OF DEEP REMISSION IN UC/CD^1,2*†

^*27% of ENTYVIO Q8W patients achieved lasting deep remission (ES=0, RBS=0, and decrease in SFS or no change from baseline) at Week 52 (p=0.0001 vs placebo) [GEMINI 1 post hoc^a,b] ¹
^†29% of patients with endoscopic assessment achieved lasting deep remission (clinical remission complete resolution of CD symptoms) and mucosal healing (absence of ulcers and/or erosions)) at Week 52 with ENTYVIO [VICTORY Consortium^c] ²

^*27% of ENTYVIO Q8W patients achieved lasting deep remission (ES=0, RBS=0, and decrease in SFS or no change from baseline) at Week 52 (p=0.0001 vs placebo) [GEMINI 1 post hoc^a,b] ¹
^†29% of patients with endoscopic assessment achieved lasting deep remission (clinical remission (complete resolution of CD symptoms) and mucosal healing (absence of ulcers and/or erosions)) at Week 52 with ENTYVIO [VICTORY Consortium^c] ²

ENTYVIO^® MODE OF ACTION

Ulcerative colitis and Crohn's disease cause chronic inflammation of the gut, and infiltrating T-lymphocytes cross the endothelium into the inflamed GI tissue.¹ ENTYVIO is the only gut-selective biologic registered in Australia with no known systemic effects, for the treatment of adult patients with moderate to severe Crohn’s disease and ulcerative colitis.^{2-7,9 **} ENTYVIO specifically binds to the α4β7 integrin and blocks the interaction between the α4β7 integrin and MAdCAM-1, which is mainly expressed on the GI tract endothelial cells.^2-8

Lymphocytes migrate into the GI tissue. An increased number of infiltrating lymphocytes and other inflammatory cells in the gut is one of the contributors to the inflammatory response.^1,2

Artist rendition

GI = gastrointestinal; MAdCAM-1 = mucosal addressin cell adhesion molecule‑1.

Inflammation in the gut due to excess lymphocyte migration in UC and Crohn's disease. — Artist rendition

ENTYVIO^® is indicated for the treatment of adult patients with moderate to severe ulcerative colitis or moderate to severe Crohn’s disease, who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a TNFα antagonist.

ENTYVIO^® is indicated for the treatment of adult patients with moderate to severe chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

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Abbreviations: CD, Crohn’s disease; UC, ulcerative colitis; TNF, tumor necrosis factor.

ENTYVIO^®, the ENTYVIO Logo^® and the Entyvio Pathway Logo^® are registered trademarks of Millennium Pharmaceuticals, Inc., a Takeda company.

^aGEMINI 1: Phase 3, randomised double-blind, placebo-controlled study with separate induction and maintenance trials in adult patients with moderately to severely active UC. Induction trial: 374 patients (Cohort 1) received ENTYVIO IV (300 mg) or placebo at Weeks 0 and 2, and 521 patients (Cohort 2) received open-label ENTYVIO at Weeks 0 and 2, with disease evaluation at Week 6. Maintenance trial: additional patients were enrolled in Cohort 2 and received the same induction regimen as Cohort 1. The patients were randomly assigned to continue ENTYVIO IV every 8 or 4 weeks or to switch to placebo. The primary endpoint was clinical remission at Week 52 (≤2 points Mayo Clinic score with all subscores ≤1). Secondary endpoints included mucosal healing (ES ≤1).^{3 b} GEMINI 1 post hoc: Analysis evaluated deep remission at Week 52 in the ITT population.^{2 c} VICTORY Consortium: Retrospective single-arm study of 212 adults with moderate to severe CD treated with ENTYVIO, with follow-up after initiation. A minimum of 6 and 12 months of follow-up were available in 133 and 44 individuals, respectively. Predictors of clinical remission or mucosal healing with ENTYVIO were identified using the multivariable Cox proportional hazard analyses. Primary endpoint was the proportion of individuals achieving clinical remission or mucosal healing. Secondary endpoints included deep remission.⁴

REFERENCES:

Enjoy the Silence Banner References:

ENTYVIO Product Information.
Sandborn WJ et al. J Crohns Colitis 2019; 13(2): 172–81.
Feagan BG et al. N Engl J Med 2013; 369: 699–710.
Dulai P et al. Am J Gastroenterol 2016; 111: 1147–55.

Page References:

Xavier RJ, Podolsky DK. Nature. 2007;448(7152):427-434.
ENTYVIO Product Information.
Fedyk E, Wyant T, Yang LL, et al. Inflamm Bowel Dis. 2012;18(11):2107-2119.
Soler D, Chapman T, Yang LL, et al. J Pharmacol Exp Ther. 2009;330(3):864-875.
Wyant T, Leach T, Sankoh S, et al. Gut. 2015;64(1):77-83.
Wyant T, Fedyk E, Abhyankar B. J Crohns Colitis. 2016;10(12):1437-1444.
Milch C, Wyant T, Xu J, et al. J Neuroimmunol. 2013;264:123-126.
Briskin M, Winsor-Hines D, Shyjan A, et al. Am J Pathol. 1997;151(1):97-110.
Australian Register of Therapeutic Goods. Available at: https://www.ebs.tga.gov.au/. Accessed May 2024.

**ARTG References: AUST R 210048 (IV), AUST R 317262 (SC).^2,9

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ENTYVIO® MODE OF ACTION

REFERENCES:

OF DEEP REMISSION IN UC/CD^1,2*†

OF DEEP REMISSION IN UC/CD^1,2*†

ENTYVIO^® MODE OF ACTION