PATIENT SUPPORT PROGRAM - ENTYVIO PATHWAY
Entyvio Pathway is a nationwide support program developed by Takeda to help people get the most out of their ENTYVIO® treatment.
The program provides access to the following resources and services:
Home infusion support for intravenous (IV) induction doses, i.e. at weeks 0, 2, 6 for ulcerative colitis (UC), chronic pouchitis and Crohn’s disease (CD) ± week 10 for CD
In-home or virtual self-injection training with the ENTYVIO subcutaneous (SC) pre-filled pen
Home delivery of self-injection supplies
Travel resources
Questionnaires to assess ongoing persistence and self-injection confidence
Tailored educational content based on patient-reported confidence
aGEMINI 1: Phase 3, randomised double-blind, placebo-controlled study with separate induction and maintenance trials in adult patients with moderately to severely active UC. Induction trial: 374 patients (Cohort 1) received ENTYVIO IV (300 mg) or placebo at Weeks 0 and 2, and 521 patients (Cohort 2) received open-label ENTYVIO at Weeks 0 and 2, with disease evaluation at Week 6. Maintenance trial: additional patients were enrolled in Cohort 2 and received the same induction regimen as Cohort 1. The patients were randomly assigned to continue ENTYVIO IV every 8 or 4 weeks or to switch to placebo. The primary endpoint was clinical remission at Week 52 (≤2 points Mayo Clinic score with all subscores ≤1). Secondary endpoints included mucosal healing (ES ≤1).3 bGEMINI 1 post hoc: Analysis evaluated deep remission at Week 52 in the ITT population.2 cVICTORY Consortium: Retrospective single-arm study of 212 adults with moderate to severe CD treated with ENTYVIO, with follow-up after initiation. A minimum of 6 and 12 months of follow-up were available in 133 and 44 individuals, respectively. Predictors of clinical remission or mucosal healing with ENTYVIO were identified using the multivariable Cox proportional hazard analyses. Primary endpoint was the proportion of individuals achieving clinical remission or mucosal healing. Secondary endpoints included deep remission.4
ENTYVIO® is indicated for the treatment of adult patients with moderate to severe ulcerative colitis or moderate to severe Crohn’s disease, who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a TNFα antagonist.
ENTYVIO® is indicated for the treatment of adult patients with moderate to severe chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.
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ENTYVIO®, the ENTYVIO Logo® and the Entyvio Pathway Logo® are registered trademarks of Millennium Pharmaceuticals, Inc., a Takeda company.