Orencia

abatacept

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This is a summary of the European public assessment report (EPAR) for Orencia. 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 Orencia.

What is Orencia?

Orencia is a medicine that contains the active substance abatacept. It is available as a powder that is made up into a solution for infusion (drip) into a vein and as a solution for injection under the skin in prefilled syringes and pre-filled pens.

What is Orencia used for?

Orencia is used in combination with methotrexate (a medicine that acts on the immune system) to treat the following diseases:

  • moderate to severe active rheumatoid arthritis (an immune-system disease causing damage and inflammation in the joints) in adults (aged 18 years or over) who have not had an adequate response to other medicines including methotrexate or a ‘tumour-necrosis-factor (TNF) blocker’;
  • moderate to severe active polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints) in adolescents and children from six years of age who have not had a sufficient response to other medicines including one TNF blocker.

The medicine can only be obtained with a prescription.

How is Orencia used?

Treatment with Orencia should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of rheumatoid arthritis or juvenile idiopathic arthritis.

Orencia given by infusion can be used for both rheumatoid and juvenile idiopathic arthritis. The infusion should last 30 minutes. The dose to use depends on the patient’s weight. It is given every two weeks for the first three doses, and then every four weeks. If there is no response within six months, the doctor should consider whether treatment should continue or not.

The solution for injection is only for use in rheumathoid arthritis and is given as an injection under the skin. If the patient is taking Orencia for the first time, the infusion should be used for the first administration, followed by an injection under the skin the next day. Subsequently, the patient will have an injection under the skin once a week. After being properly trained, patients may inject themselves if their doctor deems it appropriate.

Patients who are unable to receive an infusion may start treatment by injection under the skin.

How does Orencia work?

The active substance in Orencia, abatacept, is a protein that has been designed to suppress the activity of ‘T cells’, immune system cells that are involved in causing the inflammation in rheumatoid and polyarticular juvenile idiopathic arthritis. T cells must be ‘activated’ before they work. This happens when some signal molecules attach to receptors on the surface of the T cells. Abatacept has been designed to attach to two of these signal molecules called CD80 and CD86. This stops them activating the T cells, helping to reduce the inflammation and other symptoms of the diseases.

How has Orencia been studied?

In rheumatoid arthritis, Orencia infusion has been studied in three main studies involving a total of 1,382 adults. The first two studies included a total of 991 patients who had not had an adequate response to methotrexate in the past, and the third included 391 patients who had not had an adequate response to TNF blockers in the past. All three studies compared the effects of adding Orencia or placebo (a dummy treatment) with the other medicines that the patients were already taking for rheumatoid arthritis: these did not include a TNF blocker. In all these studies, the main measures of effectiveness were the reduction in symptoms of arthritis after six months of treatment, as well as physical function (the ability to carry out everyday tasks) and the amount of damage to the joints (assessed using X‑rays). In addition, Orencia given by injection under the skin has been compared with Orencia infusion in a study involving around 1,371 patients with rheumatoid arthritis.

In polyarticular juvenile idiopathic arthritis, Orencia infusion has been studied in one main study involving patients aged between six and 17 years whose previous treatment had failed. All of the patients received Orencia for four months, before the 122 who responded were then either switched to placebo or continued receiving Orencia. The main measure of effectiveness was how long it was before the patient’s disease flared up again. Around three quarters of the patients were also taking methotrexate.

What benefit has Orencia shown during the studies?

In rheumatoid arthritis, Orencia was more effective than placebo in improving symptoms in all of the studies. In the first study, 61% of the patients adding the approved dose of Orencia to methotrexate had a reduction in symptoms (70 out of 115), compared with 35% of the patients adding placebo (42 out of 119). The second study showed a similar effect of Orencia on symptoms of rheumatoid arthritis, as well as improved physical function and a reduced rate of joint damage after a year of treatment.

In the study of rheumatoid arthritis patients with an inadequate response to TNF blockers in the past, adding Orencia to existing treatment led to 50% of the patients having a reduction in symptoms (129 out of 256), compared with 20% of the patients adding placebo (26 out of 133). Patients taking Orencia also had a greater improvement in physical function after six months.

Orencia given by injection under the skin to patients with rheumatoid arthritis showed a similar benefit to Orencia given by infusion.

In polyarticular juvenile idiopathic arthritis, it took longer for the disease to flare up in the patients continuing to receive Orencia than those who switched to placebo. Over six months, 20% of the patients receiving Orencia had a flare-up (12 out of 60), compared with 53% of those receiving placebo (33 out of 62).

What is the risk associated with Orencia?

The most common side effect in adults taking Orencia (seen in more than 1 patient in 10) is upper-respiratory-tract infection (colds). In younger patients, side effects are similar to adults. For the full list of all side effects reported with Orencia, see the package leaflet.

Orencia must not be used in patients with severe and uncontrolled infections, such as sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) or ‘opportunistic’ infections (infections seen in patients with a weakened immune system). For the full list of restrictions, see the package leaflet.

Why has Orencia been approved?

The CHMP concluded that Orencia had a modest anti‑inflammatory effect in rheumatoid arthritis and, in combination with methotrexate, led to a reduction in the worsening of joint damage and an improvement in physical function. It also concluded that Orencia could be a valuable new tool in the treatment of polyarticular juvenile idiopathic arthritis. The Committee decided that Orencia’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 Orencia?

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

In addition, patients who receive Orencia are given a special alert card explaining that Orencia must not be used in patients with certain infections and instructing patients to contact their doctor immediately if they develop an infection during a course of treatment.

Other information about Orencia

The European Commission granted a marketing authorisation valid throughout the European Union for Orencia on 21 May 2007.

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

Name Language First published Last updated
Orencia : EPAR - Summary for the public BG = bălgarski 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public ES = español 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public CS = čeština 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public DA = dansk 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public DE = Deutsch 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public ET = eesti keel 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public EL = elliniká 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public EN = English 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public FR = français 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public IT = italiano 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public LV = latviešu valoda 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public LT = lietuvių kalba 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public HU = magyar 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public MT = Malti 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public NL = Nederlands 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public PL = polski 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public PT = português 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public RO = română 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public SK = slovenčina 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public SL = slovenščina 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public FI = suomi 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public SV = svenska 05/06/2007 30/06/2015
Orencia : EPAR - Summary for the public HR = Hrvatski 05/06/2007 30/06/2015

This EPAR was last updated on 28/07/2016 .

Authorisation details

Product details

Product details for Orencia
NameOrencia
Agency product numberEMEA/H/C/000701
Active substance

abatacept

International non-proprietary name (INN) or common name

abatacept

Therapeutic area Arthritis, RheumatoidArthritis, Juvenile Rheumatoid
Anatomical therapeutic chemical (ATC) code L04AA24

Publication details

Publication details for Orencia
Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

Revision22
Date of issue of marketing authorisation valid throughout the European Union21/05/2007

Contact address:

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
United Kingdom

Product information

Product information

09/06/2016  Orencia -EMEA/H/C/000701 -II/0099/G

Name Language First published Last updated
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016
Orencia : EPAR - Product Information HR = Hrvatski 08/07/2009 28/07/2016

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
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015
Orencia : EPAR - All Authorised presentations HR = Hrvatski 05/06/2007 30/06/2015

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis

Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) including methotrexate or a tumour-necrosis-factor (TNF)-alfa inhibitor.

A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.

Polyarticular juvenile idiopathic arthritis

Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in paediatric patients six years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor. 

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Orencia : EPAR - Procedural steps taken before authorisation HR = Hrvatski 05/06/2007  
Orencia : EPAR - Scientific Discussion HR = Hrvatski 05/06/2007