Long term focus—From the Start
For adult patients with moderately to severely active CD
for whom other therapies have not worked well enough.
Overall population
CD TRIALS I, II, AND III
Three randomized, double-blind, placebo-controlled studies enrolled adult patients with moderately to severely active CD who had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or ≥1 anti-TNFα therapy.
In CD Trial I, patients were randomized (3:2) to receive Entyvio 300 mg or placebo by intravenous infusion at Weeks 0 and 2.
In CD Trial II, patients were randomized (1:1) to receive either Entyvio 300 mg or placebo at weeks 0, 2, and 6.
In CD Trial III, patients receiving Entyvio who demonstrated clinical response (≥70-point decrease in CDAI score from baseline) at Week 6 (from CD Trial I or an open-label cohort) were randomized (1:1:1) to receive either Entyvio 300 mg every 8 weeks, Entyvio 300 mg every 4 weeks, or placebo every 4 weeks.
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In a separate study, 15% (n=158) of patients taking Entyvio who had a suboptimal response to ≥1 anti-TNFα therapy achieved clinical remission at Week 6 vs 12% (n=157) with placebo (P=NS) (primary end point, CD Trial II)
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76% of patients in CD Trial II had an inadequate response, loss of response, or intolerance to one or more TNFα blockers. CD Trial II patients were not part of the maintenance study
Three randomized, double-blind, placebo-controlled studies enrolled adult patients with moderately to severely active CD who had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or ≥1 anti-TNFα therapy.
In CD Trial I, patients were randomized (3:2) to receive Entyvio 300 mg or placebo by intravenous infusion at Weeks 0 and 2.
In CD Trial II, patients were randomized (1:1) to receive either Entyvio 300 mg or placebo at weeks 0, 2, and 6.
In CD Trial III, patients receiving Entyvio who demonstrated clinical response (≥70-point decrease in CDAI score from baseline) at Week 6 (from CD Trial I or an open-label cohort) were randomized (1:1:1) to receive either Entyvio 300 mg every 8 weeks, Entyvio 300 mg every 4 weeks, or placebo every 4 weeks.
Adult Ulcerative Colitis (UC)
ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.
Adult Crohn’s Disease (CD)
ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid-free remission.
Please see
Adult Ulcerative Colitis (UC)
ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.
Adult Crohn’s Disease (CD)
ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid-free remission.
Please see