What is ORENCIA?
ORENCIA is a vial containing a powder for solution for infusion. Each vial contains 250 mg of the active substance abatacept.
What is ORENCIA used for?
ORENCIA is an anti-inflammatory drug that is used in combination with methotrexate (another drug that acts on the immune system) in the treatment of moderate to severe active rheumatoid arthritis in adult patients. Rheumatoid arthritis is a disease of the immune system that causes inflammation and joint injuries. ORENCIA is used in patients who have had an insufficient response to other antirheumatic drugs, including at least one "tumor necrosis factor inhibitor" (TNF), or who cannot take such drugs.
The medicine can only be obtained with a prescription.
How is ORENCIA used?
Treatment with ORENCIA should be started and followed by a specialist doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
ORENCIA should be administered as an intravenous infusion (drip into a vein) lasting 30 minutes at a dose of 500, 750 or 1 000 mg. The dose to be used depends on the patient's weight. In the first month it should be given every two weeks (3 doses) and then every 4 weeks. If there is no response within 6 months, the potential benefits of continuation of treatment, potential risks and therapeutic alternatives must be considered.
How does ORENCIA work?
The active ingredient in ORENCIA, abatacept, is a protein produced to suppress the activity of "T cells", that is, specific cells present in the immune system (the body's defense system) that are responsible for inflammation and damage to load of the joints in rheumatoid arthritis.
In order to act, the T cells must first be "activated". This occurs when some molecules ("signals") bind to receptors on the surface of these T cells. Abatacept was produced to bind to two of these molecules (CD80 and CD86), thus preventing them from activating the T cells. This helps reduce inflammation, improving joint damage and other symptoms of the disease.
Abatacept is produced by a method known as "recombinant DNA technology": that is, it is obtained from a cell equipped with a gene (DNA) that makes it able to produce it.
How has ORENCIA been studied?
The effects of ORENCIA were first tested in experimental models before being studied in humans. ORENCIA has been studied in three main studies involving 1 382 patients with rheumatoid arthritis. The first two studies involved 991 patients who had not shown an adequate response to methotrexate; the third study involved 391 patients who had not shown an adequate response to TNF inhibitors in the past. All three studies compared the effects of ORENCIA or placebo (substance without effects on the organism) as an adjunctive therapy compared to other drugs that patients were already taking in the treatment of rheumatoid arthritis, among which however it was not present a TNF inhibitor. The main indicators of effectiveness were the reduction of arthritis symptoms after 6 months of treatment, the physical function and the extent of damage to the joints (assessed using the radiographic method).
In a further study the effects of the addition of ORENCIA, infliximab (a TNF inhibitor) or placebo to the methotrexate-containing treatment were compared. This study involved 266 patients who had not shown an adequate response to methotrexate.
What benefit has ORENCIA shown during the studies?
ORENCIA was more effective than placebo in improving the symptoms of rheumatoid arthritis in all
studies. In the first study, 70 patients (60.9%) out of 115 who had added the approved dose of ORENCIA to methotrexate reported at least a 20% reduction in symptoms compared to 42 patients (35.3%) out of 119 who had added placebo. The second study showed a similar effect of ORENCIA on the symptoms of rheumatoid arthritis, as well as an improvement in physical function and a reduction in the progression of joint damage after one year of treatment.
In the study of patients who previously had an inadequate response to TNF inhibitors, the addition of ORENCIA to the ongoing treatment led to a reduction of at least 20% of the symptoms in 129 patients (50.4%) out of 256 patients compared to 26 patients (19.5%) out of 113 treated with placebo. Patients who took ORENCIA also showed greater improvement in physical function after 6 months of treatment.
The additional study confirmed the improvement of symptoms with ORENCIA in patients who had not had an adequate response to methotrexate. The response after 6 months was similar to that observed with infliximab.
What is the risk associated with ORENCIA?
The most common side effect with ORENCIA (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with ORENCIA, see the Package Leaflet. ORENCIA should not be used in people who may be hypersensitive (allergic) to abatacept or any of the other substances. It is also not indicated in patients suffering from serious and uncontrolled infections, such as sepsis (a serious blood infection) or "opportunistic" infections (observed in patients with a damaged immune system). Patients treated with ORENCIA are given a special alert card explaining these restrictions and advising them to contact their doctor immediately if an infection develops during treatment with ORENCIA.
Why has ORENCIA been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that ORENCIA has a modest anti-inflammatory effect and that, in combination with methotrexate, it inhibits the progression of joint damage and leads to an improvement in physical function.
The committee decided that the benefits of ORENCIA outweigh the risks in the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying drugs including at least one necrosis factor inhibitor tumor (TNF), and therefore recommended that it be given marketing authorization.
More information on ORENCIA:
On May 21, 2007, the European Commission issued an ORENCIA marketing authorization to Bristol-Myers Squibb Pharma EEIG, valid throughout the European Union.
The full EPAR for ORENCIA can be found here.
Last update of this summary: 04-2007
