COMUNICADO: Entyvio® (vedolizumab) Shows Higher Rates of Mucosal Healing Versus TNFa-Antagonist Therapy in Ulcerative Colitis and Cr

Publicado 16/02/2018 17:01:21CET

OSAKA, Japan, February 16, 2018 /PRNewswire/ --

New clinical study also provides data for Entyvio(R) in inducing complete mucosal

healing and endoscopic remission, particularly in bio-naive patients

Takeda Pharmaceutical Company Limited ("Takeda") today announced new real-world data evaluating the comparative effectiveness of Entyvio(R) (vedolizumab) and tumor necrosis factor-alpha (TNFalpha)-antagonist therapy in patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). These data were presented as oral presentations at the 13th Congress of the European Crohn's and Colitis Organization (ECCO) from February 14 to 17, 2018 in Vienna, Austria. These analyses observed that patients with UC treated with Entyvio compared to TNFalpha-antagonist therapy had statistically significant higher 12-month cumulative rates of mucosal healing (50% vs 42%, hazard ratio [HR] 1.73, 95% confidence interval [CI] 1.10-2.73) and clinical remission (54% vs 37%; HR 1.54, 95% CI 1.08-2.18), and numerically higher steroid-free clinical remission rates (49% vs 38%; HR 1.43, 95% CI 0.79-2.60). In CD, results reported statistically significant higher 12-month cumulative rates of mucosal healing (50% vs 41%; HR 1.67, 95% CI 1.13-2.47), and numerically higher rates of clinical remission (38% vs 34%; HR 1.27, 95% CI 0.91-1.78) and steroid-free clinical remission (26% vs 18%; HR 1.75, 95% CI 0.90-3.43) compared to TNFalpha-antagonist therapy. These analyses were conducted by the VICTORY (Vedolizumab Health OuTComes in InflammatORY Bowel Diseases) Consortium.[1], [2]

"These data from the VICTORY Consortium highlight the effectiveness of Entyvio in achieving mucosal healing and clinical remission in the real-world, and support the use of Entyvio as a first-line biologic therapy," said Professor William Sandborn, M.D., Chief, Division of Gastroenterology, University of California San Diego. "While additional research is needed to confirm these findings, these are important comparative effectiveness analyses of real-world data involving Entyvio and TNFalpha-antagonist therapy, which further aid our understanding of biologic therapy in clinical practice."

Of the 646 UC and 1,122 CD VICTORY Consortium patients, data from 334 UC (n=167 Entyvio patients; 49% male; median age 36 years) and 538 CD (n=269 Entyvio patients; 44% male; median age 35 years) were analyzed. Entyvio patients were matched (1:1)* to patients on anti-TNFalpha therapy using propensity scores to control for baseline differences between groups. Researchers used Cox proportional hazard models to compare cumulative rates of mucosal healing (absence of ulcers or erosions for CD; Mayo endoscopic sub-score of 0 or 1 for UC), clinical remission (complete resolution of symptoms based on Physician Global Assessment) and steroid-free clinical remission (on steroids at baseline, tapered off, no repeat steroid prescription for 4 weeks). Findings were reported after adjusting for concomitant steroid or immunomodulator use, disease location (CD study only; isolated small bowel, ileocolonic, isolated colonic), and number of prior TNFalpha-antagonists used.[1],[2]

New clinical data also being presented at ECCO from the Phase 3b open-label prospective multicenter study (VERSIFY) evaluating the efficacy of Entyvio on complete mucosal healing (absence of ulcerations), endoscopic remission (Simple endoscopic score for CD [SES-CD] less than or equal to4) and endoscopic response (50% decrease in SES-CD from baseline) provide insight into complete mucosal healing in CD. Results at week 26 found Entyvio induced complete mucosal healing (15%), endoscopic remission (12%) and endoscopic response (25%) in the overall population of CD patients, particularly in an anti-TNFalpha-naive setting (complete mucosal healing 24%, endoscopic remission 20%, and endoscopic response 28%). The trial included 101 patients with moderately to severely active CD who had previously experienced treatment failure with corticosteroids, immunomodulators, and/or at least one TNFalpha-antagonist therapy. In this study, 46% of patients were categorized as having severe endoscopic activity at entry (SES-CD score of >15). Patients received Entyvio 300 mg intravenously at weeks 0, 2, 6, and then every 8 weeks for 26 weeks, followed by a 26-week extension period. Dose escalation was not permitted.[3]

"Endoscopic remission and mucosal healing are important targets in the management of Crohn's disease and ulcerative colitis, as they look beyond symptoms to show how disease activity could be impacting underlying bowel damage. The VERSIFY clinical study generated positive results in complete mucosal healing and endoscopic remission rates in Crohn's disease, particularly in anti-TNFalpha-naive patients. Looking across the Entyvio data presented at ECCO, we're encouraged by the large compendium of data for Entyvio regarding endoscopic remission and mucosal healing in both clinical studies and the real-world setting," said Mona Khalid, Senior Director, Head of Evidence and Value Generation, Takeda Pharmaceuticals.

At this year's ECCO congress, Takeda sponsored 33 posters and presentations on Entyvio, including real-world analyses and clinical studies evaluating the impact of Entyvio on long-term remission, comparative efficacy/effectiveness, mucosal healing, resource utilization, and in special patient populations across CD and UC. For a full list of poster titles and authors, visit https://www.ecco-ibd.eu/publications/congress-abstract-s/abstracts-2018.html.

*Propensity score matching (1:1) accounting for baseline differences between groups including age, sex, prior UC/CD-related hospitalization within the previous year, disease history, disease extent, disease severity, steroid refractoriness or dependence and prior TNFalpha-antagonist failure.

About Entyvio(R) (vedolizumab) 

Vedolizumab is a gut-selective immunosuppressive biologic.[4] It is a humanized monoclonal antibody that is designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1) and fibronectin, but not vascular cell adhesion molecule 1 (VCAM-1).[5] MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.[6] The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.[5] These cells have been shown to play a role in mediating the inflammatory process in UC and CD.[5],[7],[8] By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues. [5]

About the VICTORY Consortium 

The VICTORY (Vedolizumab Health OuTComes in InflammatORY Bowel Diseases) Consortium is a collaboration of 12 leading inflammatory bowel disease (IBD) centers from across the U.S. and represents the first large, well-characterized cohort of patients taking Entyvio (R) in a real-world setting in the U.S. Patients included in the consortium were identified at each site through electronic medical record searches, review of clinical records, and/or queries of infusion center records. More than 1,700 UC and CD patients are now included in the consortium database, which was started when Entyvio(R) was launched in the U.S. in 2014.

About Ulcerative Colitis and Crohn's Disease 

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