For U.S. Healthcare Professionals
GEMINI I
Clinical
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
Secondary End Points
RATE OF VISIBLE MUCOSAL IMPROVEMENT AT WEEK 6 AND
WEEK 521,2‡
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§
MOVE AHEAD TO
ADDITIONAL DATA
CLINICAL RESPONSE DATA
Clinical Response Data
-
ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS
Clinical response* rates—exploratory end point.
At Week 6, in the anti‑TNFα naïve subpopulation, clinical response rates were 53% for those who received Entyvio vs. 26% for those who received placebo. In the anti‑TNFα failure subpopulation, clinical response rates were 39% for those who received Entyvio vs. 21% for those who received placebo.3
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CLINICAL RESPONSE AT WEEK 63*
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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*
Clinical Response Measured by Partial Mayo Score3
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.
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LONG-TERM DATA
Entyvio Offers Long‑Term Remission Data1
-
ANTI‑TNFα NAÏVE AND ANTI‑TNFα FAILURE SUBPOPULATIONS
Long-term clinical remission* rates—exploratory end points.
At Week 52, in the anti‑TNFα naïve subpopulation, clinical remission rates were 46% for those who received Entyvio vs. 19% for those who received placebo. In the anti‑TNFα failure subpopulation, clinical remission rates were 37% for those who received Entyvio vs. 5% for those who received placebo.3
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CLINICAL REMISSION AT WEEK 523*
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* 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*
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
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IMPROVEMENT OF THE APPEARANCE OF THE MUCOSA AT WEEK 523†
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† 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†
STUDY DESIGN1-3
GEMINI I: UC Trials I and II
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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 PROFILEReferences:
- Entyvio (vedolizumab) prescribing information. Takeda Pharmaceuticals.
- Feagan BG, Rutgeerts P, Sands BE, et al; for the GEMINI 1 Study Group. N Engl J Med. 2013;369(8):699-710.
- Data on file. Takeda Pharmaceuticals.