Symptomatic Improvement With Vedolizumab Therapy For Crohn's Disease Stratified By Disease Activity And Prior Tumor Necrosis Factor Antagonist Failure: Post Hoc Analyses From The Gemini 2 Trial

Introduction: Vedolizumab, A Gut‐Selective Monoclonal Antibody Against Α4β7 Integrin, Is Used To Treat Adults With Moderately‐To‐Severely Active Ulcerative Colitis And Crohn’S Disease (Cd). We Investigated Symptomatic Improvement, Including Onset Of Action, Across Disease Activity And Prior Tumor Necrosis Factor Antagonist Α (Anti‐Tnfα) Status In Patients With Cd. Methods: This Was A Post Hoc Exploratory Analysis Of Data From Gemini 2, The Phase 3, Randomized, Placebo (Pbo)‐Controlled Trial Of Vedolizumab Treatment For Moderate‐To‐Severe Cd. Early Onset Efficacy For Abdominal Pain And Stool Frequency At Weeks 2, 4, And 6 Of Treatment Was Stratified By Baseline Moderate Disease Activity (Defined As Crohn’S Disease Activity Index [Cdai] ≤330), Prior Anti‐Tnfα Failure Status, And Also By A Composite Of Prior Anti‐Tnfα Failure And Baseline Disease Activity. Efficacy At Week 52 Was Stratified In A Similar Manner For Clinical Remission, Enhanced Clinical Response (≥100‐Point Reduction In Cdai Score From Baseline), Corticosteroid‐Free Remission, And Durable Clinical Remission (Cdai Score ≤150 Points At ≥80% Of Study Visits, Including The Final Visit [Week 52]). We Report Mean Adjusted Percentage Score Changes From Baseline At Weeks 2, 4, 6, And Percentages Of Patients Who Achieved Predefined Scores At Week 52. Results: Subgroup Analysis (Figure) Showed That Vedolizumab‐Treated Patients With Moderate Disease (Cdai ≤330) And No Prior Anti‐Tnfα Failure Achieved Significant Differences Vs Pbo Recipients In Abdominal Pain At Weeks 2, 4 And 6, And In Stool Frequency At Weeks 2 And 6. At Week 52 (Table), The Overall Population Treated With Vedolizumab Vs Pbo Had More Clinical Remission, Enhanced Clinical Response, And Corticosteroid‐Free Remission. Clinical Remission And Enhanced Clinical Response Rate With Vedolizumab Was Significantly Greater Than Pbo Regardless Of Baseline Disease Activity Or Anti‐Tnfα Exposure. Discussion: In This Post Hoc Analysis, Vedolizumab‐Treated Patients With Moderate Disease Activity (Defined As Cdai ≤330) And No Prior Anti‐Tnfα Failure Achieved Better Clinical Outcomes, Especially At Earlier Time Points, Than Patients With More Severe Disease Activity And Prior Anti‐Tnfα Failure. Funded By Takeda Pharmaceuticals U.S.A., Inc (Figure Presented) (Table Presented)