Learn from your peers

This Peer Perspectives resource center features ENTYVIO educational content, insights on clinical data from key opinion leaders, and materials related to the clinical efficacy of ENTYVIO for ulcerative colitis and Crohn’s disease.

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.

GI Perspective

Get expert perspectives from leading gastroenterologists and listen to their thoughts about ENTYVIO. Learn more about clinical trial data, along with reviews of safety and efficacy for their adult patients on ENTYVIO.

GI Perspective Video - Bincy Abraham, MD, MS

Dr. Bincy Abraham discusses how she considers patient preferences and clinical data when choosing ENTYVIO as an option for adults with moderately to severely active ulcerative colitis or Crohn’s disease.

INDICATIONS: ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active UC or CD.

IMPORTANT SAFETY INFORMATION

ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. Please see additional Important Safety Information at the end of this video.

Hi. I am Dr. Bincy Abraham, Professor of Clinical Medicine in the Academic Division of Gastroenterology and Hepatology at Houston Methodist, Weill Cornell Medical College in Houston, Texas.

Today I will answer some questions about ENTYVIO, a first-line advanced therapy for the treatment of adults with moderately to severely active ulcerative colitis or Crohn’s disease.

Having so many treatment options is wonderful, but it becomes complex to figure out which one to use first. Since we don’t have many head-to-head trials, I consider patient characteristics, including disease severity and location, presence of complications, and comorbidities, including inflammatory conditions.

I also consider patient preference and lifestyle. Do they have a preference for oral, injectable, or infusion therapies? Do they have a busy life or frequently travel for work? Do they have any specific concerns about safety? Respecting patient preferences helps us choose a medication they will stick with. Lastly, access and affordability are very important. If patients cannot get on treatment, then it is difficult to move forward.

I rely on prominent data from clinical trials to inform a shared decision-making approach, especially if there are comparative data from head-to-head studies.

Long-term data are important because patients will have their disease for the rest of their lives. They worry about safety, so these data help me reassure them and educate them on the risk and benefits of treatment versus not treating their disease.

National guidelines for ulcerative colitis and Crohn's disease are important, but I personalize therapy decisions based on my years of experience treating IBD.

The GEMINI I trial demonstrated that ENTYVIO can work quickly in moderately to severely active ulcerative colitis. GEMINI II and III were notable for the results at 1 year in moderately to severely active Crohn’s disease. VARSITY provided pertinent, comparative information about ENTYVIO and Humira in ulcerative colitis.

Safety results have been consistent. GEMINI long-term extension study showed consistent safety for up to 7 years, aligning with findings from the previous studies. All these trials support my decision to use ENTYVIO for my patients.

This patient type would have moderately to severely active disease and, in my opinion, would ideally be biologic-naïve. Patients with a preference for infusion therapy are also good candidates.

In general, all patients with moderately to severely active Crohn's disease are eligible. Symptoms do not always track with endoscopic activity in Crohn's disease, so it's important to fully evaluate your Crohn’s disease patient for disease activity and the need for treatment.

For colleagues, I describe how, back in our medical school days, we learned about diapedesis of lymphocytes.

In ulcerative colitis and Crohn’s disease, specific memory T-lymphocytes access the inflamed gut tissue using this α4β7 integrin.

This integrin binds to MAdCAM-1 receptors on the endothelial cells in the gut, allowing these T-lymphocytes to squeeze through and get into the gut, causing inflammation.

ENTYVIO blocks the α4β7 integrin to prevent this process and helps address inflammation in the gut.

For patients, I explain that ENTYVIO works by preventing certain immune cells from going to the gut. Because ENTYVIO blocks these specific cells, it helps to control damaging inflammation in the GI tract. My patients find the gut-selective mechanism of action of ENTYVIO to be an attractive attribute. They love to hear that it acts directly in the gut, and when I explain how it works, they feel more comfortable with starting therapy and are engaged in their treatment for the long term.

Because of its safety and efficacy data, I think ENTYVIO is a good first-line advanced therapy option for my patients with moderately to severely active ulcerative colitis or Crohn's disease who are TNF-naÏve or have failed TNF antagonists.

I base this on the published data and my own clinical experience with the safety and efficacy of ENTYVIO. Additionally, ENTYVIO is an agent that acts on inflammation directly in the gut. Discussing these attributes together with my patients helps us decide if ENTYVIO is right for them.

The VARSITY Trial
Stephen Hanauer, MD

Dr. Stephen Hanauer talks about the
importance of the head-to-head
VARSITY trial data in selecting a
treatment for ulcerative colitis.

ENTYVIO for Crohn’s
Asher Kornbluth, MD

Dr. Asher Kornbluth offers his
perspective on the most compelling
data from the GEMINI 2 trial.

Starting Advanced Therapy
Bincy Abraham, MD, MS

Dr. Bincy Abraham gives her
perspective on starting advanced
therapy, after failure with or loss of
response on conventional therapies
or steroids, with ENTYVIO.

Interactive Learning Modules

Explore video presentations from leading gastroenterologists on ENTYVIO clinical trial data—including their expert opinions on head-to-head studies, safety, and efficacy data.

To have the best viewing experience of the learning modules, please view on desktop.

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AN INTERACTIVE REVIEW OF THE TRIAL OF ENTYVIO HUMIRA ®* (ADALIMUMAB) vs WITH DR. STEPHEN B. HANAUER *Humira® is a registered trademark of AbbVie Inc., North Chicago, IL. For information about Humira®, please see AbbVie.com. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS For adult patients with moderately to severely active ulcerative colitis (UC) when other therapies have not worked well enough or cannot be tolerated. ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. Please see additional Important Safety Information throughout this video. STEPHEN B. HANAUER, MD Professor of Medicine, Northwestern University Feinberg School of Medicine Medical Director, Digestive Health Center, Northwestern Medicine, Chicago, IL CLICK FOR FULL BIO Biography Dr. Stephen B. Hanauer received his MD degree from University of Illinois at Chicago. He completed his Residency and Fellowship from University of Chicago. He served as the Chair at Advances in IBD. He rose through academic ranks to become Professor of Medicine and subsequently was awarded the Joseph B. Kirsner Chair in Medicine and was designated Chief of the Section of Gastroenterology, Hepatology and Nutrition where he served from 2000-2014. A 52-WEEK, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, MULTICENTER, ACTIVE-CONTROLLED, TREAT-THROUGH STUDY OF 771 adult patients1 SELECTED SAFETY INFORMATION If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment. Please see additional Important Safety Information throughout this video or select the button on the left. FULL STUDY DESIGN VARSITY Study Design 1,2 Randomized, double-blind, double-dummy, multicenter, active-controlled, treat-through study *Includes 2 patients who were randomized but never received any study drug. Moderately to severely active ulcerative colitis was defined as a complete Mayo score of 6 to 12 (range 0 to 12; higher scores represent more active disease), an endoscopic subscore of ≥2, colonic involvement of ≥15 cm, and a confirmed diagnosis of ulcerative colitis for ≥3 months. Centrally read endoscopies were performed at Weeks 14 and 52. IV=intravenous; Q2W=every 2 weeks; Q8W=every 8 weeks; SC=subcutaneous. Dosing was consistent with the US product labels for ENTYVIO and Humira ® . 1 ENTYVIO (vedolizumab) IV (300 mg) at Weeks 0, 2, 6, then Q8W until Week 46 + Placebo SC at Week 0, then Q2W until Week 50 Humira ® (adalimumab) SC at Weeks 0 (160 mg), 2 (80 mg), then Q2W (40 mg) until Week 50 + Placebo IV at Weeks 0, 2, 6, then Q8W until Week 46 After induction, patients remained in their respective treatment group throughout the maintenance phase (treat-through design).1 IV = intravenous; Q2W = every 2 weeks; Q8W = every 8 weeks; SC = subcutaneous. VARSITY Trial Primary End Point Clinical remission at Week 52 1 * *Clinical remission=complete Mayo score of ≤2 points and no individual subscore >1 point. Humira ® is a registered trademark of AbbVie Inc., North Chicago, IL. For information about Humira ® , please see AbbVie.com. CI = confidence interval ENTYVIO (vedolizumab) Humira ® (adalimumab) SELECTED SAFETY INFORMATION Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Please see additional Important Safety Information throughout this video. VARSITY Trial Secondary End Points Endoscopic improvement at Week 52 1 * Corticosteroid-free remission at Week 52 1,2† ENTYVIO (vedolizumab) Humira ® (adalimumab) Approximately 36% of randomized patients were on corticosteroids at baseline. *Endoscopic improvement was defined as a Mayo endoscopic subscore of ≤1 point. Corticosteroid-free clinical remission rates were assessed in patients who were receiving corticosteroids at baseline (as reported in electronic case report form). Corticosteroid-free clinical remission was defined as the population of patients in this subgroup who discontinued corticosteroids by Week 52 and were in clinical remission (defined as complete Mayo score ≤2 points and no subscore >1 point at Week 52). For patients on corticosteroids at baseline: Doses must have been stable for ≥2 weeks prior to the first dose and remained unaltered through Week 6. After Week 6, a nonfixed dose tapering was started upon achieving response. During tapering, patients could return to baseline doses only once for loss of response before repeating tapering. Per protocol, patients unable to taper were withdrawn from the study and considered treatment failures for each of the outcomes. Humira ® is a registered trademark of AbbVie Inc., North Chicago, IL. For information about Humira ® , please see AbbVie.com. CI=confidence interval. SELECTED SAFETY INFORMATION Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Please see additional Important Safety Information throughout this video. CONTINUE SAFETY WAS EVALUATED IN 383 PATIENTS: No new safety signals were observed for ENTYVIO 1,2 Study was not designed to assess safety differences 3 *Humira ® is a registered trademark of AbbVie Inc., North Chicago, IL. For information about Humira ® , please see AbbVie.com. Adverse events that occurred during the trial period. Trial period was the time from the first dose of a trial drug and up to 126 days after the last dose. Adverse events were classified according to the Medical Dictionary for Regulatory Activities System Organ Class categorization and preferred terms (version 21.0). The safety population was defined as all patients who received at least one dose of the study drug. No cases of progressive multifocal leukoencephalopathy. § Not related to ENTYVIO. || Updated to include final 68- week safety follow-up. CONTINUE GEMINI I Trial Primary End Points Clinical response at Week 6 4 * *Clinical response = reduction in complete Mayo score of ≥3 points and ≥30% from baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. ENTYVIO (vedolizumab) Placebo SELECTED SAFETY INFORMATION ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury. Please see additional Important Safety Information throughout this video. GEMINI I Trial Primary End Points Clinical remission at Week 52 4 *