For adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

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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.

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.

For adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD).

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. Please see additional Important Safety Information throughout 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.

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

  • Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
  • Infections: Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
  • Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • Liver Injury: There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
  • Live and Oral Vaccines: Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.

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. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed.

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 AND STRENGTHS:

  • ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
  • ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab

Please see Full Prescribing Information at ENTYVIO.com/PI.

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. Dr. Abraham is a paid consultant for Takeda.

THE GI PERSPECTIVE

TREATING EARLY IN MODERATE TO SEVERE CROHN'S DISEASE

When patients are not well controlled with conventional therapies WITH TIMOTHY RITTER,
MD & BROOKE HODNICK, PA-C, MPAS

"We know that effective, early intervention
following loss of response to conventional
therapy* or steroids can help patients with active
disease. When the disease is moderate to severe,
we talk to our patients about an advanced
therapy."† TIMOTHY RITTER, MD

*Conventional therapies include corticosteroids or
immunomodulators.

†Advanced Therapy: immunosuppressants or biologics used after
failure of conventional therapies.

Why is it important to consider advanced
therapy early for adults with moderate to
severe Crohn's disease when conventional
therapies fail?

*Advanced Therapy: immunosuppressants or biologics used after
failure of conventional therapies.

Ritter: Moderate to severe Crohn's disease is caused by inflammation in the GI tract with environmental and hereditary factors contributing to the underlying pathophysiology of the disease. The goal for treating Crohn's disease is to identify an effective treatment based on that patient's disease.

Hodnick: You really need to educate the patient from day one. I really want them to understand the disease, the potential outcomes, and understand the therapies.

Ritter: Many Crohn's disease patients will experience disease that changes over time. They can have worsening of their disease and symptoms, and this is common for many patients. This can result in complications that may need surgery and may need steroids. Current treatment guidelines emphasize controlling inflammation, and advanced therapies are crucial for managing moderate to severe Crohn's disease.

Hodnick: When they're first diagnosed, I really want to spend time with them and not only go over what Crohn's disease is, but I really want to tell them where they are now and where we could be in the future.

Ritter: I often have conversations about steroids when talking to my patients about treatments. When I talk to patients about steroids, I tell them we should always have an exit strategy in mind. Long-term steroid use is not recommended.

How do you decide a treatment plan for your various Crohn's patients?

Hodnick: You know, I really do like to get to know that patient. I want to know how the disease is affecting them during the day, uh, their jobs, and I want to know what we need to control.

Ritter: And selection of specific treatments for Crohn's disease can be very complicated for all kinds of reasons. For most every Crohn's patient that we treat, they're going to need to be on an advanced therapy because they have moderate to severe disease after they've lost response to conventional therapy or steroids.

What are the unique challenges in evaluating and finding the right Crohn's disease treatment?

Ritter: I think the main thing that doctors need to do when they first diagnose the Crohn's patient is really assess the inflammation.

Hodnick: Whenever we have a patient referred to us, I'd like to know their disease location as well as their phenotype.

Ritter: Once the patient has been assessed in the clinic, I can then determine if the patient has moderate to severe disease and if they're likely to benefit from a switch to a biologic or advanced therapy.

Advanced Therapy: immunosuppressants or biologics used after failure of conventional therapies.

How is your practice utilizing advanced practice providers?

Ritter: Our group is working hard, as you know, to develop expertise across our practice, especially, uh, with our advanced level providers. And that's how we, we've started this, our APP education platform, where a brand-new APP comes into our practice. They, they sort of do GI 101. And then there's a second tier of, of more advanced GI learning. And then ultimately, uh, they can specialize in inflammatory bowel disease. And we have dedicated educational programs in IBD for our APPs because we know that is where most of this care is going to get delivered and we really want to develop that excellence across the practice.

How do you work as a team with APPs when caring for your Crohn's patients?

Ritter: It's important that you're part of that introduction, I mean, we'll take in every member of the team that's present that day and let the patient meet our IBD nurse and meet our social worker if she's there that day. So they get a feel not only for who each one is, but what this team approach is all about.

Hodnick: I love that we're in clinic together in the same room when we're typing our notes and I can just look around the corner and say, "Hey. You know, I've got a question and I have something kind of difficult come up. Can we talk about it?" And we can kind of put our heads together and come up with what we think is the best next step.

Ritter: Brooke, you know, in our practice, as in many practices, APPs really drive the care. And they're responsible for many, if not most of the patient visits. And a really well trained APP, like yourself, that is so capable, can really raise the game for our patients.

Well, now let's talk about ENTYVIO.

For adults with moderately to severely active Crohn's Disease (CD).

CONTRAINDICATIONS

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.

When is ENTYVIO the right choice for Crohn's disease?

Ritter: So I, I like ENTYVIO in patients with moderately to severely active Crohn's disease. It's a treatment we consider for patients who have failed conventional therapy or patients who have failed anti-TNF therapy.

In clinical trials, patients had previously demonstrated an inadequate response to or intolerance of conventional treatments (corticosteroids or immunomodulators) and/or anti-tumor necrosis factor therapies.1

What experience do you have with ENTYVIO in your practice?

ENTYVIO was studied in the GEMINI II trial in adult moderate to severe Crohn's patients who had lost response to or had an intolerance to at least 1 conventional therapy, including steroids, immunomodulators and/or anti-TNFα therapies.1

  • Primary end points were clinical response at Week 6, defined as a ≥100 decrease in CDAI score from baseline, and clinical remission at Week 6 and at Week 52, defined as a CDAI score ≤1501-3
  • Secondary end points included long-term clinical response at Week 52 and corticosteroid-free remission at Week 521,2

CDAI=Crohn’s Disease Activity Index.

Ritter: I tell my moderate to severe patients that we have seen success achieving long-term remission with ENTYVIO in my practice, especially when it's used early as a first-line advanced therapy following failure of conventional therapies.

Hodnick: When a moderate to severe patient has failed on conventional therapy or is ready to get off their steroids, we use ENTYVIO frequently. I make sure to share the safety and efficacy information with my patients before starting ENTYVIO.

ENTYVIO patients achieved steroid-free remission at Week 52 vs placebo.1

How are you setting expectations for your patients?

Ritter: So, when I start a patient on new therapy, I tell them that we really have three targets. The first target centers around addressing why the patient's in the clinic, including how they're feeling and what symptoms are bothering them. The second target really focuses on assessing the patient's disease, using tests and biomarkers. And then the third target is controlling their disease long term with effective treatment.

1. Why is the patient at the clinic? How is the
patient feeling? What symptoms do they have?

2. Assessing the patient's disease using tests and
biomarkers

3. Controlling the disease long term with effective
treatment

Hodnick: When we see moderate to severe Crohn's disease, we talk about potential outcomes, and if appropriate we talk about getting on an advanced therapy. Specifically, we can talk about ENTYVIO being an option to treat these patients.

"I tell my moderate to severe patients that we have had good experience with ENTYVIO in my practice when it's used early, as a first-line therapy following failure of conventional therapies. I especially think ENTYVIO works well in our practice with Crohn's patients whose disease has recently become moderate, or, in other words, newly moderate Crohn's patients."
TIMOTHY RITTER, MD

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

  • Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
  • Infections: Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
  • Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • Liver Injury: There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
  • Live and Oral Vaccines: Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.

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. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed.

INDICATION

Adult Crohn's Disease (CD):

ENTYVIO is indicated in adults for the treatment of moderately to severely active CD.

DOSAGE FORMS & STRENGTHS

  • ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
  • ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab

Please see Full Prescribing Information at ENTYVIO.com/PI.

GI Perspective Video Timothy Ritter, MD & Brooke Hodnick, PA-C, MPAS

Dr. Timothy Ritter and his PA Ms. Brooke Hodnick discuss early intervention following the loss of response to conventional therapy, steroids, or TNF blockers for patients with moderately to severely active Crohn's disease. Dr. Ritter and PA Hodnick are paid consultants for Takeda.

VARSITY trial brochure.

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.

Download

GEMINI 2 trial brochure.

ENTYVIO for Crohn’s
Asher Kornbluth, MD

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

Download

Advanced therapy with ENTYVIO® (vedolizumab) brochure.

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.

Download

Early treatment of Crohn's disease brochure.

Treating Early in Moderate to
Severe Crohn's Disease
Timothy Ritter, MD & Brooke
Hodnick, PA-C, MPAS

Dr. Timothy Ritter and his PA Ms.
Brooke Hodnick discuss early
intervention following the loss of
response to conventional therapy,
steroids, or TNF blockers for patients
with moderately to severely active
Crohn's disease.

Download

Interactive Learning Modules

Explore interactive presentations from leading gastroenterologists on ENTYVIO—including head-to-head studies, appropriate patient types, and ENTYVIO's efficacy and safety profiles. Presenters are paid consultants for Takeda.

An Overview of the
VARSITY Trial With
Stephen Hanauer, MD

Dr. Stephen Hanauer reviews the
study design and efficacy and safety
results from the pivotal head-to-
head VARSITY study.

A Case Study in Crohn's With
Asher Kornbluth, MD

Dr. Asher Kornbluth walks through a
hypothetical patient case and the
clinical data for ENTYVIO for Crohn's.

ENTYVIO Pen for Subcutaneous
Administration for UC With
Jean-Frederic Colombel, MD

Dr. Jean-Frederic Colombel presents
the efficacy data and safety profile of
ENTYVIO SC from the VISIBLE 1 trial.

The Right Time for Advanced
Therapy in Crohn's Disease
with Bincy Abraham, MD, MS

Dr. Abraham presents a hypothetical
patient case and discusses how she
decides when it’s time to start a
biologic in this interactive
presentation.

Clinical Reprints

Review insights on ENTYVIO clinical trial data for healthcare professionals.

VISIBLE 1 trial reprint.

VISIBLE 1 Trial Reprint

Efficacy and safety of vedolizumab
subcutaneous formulation in a
randomized trial of patients with
ulcerative colitis

Download

VARSITY trial reprint.

VARSITY Trial Reprint

Vedolizumab versus adalimumab
for moderate to severe
ulcerative colitis

Download

VARSITY histologic end points reprint.

VARSITY Histologic End Points Reprint

Vedolizumab versus adalimumab
for moderate to severe
ulcerative colitis

Download

COLOMBEL trial reprint.

COLOMBEL Trial Reprint

The safety of vedolizumab for
ulcerative colitis and
Crohn’s disease

Download

GEMINI trial reprint.

GEMINI Trial Reprint

Vedolizumab long-term data
for moderate to severe
ulcerative colitis

Download

VISIBLE 2 trial reprint.

VISIBLE 2 Trial Reprint

Efficacy and safety of vedolizumab
subcutaneous formulation in a
randomized trial of patients with
Crohn's disease

Download

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The content on this page has been written and
reviewed by Takeda.