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.

Please turn
your device
for a better
experience.

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 * ENTYVIO (vedolizumab) Placebo *Clinical remission = complete Mayo score of ≤2 points and no individual subscore >1 point. 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 Secondary End Points Visible Mucosal Improvement at Week 6 4 * Visible Mucosal Improvement at Week 52 4 * ENTYVIO (vedolizumab) Placebo *Improvement of the appearance of the mucosa=Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern, mild friability). CI=confidence interval; Q8W=every 8 weeks. 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 Secondary End Point Corticosteroid-free Remission at Week 52 4 * *Assessed in the subgroup of patients who were receiving corticosteroids at baseline and who were in clinical response at Week 6 (n=72 for placebo and n=70 for ENTYVIO Q8W). Corticosteroid- free clinical remission was defined as the proportion of patients in this subgroup who discontinued corticosteroids by Week 52 and were in clinical remission at Week 52. CI=confidence interval; Q8W=every 8 weeks. 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. BASELINE CHARACTERISTICS *Plus-minus values are means ±SD. P -values for the comparison in cohort 1 between the placebo group and the vedolizumab group are all greater than 0.05. Race was self-reported. § Mayo Clinic scores range from 0 to 12, with higher scores indicating more active disease. The partial Mayo Clinic score consists of the Mayo Clinic score minus the sigmoidoscopy subscore; range, 0 to 9, with higher scores indicating more active disease. || Data on fecal calprotectin were available for 857 patients: 139 receiving placebo, 213 receiving vedolizumab in cohort 1, 505 receiving vedolizumab in cohort 2, and 718 receiving vedolizumab in the combined cohorts. # Immunosuppressants included azathioprine and mercaptopurine. **Loss of response indicates that the patient had a response initially but subsequently did not have a response. TNF α =tumor necrosis factor alpha. Adverse Reactions from UC Trials I & II and CD Trials I & III 4 Adverse reactions in ≥3% of ENTYVIO -treated patients and ≥1% higher than in placebo (UC Trials I and II* and CD Trials I and III*) *Data from patients receiving open-label ENTYVIO treatment at Weeks 0 and 2 (prior to entry into UC Trial II and CD Trial III) and from Weeks 6 to 52 (non- responders at Week 6 of UC Trial I and CD Trial I) are included. Patients who received ENTYVIO for up to 52 weeks. Patients who received placebo for up to 52 weeks. CONTINUE Adverse Events based on UC Trials I and II, CD Trials I and III4 INFECTIONS Infection rates with ENTYVIO were 0.85 per patient-year vs 0.7 for placebo - Infections consisted primarily of nasopharyngitis, upper respiratory tract infection, sinusitis, and urinary tract infection - 2% of patients discontinued ENTYVIO due to infections SERIOUS INFECTIONS Serious infection rates with ENTYVIO were 0.07 per patient-year vs 0.06 for placebo - Serious infections included anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis IMMUNOGENICITY The rate of detectable anti-vedolizumab antibodies at any time during the 52 weeks of continuous treatment with ENTYVIO was 6% (86 of 1427 patients) - 20 of 86 patients were persistently positive (at 2 or more study visits) for anti- vedolizumab antibody, and 56 of 86 patients developed neutralizing antibodies to vedolizumab - Among these 20 patients, 14 had undetectable or reduced vedolizumab serum concentrations. Five of the 20 patients with persistently positive anti-vedolizumab antibody achieved clinical remission at Week 52 in the controlled trials - Overall, there was no apparent correlation of anti-vedolizumab antibody development to adverse reactions following intravenous administration of ENTYVIO PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) Although unlikely, a risk of PML cannot be ruled out: - 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 is caused by the John Cunningham (JC) virus and typically only occurs in patients who are immunocompromised - 1 case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported in the postmarketing setting (e.g., human immunodeficiency virus [HIV] infection with a CD4 count of 300 cells/mm3 and prior and concomitant immunosuppression) LIVER INJURY ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury 3 patients reported serious adverse reactions of hepatitis with ENTYVIO; 1 additional case of serious hepatitis was seen in the open-label trial - These adverse reactions occurred following 2 to 5 ENTYVIO doses; however, it is unclear if the reactions indicated drug-induced or autoimmune etiology - There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO - All patients recovered following discontinuation of therapy with or without treatment with corticosteroids MALIGNANCIES Malignancies (excluding dysplasia and basal cell carcinoma) were in 0.4% (6 of 1434) of patients treated with ENTYVIO and in 0.3% (1 of 297) of patients treated with placebo - The number of malignancies in clinical trials was small; however, long-term exposure was limited ADVERSE REACTIONS Adverse reactions were reported in 52% of patients treated with ENTYVIO (N=1434) and 45% of patients treated with placebo (N=297) - Over 52 weeks, 7% of patients treated with ENTYVIO experienced serious adverse reactions compared to 4% treated with placebo INFUSION-RELATED REACTIONS (IRRs) AND HYPERSENSITIVITY REACTIONS 4% of patients treated with ENTYVIO (N=1434) experienced an IRR vs 3% of patients on placebo (N=297) 1 case of anaphylaxis (1 of 1434 patients treated with ENTYVIO) was reported by a CD patient during the second infusion (symptoms reported were dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) and was managed with discontinuation of infusion and treatment with antihistamine and IV hydrocortisone Most frequently observed IRRs were nausea, headache, pruritus, dizziness, fatigue, infusion-related reaction, pyrexia, urticaria, and vomiting. These reactions generally occurred within the first two hours after the infusion and resolved with no treatment or following antihistamine and or IV hydrocortisone treatment CONTINUE HOW FAMILIAR ARE YOU WITH THE TRIAL? DRAG THE SLIDER Not familiar Very familiar SUBMIT CHOOSE THE CHARACTERISTICS OF THE PATIENT YOU WANT TO RANDOMIZE: AGE 30 50 30 DURATION OF UC (YEARS) 4 9 4 MAYO SCORE 6 10 6 SUBMIT GO BACK HERE’S YOUR STUDY PARTICIPANT: Age: 30 years old Duration of ulcerative colitis: 4 years Mayo score: 6 CLICK TO RANDOMIZE GO BACK YOUR STUDY PARTICIPANT WAS RANDOMIZED TO THE ENTYVIO ARM CONTINUE CLICK EACH STUDY PARTICIPANT TO LEARN MORE ABOUT THE STUDY POPULATION. 1 Stratification by previous therapy Patients were stratified by prior use of TNFα inhibitor and concomitant use of oral corticosteroids. Previous exposure to TNFα inhibitors Previous exposure to TNFα inhibitors other than Humira was permitted in up to 25% of patients. Previous response to conventional therapy Patients who had no response or lost response to conventional therapies were eligible for the VARSITY study. Anti-TNFα- naïve patients Patients naïve to anti-TNFα therapy were enrolled if they were failing conventional therapy. Concomitant conventional therapy Patients on a 5-ASA or immuno- modulator at baseline maintained stable doses throughout the study. BASELINE CHARACTERISTICS CONTINUE SELECTED SAFETY INFORMATION ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Please see additional Important Safety Information throughout this video. VARSITY Baseline Characteristics Most of the trial population (97.3%) had moderately to severely active disease. Patients with mild disease represented significant protocol deviations. Per-protocol sensitivity analyses indicated no change from overall population results. The proportion of patients who discontinued treatment with an anti-TNF α , except adalimumab, due to documented reasons other than safety, was 21%. *Data on smoking status were missing for 2 patients in the ENTYVIO group. One patient in the Humira ® group had ulcerative colitis of unknown duration. Scores were available for 384 patients in the Humira ® group and 380 patients in the ENTYVIO group. § Data on fecal calprotectin were available for 332 patients in the Humira ® group and 341 patients in the ENTYVIO group. || The commonly used immunomodulators in the order of greatest to least were azathioprine, mercaptopurine, and methotrexate. TNF α =tumor necrosis factor alpha. VARSITY builds on the foundation of the pivotal GEMINI 1 trial The trial studied ENTYVIO vs placebo in adult patients with moderately to severely active ulcerative colitis. 4 SEE FULL STUDY DESIGN CONTINUE 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. GEMINI Study Design 4-6 Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted. Corticosteroids were tapered after Week 6; in the United States, immunosuppressants were discontinued after induction. *Not included in Ulcerative Colitis Trial I efficacy analysis. 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. Nonresponders (n=373) received open-label ENTYVIO Q4W for up to 52 weeks (not included in Ulcerative Colitis Trial II efficacy analysis). The ENTYVIO Q4W dosing regimen did not demonstrate additional clinical benefit over the Q8W dosing regimen and is not the recommended dosing regimen. HOW DO YOU RESPOND WHEN A PATIENT EXPRESSES CONCERN ABOUT THE SAFETY RISKS OF ADVANCED THERAPY?* Please select all that apply. Probe further on their specific safety concerns Review the safety profiles of advanced treatments with them Propose treatment options you think they'd be more comfortable with SUBMIT *Advanced therapies are used after failure of conventional therapies. IN THE FIRST of biologics in moderate to severe ulcerative colitis 1,7 DEMONSTRATED SUPERIORITY TO HUMIRA ® IN CLINICAL REMISSION RATES AT WEEK 52 IN THE OVERALL POPULATION¹ See more results at ENTYVIOHCP.COM If you are a Colorado prescriber, please see the Colorado WAC disclosure form. ©2023 Takeda Pharmaceuticals U.S.A., Inc. 95 Hayden Ave., Lexington, MA 02421. 1-877-TAKEDA-7 (1-877-825-3327). All rights reserved. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited. ENTYVIO and the ENTYVIO logo are registered trademarks of Millennium Pharmaceuticals, Inc. All other trademarks are the property of their respective owners. US-VED-1873v1.0 10/23 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. 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: ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab Please see Full Prescribing Information at ENTYVIO.com/PI . REFERENCES 1. Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis. N Engl J Med. 2019;381(13):1215-1226. 2. Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis.N Engl J Med. 2019;381(13):1215-1226. (supplemental appendix). 3. Data on File. Takeda Pharmaceuticals. 4. ENTYVIO (vedolizumab) prescribing information. Takeda Pharmaceuticals. 5. Feagan BG, Rutgeerts P, Sands BE, et al; for the GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699-710. 6. Feagan BG, Rutgeerts P, Sands BE, et al; for the GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699-710 (supplemental appendix). 7. Macaluso FS, Maida M, Grova M, et al. Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience. Therap Adv Gastroenterol. 2021;14:1-11. 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. 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: ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab Please see Full Prescribing Information at ENTYVIO.com/PI .

VARSITY Interactive Video, featuring Stephen Hanauer, MD

Watch Dr. Stephen Hanauer provide his expertise on ENTYVIO, supported by head-to-head clinical trial data from the VARSITY study.

Moving Beyond Conventional Therapy

A Case Study in Crohn’s Disease

with Dr. Asher Kornbluth

Asher Kornbluth, MD

Clinical Professor of Medicine at the Icahn
School of Medicine at Mount Sinai

Mark,
22 years old

Hypothetical Patient

Mark’s CDAI is 350

The CDAI is often used in clinical trials. It is a weighted composite score based on 8 clinical factors1

  • General well-being
  • Abdominal pain
  • Presence of abdominal mass
  • Number of liquid stools
  • Systemic complications
  • Taking anti-diarrheal
  • Hematocrit in men <47% and <42% in women
  • Percentage deviation from standard body weight

CDAI=Crohn’s Disease Activity Index.

Social History

Mark is a 22-year-old man who works as a waiter at a busy restaurant and enjoys the fast-paced environment. He mentions that he feels his Crohn’s disease has become difficult to manage, his symptoms are getting worse, and he is concerned he’ll miss work.

Medical History

Diagnosis: Moderate Crohn’s disease

Type: Ileal

Disease Duration: 3 years

Medication History: Short course of steroids for initial presentation

Current Medications: Anti-diarrheal and anti-anxiety

Symptoms

  • Severe abdominal pain
  • 8 loose stools daily
  • Below ideal body weight
  • Weight loss (approximately 15 lbs. lost from baseline weight of 170 over last 4 months)
  • Poor overall well-being

Colonoscopy Result

Colonoscopy reveals deep inflammatory ulcers in the sigmoid colon and rectum. There is moderate inflammation of the terminal ileum and slight narrowing.1

Lab Results

  • CRP: 10.6 mg/L
  • FCal: 688 μg/g
  • Hemoglobin: 12.4 g/dL
  • ESR: 47 mm/hr
  • Albumin: 3.6 g/dL

Current Treatment

Course of steroids for initial
presentation.

Month 1: Attempt to taper steroids

Month 2: Patient still reports symptoms

Month 3: Steroid dosage increased

Month 4: Follow-up visit

CHART NOTES:

– Not receiving relief from steroid treatment

– Symptoms remain uncontrolled

The Advanced Therapy*
Consultation

Help patients understand why it may be time to consider advanced therapy

  • Conventional therapy is not providing adequate relief
  • Patient is dependent on steroids

Ask about the patient’s preferences and lifestyle to ensure a
treatment fit

  • Preference for certain routes of administration
  • Specific concerns about safety and efficacy
  • Fear of using advanced therapies because of access and administration

Be aware of common barriers to advanced therapy

Barriers may sound like:

  • “I’m not sure I need this. I don’t feel that bad.”
  • “I’m worried about side effects and infections.”
  • “I won’t remember to take my medicine.”
  • “I‘m too busy to deal with this.”

*Advanced therapies are used after failure of conventional therapies.

For adult patients with moderately to severely active Crohn’s disease (CD) when other therapies have not worked well enough or cannot be tolerated.

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 or by selecting the button at the bottom of your screen.

Crohn’s Disease Trials I and III Study Design1-3

~48%

of ENTYVIO-treated patients from CD Trial I and the
open-label cohort achieved ≥70-point decrease in CDAI

Crohn’s Disease Trial I Primary End Point1-3

Clinical Remission at Week 6*

*Clinical remission=CDAI score ≤150.

CI=confidence interval.

Crohn’s Disease Trial I Primary End Point1-3

Clinical Response at Week 6*

*Clinical response=≥100-point decrease in CDAI from baseline.

CDAI=Crohn’s Disease Activity Index;
CI=confidence interval; NS=not significant.

Crohn’s Disease Trial III Primary End Point1,2

Clinical Remission at Week 52*

*Clinical remission=CDAI score ≤150.

CDAI=Crohn’s Disease Activity Index;
CI=confidence interval; Q8W=every 8 weeks.

Crohn’s Disease Trial III Secondary End Point1,2

Clinical Response at Week 52*

*Clinical response=≥100-point decrease in CDAI from baseline.

CDAI=Crohn’s Disease Activity Index;
CI=confidence interval; Q8W=every 8 weeks.

Crohn’s Disease Trial III Secondary End Points1,2

Corticosteroid-free Remission at Week 52*

*Corticosteroid-free clinical remission: Assessed in the subgroup of patients who were receiving corticosteroids at baseline and who were in clinical response (defined as ≥70 decrease in CDAI from baseline) at Week 6 (n=82 for placebo and n=82 for ENTYVIO every 8 weeks). Corticosteroid-free clinical remission was defined as the proportion of patients in this subgroup that discontinued corticosteroids by Week 52 and were in clinical remission at Week 52.

CDAI=Crohn’s Disease Activity Index;
CI=confidence interval; Q8W=every 8 weeks.

Crohn’s Disease Trial II Study Design2,4

Crohn’s Disease Trial II was a randomized, double-blind, placebo-controlled study that enrolled adult patients with moderately to severely active Crohn’s disease who had failed at least one conventional therapy, including corticosteroids or immunomodulators and/or ≥1 anti-TNFα therapies.

Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted.

The primary end point of Crohn’s Disease Trial II was not statistically significant.

Because the primary outcome was not statistically significant, formal hypothesis testing of ranked secondary outcomes was not performed and considered exploratory.


*Clinical remission=CDAI score ≤150.

IV=intravenous; TNFα=tumor necrosis factor alpha.

Crohn’s Disease Trial II2,4

Adverse Reactions from UC Trials I & II and CD Trials I & III2

Adverse reactions in ≥3% of ENTYVIO-treated patients and ≥1%
higher than in placebo (UC Trials I and II* and CD Trials I and III*)

Adverse Events based on UC Trials I and II, CD Trials I and III2

INFECTIONS

  • Infection rates with ENTYVIO were 0.85 per patient-year vs 0.7 for placebo
    • Infections consisted primarily of nasopharyngitis, upper respiratory tract infection, sinusitis, and urinary tract infection
    • 2% of patients discontinued ENTYVIO due to infections

Serious Infections

  • Serious infection rates with ENTYVIO were 0.07 per patient-year vs 0.06 for placebo
    • Serious infections included anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis

IMMUNOGENICITY

  • The rate of detectable anti-vedolizumab antibodies at any time during the 52 weeks of continuous treatment with ENTYVIO was 6% (86 of 1427 patients)
    • 20 of 86 patients were persistently positive (at 2 or more study visits) for anti-vedolizumab antibody, and 56 of 86 patients developed neutralizing antibodies to vedolizumab
    • Among these 20 patients, 14 had undetectable or reduced vedolizumab serum concentrations. Five of the 20 patients with persistently positive anti-vedolizumab antibody achieved clinical remission at Week 52 in the controlled trials
    • Overall, there was no apparent correlation of anti-vedolizumab antibody development to adverse reactions following intravenous administration of ENTYVIO

Progressive Multifocal Leukoencephalopathy (PML)

  • Although unlikely, a risk of PML cannot be ruled out:
    • 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 is caused by the John Cunningham (JC) virus and typically only occurs in patients who are immunocompromised
    • 1 case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported in the postmarketing setting (e.g., human immunodeficiency virus [HIV] infection with a CD4 count of 300 cells/mm3 and prior and concomitant immunosuppression)

LIVER INJURY

  • ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury
  • 3 patients reported serious adverse reactions of hepatitis with ENTYVIO; 1 additional case of serious hepatitis was seen in the open-label trial
    • These adverse reactions occurred following 2 to 5 ENTYVIO doses; however, it is unclear if the reactions indicated drug-induced or autoimmune etiology
    • There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO
    • All patients recovered following discontinuation of therapy with or without treatment with corticosteroids

MALIGNANCIES

  • Malignancies (excluding dysplasia and basal cell carcinoma) were in 0.4% (6 of 1434) of patients treated with ENTYVIO and in 0.3% (1 of 297) of patients treated with placebo
    • The number of malignancies in clinical trials was small; however, long-term exposure was limited

Adverse Reactions

  • Adverse reactions were reported in 52% of patients treated with ENTYVIO (N=1434) and 45% of patients treated with placebo (N=297)
    • Over 52 weeks, 7% of patients treated with ENTYVIO experienced serious adverse reactions compared to 4% treated with placebo

Infusion-related reactions (IRRs) and hypersensitivity reactions

  • 4% of patients treated with ENTYVIO (N=1434) experienced an IRR vs 3% of patients on placebo (N=297)
  • 1 case of anaphylaxis (1 of 1434 patients treated with ENTYVIO) was reported by a CD patient during the second infusion (symptoms reported were dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) and was managed with discontinuation of infusion and treatment with antihistamine and IV hydrocortisone
  • Most frequently observed IRRs were nausea, headache, pruritus, dizziness, fatigue, infusion-related reaction, pyrexia, urticaria, and vomiting. These reactions generally occurred within the first two hours after the infusion and resolved with no treatment or following antihistamine and or IV hydrocortisone treatment

SELECTED SAFETY INFORMATION

  • If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
  • ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled.
  • Although unlikely, a risk of PML cannot be ruled out.
    Monitor patients for any new or worsening neurological
    signs or symptoms.
  • ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.

Please see additional Important Safety Information throughout this video.

Crohn’s Disease Trials I and III were randomized, double-blind, placebo-controlled studies that enrolled adult patients with moderately to severely active Crohn’s disease who had failed at least one conventional therapy, including corticosteroids or immunomodulators and/or ≥1 TNFα therapy.

Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted. Corticosteroids were tapered after Week 6, and in the United States, immunosuppressants were discontinued after Week 6.

*Not included in Crohn’s Disease Trial I efficacy analysis.

Clinical response=≥70-point decrease in CDAI from baseline. Nonresponders (n=506) received open-label Entyvio Q4W for up to 52 weeks (not included in Crohn’s Disease Trial III efficacy analysis).

The ENTYVIO Q4W dosing regimen did not demonstrate additional clinical benefit over the Q8W dosing regimen and is not the recommended dosing regimen.

CDAI=Crohn’s disease activity index; IV=intravenously; Q4W=every 4 weeks; Q8W=every 8 weeks; TNFα=tumor necrosis factor alpha.

76% of patients in Crohn’s disease Trial II had an inadequate response, loss of response, or intolerance to one or more anti-TNFα therapies.

*Clinical remission=CDAI ≤150.

CDAI=Crohn’s Disease Activity Index; CI=confidence interval; TNFα=tumor necrosis factor alpha.

*Data from patients receiving open-label ENTYVIO treatment at Weeks 0 and 2 (prior to entry into UC Trial II and CD Trial III) and from Weeks 6 to 52 (nonresponders at Week 6 of UC Trial I and CD Trial I) are included.

Patients who received ENTYVIO for up to 52 weeks.

Patients who received placebo for up to 52 weeks.

Patients Can Reach Long-Term Remission with ENTYVIO

Patient status at 1 year

  • Achieved clinical remission (CDAI=47)
  • Symptoms improved
  • Successfully tapered steroids

PATIENTS CAN REACH LONG-TERM REMISSION WITH ENTYVIO

Long-term remission was evaluated at Week 52.2

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, and pain in extremities.

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 FORM & STRENGTH:

  • ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab

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

Crohn's disease Interactive Video, featuring Asher Kornbluth, MD

See Dr. Asher Kornbluth offer his expertise on long-term remission data for ENTYVIO from his learnings in the GEMINI 2 study.

VARSITY Interactive Video,
featuring Stephen
Hanauer, MD

Watch Dr. Stephen Hanauer provide
his expertise on ENTYVIO, supported
by head-to-head clinical trial data
from the VARSITY study.

Crohn's disease Interactive
Video, featuring Asher
Kornbluth, MD

See Dr. Asher Kornbluth offer his
expertise on long-term remission
data at week 52 for ENTYVIO
from his learnings in the
GEMINI 2 study.

Clinical Reprints

Review insights on ENTYVIO clinical trial data for healthcare professionals.

VISIBLE 1 Trial Reprint

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

VARSITY Trial Reprint

Vedolizumab versus adalimumab
for moderate to severe
ulcerative colitis

VARSITY Histologic End Points Reprint

Vedolizumab versus adalimumab
for moderate to severe
ulcerative colitis

COLOMBEL Trial Reprint

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

GEMINI Trial Reprint

Vedolizumab long-term data
for moderate to severe
ulcerative colitis

Explore more topics

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ENTYVIO?

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

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

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.

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:

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

Please click for Full Prescribing Information.