ENTYVIO (védolizumab)

• Key points

Favourable opinion for reimbursement in the treatment of ulcerative colitis (UC) in TNFα antagonist-naive adult patients who have had an inadequate response with, lost response to, or were intolerant to conventional therapy.

Clinical benefit now substantial (previously it was insufficient) in this indication.

• What therapeutic improvement?

No clinical added value in the management of ulcerative colitis in TNFα antagonist-naive patients.

• Role in the care pathway?

The objectives of medical treatment are first to induce remission and then to maintain remission without corticosteroid and improve quality of life. The choice of treatment is governed, in particular, by the severity of the disease and the extent of colon damage.

In the second-line treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with conventional therapy, or in whom this treatment is contraindicated or poorly tolerated, TNF inhibitors (infliximab, adalimumab and golimumab) are currently the reference treatment.

Role of the medicinal product in the care pathway

As a second-line treatment for moderately to severely active ulcerative colitis, i.e., in patients presenting failure of or intolerance to conventional therapy, ENTYVIO (vedolizumab) now represents a new alternative to TNF inhibitors.

However, a TNF inhibitor should be preferred to vedolizumab in two specific clinical situations:

- in the event of extra-intestinal manifestations (rheumatic, cutaneous and ocular manifestations, in particular), given the local action mechanism of vedolizumab;

- with infliximab being the recommended biologic therapy in the event of severe acute colitis (expert opinion).