What is Entyvio - vedolizumab used for and what is it used for?
Entyvio is a medicine that contains the active substance vedolizumab . It is used to treat adult patients with ulcerative colitis (a disease that causes inflammation and ulcers in the lining of the intestine) or with Crohn's disease (a disease that causes inflammation of the gastrointestinal tract). Vedolizumab is used for the treatment of moderate to severe active disease, when conventional therapy or medicines called TNF-alpha antagonists are ineffective, are no longer effective or cannot be tolerated by the patient.
How is Entyvio - vedolizumab used?
Entyvio is available as a powder to be made into a solution for infusion (drip) into a vein. The medicine can only be obtained with a prescription and treatment should be started and supervised by a specialist who is experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease. The recommended dose is 300 mg administered at zero, two and six weeks and then every eight weeks in patients responding to therapy. Entyvio is administered as an infusion lasting 30 minutes. All patients are monitored for reactions, during the infusion and for at least one or two hours after the end of the infusion. For more information, see the package leaflet.
Patients treated with Entyvio must receive a special alert card, which summarizes the information regarding the safety of the medicine
How does Entyvio - vedolizumab work?
The active substance in Entyvio, vedolizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and bind to a specific structure (called an antigen) in the body. Vedolizumab has been studied to bind to "integrin alpha-4-beta-7", a protein that is found mainly on the surface of some white blood cells in the intestine. In ulcerative colitis and Crohn's disease these cells help cause inflammation in the intestine. By blocking the integrin alpha-4-beta-7, vedolizumab reduces inflammation in the intestine and the symptoms of these diseases. Entyvio is produced by a method known as "recombinant DNA technology"; it is made by cells in which a gene (DNA) has been introduced that allows them to produce vedolizumab.
What benefit has Entyvio - vedolizumab shown during the studies?
In ulcerative colitis, Entyvio was tested in a main study conducted in patients with moderate to severe active disease in which conventional therapy or TNF-alpha antagonists were ineffective or not tolerated. Patients received Entyvio or placebo (a dummy treatment) and the main measure of effectiveness was the percentage of patients who showed improvement in symptoms after 6 weeks of treatment. Entyvio was more effective than placebo: 47% of patients (106 of 225) treated with Entyvio showed improvement in their symptoms, compared with 26% of patients (38 of 149) who received placebo. Furthermore, the study showed that Entyvio maintained the effect for up to 52 weeks, more effectively than placebo. Entyvio was also more effective than placebo at improving symptoms of Crohn's disease. In one main study, conducted in adult patients with moderate to severe active Crohn's disease in whom conventional therapy or TNF-alpha antagonists were ineffective or not tolerated, 15% of patients (32 out of 220) treated with Entyvio showed an improvement in symptoms after 6 weeks of treatment, compared to 7% of patients (10 out of 148) treated with placebo. Similarly, in this study the maintenance of the effect for up to 52 weeks with Entyvio was more effective than with placebo.
What is the risk associated with Entyvio - vedolizumab?
The most common side effects of Entyvio (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat, such as a cold), headache and arthralgia (joint pain). For the full list of all side effects reported with Entyvio, see the package leaflet. Entyvio should not be used in people with serious infections such as tuberculosis, sepsis (blood infection), listeriosis (infection with bacteria called Listeria) or opportunistic infections (those seen in patients with a weakened immune system), such as progressive multifocal leukoencephalopathy ( PML, a rare brain infection that usually leads to severe disability or death). For the full list of limitations, see the package leaflet.
Why has Entyvio - vedolizumab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entyvio's benefits are greater than its risks and recommended that it be approved for use in the EU. In ulcerative colitis, the committee considered that the benefits of Entyvio had been clearly demonstrated, and this is important for patients who do not respond to TNF-alpha antagonist therapy. Furthermore, the risks are considered manageable, despite the lack of long-term security data, if the existing recommendations are followed. In Crohn's disease, the CHMP believes that although the time required for improvement of symptoms may be longer and the magnitude of the effect limited compared to anti-TNF-alpha therapy, Entyvio still offers a benefit for patients, thanks to its different mechanism of action and its safety profile.
What measures are being taken to ensure the safe and effective use of Entyvio - vedolizumab?
A risk management plan has been developed to ensure that Entyvio 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 Entyvio, including the appropriate precautions to be followed by healthcare professionals and patients. The company will also provide training material to all healthcare professionals designed to prescribe Entyvio, to remind them of the need to keep patients under observation in order to detect any signs of neurological disease or PML, particularly those treated with certain biopharmaceuticals that could cause PML. Further information is available in the summary of the risk management plan.
Other information on Entyvio - vedolizumab
On 22 May 2014, the European Commission issued a marketing authorization for Entyvio, valid throughout the European Union. For more information about treatment with Entyvio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 06-2014.
