Orencia

abatacept

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

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

What is Orencia and what is it used for?

Orencia is a medicine that is often 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 using it in combination with methotrexate when other medicines including methotrexate or a ‘tumour necrosis factor (TNF) blocker’ have not worked well enough;
  • highly active and progressive rheumatoid arthritis, used in combination with methotrexate in adults who have not previously been treated with methotrexate;
  • moderate to severe active polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), used in combination with methotrexate in adolescents and children from six years of age in whom other medicines including at least one TNF blocker have not worked well enough.
  • psoriatic arthritis (arthritis combined with psoriasis, a condition causing red, scaly patches on the skin) in adults in whom treatment with other medicines, including methotrexate, has not worked well enough. It is used alone or in combination with methotrexate for patients who do not need other medicines by mouth or by injection to control their psoriasis.

Orencia contains the active substance abatacept.

How is Orencia used?

Orencia can only be obtained with a prescription, and treatment with it should be started and supervised by a specialised doctor with experience in the diagnosis and treatment of rheumatoid arthritis or juvenile idiopathic arthritis.

Orencia 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 pre-filled syringes and pre-filled pens. Orencia given by infusion can be used for rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis. The dose depends on the patient’s weight. It is given every two weeks for the first three doses, and then every four weeks.

Orencia can be injected under the skin for rheumatoid arthritis and psoriatic arthritis. It is given once a week. In rheumatoid arthritis, if the patient is receiving Orencia for the first time, the first dose can be given by infusion. In this case it should be followed by an injection under the skin the next day. Subsequently, it is injected under the skin once a week. After being trained and with the agreement of their doctor, patients may inject themselves.

If Orencia has not worked within six months, the doctor should consider if treatment should continue.

How does Orencia work?

The active substance in Orencia, abatacept, is a protein that suppresses the activation of T cells. T cells are immune system cells that are involved in causing the inflammation in rheumatoid and polyarticular juvenile idiopathic arthritis. T cells are activated when signal molecules attach to receptors on the cells. By attaching to signal molecules called CD80 and CD86, abatacept stops them activating the T cells, helping to reduce the inflammation and other symptoms of the diseases.

What benefits has Orencia have been shown in studies?

Rheumatoid arthritis

Four main studies involving a total of 1,733 adults found Orencia effective in rheumatoid arthritis. The main measures of effectiveness were the reduction in symptoms of arthritis after 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).

The first two studies included 991 patients in whom methotrexate had not worked well enough. In the first study, symptoms of the disease were reduced in 61% (70 out of 115) of the patients adding the recommended dose of Orencia to methotrexate for 6 months, compared with 35% (42 out of 119) of the patients adding placebo (a dummy treatment). The second study found 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.

The third study included 391 patients in whom TNF blockers had not worked well enough. Adding Orencia to existing treatment led to a reduction in symptoms in 50% of the patients (129 out of 256) after 6 months, 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.

In the fourth study, Orencia in combination with methotrexate was compared with Orencia alone and methotrexate alone in 351 adults who had not been treated with methotrexate (or with any biologic agents such as TNF alpha blockers), but may have been on other medicines for management of rheumatoid arthritis. Adding Orencia and methotrexate to existing treatment for 12 months reduced symptoms in 61% of the patients (70 out of 115), compared with 42% of the patients on Orencia alone (48 out of 113) and 45% of the patients on methotrexate alone (52 out of 115).

In addition, a study involving around 1,370 patients with rheumatoid arthritis found similar benefit for both Orencia given by injection under the skin and Orencia given by infusion.

Polyarticular juvenile idiopathic arthritis

In polyarticular juvenile idiopathic arthritis, Orencia infusion was found effective in one main study involving patients aged between 6 and 17 years whose previous treatment had not worked. The main measure of effectiveness was how long it was before the patient’s disease flared up again. All patients received Orencia for 4 months, after which the 122 whose condition had improved on Orencia were either switched to placebo or continued receiving Orencia. Around three-quarters of the patients were also taking methotrexate. 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).

Psoriatic arthritis

Orencia was found effective in one main study involving 424 adult patients with psoriatic arthritis. The study included 259 patients who had previously been treated with a TNF alpha blocker. In around 60% of these patients the TNF alpha blocker had not worked well enough. The main measure of effectiveness was a reduction in symptoms of at least 20% after 24 weeks of treatment. Orencia given by injection under the skin reduced symptoms in 39% of the patients (84 out of 213) compared with 22% of the patients (47 out of 211) who received placebo.

In another study involving 170 patients with psoriatic arthritis, Orencia given by infusion at the recommended dose reduced symptoms by at least 20% after 24 weeks in over 47% of the patients (19 out of 40) compared with 19% of the patients (8 out of 42) who received placebo.

What are the risks associated with Orencia?

The most common side effects in adults taking Orencia (seen in more than 1 patient in 10) are upper respiratory tract infections (nose and throat infection). In younger patients, the most common side effects (seen in up to 1 in 10 patients) are upper respiratory tract infections, ear infection, blood in the urine and fever.

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 side effects and restrictions, see the package leaflet.

Why is Orencia approved?

The European Medicines Agency concluded that Orencia had a modest anti‑inflammatory effect in rheumatoid arthritis and, in combination with methotrexate, it reduced the worsening of joint damage and improved physical function. The Agency also concluded that Orencia could be a valuable option in the treatment of polyarticular juvenile idiopathic arthritis. Orencia reduced symptoms of psoriatic arthritis when used alone or in combination with methotrexate in patients whose psoriasis was not severe enough to require additional medicines given by mouth or by injection. The Agency 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?

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orencia have also been included in the summary of product characteristics and the package leaflet.

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 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public ES = español 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public CS = čeština 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public DA = dansk 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public DE = Deutsch 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public ET = eesti keel 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public EL = elliniká 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public EN = English 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public FR = français 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public IT = italiano 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public LV = latviešu valoda 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public LT = lietuvių kalba 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public HU = magyar 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public MT = Malti 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public NL = Nederlands 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public PL = polski 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public PT = português 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public RO = română 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public SK = slovenčina 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public SL = slovenščina 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public FI = suomi 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public SV = svenska 2007-06-05 2017-08-09
Orencia : EPAR - Summary for the public HR = Hrvatski 2007-06-05 2017-08-09

This EPAR was last updated on 09/08/2017 .

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

Revision25
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

25/07/2017  Orencia -EMEA/H/C/000701 -II/0105

Name Language First published Last updated
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09
Orencia : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-08-09

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

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis ORENCIA, in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
  • the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.

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

Psoriatic Arthritis

ORENCIA, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.

Polyarticular juvenile idiopathic arthritis

ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 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 2007-06-05  
Orencia : EPAR - Scientific Discussion HR = Hrvatski 2007-06-05