943b Induction Therapy for Ulcerative Colitis: Results of GEMINI I, a Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase 3 Trial

Feagan, Brian G.; Rutgeerts, Paul; Sands, B E; Colombel, J F; Sandborn, W.; Hanauer, Stephen B.; Assche, Gen A Van; Axler, Jeffrey; Kim, H.; Danese, Silvio; Fox, Irving H.; Milch, Catherine; Sankoh, Serap; Wyant, Timothy; Xu, Jing; Parikh, Ami

doi:10.1016/s0016-5085(12)60607-6

Cited by 41 publications

(33 citation statements)

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“…The GEMINI 1 trial was published in 2013 by Feagan et al [16] . This phase Ⅲ trial was a randomised, doubleblinded, placebo-controlled study on the efficacy, safety and tolerability of vedolizumab (MLN002) in patients with moderate to severe UC.…”

Section: Phase ⅲ Trialmentioning

confidence: 99%

“…The large GEMINI 1 trial [16] reported the most common adverse effects included an exacerbation of colitis, headache and nasopharyngitis. A similar set of adverse effects were reported by Parikh et al [15] However, overall the frequency for which these events occur are uncommon.…”

Section: Adverse Effectsmentioning

confidence: 99%

“…Certainly Parikh et al [15] reported no withdrawal from their clinical trial as a consequence of adverse effects. The concern regarding PML has also not proven to be of significance [15,16] .…”

Section: Adverse Effectsmentioning

confidence: 99%

“…Overall, it is reassuring that meta-analyses of several RCTs have [16] , Collective results for all vedolizumab groups combined. IV: Intravenously.…”

Section: Adverse Effectsmentioning

confidence: 99%

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Review of vedolizumab for the treatment of ulcerative colitis

Lau

Tsai

2016

WJGPT

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Section: Phase ⅲ Trialmentioning

confidence: 99%

Section: Adverse Effectsmentioning

confidence: 99%

Section: Adverse Effectsmentioning

confidence: 99%

“…Overall, it is reassuring that meta-analyses of several RCTs have [16] , Collective results for all vedolizumab groups combined. IV: Intravenously.…”

Section: Adverse Effectsmentioning

confidence: 99%

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Review of vedolizumab for the treatment of ulcerative colitis

Lau

Tsai

2016

WJGPT

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“…In the peripheral blood, the frequency of circulating CCR9 + T cells is elevated during small intestinal Crohn's disease, suggesting a role of CCR9 + T cells in small intestinal inflammation (11). CCR9, CCL25, a 4 b 7 , and MAdCAM-1 are attractive therapeutic targets in IBD because of their tissue and cell specificity, and clinical studies show positive effects on blocking these proteins in subsets of IBD patients (12)(13)(14)(15).…”

mentioning

confidence: 99%

Glucocorticoids Suppress CCR9-Mediated Chemotaxis, Calcium Flux, and Adhesion to MAdCAM-1 in Human T Cells

Wendt

White

Ferry

et al. 2016

The Journal of Immunology

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CCR9 expressed on T lymphocytes mediates migration to the small intestine in response to a gradient of CCL25. CCL25-stimulated activation of α4β7 integrin promotes cell adherence to mucosal addressin cell adhesion molecule-1 (MAdCAM-1) expressed by vascular endothelial cells of the intestine, further mediating gut-specific homing. Inflammatory bowel disease is a chronic inflammatory condition that primarily affects the gastrointestinal tract and is characterized by leukocyte infiltration. Glucocorticoids (GCs) are widely used to treat inflammatory bowel disease but their effect on intestinal leukocyte homing is not well understood. We investigated the effect of GCs on the gut-specific chemokine receptor pair, CCR9 and CCL25. Using human peripheral blood-derived T lymphocytes enriched for CCR9 by cell sorting or culturing with all-trans retinoic acid, we measured chemotaxis, intracellular calcium flux, and α4β7-mediated cell adhesion to plate-bound MAdCAM-1. Dexamethasone (DEX), a specific GC receptor agonist, significantly reduced CCR9-mediated chemotaxis and adhesion to MAdCAM-1 without affecting CCR9 surface expression. In contrast, in the same cells, DEX increased CXCR4 surface expression and CXCL12-mediated signaling and downstream functions. The effects of DEX on human primary T cells were reversed by the GC receptor antagonist mifepristone. These results demonstrate that GCs suppress CCR9-mediated chemotaxis, intracellular calcium flux, and α4β7-mediated cell adhesion in vitro, and these effects could contribute to the efficacy of GCs in treating intestinal inflammation in vivo.

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Vedolizumab for induction and maintenance of remission in ulcerative colitis

Bickston

Behm

Tsoulis

et al. 2014

Cochrane Database of Systematic Reviews

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Moderate to high quality data from four studies shows that vedolizumab is superior to placebo for induction of clinical remission and response and endoscopic remission in patients with moderate to severely active ulcerative colitis and prevention of relapse in patients with quiescent ulcerative colitis. Moderate quality data from one study suggests that vedolizumab is superior to placebo for prevention of relapse in patients with quiescent ulcerative colitis. Adverse events appear to be similar to placebo. Future trials are needed to define the optimal dose, frequency of administration and long-term efficacy and safety of vedolizumab used for induction and maintenance therapy of ulcerative colitis. Vedolizumab should be compared to other currently approved therapies for ulcerative colitis in these trials.

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943b Induction Therapy for Ulcerative Colitis: Results of GEMINI I, a Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase 3 Trial

Cited by 41 publications

References 0 publications

Review of vedolizumab for the treatment of ulcerative colitis

Review of vedolizumab for the treatment of ulcerative colitis

Glucocorticoids Suppress CCR9-Mediated Chemotaxis, Calcium Flux, and Adhesion to MAdCAM-1 in Human T Cells

Vedolizumab for induction and maintenance of remission in ulcerative colitis

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