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For U.S. Healthcare Professionals

Patient

GEMINI I
UC Trials
I & II

Clinical
Response &
Long‐Term
Data

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 I DATA

UC Trials I and II

Primary End Points

RAPID RESPONSE AT WEEK 6 AND LONG-TERM REMISSION AT
WEEK 521

GEMINI I rapid response and long-term remission data

Secondary End Points

RATE OF VISIBLE MUCOSAL IMPROVEMENT AT WEEK 6 AND
WEEK 521,2‡

GEMINI I rate of visible improvement

Study Design: 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.1,2 In UC Trial I, patients were randomized (3:2) to receive Entyvio 300 mg or placebo by intravenous infusion at Weeks 0 and 2. 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.1 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.

Secondary End Point

CORTICOSTEROID-FREE CLINICAL REMISSION AT WEEK 521,2§

GEMINI I corticosteroid-free remission data

* 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.

Clinical remission = complete Mayo score of ≤2 points and no individual subscore >1 point.

Improvement of endoscopic appearance of the mucosa = Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern, mild friability).

§ 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; Q4W = every 4 weeks; Q8W = every 8 weeks; TNFα = tumor necrosis factor alpha.

Clinical Response Data

  • ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS

    Clinical response* rates—exploratory end point.

    Go back to top of page for GEMINI I Primary End Point Data

    CLINICAL RESPONSE AT WEEK 63*

    GEMINI I response at Week 6 Anti-TNF data

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* 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.

CI = confidence interval; TNFα = tumor necrosis factor alpha.

CLINICAL RESPONSE AT WEEK 63*

GEMINI I response at Week 6 Anti-TNF data

Clinical Response Measured by Partial Mayo Score3

CLINICAL RESPONSE RATES BASED ON PARTIAL MAYO SCORE AT WEEKS 2, 4, AND 63†
GEMINI I clinical response measured by partial Mayo score

Clinical response rates based on partial Mayo score

The partial Mayo score is a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician’s global assessment), each scored on a scale from 0 to 3 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore.3

Clinical response was defined as a reduction in partial Mayo score of ≥2 points and ≥25% from baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point.3

Partial Mayo score and complete Mayo score were highly correlated at baseline and Week 6. Pearson correlation coefficients were 0.95 (95% CI: 0.94, 0.96) and 0.98 (95% CI: 0.97, 0.98) at baseline and Week 6, respectively. When further evaluating the clinical response at Week 6 correlation using kappa statistics, there was also substantial agreement between the 2 scores (0.78 [95% CI: 0.70, 0.86]).

CI = confidence interval.

Go back to top of page for GEMINI I Primary End Point Data

Entyvio Offers Long‑Term Remission Data1

  • ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS

    Long-term clinical remission* rates—exploratory end points.

    Go back to top of page for GEMINI I Primary End Point Data

    CLINICAL REMISSION AT WEEK 523*

    GEMINI I remission at Week 52 Anti-TNF data

Go back to top of page for GEMINI I Primary End Point Data

* Clinical remission = complete Mayo score of ≤2 points and no individual subscore >1 point.

CI = confidence interval; Q8W = every 8 weeks; TNFα = tumor necrosis factor alpha.

CLINICAL REMISSION AT WEEK 523*

GEMINI I remission at Week 52 Anti-TNF data

Improvement of Endoscopic Appearance Rates1

  • ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS

    Improvement of the endoscopic appearance of the mucosa—exploratory end points.

    At Week 52, in the anti‑TNFα naïve subpopulation, improvement of the endoscopic appearance of the mucosa rates were 60% for patients who received Entyvio vs. 24% for those who received placebo. In the anti‑TNFα failure subpopulation, improvement of the endoscopic appearance of the mucosa rates were 42% for those who received Entyvio vs. 8% for those who received placebo.3

    Go back to top of page for GEMINI I Primary End Point Data

    IMPROVEMENT OF THE APPEARANCE OF THE MUCOSA AT WEEK 523†

    GEMINI I Anti-TNF endoscopic subscore data

Go back to top of page for GEMINI I Primary End Point Data

Endoscopic improvement = Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern, mild friability).

CI = confidence interval; Q8W = every 8 weeks; TNFα = tumor necrosis factor alpha.

IMPROVEMENT OF THE APPEARANCE OF THE MUCOSA AT WEEK 523†

GEMINI I Anti-TNF endoscopic subscore data

GEMINI I: UC Trials I and II

GEMINI I study design

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  • 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
  • UC Trial I: 2 cohorts with primary end point evaluation at Week 6
  • UC Trial II: 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

* 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 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.

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

IV = intravenously; Q4W = every 4 weeks; Q8W = every 8 weeks; TNFα = tumor necrosis factor alpha.

Entyvio vs. Humira® (adalimumab) Data

SEE VARSITY STUDY RESULTS

Humira® (AbbVie Inc. North Chicago, IL).
For more information related to Humira, please see AbbVie.com.

Entyvio Safety Profile

VIEW SAFETY PROFILE

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. Feagan BG, Rutgeerts P, Sands BE, et al; for the GEMINI 1 Study Group. N Engl J Med. 2013;369(8):699-710.
  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.