What is Aubagio - teriflunomide used for?
Aubagio is a medicine that contains the active substance teriflunomide . It is indicated for the treatment of adults with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath that covers the nerve fibers. Aubagio is indicated in the form of multiple sclerosis known as "relapsing-remitting" (that is when the patient suffers from exacerbations of symptoms (relapses) followed by periods of recovery (remissions)).
How is Aubagio - teriflunomide used?
Aubagio can only be obtained with a prescription, and treatment must be started and supervised by a doctor experienced in the management of multiple sclerosis. Aubagio is available as tablets (14 mg). The recommended dosage is 14 mg once a day.
How does Aubagio - teriflunomide work?
In multiple sclerosis the body's immune system does not function properly and attacks certain parts of the central nervous system (consisting of brain and spinal cord), causing inflammation that damages nerve sheaths. The active ingredient in Aubagio, teriflunomide, blocks an enzyme called "dihydroorotate dehydrogenase", which is necessary for cell proliferation. The exact mechanism of action of teriflunomide in multiple sclerosis is not known, but it is believed that it reduces the number of lymphocytes that form part of the immune system and are involved in the inflammatory process. By decreasing lymphocytes, inflammation is reduced and it is easier to control the symptoms of multiple sclerosis.
What benefit has Aubagio - teriflunomide shown during the studies?
Aubagio has been studied in four main studies, involving over 2 700 adults with relapsing-remitting multiple sclerosis. In a study of 179 patients the effects of Aubagio were compared to those of a placebo (a substance with no effect on the organism), examining the number of active lesions (damaged areas) by brain MRI. Aubagio was more effective than placebo: after about 9 months (36 weeks), in patients treated with Aubagio, each scan exhibited about 1 active lesion, compared to about 2.7 lesions active in subjects treated with placebo. Two studies conducted on 257 patients compared the effects of Aubagio on reducing the number of relapses per patient per year (ie the "annualized recurrence rate") with those of a placebo. The treatment lasted for a maximum period of about three years (152 weeks). Aubagio was more effective than placebo: in patients treated with Aubagio the decrease in relapses was about 30% higher than that seen in subjects treated with placebo (for Aubagio the annualized rate of recurrence was 0.35, while for the placebo it was 0.53). The studies also examined the effect of Aubagio on changes in the degree of disability of patients, showing that the risk of worsening of disability was 30% lower than that obtained with placebo after about two and a half years (132 weeks) of treatment. The fourth study, conducted on 324 patients, compared the effects of Aubagio and interferon beta-1a (another treatment of multiple sclerosis) on the therapeutic failure rate, measuring the time elapsed until the first recurrence or until the definitive interruption of the therapy. The study lasted for a maximum of two years. The results of the study did not allow definitive conclusions to be drawn. In patients treated with Aubagio, a permanent treatment interruption rate of 13.5% was observed, compared to 24% in subjects treated with interferon beta-1a. However, the relapse rate was 23.4% with Aubagio, compared with 15.4% obtained with interferon beta-1a. Overall, no conclusions could be drawn from this study regarding the differences between Aubagio and interferon beta-1a in the treatment of multiple sclerosis.
What is the risk associated with Aubagio - teriflunomide?
The most common side effects of Aubagio (which may affect more than 1 in 10 people) are influenza, upper respiratory tract infection (cold), urinary tract infection (ie structures that carry urine), paresthesia (abnormal sensations such as tingling and prickling), diarrhea, increase in liver enzymes, nausea and alopecia (hair loss). In general, diarrhea, nausea and alopecia are mild to moderate, resolve over time and usually do not require treatment interruption. For the full list of all side effects reported with Aubagio, see the package leaflet. Aubagio should not be used in patients:
- suffering from severe liver disease;
- in states of severe immunodeficiency, such as acquired immune deficiency syndrome (AIDS);
- with impaired bone marrow function or low blood cell counts (red blood cells, white blood cells or platelets);
- with serious infections in place;
- with severe renal impairment that makes dialysis necessary; with severe hypoproteinemia (decreased protein in the blood).
Aubagio must also not be used in women who are pregnant or breast-feeding. Women of child-bearing age should not take Aubagio without using reliable contraceptive measures. For the full list of limitations, see the package leaflet.
Why has Aubagio - teriflunomide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Aubagio's benefits are greater than its risks and recommended that it be approved for use in the EU. In the studies conducted Aubagio has been shown to reduce relapses and to delay the progression of disability in patients with relapsing-remitting multiple sclerosis. The effects of the medicine, albeit modest, were considered significant and similar to those observed with other multiple sclerosis therapies, although it was not possible to draw firm conclusions from direct comparison with interferon beta-1a. Aubagio is administered orally, which was considered an advantage over other medicines such as interferon beta-1a. Regarding safety, the undesirable effects were similar to those detected with the leflunomide immunosuppressant, since leflunomide is transformed into teriflunomide in the body. The risk of serious adverse effects on the liver and spinal cord is considered manageable and adequately contained with risk reduction measures.
What measures are being taken to ensure the safe and effective use of Aubagio - teriflunomide?
A risk management plan has been developed to ensure that Aubagio is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aubagio, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that produces Aubagio must ensure that all healthcare professionals who could use Aubagio receive an information pack containing important safety information, including tests and checks to be performed by patients before and after starting treatment. The package will also contain information on a register that the company will create to collect data on children born to women treated with Aubagio, as well as a reminder for patients with basic safety information.
More information on Aubagio - teriflunomide
On 26 August 2013, the European Commission issued a marketing authorization for Aubagio, valid throughout the European Union. The full EPAR for Aubagio 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 Aubagio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08-2013.
