Full Text Journal Articles by
Author Wojciech Niezychowski

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Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials.

Brian G Feagan, Reena Khanna, William J Sandborn, Séverine Vermeire, Walter Reinisch, Chinyu Su, Leonardo Salese, Haiyun Fan, Jerome Paulissen, Deborah A Woodworth, Wojciech Niezychowski, Bruce E Sands,

<h4>Background</h4>Endoscopy is routine in trials of ulcerative colitis therapies.<h4>Aim</h4>To investigate agreement between central and local Mayo endoscopic subscore (MES) reads in the OCTAVE programme METHODS: Flexible sigmoidoscopy was performed in tofacitinib induction (OCTAVE Induction 1&2, NCT01465763 and NCT01458951), maintenance (OCTAVE Sustain, NCT01458574) and open-label, long-term extension (OCTAVE Open, NCT01470612) studies. ... Read more >>

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2021, :]

Cited: 0 times

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Challenges and Opportunities in IBD Clinical Trial Design.

Marla C Dubinsky, Rory Collins, Maria T Abreu, ,

Gastroenterology (Gastroenterology)
[2021, 161(2):400-404]

Cited: 0 times

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Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study.

Julián Panés, Geert R D'Haens, Peter D R Higgins, Linda Mele, Michele Moscariello, Gary Chan, Wenjin Wang, Wojciech Niezychowski, Chinyu Su, Eric Maller,

<h4>Background</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for inflammatory bowel disease.<h4>Aims</h4>This 48-week open-label extension study primarily investigated long-term safety of tofacitinib 5 and 10 mg b.d. and secondarily investigated efficacy as maintenance therapy in patients with Crohn's disease.<h4>Methods</h4>Patients who had completed the phase 2b ... Read more >>

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2019, 49(3):265-276]

Cited: 7 times

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Exposure-response characterization of tofacitinib efficacy in moderate to severe ulcerative colitis: Results from a dose-ranging phase 2 trial.

Arnab Mukherjee, Anasuya Hazra, Mike K Smith, Steven W Martin, Diane R Mould, Chinyu Su, Wojciech Niezychowski,

<h4>Aims</h4>Tofacitinib is an oral, small molecule JAK inhibitor being investigated for ulcerative colitis (UC). In a phase 2 dose-ranging study, tofacitinib demonstrated efficacy vs. placebo as UC induction therapy. In this posthoc analysis, we aimed to compare tofacitinib dose and plasma concentration as predictors of efficacy and identify covariates that ... Read more >>

Br J Clin Pharmacol (British journal of clinical pharmacology)
[2018, 84(6):1136-1145]

Cited: 6 times

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Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis.

William J Sandborn, Chinyu Su, Bruce E Sands, Geert R D'Haens, Séverine Vermeire, Stefan Schreiber, Silvio Danese, Brian G Feagan, Walter Reinisch, Wojciech Niezychowski, Gary Friedman, Nervin Lawendy, Dahong Yu, Deborah Woodworth, Arnab Mukherjee, Haiying Zhang, Paul Healey, Julian Panés, ,

<h4>Background</h4>Tofacitinib, an oral, small-molecule Janus kinase inhibitor, was shown to have potential efficacy as induction therapy for ulcerative colitis in a phase 2 trial. We further evaluated the efficacy of tofacitinib as induction and maintenance therapy.<h4>Methods</h4>We conducted three phase 3, randomized, double-blind, placebo-controlled trials of tofacitinib therapy in adults with ... Read more >>

N Engl J Med (The New England journal of medicine)
[2017, 376(18):1723-1736]

Cited: 251 times

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Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials.

Julian Panés, William J Sandborn, Stefan Schreiber, Bruce E Sands, Séverine Vermeire, Geert D'Haens, Remo Panaccione, Peter D R Higgins, Jean-Frederic Colombel, Brian G Feagan, Gary Chan, Michele Moscariello, Wenjin Wang, Wojciech Niezychowski, Amy Marren, Paul Healey, Eric Maller,

<h4>Objective</h4>Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD).<h4>Design</h4>We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised ... Read more >>

Gut (Gut)
[2017, 66(6):1049-1059]

Cited: 85 times

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Correlation Between Concentrations of Fecal Calprotectin and Outcomes of Patients With Ulcerative Colitis in a Phase 2 Trial.

William J Sandborn, Julian Panés, Haiying Zhang, Dahong Yu, Wojciech Niezychowski, Chinyu Su,

<h4>Background & aims</h4>Accurate biomarkers of disease activity and therapeutic response can be valuable for clinical trials. We performed a post hoc analysis of data from a phase 2 trial to assess the relationship between the concentration of fecal calprotectin (FCP) and clinical and endoscopic outcomes of patients with moderate to severe ... Read more >>

Gastroenterology (Gastroenterology)
[2016, 150(1):96-102]

Cited: 35 times

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A phase 2 study of tofacitinib, an oral Janus kinase inhibitor, in patients with Crohn's disease.

William J Sandborn, Subrata Ghosh, Julian Panes, Ivana Vranic, Wenjin Wang, Wojciech Niezychowski, ,

<h4>Background & aims</h4>Tofacitinib, an orally administered Janus kinase inhibitor, blocks signaling through γ-chain-containing cytokines (interleukins 2, 4, 7, 9, 15, and 21). We performed a phase 2 trial to measure its efficacy in patients with moderate-to-severe active Crohn's disease.<h4>Methods</h4>Patients (N = 139; age, ≥18 y) with moderate-to-severe active Crohn's disease were ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2014, 12(9):1485-93.e2]

Cited: 115 times

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Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis.

William J Sandborn, Subrata Ghosh, Julian Panes, Ivana Vranic, Chinyu Su, Samantha Rousell, Wojciech Niezychowski, ,

<h4>Background</h4>Ulcerative colitis is a chronic inflammatory disease of the colon for which current treatments are not universally effective. One additional treatment may be tofacitinib (CP-690,550), an oral inhibitor of Janus kinases 1, 2, and 3 with in vitro functional specificity for kinases 1 and 3 over kinase 2, which is ... Read more >>

N Engl J Med (The New England journal of medicine)
[2012, 367(7):616-624]

Cited: 340 times

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The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study.

Séverine Vermeire, Subrata Ghosh, Julian Panes, Jens F Dahlerup, Andreas Luegering, Jana Sirotiakova, Ulrike Strauch, Gary Burgess, Jacqueline Spanton, Steven W Martin, Wojciech Niezychowski,

<h4>Background and aims</h4>Leucocyte migration to gut mucosa, mediated by integrin binding to mucosal addressin cell adhesion molecule (MAdCAM), is a promising target for therapeutic intervention in inflammatory bowel disease. This first-in-human study of a monoclonal antibody to MAdCAM, PF-00547,659, aimed to explore the safety and preliminary efficacy of this gut-specific ... Read more >>

Gut (Gut)
[2011, 60(8):1068-1075]

Cited: 76 times

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