Aubagio - teriflunomide

What is Aubagio - teriflunomide and what is it 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 an "inflammation destroys the protective sheath that lines the nerve fibers. Aubagio is indicated in the form of multiple sclerosis known as" relapsing-remitting "(when the patient suffers from exacerbations of symptoms (relapses) followed by periods of recovery (remissions)).

How is Aubagio used - teriflunomide?

Aubagio can only be obtained with a prescription, and treatment should 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 some parts of the central nervous system (made up of the brain and spinal cord), causing inflammation that damages the nerve sheaths. The active substance in Aubagio, teriflunomide, blocks an enzyme called 'dihydroorotate dehydrogenase', which is needed for cell proliferation. The exact mechanism of action of teriflunomide in multiple sclerosis is not known, but it is thought to reduce 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 involving 179 patients, the effects of Aubagio were compared with those of a placebo (a substance with no effects on the body), examining the number of active lesions (damaged areas) by means of brain magnetic resonance imaging. effective than placebo: after approximately 9 months (36 weeks), each scan showed approximately 1 active lesion in patients treated with Aubagio, compared with approximately 2.7 active lesions in subjects treated with placebo. effects of Aubagio on reducing the number of relapses per patient per year (ie the "annualized relapse rate") compared with those of a placebo. The treatment lasted for a maximum period of approximately three years (152 weeks). Aubagio was more effective than placebo: in patients treated with Aubagio the decrease in relapses was approximately 30% greater than that seen in subjects treated with placebo (for Aubagio the annualized relapse rate was 0.35 , while for placebo it was 0.53). The studies also examined the effect of Aubagio on changes in patients' degree of disability, showing that the risk of disability worsening was 30% lower than that obtained with placebo after approximately two and a half years (132 weeks) of Treatment. The fourth study, conducted in 324 patients, compared the effects of Aubagio and interferon beta-1a (another multiple sclerosis treatment) on the rate of treatment failure, measuring the time to the first relapse or to discontinuation. definitive of the therapy. The study lasted for up to two years. The results of the study did not allow definitive conclusions to be drawn. A permanent discontinuation rate of 13.5% was observed in patients treated with Aubagio, compared with 24% in subjects treated with interferon beta-1a. However, the relapse rate was 23.4% with Aubagio, compared with 15.4% 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 flu, upper respiratory tract infection (cold), urinary tract infection (ie of the structures that carry urine), paraesthesia (abnormal sensations such as tingling and pricking), diarrhea, increased 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 discontinuation of treatment. For the full list of side effects reported with Aubagio, see the package leaflet. Aubagio must not be used in patients:

  • suffering from severe liver disease;
  • in severe immunodeficiency states, for example acquired immunodeficiency syndrome (AIDS);
  • with impaired bone marrow function or low blood cell counts (red blood cells, white blood cells or platelets);
  • with severe ongoing infections;
  • with severe renal impairment requiring dialysis; with severe hypoproteinemia (decrease in blood proteins).

Aubagio must also not be used in pregnant or breastfeeding women. Women of childbearing potential should not take Aubagio without using reliable contraceptive measures. For the full list of restrictions, 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. to delay the progression of disability in patients with relapsing-remitting multiple sclerosis. The effects of the drug, although modest, were considered significant and similar to those seen with other multiple sclerosis therapies, although it was not possible to draw firm conclusions from the comparison direct with interferon beta-1a. Aubagio is administered orally, which was considered an advantage over other medicines such as interferon beta-1a. As regards safety, side effects were similar to those seen with the immunosuppressant. leflunomide, as leflunomide is transformed into teriflunomide in the body. The risk of serious side effects in the body. 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 added to the summary of product characteristics and package leaflet for Aubagio, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that makes Aubagio must ensure that all healthcare professionals who may use Aubagio receive an information pack containing important safety information, including the tests and checks that patients must undergo before and after starting therapy. The package will also contain information on a registry that the company will create to collect data on children born to women treated with Aubagio, as well as a reminder for patients with essential safety information.

Other information about Aubagio - teriflunomide

On 26 August 2013, the European Commission issued a "Marketing Authorization" for Aubagio, valid throughout the European Union. For the full version of the Aubagio EPAR, see the Agency's website: ema.Europa.eu / Find medicine / Human medicines / European public assessment reports For more information on Aubagio therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08-2013.


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