Enbrel

etanercept

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This is a summary of the European public assessment report (EPAR) for Enbrel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Enbrel.

What is Enbrel?

Enbrel is a medicine that contains the active substance etanercept. It is available as vials containing a powder that is made up into a solution for injection, and as prefilled syringes and pens containing a solution for injection.

What is Enbrel used for?

Enbrel is an anti-inflammatory medicine. It is used for the treatment of the following diseases:

  • moderate to severe rheumatoid arthritis (an immune-system disease causing inflammation of the joints) in adults (aged 18 years or over). Enbrel is used with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient. Enbrel can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before;
  • certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints) in the following groups:
    • patients aged two to 17 years who have polyarthritis (rheumatoid-factor-positive or -negative) and extended oligoarthritis and have not responded adequately to or cannot take methotrexate;
    • adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and have not responded adequately to or cannot take methotrexate;
    • adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment;
  • psoriatic arthritis in adults who have not responded adequately to other treatments;
  • severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults who have not responded adequately to other treatments;
  • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults with moderate to severe disease and in patients from the age of six years with long-term severe disease. Enbrel is used in patients who have not responded to or cannot receive other treatments for this disease.
  • Severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray.

For more information, see the summary of product characteristics (also part of the EPAR).

The medicine can only be obtained with a prescription.

How is Enbrel used?

Enbrel treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Enbrel is used to treat.

Enbrel is given by injection under the skin. For adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week. Treatment with 50 mg twice a week can also be used during the first 12 weeks of treatment for plaque psoriasis. For patients below 18 years of age, the dose depends on body weight. The patient or carer can give the injection if they have been trained appropriately. For more information, see the package leaflet.

Patients who take Enbrel must be given the special alert card that summarises important safety information about the medicine.

How does Enbrel work?

The active substance in Enbrel, etanercept, is a protein that has been designed to block the activity of a chemical messenger in the body called tumour necrosis factor (TNF). This messenger is found at high levels in patients with the diseases that Enbrel is used to treat. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases. Etanercept is produced by a method known as ‘recombinant DNA technology’: it is made by cells that have received a gene (DNA) that makes them able to produce etanercept.

How has Enbrel been studied?

Enbrel has been studied in five main studies in rheumatoid arthritis, involving about 2,200 patients and lasting from three months to two years. Three studies compared Enbrel with placebo (a dummy treatment) in patients who had taken arthritis medicines in the past. One of these studies examined Enbrel’s effects as an add-on to methotrexate in 89 patients. In the fourth study, Enbrel was compared with methotrexate in 632 patients who had not taken methotrexate before. The fifth study compared the effectiveness of Enbrel, methotrexate and a combination of both in 686 patients.

Enbrel was also compared with placebo in 51 children with polyarticular juvenile idiopathic arthritis, 205 adults with psoriatic arthritis, 357 adults with ankylosing spondylitis, 1,263 adults and 211 children with plaque psoriasis, as well as in 225 patients with non-radiographic axial spondyloarthritis. In all of the studies, the main measure of effectiveness was the change in symptoms.

The studies in children with polyarticular juvenile idiopathic arthritis and plaque psoriasis were followed up with long-term studies to assess the safety of long-term treatment in children.

What benefit has Enbrel shown during the studies?

Overall, in the studies of rheumatoid arthritis, about two thirds of the patients receiving Enbrel had a reduction in symptoms of 20% or more after three months. This compared with around a quarter of the patients receiving placebo. In the study of patients who had not taken methotrexate before, those receiving 25 mg Enbrel twice a week had less joint damage than those taking methotrexate alone after 12 and 24 months. In the fifth study, Enbrel on its own or in combination with methotrexate was more effective than methotrexate alone.

For all other diseases studied, Enbrel produced a greater improvement in symptoms than placebo after three to four months.

The long term safety studies found that Enbrel could be used in polyarticular juvenile idiopathic arthritis in children from the age of two years and plaque psoriasis from the age of six years.

What is the risk associated with Enbrel?

The most common side effects with Enbrel (seen in more than 1 patient in 10) are injection site reactions (including bleeding, bruising, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections). Patients developing a serious infection should stop Enbrel treatment. For the full list of all side effects reported with Enbrel, see the package leaflet.

Enbrel must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections.

For the full list of restrictions, see the package leaflet.

Why has Enbrel been approved?

The CHMP decided that Enbrel’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

A risk management plan has been developed to ensure that Enbrel 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 Enbrel, including the appropriate precautions to be followed by healthcare professionals and patients.

The company that makes Enbrel will provide educational material for doctors expected to prescribe the product (to teach patients how to use the pre-filled pen correctly) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).

Other information about Enbrel

The European Commission granted a marketing authorisation valid throughout the European Union for Enbrel on 3 February 2000.

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

Name Language First published Last updated
Enbrel : EPAR - Summary for the public BG = bălgarski 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public ES = español 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public CS = čeština 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public DA = dansk 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public DE = Deutsch 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public ET = eesti keel 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public EL = elliniká 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public EN = English 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public FR = français 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public IT = italiano 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public LV = latviešu valoda 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public LT = lietuvių kalba 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public HU = magyar 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public MT = Malti 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public NL = Nederlands 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public PL = polski 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public PT = português 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public RO = română 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public SK = slovenčina 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public SL = slovenščina 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public FI = suomi 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public SV = svenska 11/09/2009 03/09/2014
Enbrel : EPAR - Summary for the public HR = Hrvatski 11/09/2009 03/09/2014

This EPAR was last updated on 04/05/2016 .

Authorisation details

Product details

Product details for Enbrel
NameEnbrel
Agency product numberEMEA/H/C/000262
Active substance

etanercept

International non-proprietary name (INN) or common name

etanercept

Therapeutic area Spondylitis, AnkylosingArthritis, RheumatoidArthritis, PsoriaticPsoriasisArthritis, Juvenile Rheumatoid
Anatomical therapeutic chemical (ATC) code L04AB01

Publication details

Publication details for Enbrel
Marketing-authorisation holder

Pfizer Limited

Revision48
Date of issue of marketing authorisation valid throughout the European Union03/02/2000

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

Product information

01/04/2016  Enbrel -EMEA/H/C/000262 -II/0194

Name Language First published Last updated
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016
Enbrel : EPAR - Product Information HR = Hrvatski 11/09/2009 04/05/2016

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
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014
Enbrel : EPAR - All Authorised presentations HR = Hrvatski 11/09/2009 03/02/2014

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis

Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.

Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.

Juvenile idiopathic arthritis

Treatment of polyarthritis (rheumatoid-factor-positive or -negative) and extended oligoarthritis in children and adolescents from the age of two years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Enbrel has not been studied in children aged less than two years.

Psoriatic arthritis

Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.

 Axial spondyloarthritis

Ankylosing spondylitis (AS)

Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Non-radiographic axial spondyloarthritis

Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). 

Plaque psoriasis

Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).

Paediatric plaque psoriasis

Treatment of chronic severe plaque psoriasis in children and adolescents from the age of six years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Enbrel : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 11/09/2009 04/05/2016
Enbrel-H-C-262-P46-0163 : EPAR - Assessment Report HR = Hrvatski 24/03/2015  
Enbrel-H-C-262-II-0167 : EPAR - Assessment Report - Variation HR = Hrvatski 03/09/2014  
CHMP post-authorisation summary of positive opinion for Enbrel HR = Hrvatski 27/06/2014  
Enbrel-H-C-262-P46-134: EPAR - Assessment Report HR = Hrvatski 17/01/2013  
Enbrel-H-C-262-P46-145.1: EPAR - Assessment Report HR = Hrvatski 17/01/2013  
Enbrel-H-C-262-P46-134.1 : EPAR - Assessment Report HR = Hrvatski 17/01/2013  
Enbrel-H-C-262-P46-145: EPAR - Assessment Report HR = Hrvatski 17/01/2013  
Enbrel-H-C-262-II-145 : EPAR - Assessment Report - Variation HR = Hrvatski 24/08/2012  
CHMP post-authorisation summary of positive opinion for Enbrel HR = Hrvatski 22/06/2012  
Enbrel-H-C-262-II-126 : EPAR - Assessment Report - Variation HR = Hrvatski 26/09/2011  
Enbrel-H-C-262-II-134 : EPAR - Assessment Report - Variation HR = Hrvatski 26/09/2011  
CHMP post-authorisation summary of positive opinion for Enbrel HR = Hrvatski 22/07/2011  
CHMP post-authorisation summary of positive opinion for Enbrel HR = Hrvatski 22/07/2011  
Enbrel : EPAR - Steps taken after authorisation when a cutoff date has been used HR = Hrvatski 18/10/2006 20/01/2010
Enbrel-H-C-262-II-94 : EPAR - Assessment Report - Variation HR = Hrvatski 05/02/2009  
CHMP post-authorisation summary of positive opinion for Enbrel on 20 November 2008 HR = Hrvatski 19/11/2008  
Enbrel-H-C-262-X-47 : EPAR - Scientific Discussion - Extension HR = Hrvatski 18/10/2006  

Initial marketing-authorisation documents

Name Language First published Last updated
Enbrel : EPAR - Procedural steps taken before authorisation HR = Hrvatski 18/10/2006  
Enbrel : EPAR - Scientific Discussion HR = Hrvatski 18/10/2006