščina 16/02/2015  
Otezla : EPAR - Summary for the public FI = suomi 16/02/2015  
Otezla : EPAR - Summary for the public SV = svenska 16/02/2015  
Otezla : EPAR - Summary for the public HR = Hrvatski 16/02/2015  
Name Language First published Last updated
Otezla : EPAR - Risk-management-plan summary (English only) 16/02/2015  

This EPAR was last updated on 08/02/2016 .

Authorisation details

Product details

Product details for Otezla
NameOtezla
Agency product numberEMEA/H/C/003746
Active substance

apremilast

International non-proprietary name (INN) or common name

apremilast

Therapeutic area Arthritis, PsoriaticPsoriasis
Anatomical therapeutic chemical (ATC) code L04AA32
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Otezla
Marketing-authorisation holder

Celgene Europe Limited

Revision1
Date of issue of marketing authorisation valid throughout the European Union15/01/2015

Contact address:

Celgene Europe Limited
1 Longwalk road
Stockley park
Uxbridge
Middlesex UB11 1DB 
United Kingdom

Product information

Product information

22/01/2016  Otezla -EMEA/H/C/003746 -IB/0008

Name Language First published Last updated
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016
Otezla : EPAR - Product Information EN = English 16/02/2015 08/02/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  
Otezla : EPAR - All Authorised presentations EN = English 16/02/2015  

Pharmacotherapeutic group

Immunosuppressants

Therapeutic 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).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Otezla : EPAR - Procedural steps taken and scientific information after authorisation EN = English 08/02/2016  

Initial marketing-authorisation documents

Name Language First published Last updated
Otezla : EPAR - Public assessment report EN = English 16/02/2015  
CHMP summary of positive opinion for Otezla EN = English 21/11/2014