For adults with moderately to severely active ulcerative colitis and Crohn’s disease

Indications

Adult Ulcerative Colitis (UC) ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid‐free remission.
Adult Crohn’s Disease (CD) ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid‐free remission.

ENGINEERED FOR UC AND CD

For patients with moderately to severely active UC

Efficacy data from UC Trials I and II

Rapid response1

Entyvio efficacy in UC: Clinical response at Week 6 chart Entyvio efficacy in UC: Clinical response at Week 6 chart

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 one conventional therapy, including corticosteroids or immunomodulators and/or ≥1 anti-TNFα therapy. In UC Trial I (N=374), patients were randomized (3:2) to receive Entyvio 300 mg or placebo by intravenous infusion at Weeks 0 and 2. The primary end point for UC Trial I was the proportion of patients with 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) at Week 6. In UC Trial II (N=373), patients receiving Entyvio who demonstrated clinical response at Week 6 (from UC Trial 1 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 proportion of patients in clinical remission (complete Mayo score ≤2 and no individual subscore >1) at Week 52. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted.

UC trials overview

Lasting remission1

Entyvio efficacy in UC: Clinical remission at Week 52 Entyvio efficacy in UC: Clinical remission at Week 52

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 one conventional therapy, including corticosteroids or immunomodulators and/or ≥1 anti-TNFα therapy. In UC Trial I (N=374), patients were randomized (3:2) to receive Entyvio 300 mg or placebo by intravenous infusion at Weeks 0 and 2. The primary end point for UC Trial I was the proportion of patients with 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) at Week 6. In UC Trial II (N=373), patients receiving Entyvio who demonstrated clinical response at Week 6 (from UC Trial 1 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 proportion of patients in clinical remission (complete Mayo score ≤2 and no individual subscore >1) at Week 52. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted.

UC trials overview

Visible mucosal improvement1

Improvement of endoscopic appearance of the mucosa*

Entyvio efficacy in UC: Endoscopic improvement at Week 6 chart Entyvio efficacy in UC: Endoscopic improvement at Week 6 chart Entyvio efficacy in UC: Endoscopic improvement at Week 52 chart

At baseline, patients in the clinical studies presented with an endoscopic subscore of 2 or 3. Improvement of endoscopic appearance of the mucosa was defined as an endoscopic subscore of 0 or 1.1

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

Over 2X as many Entyvio patients achieved an endoscopic subscore of 0 or 1 at Week 521

At baseline, patients had an endoscopic subscore of 2 or 3.1 At Week 52, 52% (n=122) of Entyvio patients achieved a subscore of 0 or 1 versus 20% (n=126) of placebo patients.

Entyvio efficacy in UC: Mucosal healing at Week 52 Entyvio efficacy in UC: Mucosal healing at Week 52

Images are for example purposes only and are not representative of corresponding subscores shown, as multiple images can represent a single subscore; images are not results from studied patients. Adapted from de Lange T, Larsen S, Aabakken L. BMC Gastroenterology. 2004;4:9. Copyright 2004 BioMed Central.

UC trials overview

Remission without steroids1

Entyvio efficacy in UC: Steroid-free remission at Week 52. Over 2x as many patients achieved steroid-free remission with Entyvio every 8 weeks vs placebo. Entyvio efficacy in UC: Steroid-free remission at Week 52. Over 2x as many patients achieved steroid-free remission with Entyvio every 8 weeks vs placebo Entyvio efficacy in UC: Steroid-free remission at Week 52. Over 2x as many patients achieved steroid-free remission with Entyvio every 8 weeks vs placebo

Steroid-free remission: Assessed in the subgroup of patients who were receiving steroids at baseline and who were in clinical response at Week 6 (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). Steroid-free remission was defined as the proportion of patients in this subgroup who had discontinued steroids by Week 52 and were in clinical remission at Week 52.

UC Trials Overview1

  • Two randomized, double-blind, placebo-controlled studies enrolled adult patients with moderately to severely active UC
  • Corticosteroids were tapered after Week 6; in the United States, immunosuppressants were discontinued after induction
See more study design information

Patient population

  • Patients had failed* at least one conventional therapy, including corticosteroids, immunomodulators, and/or ≥1 anti-TNFα therapy
  • Patients who had received natalizumab ever in the past or a TNF blocker in the past 60 days were excluded from enrollment
Entyvio study overall population Entyvio study overall population

Treatment arms

  • Entyvio: Entyvio 300-mg infusion + concomitant therapies
  • Placebo: placebo saline infusion + concomitant therapies
Selected baseline
characteristics of patients
UC Trials4
Mean age 40.3 years
Mean disease duration 6.9 years
Mean Mayo Clinic score 8.6
UC Trial I1   UC Trial II1
Concomitant medications
Corticosteroids 54% 61%
Immunomodulators 30% 32%
Aminosalicylates 74% 75%
Prior anti-TNFα therapy failure 39% 32%

UC Trial I1,4

UC Trial II1,4

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

Study design: Patients receiving Entyvio in cohorts 1 and 2 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

Entyvio efficacy in UC: Study design flow chart Entyvio efficacy in UC: Study design flow chart

Week 6 end points

Primary outcome Secondary outcomes
Clinical response§ Clinical remissionII
Improvement of endoscopic appearance of the mucosa

Week 52 end points

Primary outcome Secondary outcomes
Clinical remissionII 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††
*
Inadequate response, loss of response, or intolerance to TNF blockers or immunomodulators; or inadequate response, intolerance, or dependence on corticosteroids.
Data from patients receiving blinded and open-label Entyvio treatment at Weeks 0 and 2 (prior to entry into UC Trial II) are included.
Concomitant therapies included aminosalicylates, steroids, and/or immunomodulators.
§
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).
**
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.
††
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.

IMPORTANT SAFETY INFORMATION

Expand
  • 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 have occurred. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. If anaphylaxis or other serious allergic 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.
  • Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. 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 adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid‐free remission.

Adult Crohn’s Disease (CD)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid‐free remission.

Please see full Prescribing Information, including Medication Guide.

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