For adult patients with moderately to severely active UC or CD when other therapies have not worked well enough.
For U.S. Healthcare Professionals
Clinical Data
CD Study Design
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.
Designed to assess 6-week and 52-week remission in CD1,4
CD Trial I
Study design: 2 cohorts with primary end point evaluation at Week 6*
CD Trial III
Study design: Patients receiving Entyvio 300 mg in cohorts 1 and 2 of CD Trial I who had a clinical response (ie, ≥70-point decrease in the CDAI score) 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*
Cohort 1—Blinded
Randomized 3:2 to receive 300 mg Entyvio or placebo intravenously at Weeks 0, 2
Cohort 2—
Open-label
Open-label
300 mg Entyvio intravenously at Weeks 0, 2 (not included in CD Trial I efficacy analyses)
Baseline characteristics: Cohorts 1 and 2
Overall (N=1115)
Anti-TNFα naïve: ~40%
Anti-TNFα exposed: ~5% Anti-TNFα failure: ~55%
Anti-TNFα exposed: ~5% Anti-TNFα failure: ~55%
- ~48% of Entyvio-treated patients from CD Trial I and the open-label cohort qualified for CD Trial III
Designed to assess 6-week and 52-week remission in CD1,4
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. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted. For CD Trials I and III, corticosteroids were tapered after
Week 6; in the United States, immunosuppressants were discontinued after Week 6.
CD 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
Cohort 2—Open-label
300 mg Entyvio intravenously at Weeks 0, 2
(not included in CD Trial I efficacy analyses)
Baseline characteristics: Cohorts 1 and 2
Overall (N=1115)
Anti-TNFα naïve: ~40%
Anti-TNFα exposed: ~5%
Anti-TNFα failure: ~55%
In CD Trial I (N=368), 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 CD Trial I was the proportion of patients with clinical remission (CDAI score ≤150) at Week 6. Another primary end point, the difference in percentage of patients who demonstrated clinical response (≥100-point decrease in CDAI score from baseline), was not statistically significant at
Week 6.
WEEK 6 END POINTS
Co-Primary outcomes
Clinical remission*
Clinical response†
CD Trial III
Study design: Patients receiving Entyvio 300 mg in cohorts 1 and 2 of CD Trial I who had a clinical response (ie, ≥70-point decrease in the CDAI score) 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
Patients who achieved clinical response from CD Trial I
In CD Trial III (N=461), 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. The primary end point for CD Trial III was the proportion of patients achieving clinical remission (CDAI score ≤150) at Week 52.
~48% of Entyvio-treated patients from CD Trial I and the open-label cohort qualified for CD Trial III
Patients who failed to achieve clinical response from CD Trial I
For patients who did not achieve clinical response (≥ 70-point decrease in the CDAI score from baseline) in cohorts 1 and 2 of CD 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 CD Trial I. These findings are not included in the CD Trial III efficacy analysis.
(Not included in CD Trial III efficacy analyses)
WEEK 52 END POINTS
Primary outcome
Clinical remission*
Secondary outcomes
Clinical response†
Corticosteroid-free clinical remission§
CD Trial II
Study design: Patients were randomized in a double-blinded fashion (1:1) to receive either placebo or Entyvio 300 mg intravenously at Weeks 0, 2, and 6
In CD Trial II (N=416), patients were randomized (1:1) to receive either Entyvio 300 mg or placebo at weeks 0, 2, and 6. A majority (76%) of enrolled patients had an inadequate response, loss of response, or intolerance to
≥1 TNF blockers; this was the primary analysis population. The primary end point for CD Trial II was the proportion of patients achieving clinical remission (CDAI score ≤150) at Week 6. Treatment with Entyvio did not result in statistically significant improvement over placebo. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted in all trials.
Assessment done at Week 6
(after doses at Weeks 0 and 2)
WEEK 6 PRIMARY END POINT
Clinical remission* in patients who had an inadequate response, loss of response, or intolerance to one or more TNF blockers
WEEK 10 SECONDARY END POINTS
Including assessment at Week 10 were not tested because the primary end point was not statistically significant
Week 6 end points
Co-Primary outcomes
Week 52 end points
Primary outcome
Secondary outcomes
Clinical remission‡
Clinical response§
Clinical remission‡
Clinical response§
Corticosteroid-free clinical remission||
CD Trial II
Study design: Patients were randomized in a double-blinded fashion (1:1)
to receive either placebo or Entyvio 300 mg at Weeks 0, 2, and 6*
76% of patients in CD Trial II had an inadequate response,
loss of response, or intolerance to one or more TNF blockers
*
CD Trials I, II, 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 anti-TNFα therapy. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted. For CD Trials I and III, corticosteroids were tapered after Week 6; in the United States, immunosuppressants were discontinued after Week 6.
†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 = Crohn's Disease Activity Index (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.
