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For U.S. Healthcare Professionals

Patient

Made
For

Long-term
Remission
in CD

Remission was evaluated at Week 52.1
Individual results may vary.

Healthcare professional

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

OVERVIEW OF GEMINI II AND III DATA

CD Trials I, II, and III

CD Trial I: Primary End Points

CLINICAL REMISSION
AND
RESPONSE RATES AT WEEK 61,2

CD trial I primary end points at Week 6

CD Trial III: Primary and Secondary End Points

CLINICAL REMISSION, CLINICAL RESPONSE AND STEROID-FREE REMISSION AT WEEK 521,2

CD trial III primary and secondary end points at Week 52

Study Design: 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. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted in all three trials.
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.

CD Trial II: Primary End Point

CLINICAL REMISSION RATE AT WEEK 61*

CD trial II primary end point at Week 6

* Clinical remission = CDAI score ≤150.

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

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.

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

CDAI = Crohn's Disease Activity Index; CI = confidence interval; NS = not significant; Q8W = every 8 weeks; TNFα = tumor necrosis factor alpha.

CD Trial I: Remission Rates

ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS

Clinical remission* rates—exploratory end points.

At Week 6, in the anti‑TNFα naïve subpopulation, clinical remission rates were 17% for those who received Entyvio vs. 9% for those who received placebo. In the anti‑TNFα failure subpopulation, clinical remission rates were 12% for those who received Entyvio vs. 4% for those who received placebo.3

Go back to top of page for GEMINI II and III Primary End Point Data

Go back to top of page for GEMINI II and III Primary End Point Data

* Clinical remission = CDAI score ≤150.

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

CLINICAL REMISSION RATES AT WEEK 63*
CD trial I remission rates at Week 6

CD Trial I: Response Rates

ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS

Clinical response rates—exploratory end points.

At Week 6, in the anti‑TNFα naïve subpopulation, clinical response rates were 42% for those who received Entyvio vs. 30% for those who received placebo. In the anti‑TNFα failure subpopulation, clinical response rates were 21% in both groups.3

Go back to top of page for GEMINI II and III Primary End Point Data

Go back to top of page for GEMINI II and III Primary End Point Data

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

CDAI = Crohn's Disease Activity Index; CI = confidence interval; NS = not significant; TNFα = tumor necrosis factor alpha.

CLINICAL RESPONSE RATES AT WEEK 63†
CD trial I response rates at Week 6

CD Trial III: Remission Rates

ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS

Clinical remission* rates—exploratory end points.

At Week 52, in the anti‑TNFα naïve subpopulation, clinical remission rates were 52% for those who received Entyvio vs. 27% for those who received placebo. In the anti‑TNFα failure subpopulation, clinical remission rates were 28% for those who received Entyvio vs. 13% for those who received placebo.3

Go back to top of page for GEMINI II and III Primary End Point Data

Go back to top of page for GEMINI II and III Primary End Point Data

* Clinical remission = CDAI score ≤150.

CDAI = Crohn's Disease Activity Index; CI = confidence interval; Q8W = every 8 weeks; TNFα = tumor necrosis factor alpha.

CLINICAL REMISSION RATES AT WEEK 523*
CD trial III remission rates at Week 52

CD Trial III: Response Rates

ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS

Clinical response rates—exploratory end points.

At Week 52, in the anti‑TNFα naïve subpopulation, clinical response rates were 61% for those who received Entyvio vs. 38% for those who received placebo. In the anti‑TNFα failure subpopulation, clinical response rates were 29% for those who received Entyvio vs. 21% for those who received placebo.3

Go back to top of page for GEMINI II and III Primary End Point Data

Go back to top of page for GEMINI II and III Primary End Point Data

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

CDAI = Crohn's Disease Activity Index; CI = confidence interval; Q8W = every 8 weeks; TNFα = tumor necrosis factor alpha.

CLINICAL RESPONSE RATES AT WEEK 523†
CD trial III response rates at Week 52

CD Trial III: Steroid-Free Remission Rates

ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS

Steroid-free clinical remission rates—exploratory end points.

At Week 52, in the anti‑TNFα naïve subpopulation, steroid-free clinical remission rates were 40% for those who received Entyvio vs. 28% for those who received placebo. In the anti‑TNFα failure subpopulation, steroid-free clinical remission rates were 24% for those who received Entyvio vs. 0% for those who received placebo.3

Go back to top of page for GEMINI II and III Primary End Point Data

Go back to top of page for GEMINI II and III Primary End Point Data

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; TNFα = tumor necrosis factor alpha.

STEROID-FREE CLINICAL REMISSION RATES AT WEEK 523‡
CD trial III steroid free data at Week 52

CD Trials I and III1-3

CD Trials I and III were randomized, double-blind, placebo-controlled studies that enrolled adult patients with moderately to severely active CD 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.

CD trial I and III study design

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  • CD Trial I: 2 cohorts with primary end point evaluation at Week 6
  • CD Trial III: Patients receiving Entyvio 300 mg in cohorts 1 and 2 of CD Trial I who had a clinical response at Week 6 were randomly assigned to continue receiving Entyvio 300 mg every 8 weeks, Entyvio 300 mg every 4 weeks, or placebo for up to 52 weeks

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

Clinical remission = CDAI ≤150.

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

§ Assessed in the subgroup of patients who were receiving corticosteroids at baseline and who were in clinical response at Week 6 (n=82 for placebo, and n=82 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.

CDAI = Crohn's Disease Activity Index; IV = intravenous; Q4W = every 4 weeks; Q8W = every 8 weeks; TNFα = tumor necrosis factor alpha.

CD Trial II1

CD Trial II was a randomized, double-blind, placebo-controlled study that enrolled adult patients with moderately to severely active CD who had failed at least one conventional therapy, including corticosteroids or immunomodulators and/or ≥1 anti‑TNFα therapy. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted.

CD trial II study design

Scroll left and right to see more

  • CD Trial II: Patients were randomized in a double-blinded fashion (1:1) to receive either placebo or Entyvio
  • 76% of patients in CD Trial II had an inadequate response, loss of response, or intolerance to one or more TNF blockers

Clinical remission = CDAI ≤150.

CDAI = Crohn's Disease Activity Index; IV = intravenous; TNFα = tumor necrosis factor alpha.

GEMINI I Data: UC Trials I and II

SEE THE DATA

See How Entyvio Works

VIEW THE MOA

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.
  • 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.

References:

  1. Entyvio (vedolizumab) prescribing information. Takeda Pharmaceuticals.
  2. Sandborn WJ, Feagan BG, Rugeerts P, et al for the GEMINI 2 Study Group. N Engl J Med. 2013;369(8):711-721.
  3. Data on file. Takeda Pharmaceuticals.

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.
  • 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.