When conventional
treatments fail
with entyvio
For adult patients with moderately to severely active ulcerative colitis
(UC) or Crohn's disease (CD) when other therapies have not worked
well enough or cannot be tolerated.
*Based on a quarterly analysis of Symphony medical and pharmacy claims with data from June 2022
through June 2023. Biologics include Cimzia® (certolizumab pegol; UCB, Inc.), Humira® (adalimumab;
AbbVie Inc.), Skyrizi® (risankizumab-rzaa; AbbVie Inc.), Remicade® (infliximab; Janssen Biotech, Inc.),
Stelara® (ustekinumab; Janssen Biotech, Inc.), Simponi® (golimumab; Janssen Biotech, Inc.), Amjevita™ (adalimumab-atto; Amgen Inc.), and infliximab biosimilars. September 2023.
TREAT EARLY
The moment your adult patients with moderate
to severe Crohn’s or UC are not well-controlled
with conventional therapies, seek long-term
relief and remission. Patients achieved
remission at Week 52 vs placebo.1
Individual results may vary.
TREAT DIRECTLY
ENTYVIO helps address inflammation where it
occurs—in the gut.1 ENTYVIO specifically binds to
the α4β7 integrin and blocks its interaction with
MAdCAM-1, which is mainly expressed on the GI
tract endothelial cells.1-7
TREAT CONFIDENTLY
With 9 years of patient experience and
91% unrestricted commercial coverage for
ENTYVIO IV*†
TREAT FLEXIBLY
ENTYVIO has 2 options for UC
maintenance therapy—IV infusion
or subcutaneous injection1
*Based on Symphony claims data from June 2014 to preliminary June 2023. August 2023.
†Unrestricted refers to coverage that does not require biologic step-edits. Data regarding current unrestricted commercial coverage for ENTYVIO as of July 2023 are derived from Managed Markets Insights & Technology (MMIT). September 2023.
GI=gastrointestinal; IV=intravenous; MAdCAM-1=mucosal addressin cell adhesion molecule-1.
GEMINI I
GEMINI I was a randomized, double-blind, placebo-controlled study of
adult patients with moderately to severely active ulcerative colitis1
The foundational study of ENTYVIO
vs placebo
Patients achieved clinical response at Week 6 and clinical remission at Week 52 vs placebo.1
TRIAL
VARSITY, which studied ENTYVIO vs Humira® (adalimumab), was the first
head-to-head trial of biologics in moderate to severe ulcerative colitis8,9
ENTYVIO DEMONSTRATED SUPERIORITY
TO HUMIRA®*
In clinical remission at Week 52 in the overall population.8†
VARSITY was a double‑blind, double‑dummy, active‑controlled trial that compared ENTYVIO with Humira®* (adalimumab) in adults with moderately to severely active ulcerative colitis.
*Humira® is a registered trademark of AbbVie Inc., North Chicago, IL. For information about Humira®, please see AbbVie.com.
†Clinical remission was defined as a complete Mayo score of ≤2 points and no subscore >1 point. Superiority was demonstrated in the overall population. Individual results may vary.
Up to 7 years of consistent
safety data
Clinical trials evaluated safety in more than
3300 adults (UC, Crohn's, and healthy
volunteers).1
A separate open-label study of up to 7 years
demonstrated consistent results across
safety parameters.1,10,11*
*In a single-arm, open-label extension study, 2243 patients
received ENTYVIO with a median exposure of 1072 days (range 1 to
3412 days).10,11
Support for patients prescribed ENTYVIO
EntyvioConnect offers a range of programs tailored to help patients with access and affordability.
The content on this page has been written and
reviewed by Takeda.
IMPORTANT SAFETY INFORMATION
Contraindications
WARNINGS AND PRECAUTIONS
IMPORTANT SAFETY INFORMATION
Contraindications
ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
Warnings and precautions
Adverse reactions
The most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) were: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities, and injection site reactions with subcutaneous administration.
Drug interactions
Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products and with TNF blockers.
INDICATIONS
Adult Ulcerative Colitis (UC):
ENTYVIO is indicated in adults for the treatment of moderately to severely active UC.
Adult Crohn’s Disease (CD):
ENTYVIO is indicated in adults for the treatment of moderately to severely active CD.
Dosage forms & strengths:
Please click for Full Prescribing Information.
References: