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Author Leonardo Salese

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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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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 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]

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Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies.

Marla C Dubinsky, Marco DiBonaventura, Haiyun Fan, Andrew G Bushmakin, Joseph C Cappelleri, Eric Maller, Andrew J Thorpe, Leonardo Salese, Julian Panés,

<h4>Background</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We examined the effect of tofacitinib induction treatment on Inflammatory Bowel Disease Questionnaire (IBDQ) items in adults with moderate to severe UC.<h4>Methods</h4>Data were pooled from the randomized, 8‑week, double-blind, phase 3 OCTAVE Induction 1 ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, 27(7):983-993]

Cited: 1 time

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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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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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P021 Characteristics of Patients Treated with Tofacitinib for Ulcerative Colitis in the Real World: Findings from a Large US Claims Database.

Chiorean Michael, Sharma Puza, Chastek Benjamin, Salese Leonardo, Bell Elizabeth, Peterson-Brandt Jesse, Cappelleri Joseph, Guo Xiang, Khan Nabeel,

Am J Gastroenterol (The American journal of gastroenterology)
[2020, 115(Suppl 1):S5-S6]

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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Review of the epidemiology and burden of ulcerative colitis in Latin America.

Paulo Gustavo Kotze, Flavio Steinwurz, Carlos Francisconi, Cyrla Zaltman, Marcia Pinheiro, Leonardo Salese, Dario Ponce de Leon,

The incidence and prevalence of ulcerative colitis (UC) has been reported to be rising in newly industrialised regions, such as Latin America. Here, we review data from published studies reporting demographics and clinical aspects of UC in Latin America to further understand epidemiology and disease burden. The incidence and prevalence ... Read more >>

Therap Adv Gastroenterol (Therapeutic advances in gastroenterology)
[2020, 13:1756284820931739]

Cited: 2 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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Real-world Effectiveness of Advanced Therapies Among Patients With Moderate to Severe Ulcerative Colitis in the United States.

Millie D Long, Timothy W Smith, Marco Dibonaventura, David Gruben, Danielle Bargo, Leonardo Salese, Daniel Quirk,

<h4>Background</h4>Ulcerative colitis (UC) treatment aims to induce response and maintain steroid-free remission. For patients with moderate to severe UC and/or nonresponse to conventional treatment, advanced therapies (immunosuppressants and biologics) are available. We assessed real-world effectiveness of advanced UC therapies.<h4>Methods</h4>This retrospective analysis of claims data included adult patients with UC initiating ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2020, 26(6):941-948]

Cited: 2 times

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The association between disease activity and patient-reported outcomes in patients with moderate-to-severe ulcerative colitis in the United States and Europe.

Alessandro Armuzzi, Miriam Tarallo, James Lucas, Daniel Bluff, Benjamin Hoskin, Danielle Bargo, Joseph C Cappelleri, Leonardo Salese, Marco daCosta DiBonaventura,

BACKGROUND:Patients with ulcerative colitis (UC) experience periods of recurring and episodic clinical signs and symptoms. This study sought to establish the association between disease activity and health-related quality of life (HRQoL) and other patient-reported outcomes. METHODS:United States (US) and European Union 5 ([EU5]; i.e., France, Germany, Italy, Spain, and the ... Read more >>

BMC Gastroenterol (BMC gastroenterology)
[2020, 20(1):18]

Cited: 4 times

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Treatment patterns among patients with moderate-to-severe ulcerative colitis in the United States and Europe.

Alessandro Armuzzi, Marco daCosta DiBonaventura, Miriam Tarallo, James Lucas, Daniel Bluff, Benjamin Hoskin, Danielle Bargo, Joseph C Cappelleri, Daniel Quirk, Leonardo Salese,

OBJECTIVE:The aim of the present study is to examine how moderate-to-severe ulcerative colitis (UC) is currently managed in real-world clinical practice across the United States (US) and European Union Five (EU5; France, Germany, Italy, Spain, and the United Kingdom). METHODS:Data from the 2017 Adelphi Inflammatory Bowel-Disease Specific Programme (IBD-DSP) were ... Read more >>

PLoS One (PloS one)
[2020, 15(1):e0227914]

Cited: 4 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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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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Epidemiology, disease burden, and treatment challenges of ulcerative colitis in Africa and the Middle East.

Ala I Sharara, Samir Al Awadhi, Othman Alharbi, Hisham Al Dhahab, Mohamed Mounir, Leonardo Salese, Ena Singh, Nancy Sunna, Nadine Tarcha, Mahmoud Mosli,

<h4>Introduction</h4>Ulcerative colitis is an idiopathic, chronic, inflammatory bowel disorder characterized by an unpredictable course of alternating cycles of relapse and remission. Traditionally viewed as a disease of Western countries, the prevalence of ulcerative colitis is reported to be increasing in the developing world. In these regions, there is the potential ... Read more >>

Expert Rev Gastroenterol Hepatol (Expert review of gastroenterology & hepatology)
[2018, 12(9):883-897]

Cited: 6 times

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Post-sphincterotomy transampullary balloon dilation is a safe and effective technique.

Thomas Kowalski, Rahul A Nathwani, David Assis, Leonardo Salese, Kuldip Banwait, David Loren,

<h4>Purpose</h4>To evaluate the safety and efficacy of performing ampullary balloon dilation (ABD) following endoscopic sphincterotomy (ES).<h4>Methods</h4>Retrospective review of patients that underwent ABD at Thomas Jefferson University from 2000 to 2007. In all cases, dilation was performed with Hurricane RX hydrostatic balloons (Boston Scientific, Natick MA) or CRE esophageal dilating balloons ... Read more >>

Dig Dis Sci (Digestive diseases and sciences)
[2009, 54(3):670-674]

Cited: 2 times

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Evaluation of pediatric bladder reservoir trauma.

Leonardo Salese, Joseph Barone,

We present a case where computed tomographic cystography of the bladder failed to identify a bladder rupture in a girl with an Indiana pouch after falling from her bicycle. Despite the normal cystogram, surgery was performed because of unresolving abdominal pain and free fluid identified on abdominal computed tomography. Upon ... Read more >>

Pediatr Emerg Care (Pediatric emergency care)
[2004, 20(11):803-804]

Cited: 0 times

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