For adult patients with moderately to severely active UC or CD when other therapies have not worked well enough or cannot be tolerated.

Clinical Data

Long-term focus—From the Start

UC Study Design

For adult patients with moderately to severely active UC or CD when other therapies have not worked well enough or cannot be tolerated.

Designed to show rapid response and long-term remission1,2,3

UC Trial I

Study design: 2 cohorts with primary end point evaluation at Week 6*

UC Trial II

Study design: Patients receiving Entyvio in cohorts 1 and 2 of UC Trial I who achieved clinical response at Week 6 were randomly assigned to continue receiving Entyvio every 4 or 8 weeks or placebo every 4 weeks for up to 52 weeks*

Cohort 1—Blinded

Randomized 3:2 to receive 300 mg Entyvio or placebo intravenously at Weeks 0, 2

Cohort 2—
Open-label

300 mg Entyvio intravenously at Weeks 0, 2 (not included in UC Trial I efficacy analyses)

Blinded and open-label
Baseline characteristics: Cohorts 1 and 2
Overall (N=895)
Anti-TNFα naïve: ~50%
Anti-TNFα exposed: ~10% Anti-TNFα failure: ~40%

Week 6 end points

Primary outcome
Secondary outcomes

Week 52 end points

Primary outcome
Secondary outcomes

Clinical response

Clinical remission§
Improvement of endoscopic appearance of the mucosa||

Clinical remission§

Clinical response at both Weeks 6 and 52
Clinical remission at both Weeks 6 and 52
Improvement of endoscopic appearance of the mucosa|| Corticosteroid-free clinical remission

Designed to show rapid response and long-term remission1,2,3

UC Trials I and II

Two randomized, double-blind, placebo-controlled studies enrolled adult patients with moderately to severely active UC who had failed at least 1 conventional therapy, including corticosteroids or immunomodulators and/or ≥1 anti-TNFα therapy. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted. Corticosteroids were tapered after Week 6; in the United States, immunosuppressants were discontinued after induction.

UC Trial I

Study design: 2 cohorts with primary end point evaluation at Week 6

Cohort 1—Blinded
Randomized 3:2 to receive 300 mg Entyvio or placebo intravenously at Weeks 0, 2

Ulcerative colitis cohort 1

Cohort 2—Open-label
300 mg Entyvio intravenously at Weeks 0, 2 (not included in UC Trial I efficacy analyses)

Ulcerative colitis cohort 2
Baseline characteristics: Cohorts 1 and 2
Overall (N=895)

Anti-TNFα naïve: ~50%
Anti-TNFα exposed: ~10%
Anti-TNFα failure: ~40%

In UC Trial I, patients were randomized (3:2) to receive Entyvio 300 mg or placebo by intravenous infusion. The primary end point for UC Trial I was the rate of clinical response (reduction in complete Mayo score of ≥3 points and ≥30% from baseline with a decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point) at Week 6.

Week 6 END POINTS

Primary outcome

Clinical response*

Secondary outcomes

Clinical remission
Improvement of endoscopic appearance of
the mucosa

UC Trial II

Study design: Patients receiving Entyvio in cohorts 1 and 2 of UC Trial I who achieved clinical response at Week 6 were randomly assigned to continue receiving Entyvio every 4 or 8 weeks or placebo every 4 weeks for up to 52 weeks. For patients who did not achieve clinical response in cohorts 1 and 2 of UC Trial I, they continued receiving open-label Entyvio every 4 weeks up to 52 weeks (these findings are not included in the UC Trial II efficacy analysis).

Patients who achieved clinical response from UC Trial I

In UC Trial II, patients receiving Entyvio who demonstrated clinical response at Week 6 (from UC Trial I or an open-label cohort) were randomized (1:1:1) to receive either Entyvio
300 mg every 8 weeks, Entyvio 300 mg every
4 weeks, or placebo every 4 weeks. The primary end point for UC Trial II was the rate of clinical remission (complete Mayo score ≤2 and no individual subscore >1) at Week 52.

Ulcerative colitis trial

Patients who failed to achieve clinical response from UC Trial I

For patients who did not achieve clinical response in cohorts 1 and 2 from UC Trial I, they continued receiving open-label Entyvio 300 mg every 4 weeks up to 52 weeks. Placebo group carried over from cohort 1 of UC Trial II. These findings are not included in the UC Trial II efficacy analysis.

Ulcerative colitis trial

Week 52 END POINTS

Primary outcome

Clinical remission

Secondary outcomes

Clinical response at both Weeks 6 and 52
Clinical remission at both Weeks 6 and 52
Improvement of endoscopic appearance
of the mucosa
Corticosteroid-free clinical remission||

Important Safety Information and Indications

  • 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.
  • 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.
  • 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), 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. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported in the post marketing setting (e.g., human immunodeficiency virus [HIV] infection with a CD4 count of 300 cells/mm3 and prior and concomitant immunosuppression). Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and 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 a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • 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.
  • 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.
  • Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Indications

Adult Ulcerative Colitis (UC)

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

Adult Crohn’s Disease (CD)

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

Please see full Prescribing Information, including Medication Guide.

  1. Entyvio (vedolizumab) prescribing information. Takeda Pharmaceuticals.
  2. Data on file. Takeda Pharmaceuticals.
  3. Feagan BG, Rutgeerts P, Sands BE, et al; for the GEMINI 1 Study Group. N Engl J Med. 2013;369(8):699-710.
  4. Sandborn WJ, Feagan BG, Rutgeerts P, et al; for GEMINI 2 Study Group. N Engl J Med. 2013;369(8):711-721.
  5. Colombel JF, Sands BE, Rutgeerts P, et al. Gut. 2017;66(5):839-851.
  6. Feagan BG, Rubin DT, Danese S, et al. Clin Gastroenterol Hepatol. 2017;15(2):229-239.e5.
  7. Sands BE, Feagan BG, Rutgeerts P, et al. Gastroenterology. 2014;147(3):618-627.e3.
  8. Xavier RJ, Podolsky DK. Nature. 2007;448(7152):427-434.
  9. Briskin M, Winsor-Hines D, Shyjan A, et al. Am J Pathol. 1997;151(1):97-110.
  10. Fedyk E, Wyant T, Yang LL, et al. Inflamm Bowel Dis. 2012;18(11):2107-2119.
  11. Soler D, Chapman T, Yang LL, et al. J Pharmacol Exp Ther. 2009;330(3):864-875.
  12. Wyant T, Fedyk E, Abhyankar B. J Crohns Colitis. 2016;10(12):1437-1444.
  13. Wyant T, Leach T, Sankoh S, et al. Gut. 2015;64(1):77-83.
  14. Milch C, Wyant T, Xu J, et al. J Neuroimmunol. 2013;264:123-126.
  15. Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. N Engl J Med. 2019;381(13):1215-1226.

Important Safety Information and Indications

  • 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.
  • 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.
  • 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), 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. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported in the post marketing setting (e.g., human immunodeficiency virus [HIV] infection with a CD4 count of 300 cells/mm3 and prior and concomitant immunosuppression). Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and 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 a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • 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.
  • 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.
  • Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Indications

Adult Ulcerative Colitis (UC)

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

Adult Crohn’s Disease (CD)

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

Please see full Prescribing Information, including Medication Guide.

  1. Entyvio (vedolizumab) prescribing information. Takeda Pharmaceuticals.
  2. Data on file. Takeda Pharmaceuticals.
  3. Feagan BG, Rutgeerts P, Sands BE, et al; for the GEMINI 1 Study Group. N Engl J Med. 2013;369(8):699-710.
  4. Sandborn WJ, Feagan BG, Rutgeerts P, et al; for GEMINI 2 Study Group. N Engl J Med. 2013;369(8):711-721.
  5. Colombel JF, Sands BE, Rutgeerts P, et al. Gut. 2017;66(5):839-851.
  6. Feagan BG, Rubin DT, Danese S, et al. Clin Gastroenterol Hepatol. 2017;15(2):229-239.e5.
  7. Sands BE, Feagan BG, Rutgeerts P, et al. Gastroenterology. 2014;147(3):618-627.e3.
  8. Xavier RJ, Podolsky DK. Nature. 2007;448(7152):427-434.
  9. Briskin M, Winsor-Hines D, Shyjan A, et al. Am J Pathol. 1997;151(1):97-110.
  10. Fedyk E, Wyant T, Yang LL, et al. Inflamm Bowel Dis. 2012;18(11):2107-2119.
  11. Soler D, Chapman T, Yang LL, et al. J Pharmacol Exp Ther. 2009;330(3):864-875.
  12. Wyant T, Fedyk E, Abhyankar B. J Crohns Colitis. 2016;10(12):1437-1444.
  13. Wyant T, Leach T, Sankoh S, et al. Gut. 2015;64(1):77-83.
  14. Milch C, Wyant T, Xu J, et al. J Neuroimmunol. 2013;264:123-126.
  15. Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. N Engl J Med. 2019;381(13):1215-1226.