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
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?
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
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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
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
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.
The full EPAR for Orencia can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Orencia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in