What is RoActemra?
RoActemra is a concentrate for the preparation of a solution for infusion (drip into a vein). It contains the active substance tocilizumab.
What is RoActemra used for?
RoActemra is used to treat moderate to severe active patients with rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints). The medicine is used in combination with methotrexate (another medicine used against rheumatoid arthritis) in patients who have not responded satisfactorily to other treatments or who do not tolerate other treatments, including conventional drugs for rheumatoid arthritis ( like methotrexate) or tumor necrosis factor inhibitors (TNF). RoActemra can be used alone in patients who cannot be treated with methotrexate.
The medicine can only be obtained with a prescription.
How is RoActemra used?
Treatment with RoActemra should be established by a doctor experienced in the diagnosis and treatment of rheumatoid arthritis.
RoActemra is given every four weeks for an hour-long infusion. The recommended dose is 8 mg per kilogram of body weight. The minimum dose is 480 mg; doses above 1200 mg have not been tested. If the patient develops liver or blood problems, it may be necessary to adapt the dose of RoActemra or methotrexate or discontinue treatment. The renal state of patients with moderate to severe kidney problems should be carefully monitored by the doctor.
Patients taking RoActemra should be given the special alert card containing a summary of the safety data for the medicine.
How does RoActemra work?
The active ingredient of RoActemra is tocilizumab, a monoclonal antibody, or an antibody (a type of protein) made to recognize a specific structure (antigen) present in the body and bind to it. Tocilizumab was made to bind to the receptor of a messenger molecule (cytokine) present in the body, interleukin-6. It is involved in the genesis of inflammation and is present at high levels in patients with rheumatoid arthritis. By preventing interleukin-6 from attacking the receptors, tocilizumab reduces inflammation and other symptoms of rheumatoid arthritis.
What studies have been carried out on RoActemra?
The effects of RoActemra were first tested in experimental models before being studied in humans.
RoActemra has been the subject of five main studies involving a total of over 4000 adults with moderate to severe rheumatoid arthritis. Four of these studies compared RoActemra with a placebo (a dummy treatment). In three of these studies, medicines were administered to over 3, 000 patients altogether in addition to the unsuccessful treatment of methotrexate or other medicines for rheumatoid arthritis. In the fourth study, the drugs were administered in combination with methotrexate in 498 patients with insufficient response to previous treatment with TNF inhibitors. The fifth study compared RoActemra administered alone with methotrexate in a total of 673 patients. In all five studies the main measure of effectiveness was the number of patients who responded to treatment after six months. Response was intended to reduce symptom scores by at least 20%, measured using a standard rheumatoid arthritis scale.
A total of 2439 patients who participated in these studies also underwent two studies on the long-term effects of RoActemra treatment.
What benefit has RoActemra shown during the studies?
RoActemra was more effective than comparator medicines in reducing the symptoms of rheumatoid arthritis.
In the three studies of patients with insufficient methotrexate response or other conventional treatments for rheumatoid arthritis, in patients who added the approved dose of RoActemra, the probability of treatment response is approximately quadrupled compared to patients who added placebo . In the study of patients with insufficient response to TNF inhibitors, patients treated with RoActemra and methotrexate had about nine times greater chance of positive response than those treated with placebo. The fifth study showed that patients taking RoActemra alone were more likely to have a positive response than patients taking methotrexate alone.
Long-term studies have shown that the response to RoActemra lasts for at least a year.
What is the risk associated with RoActemra?
The most common side effect associated with RoActemra (or that seen in more than 1 in 10 patients) is upper respiratory tract infections (colds). For the full list of all side effects reported with RoActemra, see the Package Leaflet.
RoActemra should not be used in patients who may be hypersensitive (allergic) to tocilizumab or any of the other ingredients. It should also not be used in patients with severe ongoing infection. During treatment, doctors must carefully monitor patients for signs of infection, prescribing RoActemra with caution in patients with a history of recurrent or long-term infections, or diseases that could increase the risk of infection, such as diverticulitis (infection of the intestine). ) or diabetes.
Why has RoActemra been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that RoActemra's benefits are greater than its risks, in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately, or could not tolerate the previous therapy based on one or more antirheumatic drugs that modify the course of the disease or TNF antagonists, or in monotherapy in cases of intolerance to methotrexate or where it is not appropriate to continue treatment with methotrexate. The committee recommended the granting of the marketing authorization for RoActemra.
What measures are being taken to ensure the safe use of RoActemra?
The company that makes RoActemra is committed to providing information kits for doctors, nurses and patients before marketing the medicine in the various Member States. These kits will include information on the safety of RoActemra and how to administer it to patients.
More information on RoActemra:
On 16 January 2009, the European Commission granted a marketing authorization for RoActemra, valid throughout the European Union, to Roche Registration Limited.
For the full EPAR version of RoActemra, click here.
Last update of this summary: 12-2008.
