For adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).
*Quarterly analysis of IQVIA medical and pharmacy claims data from January 2023 through December 2025.
Proven efficacy in Crohn’s disease
Results U Need
Rapid symptom relief
Clinical remission at Week 6 vs placebo1*
Week 6 results with ENTYVIO IV only.
Symptom relief and CS-free remission
Clinical remission at Week 52 vs placebo, some without steroids1*
Exploratory insights
Data for early vs late Crohn's patients†
Not powered for statistical significance.
Individual results may vary.
*Some patients reached remission as early as Week 6 (IV). Many reached remission at Week 52 (IV and SC), some without steroids (IV). Clinical remission=CDAI score ≤150. CS-free remission=clinical remission at Week 52 after discontinuing baseline corticosteroids.
†Early Crohn’s=≤2 years since diagnosis, prior corticosteroid and/or immunomodulator treatment, and no prior anti-TNF therapy. Late Crohn’s=>2 years since diagnosis and prior corticosteroid, immunomodulator, and anti-TNF therapy.
Anti-TNF=anti-tumor necrosis factor; CDAI=Crohn's Disease Activity Index; CS=corticosteroid; IV=intravenous; SC=subcutaneous.
Current ACG Guidelines strongly recommend ENTYVIO IV
as an option for remission of Crohn’s*
*Supported by Moderate Quality of Evidence, which means the true effect is likely close to the estimated effect. ACG recommendations are graded “Strong” when benefits outweigh risks.
STUDY DESIGNS
ENTYVIO (vedolizumab) Clinical Trials for Crohn's Disease
GEMINI II (N=829) was a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety profile of ENTYVIO IV in adults with moderate to severe Crohn’s disease.1-3 Study Design and Baseline Characteristics
GEMINI III (N=416) was a randomized, double-blind, placebo-controlled study evaluating ENTYVIO IV in a majority TNFα-failure Crohn’s disease population.1 Study Design and Baseline Characteristics
VISIBLE 2 (N=644) was a randomized, double-blind, placebo-controlled study evaluating the long-term efficacy and safety profile of ENTYVIO SC in Crohn’s disease.1,4 Study Design and Baseline Characteristics
LOVE-CD (N=260) was a prospective, single-arm, open-label clinical study assessing the efficacy of ENTYVIO IV in early and late Crohn’s disease. The LOVE-CD Subgroup Analysis (n=96) was a post-hoc, exploratory analysis that excluded patients who received ENTYVIO in a manner considered off-label per the USPI.5,6 Study Design and Baseline Characteristics
IV=intravenous; SC=subcutaneous; TNFα=tumor necrosis factor alpha.
Rapid symptom relief as early as Week 6
Overall population compared with placebo
GEMINI II TRIAL PRIMARY ENDPOINTS
15% of patients (vs 7% placebo) achieved clinical remission1-3*
31% of patients (vs 26% placebo) achieved clinical response1-3†
No significant differences
GEMINI III TRIAL PRIMARY ENDPOINTS
15% of patients (vs 12% placebo) achieved clinical remission1*
No significant differences
76% of patients in Crohn’s disease Trial II had an inadequate response, loss of response, or intolerance to one or more anti-TNFα therapies.
ENTYVIO IV
Placebo
*Clinical remission=CDAI score ≤150.
†Clinical response=≥100-point decrease in CDAI from baseline.
CDAI=Crohn’s Disease Activity Index; CI=confidence interval; IV=intravenous; NS=not significant; TNFα=tumor necrosis factor alpha.
Symptom relief at Week 52 for IV and SC
Overall population compared with placebo
GEMINI II TRIAL PRIMARY ENDPOINT
39% of patients (vs 22% placebo) achieved clinical remission1,2*
VISIBLE 2 TRIAL PRIMARY ENDPOINT
48% of patients (vs 34% placebo) achieved clinical remission1,4*
ENTYVIO IV
ENTYVIO SC
Placebo
*Clinical remission=CDAI score ≤150.
CDAI=Crohn’s Disease Activity Index; CI=confidence interval; CS=corticosteroid; IV=intravenous; Q2W=every 2 weeks; Q8W=every 8 weeks; SC=subcutaneous.
CS-free remission at Week 52 for IV and SC
Overall population compared with placebo
GEMINI II TRIAL SECONDARY ENDPOINT
32% of patients (vs 16% placebo) achieved CS-free remission1,2*
VISIBLE 2 TRIAL SECONDARY ENDPOINT
This result was not statistically significant under the prespecified multiple testing procedure.
Secondary endpoints of enhanced clinical response and clinical remission in anti-TNFα naïve patients were not statistically significant.
ENTYVIO IV
ENTYVIO SC
Placebo
*CS-free remission=clinical remission after discontinuing baseline corticosteroids.
CI=confidence interval; CS=corticosteroid; IV=intravenous; Q2W=every 2 weeks; Q8W=every 8 weeks; SC=subcutaneous.
No statistical comparisons were made between GEMINI II and VISIBLE 2.
GEMINI II SUBGROUP ANALYSIS
Clinical remission subgroup data for ENTYVIO
Study context and data limitations for Week 6 and Week 52 exploratory endpoints1,3:
- Data are derived from a post-hoc pooled analysis and are therefore not powered for statistical significance and should be considered exploratory
- Patients receiving ENTYVIO who demonstrated clinical response (≥70-point decrease in CDAI score from baseline) at Week 6 (from Crohn’s Trial I or an open-label cohort) were randomized (1:1:1) to ENTYVIO 300 mg Q8W, ENTYVIO 300 mg Q4W, or placebo Q4W
- For the Week 6 analysis, the open-label induction cohort was not included
- For Week 52, only patients randomized to the maintenance phase were included in the analysis. The Q4W dosing regimen is not the recommended dosing regimen and is not included in this analysis
Clinical remission by TNF status and disease severity
Not powered for statistical significance.
TNF status and disease severity subgroups compared to placebo
Moderate (baseline CDAI ≤330)3*
Severe (baseline CDAI >330)3*
ENTYVIO
Placebo
*Clinical remission=CDAI score ≤150.
TNF status and disease severity subgroups compared to placebo
Moderate (baseline CDAI ≤330)3*
Severe (baseline CDAI >330)3*
ENTYVIO
Placebo
*Clinical remission=CDAI score ≤150.
CDAI=Crohn’s Disease Activity Index; CI=confidence interval; Q4W=every 4 weeks; Q8W=every 8 weeks; TNFα=tumor necrosis factor alpha.
LOVE-CD POST-HOC SUBGROUP ANALYSIS | ENTYVIO DATA FOR PATIENTS WITH EARLY VS LATE CROHN'S5,6
Study context and data limitations6:
- Open-label, single-arm, nonrandomized design may have introduced bias and have less evidentiary value than a blinded, controlled study
- Post-hoc analyses were descriptive/exploratory and not powered for statistical significance. Secondary endpoints were not adjusted for multiplicity
- Missing endoscopy/CDAI data were handled conservatively by classifying patients as nonresponders, which may have underestimated the treatment effect
- Conducted in Belgium, Hungary, and the Netherlands, which may limit generalizability to the US patient population
- Sample size was small and only included patients taking ENTYVIO IV
Deep remission and endoscopic response data in early vs late Crohn’s disease*
Not powered for statistical significance
Deep remission† at Weeks 26 and 525
Endoscopic response5‡
Early Crohn’s
Late Crohn’s
*Early Crohn’s=≤2 years since diagnosis, prior corticosteroid and/or immunomodulator treatment, and no prior anti-TNF therapy. Late Crohn’s=>2 years since diagnosis and prior corticosteroid, immunomodulator, and anti-TNF therapy.
†Deep remission=clinical + endoscopic remission (CDAI ≤150; SES‑CD <4).
‡Endoscopic response=≥50% SES‑CD reduction from baseline.
CDAI=Crohn’s Disease Activity Index; CI=confidence interval; IV=intravenous; SES-CD=Simple Endoscopic Score for Crohn’ disease; TNF=tumor necrosis factor.
Explore more topics
The content on this page has been written and reviewed by Takeda.
References:
- ENTYVIO (vedolizumab) prescribing information. Takeda Pharmaceuticals.
- Sandborn WJ, Feagan BG, Rutgeerts P, et al; for the GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013;369(8):711-721.
- Data on file. Takeda Pharmaceuticals.
- Vermeire S, D’Haens G, Baert F, et al. Efficacy and safety of subcutaneous vedolizumab in patients with moderately to severely active Crohn’s disease: results from the VISIBLE 2 randomised trial. J Crohn’s Colitis. 2022;16(1):27-38.
- Data on file. Takeda Pharmaceuticals. REF-72861.
- D’Haens GR, Löwenberg M, Baert F, et al. Vedolizumab in early and late Crohn’s disease (LOVE-CD): a phase 4 open-label cohort study. Lancet Gastroenterol Hepatol. 2026;11(1):12-21.
GEMINI II Full Study Design and Baseline Characteristics1-3
- GEMINI II (CD Trial I, N=368, CD Trial III, N=461) were randomized, double-blind, placebo-controlled studies of adults with moderately to severely active Crohn’s disease (CDAI 220-450) who had failed corticosteroids or immunomodulators and/or ≥1 TNFα therapy (58%)
- In CD Trial I, patients were randomized 3:2 to receive ENTYVIO IV 300 mg or placebo at Weeks 0 and 2. 48% of patients achieved clinical response at Week 6. In CD Trial III, responders were randomized 1:1:1 to maintenance with ENTYVIO IV 300 mg Q8W, ENTYVIO IV 300 mg Q4W, or placebo Q4W
*Not included in efficacy analysis.
†Clinical response=≥70-point decrease in CDAI from baseline. Not a study endpoint. Data includes responders from both blinded and open-label cohorts.
‡The ENTYVIO Q4W dosing regimen did not demonstrate additional clinical benefit over the Q8W dosing regimen and is not the recommended dosing regimen.
CDAI=Crohn's Disease Activity Index; IV=intravenous; Q4W=every 4 weeks; Q8W=every 8 weeks; TNFα=tumor necrosis factor alpha.
*Plus–minus values are means ± SD. Cohort 1 included patients who were randomly assigned, in a 3:2 ratio, as part of the double-blind trial of induction therapy, to receive intravenous vedolizumab, at a dose of 300 mg, or placebo at Weeks 0 and 2. Cohort 2 included patients who received open-label vedolizumab at a dose of 300 mg at Weeks 0 and 2. There were no significant differences (at P<0.05) between the placebo group and the vedolizumab group in cohort 1.
†Race was determined by the investigator.
‡The Crohn’s Disease Activity Index (CDAI) consists of 8 components, each of which is adjusted by a weighting factor. The components are subsequently added together to yield a composite score; scores range from 0 to approximately 600, with higher scores indicating more severe disease activity.
§Data on fecal calprotectin concentrations were available for 142 patients in the placebo group, 210 in vedolizumab cohort 1, and 719 in vedolizumab cohort 2.
∥The glucocorticoids used included prednisone, methylprednisolone, prednisolone, budesonide, hydrocortisone, and triamcinolone. The immunosuppressive agents included azathioprine, mercaptopurine, and methotrexate.
¶Included in this category were patients who did not have an initial response.
#Loss of response indicates that the patient had a response initially but subsequently did not have a response.
CDAI=Crohn's Disease Activity Index; IV=intravenous; Q4W=every 4 weeks; Q8W=every 8 weeks; TNFα=tumor necrosis factor alpha.
GEMINI III Full Study Design1
- GEMINI III (CD Trial II, N=416) was a randomized, double-blind, placebo-controlled study that enrolled adults with moderately to severely active Crohn's disease (CDAI 220-450) who had failed corticosteroids, immunomodulators, and/or ≥1 anti-TNFα therapy (76%)
- Patients were randomized 1:1 to receive ENTYVIO IV 300 mg or placebo at Weeks 0, 2, and 6
- CD Trial II patients were not enrolled in the maintenance study
*Clinical remission=CDAI score ≤150.
CDAI=Crohn's Disease Activity Index; IV=intravenous; TNFα=tumor necrosis factor alpha.
VISIBLE 2 Full Study Design and Baseline Characteristics1,3,4
Phase 3, randomized, double-blind, multicenter, placebo-controlled trial
- VISIBLE 2 (N=644) was a randomized, double-blind, placebo-controlled study that enrolled adults with moderately to severely active Crohn’s disease (CDAI 220-450) who had failed treatment with corticosteroids, immunomodulators, and/or anti-TNF therapy (51%)
- 64% of patients achieved clinical response at Week 6 and were randomized 2:1 to maintenance with ENTYVIO SC or placebo Q2W
- Patients who did not achieve clinical response at Week 6 received a third dose of ENTYVIO IV, and 65% (n=125/192) achieved clinical response at Week 14 (not randomized to the maintenance phase or included in efficacy analysis)
CDAI=Crohn’s Disease Activity Index; IV=intravenous; Q2W=every 2 weeks; SC=subcutaneous; TNF=tumor necrosis factor.
*Not a study endpoint. Data include responders from an open-label cohort.
LOVE-CD Full Study Design and Baseline Characteristics3,5,6
Post-hoc subgroup analysis of LOVE-CD: a prospective, single-arm, open-label, phase 4 clinical trial to assess the efficacy of ENTYVIO IV in early and late Crohn’s disease6
*Deep remission=clinical + endoscopic remission (CDAI ≤150; SES-CD <4).
Anti-TNF=anti-tumor necrosis factor; CDAI=Crohn’s Disease Activity Index; CRP=C-reactive protein; IQR=interquartile range; IV=intravenous; Q8W=every 8 weeks; SES-CD=Simple Endoscopic Score for Crohn’s disease.