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

CD Data

Clinical Data

Long-term focus—From the Start

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

For adult patients with moderately to severely active CD
for whom other therapies have not worked well enough.

Turn to Entyvio first to achieve remission1,2,4

Overall population

Crohn's disease trial I
  • In a separate study, 15% (n=158) of patients taking Entyvio who had a suboptimal response to ≥1 anti-TNFα therapy achieved clinical remission at Week 6 vs 12% (n=157) with placebo (P=NS) (primary end point, CD Trial II)
Crohn's disease trial I and III

Remission and Response Rates at Week 6

Crohn's disease trial II
  • 76% of patients in CD Trial II had an inadequate response, loss of response, or intolerance to one or more TNFα blockers. CD Trial II patients were not part of the maintenance study
Crohn's disease trial II

CD TRIALS I, II, AND III


Three randomized, double-blind, placebo-controlled studies enrolled adult patients with moderately to severely active CD who had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or ≥1 anti-TNFα therapy.

In CD Trial I, patients were randomized (3:2) to receive Entyvio 300 mg or placebo by intravenous infusion at Weeks 0 and 2.

In CD Trial II, patients were randomized (1:1) to receive either Entyvio 300 mg or placebo at weeks 0, 2, and 6.

In CD Trial III, patients receiving Entyvio who demonstrated clinical response (≥70-point decrease in CDAI score from baseline) at Week 6 (from CD 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.

Crohn's disease data overall

-

In a separate study, 15% (n=158) of patients taking Entyvio who had a suboptimal response to ≥1 anti-TNFα therapy achieved clinical remission at Week 6 vs 12% (n=157) with placebo (P=NS) (primary end point, CD Trial II)

Remission and Response Rates at Week 6

Crohn's disease trial II

-

76% of patients in CD Trial II had an inadequate response, loss of response, or intolerance to one or more TNFα blockers. CD Trial II patients were not part of the maintenance study

CD TRIALS I, II, AND III

Three randomized, double-blind, placebo-controlled studies enrolled adult patients with moderately to severely active CD who had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or ≥1 anti-TNFα therapy.

In CD Trial I, patients were randomized (3:2) to receive Entyvio 300 mg or placebo by intravenous infusion at Weeks 0 and 2.

In CD Trial II, patients were randomized (1:1) to receive either Entyvio 300 mg or placebo at weeks 0, 2, and 6.

In CD Trial III, patients receiving Entyvio who demonstrated clinical response (≥70-point decrease in CDAI score from baseline) at Week 6 (from CD 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.

Anti-TNFα naïve subpopulation: Remission rates1,2

Remission rates Remission rates

Anti-TNFα failure subpopulation: Remission rates1,2

Remission rates Remission rates

Remission rates at Week 6 and Week 101,2,7

Remission rates at Week 6 and Week 101,2,7

 

Remission rates Remission rates

Steroid-free remission rates1,2¶

Steroid-free remission rates1,2¶

Remission rates Remission rates

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.