What is Entyvio - vedolizumab 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 gut) or with Crohn's disease (a disease that causes inflammation of the gastrointestinal tract). Vedolizumab is used to treat active disease moderate to severe, when conventional therapy or medicines called TNF-alpha antagonists are ineffective, no longer effective or cannot be tolerated by the patient.
How is Entyvio used - vedolizumab?
Entyvio is available as a powder to be made up 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 experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease. The recommended dose is 300 mg given at zero, two and six weeks and every eight weeks thereafter in patients who respond to therapy. Entyvio is given as an infusion lasting 30 minutes. All patients are monitored for any 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 should 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 attach to a specific structure (called an antigen) in the body. Vedolizumab has been designed to attach to 'integrin alpha-4-beta-7', a protein that it is found mainly on the surface of some white blood cells in the intestine. In ulcerative colitis and Crohn's disease, these cells contribute to inflammation in the intestines. By blocking integrin alpha-4-beta-7, vedolizumab reduces inflammation in the gut and the symptoms of these diseases. Entyvio is produced by a method known as 'recombinant DNA technology'; it is made by cells into which it was introduced. a gene (DNA) that allows them to make vedolizumab.
What benefit has Entyvio - vedolizumab shown during the studies?
In ulcerative colitis, Entyvio was tested in one main study in patients with moderate to severe active disease in whom 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 proportion of patients who had improvement in symptoms after 6 weeks of treatment. Entyvio was more effective than placebo: 47% of patients (106 out of 225) treated with Entyvio showed improvement in symptoms, compared with 26% of patients (38 out of 149) who received placebo. Furthermore, the study showed that Entyvio maintained the effect for up to 52 weeks, with greater efficacy than placebo. Entyvio was also more effective than placebo in 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 with 7% of patients (10 out of 148) treated with placebo. Similarly, maintenance of effect for up to 52 weeks with Entyvio was more effective in this study than with placebo.
What is the risk associated with Entyvio - vedolizumab?
The most common side effects with 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 (pain in the joints). For the full list of side effects reported with Entyvio, see the package leaflet. Entyvio must not be used in people with severe infections such as tuberculosis, sepsis (blood infection), listeriosis (infection with bacteria called Listeria) or infections opportunistic (those seen in patients with weakened immune systems), such as progressive multifocal leukoencephalopathy (PML, a rare "brain infection that usually leads to severe disability or death). For the full list of restrictions, 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 unresponsive to TNF-alpha antagonist therapy. Furthermore, the risks are considered manageable, despite the lack of long-term safety data, if the recommendations are followed. In Crohn's disease, the CHMP considers that although the time required for symptom improvement 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 added to the summary of product characteristics and package leaflet for Entyvio, including the appropriate precautions to be followed by healthcare professionals and patients. The company will also provide training materials to all healthcare professionals intended to prescribe Entyvio, to remind them of the need to monitor patients for any signs of neurological disease or PML, particularly those treated with certain biopharmaceuticals that could cause the PML. Further information is available in the summary of the risk management plan.
Other information about Entyvio - vedolizumab
On May 22, 2014, the European Commission issued a "Marketing Authorization" for Entyvio, valid throughout the European Union. For more information on therapy with Entyvio, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 06-2014.
The information on Entyvio - vedolizumab published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
