ENTYVIO (vedolizumab), anti-α4β7 integrin

In patients who failed corticosteroids, immunomodulators and TNFα antagonist therapy:  minor improvement in the treatment of ulcerative colitis and no clinical benefit demonstrated in the treatment of Crohn's disease.

In TNFα antagonist naϊve patients, reimbursement is not recommended due to an insufficient actual benefit.

• ENTYVIO is a biologic treatment  with a Marketing Authorisation for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist .

• In TNFα antagonist naϊve patients, due to lack of Head-to-Head comparison data betweenvedolizumab and TNFα antagonist , the role of ENTYVIO relative to  TNFα antagonist cannot be determined.

• In patients with immunomodulators failure and TNFα antagonist failure, there is no treatment alternative with Marketing Authorisation.

• Its efficacy is well established in UC.

• In CD, at theinduction phase, the efficacy data are contrasted with negative results versus placebo.

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