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I. Fox
Takeda Pharmaceutical Company
38Publications
15H-index
3,156Citations
Publications 36
Newest
#1Maria Rosario (Takeda Pharmaceutical Company)H-Index: 12
#2Nathanael L. DirksH-Index: 6
Last.I. Fox (Takeda Pharmaceutical Company)H-Index: 15
view all 7 authors...
Source
#1Asit Parikh (Takeda Pharmaceutical Company)H-Index: 18
#2Kristin Stephens (Takeda Pharmaceutical Company)H-Index: 1
Last.David B. Clifford (WashU: Washington University in St. Louis)H-Index: 67
view all 13 authors...
Introduction Over the past decade, the potential for drug-associated progressive multifocal leukoencephalopathy (PML) has become an increasingly important consideration in certain drug development programmes, particularly those of immunomodulatory biologics. Whether the risk of PML with an investigational agent is proven (e.g. extrapolated from relevant experience, such as a class effect) or merely theoretical, the serious consequences of acquiring PML require careful risk minimisation and asses...
1 CitationsSource
#1Maria Rosario (Takeda Pharmaceutical Company)H-Index: 12
#2Nathanael L. DirksH-Index: 6
Last.I. Fox (Takeda Pharmaceutical Company)H-Index: 15
view all 8 authors...
Vedolizumab is a humanized anti-α4β7 integrin monoclonal antibody that selectively blocks trafficking of memory T cells to inflamed gut tissue by inhibiting the α4β7-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) interaction. Approved for treating patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), vedolizumab is administered as a 300 mg intravenous infusion. Vedolizumab undergoes a rapid, saturable, non-linear, target-mediated elimination process ...
35 CitationsSource
#1Maria Rosario (Takeda Pharmaceutical Company)H-Index: 12
#2Jonathan L FrenchH-Index: 1
Last.I. Fox (Takeda Pharmaceutical Company)H-Index: 15
view all 15 authors...
56 CitationsSource
#1Jean-Frederic Colombel (ISMMS: Icahn School of Medicine at Mount Sinai)H-Index: 129
#2Bruce E. Sands (ISMMS: Icahn School of Medicine at Mount Sinai)H-Index: 70
Last.Brian G. Feagan (UWO: University of Western Ontario)H-Index: 95
view all 14 authors...
Objective Vedolizumab is a gut-selective antibody to α 4 β 7 integrin for the treatment of ulcerative colitis (UC) and Crohn9s disease (CD). We report an integrated summary of the safety of vedolizumab. Design Safety data (May 2009–June 2013) from six trials of vedolizumab were integrated. Adverse events were evaluated in patients who received ≥1 dose of vedolizumab or placebo and were reported as exposure-adjusted incidence rates as the number of patients experiencing the event per 100 person-y...
220 CitationsSource
#1Maria Rosario (Takeda Pharmaceutical Company)H-Index: 12
#2Timothy Wyant (Takeda Pharmaceutical Company)H-Index: 4
Last.Brian G. Feagan (UWO: University of Western Ontario)H-Index: 95
view all 8 authors...
Background and Objectives Vedolizumab, a humanized monoclonal antibody against the α4β7 integrin, is indicated for treatment of moderately to severely active ulcerative colitis or Crohn’s disease. In this placebo-controlled, double-blind, randomized, single ascending-dose study, the pharmacokinetics, pharmacodynamics, safety, and tolerability of vedolizumab were evaluated in healthy volunteers.
29 CitationsSource
#1Megan McAuliffe (Takeda Pharmaceutical Company)H-Index: 3
#2Stephan F. LanesH-Index: 16
Last.I. Fox (Takeda Pharmaceutical Company)H-Index: 15
view all 10 authors...
AbstractObjectives:Inflammatory bowel disease (IBD) is a chronic condition commonly requiring lifelong care. Both IBD and IBD-related treatments can cause significant morbidity, and it is often difficult to differentiate their relative etiologic contribution to adverse events (AEs). The objectives of this study were to assess the rates of select AEs among patients with IBD as a function of disease severity and of the use of anti-tumor necrosis factor alpha (anti-TNFα) medications.Methods:We cond...
14 CitationsSource
#1Maria Rosario (Takeda Pharmaceutical Company)H-Index: 12
#2Nathanael L. DirksH-Index: 6
Last.I. Fox (Takeda Pharmaceutical Company)H-Index: 15
view all 10 authors...
SummaryBackground Vedolizumab, an anti-α4β7 integrin monoclonal antibody (mAb), is indicated for treating patients with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD). As higher therapeutic mAb concentrations have been associated with greater efficacy in inflammatory bowel disease, understanding determinants of vedolizumab clearance may help to optimise dosing. Aims To characterise vedolizumab pharmacokinetics in patients with UC and CD, to identify clinically rel...
93 CitationsSource
#1WilliamJSandborn (UCSD: University of California, San Diego)H-Index: 142
#2Brian G. Feagan (Robarts Research Institute)H-Index: 95
Last.I. Fox (Takeda Pharmaceutical Company)H-Index: 15
view all 7 authors...
6 CitationsSource
#1Bruce E. Sands (ISMMS: Icahn School of Medicine at Mount Sinai)H-Index: 70
#2Brian G. Feagan (UWO: University of Western Ontario)H-Index: 95
Last.Stephen B. Hanauer (U of C: University of Chicago)H-Index: 104
view all 14 authors...
Background & Aims There is an increasing need for new treatments for patients with Crohn's disease (CD) in whom previous therapy with tumor necrosis factor (TNF) antagonists has failed. We performed a placebo-controlled, phase 3, double-blind trial to evaluate the efficacy and safety of vedolizumab, an antibody against the integrin α 4 β 7 , as induction therapy. Methods Patients with moderately to severely active CD (CD activity index [CDAI] score, 220–400 points) were assigned randomly to grou...
322 CitationsSource
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