ENTYVIO (vedolizumab), anti-α4β7 integrin

In the treatment of Crohn’s disease:

• Noclinical added value but Substantial clinical benefit in patients who have failed a conventional therapy (corticosteroids or  immunomodulators) and at least one TNF inhibitor or having counter indication to those treatments

• Insufficient clinical benefit to justify its inclusion on the list of reimbursable products in patients naïve to anti-TNFs due to lack of specific place in the therapeutic strategy

• ENTYVIO has a Marketing Authorisation in the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to conventional treatment or anti-TNFs.
• In anti-TNF naïve patients, in the absence of a head to head comparison of vedolizumab with an anti-TNF, the role of ENTYVIO relative to anti-TNFs cannot be determined.