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Author Chinyu Su

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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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Correction to: Characterization of Creatine Kinase Levels in Tofacitinib‑Treated Patients with Ulcerative Colitis: Results from Clinical Trials.

Remo Panaccione, John D Isaacs, Lea Ann Chen, Wenjin Wang, Amy Marren, Kenneth Kwok, Lisy Wang, Gary Chan, Chinyu Su,

Dig Dis Sci (Digestive diseases and sciences)
[2021, 66(9):3214-3215]

Cited: 0 times

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Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia.

Patrícia O Guimarães, Daniel Quirk, Remo H Furtado, Lilia N Maia, José F Saraiva, Murillo O Antunes, Roberto Kalil Filho, Vagner M Junior, Alexandre M Soeiro, Alexandre P Tognon, Viviane C Veiga, Priscilla A Martins, Diogo D F Moia, Bruna S Sampaio, Silvia R L Assis, Ronaldo V P Soares, Luciana P A Piano, Kleber Castilho, Roberta G R A P Momesso, Frederico Monfardini, Helio P Guimarães, Dario Ponce de Leon, Majori Dulcine, Marcia R T Pinheiro, Levent M Gunay, J Jasper Deuring, Luiz V Rizzo, Tamas Koncz, Otavio Berwanger, ,

<h4>Background</h4>The efficacy and safety of tofacitinib, a Janus kinase inhibitor, in patients who are hospitalized with coronavirus disease 2019 (Covid-19) pneumonia are unclear.<h4>Methods</h4>We randomly assigned, in a 1:1 ratio, hospitalized adults with Covid-19 pneumonia to receive either tofacitinib at a dose of 10 mg or placebo twice daily for up ... Read more >>

N Engl J Med (The New England journal of medicine)
[2021, 385(5):406-415]

Cited: 19 times

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Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial.

Séverine Vermeire, Chinyu Su, Nervin Lawendy, Taku Kobayashi, William J Sandborn, David T Rubin, Irene Modesto, Sean Gardiner, Nicole Kulisek, Haiying Zhang, Wenjin Wang, Julian Panés,

<h4>Background and aims</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. We present primary completion analysis from RIVETING, an ongoing, double-blind, randomised, parallel-group trial evaluating efficacy and safety of tofacitinib dose reduction to 5 mg twice daily [BID] versus remaining on 10 mg BID ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, 15(7):1130-1141]

Cited: 1 time

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Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical Programme.

Kevin L Winthrop, Edward V Loftus, Daniel C Baumgart, Walter Reinisch, Chudy I Nduaka, Nervin Lawendy, Gary Chan, Rajiv Mundayat, Gary S Friedman, Leonardo Salese, Andrew J Thorpe, Chinyu Su,

<h4>Background and aims</h4>Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We report integrated analyses of infections in the Phase [P]2 and P3 OCTAVE programmes.<h4>Methods</h4>Three cohorts were analysed: Induction [P2/3 induction studies]; Maintenance [P3 maintenance study]; and Overall [all tofacitinib-treated patients in induction, maintenance, or ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, 15(6):914-929]

Cited: 0 times

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Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program.

Gary R Lichtenstein, Gerhard Rogler, Matthew A Ciorba, Chinyu Su, Gary Chan, Ronald D Pedersen, Nervin Lawendy, Daniel Quirk, Chudy I Nduaka, Andrew J Thorpe, Julian Panés,

<h4>Background</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Here, we performed an integrated analysis of malignancy events from the tofacitinib phase 3 UC clinical development program (excluding nonmelanoma skin cancer [NMSC]).<h4>Methods</h4>Data (up to May 2019) were pooled from two phase 3 induction ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, 27(6):816-825]

Cited: 0 times

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Efficacy and Safety of Tofacitinib Retreatment for Ulcerative Colitis After Treatment Interruption: Results From the OCTAVE Clinical Trials.

Julian Panés, Séverine Vermeire, Marla C Dubinsky, Edward V Loftus, Nervin Lawendy, Wenjin Wang, Leonardo Salese, Chinyu Su, Irene Modesto, Xiang Guo, Jean-Frederic Colombel,

<h4>Background and aims</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. Here, we evaluate the efficacy and safety of tofacitinib retreatment following treatment interruption in patients with ulcerative colitis.<h4>Methods</h4>Here, patients with clinical response to tofacitinib 10mg b.d. induction therapy were randomised to receive placebo ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, :]

Cited: 1 time

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Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Nonmelanoma Skin Cancer Rates From the Ulcerative Colitis Clinical Program.

Bruce E Sands, Millie D Long, Walter Reinisch, Julian Panés, Edward V Loftus, Chudy I Nduaka, Arif Soonasra, Rajiv Mundayat, Nervin Lawendy, Gary Chan, Gary S Friedman, Chinyu Su,

<h4>Background</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present integrated analyses of nonmelanoma skin cancer (NMSC) incidence in the tofacitinib UC clinical program.<h4>Methods</h4>Nonmelanoma skin cancer events were evaluated from 3 randomized, placebo-controlled studies: 2 identical, 8-week induction studies (NCT01465763, NCT01458951), a ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, :]

Cited: 0 times

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Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status.

William J Sandborn, Laurent Peyrin-Biroulet, Ala I Sharara, Chinyu Su, Irene Modesto, Rajiv Mundayat, L Mert Gunay, Leonardo Salese, Bruce E Sands,

<h4>Background & aims</h4>Tofacitinib is an oral, small-molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We summarize the efficacy and safety data of tofacitinib 5 or 10 mg twice daily in the UC clinical program, stratified by prior tumor necrosis factor inhibitor (TNFi) failure status.<h4>Methods</h4>Efficacy was assessed in ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2021, :]

Cited: 0 times

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Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis.

Camille Vong, Steven W Martin, Chenhui Deng, Rujia Xie, Kaori Ito, Chinyu Su, William J Sandborn, Arnab Mukherjee,

Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We characterized tofacitinib pharmacokinetics in patients with moderate to severe UC, and the effects of covariates on variability in pharmacokinetic parameter estimates. Data were pooled from 1 8-week phase 2 and 2 8-week phase ... Read more >>

Clin Pharmacol Drug Dev (Clinical pharmacology in drug development)
[2021, 10(3):229-240]

Cited: 2 times

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Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis.

William J Sandborn, Laurent Peyrin-Biroulet, Daniel Quirk, Wenjin Wang, Chudy I Nduaka, Arnab Mukherjee, Chinyu Su, Bruce E Sands,

<h4>Background & aims</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib were demonstrated in a dose-ranging phase 2 induction trial, 3 phase 3 randomized, placebo-controlled trials (OCTAVE Induction 1 and 2; and OCTAVE Sustain), and an ongoing, ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2020, :]

Cited: 0 times

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Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis.

Jean-Frederic Colombel, Mark T Osterman, Andrew J Thorpe, Leonardo Salese, Chudy I Nduaka, Haiying Zhang, Nervin Lawendy, Gary S Friedman, Daniel Quirk, Chinyu Su, Walter Reinisch,

<h4>Background & aims</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib in patients with moderate to severe UC, up to 1 year, have been reported. We investigated maintenance of efficacy in patients in remission after 52 weeks ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2020, :]

Cited: 0 times

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Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials.

Remo Panaccione, John D Isaacs, Lea Ann Chen, Wenjin Wang, Amy Marren, Kenneth Kwok, Lisy Wang, Gary Chan, Chinyu Su,

<h4>Background</h4>Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Creatine kinase (CK) levels and CK-related adverse events (AEs) in tofacitinib-treated patients with UC were evaluated.<h4>Methods</h4>Data were analyzed for three UC cohorts: Induction (phase 2 and 3 induction studies); Maintenance (phase 3 maintenance study); Overall [patients ... Read more >>

Dig Dis Sci (Digestive diseases and sciences)
[2021, 66(8):2732-2743]

Cited: 1 time

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Letter: thromboembolic and cardiovascular events with tofacitinib in ulcerative colitis-two cases in real world clinical practice. Authors' reply.

William J Sandborn, Julian Panés, Bruce E Sands, Walter Reinisch, Chinyu Su, Nervin Lawendy, Nana Koram, Haiyun Fan, Thomas V Jones, Irene Modesto, Daniel Quirk, Silvio Danese,

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2020, 51(11):1209-1210]

Cited: 0 times

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Letter: corticosteroid use alongside tofacitinib in OCTAVE Open. Authors' reply.

Bruce E Sands, Alessandro Armuzzi, John K Marshall, James O Lindsay, William J Sandborn, Silvio Danese, Julián Panés, Brian Bressler, Jean-Frédéric Colombel, Nervin Lawendy, Eric Maller, Haiying Zhang, Gary Chan, Leonardo Salese, Konstantinos Tsilkos, Amy Marren, Chinyu Su,

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2020, 51(10):997-998]

Cited: 0 times

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Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open.

Bruce E Sands, Alessandro Armuzzi, John K Marshall, James O Lindsay, William J Sandborn, Silvio Danese, Julián Panés, Brian Bressler, Jean-Frédéric Colombel, Nervin Lawendy, Eric Maller, Haiying Zhang, Gary Chan, Leonardo Salese, Konstantinos Tsilkos, Amy Marren, Chinyu Su,

<h4>Background</h4>For patients with UC, flexible maintenance dosing therapy may confer advantages for safety, efficacy, costs and patient preference. Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC.<h4>Aim</h4>To assess the efficacy and safety of tofacitinib dose de-escalation and escalation in patients with UC.<h4>Methods</h4>We evaluated data (November 2017 ... Read more >>

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2020, 51(2):271-280]

Cited: 10 times

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Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme.

William J Sandborn, Julian Panés, Bruce E Sands, Walter Reinisch, Chinyu Su, Nervin Lawendy, Nana Koram, Haiyun Fan, Thomas V Jones, Irene Modesto, Daniel Quirk, Silvio Danese,

<h4>Background</h4>Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC).<h4>Aim</h4>To report incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the tofacitinib UC programme.<h4>Methods</h4>DVT and PE were evaluated from one phase 2 and two phase 3 induction studies, one phase 3 maintenance study ... Read more >>

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2019, 50(10):1068-1076]

Cited: 29 times

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The Impact of Raising the Bar for Clinical Trials in Ulcerative Colitis.

Bruce E Sands, Adam S Cheifetz, Chudy I Nduaka, Daniel Quirk, Wenjin Wang, Eric Maller, Gary S Friedman, Chinyu Su, Peter D R Higgins,

In order to identify the practical implications for both health care practitioners and patients in understanding differences between the results of trials assessing therapies for ulcerative colitis [UC], we reviewed clinical trials of therapies for moderate to severe UC, with a focus on trial design. Over time, patient populations in ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2019, 13(9):1217-1226]

Cited: 2 times

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Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis.

Bruce E Sands, Pam R Taub, Alessandro Armuzzi, Gary S Friedman, Michele Moscariello, Nervin Lawendy, Ronald D Pedersen, Gary Chan, Chudy I Nduaka, Daniel Quirk, Leonardo Salese, Chinyu Su, Brian G Feagan,

<h4>Background & aims</h4>Tofacitinib is an oral, small-molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We analyzed inflammation, lipid concentrations, and incidence rates of major adverse cardiovascular (CV) events (MACEs) in patients who received tofacitinib in worldwide studies.<h4>Methods</h4>We collected data from 1157 patients who participated in 3 8-week induction ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2020, 18(1):123-132.e3]

Cited: 13 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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Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies.

Julian Panés, Séverine Vermeire, James O Lindsay, Bruce E Sands, Chinyu Su, Gary Friedman, Haiying Zhang, Aaron Yarlas, Martha Bayliss, Stephen Maher, Joseph C Cappelleri, Andrew G Bushmakin, David T Rubin,

J Crohns Colitis (Journal of Crohn's & colitis)
[2019, 13(1):139-140]

Cited: 2 times

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Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials.

William J Sandborn, Julián Panés, Geert R D'Haens, Bruce E Sands, Chinyu Su, Michele Moscariello, Thomas Jones, Ron Pedersen, Gary S Friedman, Nervin Lawendy, Gary Chan,

<h4>Background & aims</h4>Tofacitinib is an oral, small-molecule inhibitor of JAK approved in several countries for the treatment of ulcerative colitis (UC). We report integrated safety analyses of tofacitinib-treated patients with moderate to severe UC.<h4>Methods</h4>Patients receiving placebo or tofacitinib (5 or 10 mg) twice daily were analyzed as 3 cohorts: induction ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2019, 17(8):1541-1550]

Cited: 42 times

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Outcomes of Pregnancies With Maternal/Paternal Exposure in the Tofacitinib Safety Databases for Ulcerative Colitis.

Uma Mahadevan, Marla C Dubinsky, Chinyu Su, Nervin Lawendy, Thomas V Jones, Amy Marren, Haiying Zhang, Daniela Graham, Megan E B Clowse, Steven R Feldman, Daniel C Baumgart,

<h4>Background</h4>Active inflammatory bowel disease increases the risk of adverse pregnancy outcomes. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). As a small molecule, tofacitinib is likely to cross the placental barrier; however, information on the effects of tofacitinib on pregnancy outcomes is ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2018, 24(12):2494-2500]

Cited: 29 times

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Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis.

Stephen Hanauer, Remo Panaccione, Silvio Danese, Adam Cheifetz, Walter Reinisch, Peter D R Higgins, Deborah A Woodworth, Haiying Zhang, Gary S Friedman, Nervin Lawendy, Daniel Quirk, Chudy I Nduaka, Chinyu Su,

<h4>Background & aims</h4>Tofacitinib is an oral, small molecule inhibitor of JAK for the treatment of ulcerative colitis (UC). We evaluated the onset of symptom improvement in post-hoc analyses of data from 2 phase 3 trials of induction therapy with tofacitinib in patients with UC (OCTAVE Induction 1 and 2).<h4>Methods</h4>The studies ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2019, 17(1):139-147]

Cited: 27 times

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Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib.

Kevin L Winthrop, Gil Y Melmed, Séverine Vermeire, Millie D Long, Gary Chan, Ronald D Pedersen, Nervin Lawendy, Andrew J Thorpe, Chudy I Nduaka, Chinyu Su,

Background:Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). Tofacitinib is approved for rheumatoid arthritis and psoriatic arthritis, where it has been shown to increase herpes zoster (HZ) risk. We evaluated HZ risk among UC patients using tofacitinib. Methods:HZ cases were identified ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2018, 24(10):2258-2265]

Cited: 44 times

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