Full Text Journal Articles by
Author Irene Modesto

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Worldwide post-marketing safety surveillance experience with tofacitinib in ulcerative colitis.

David T Rubin, Irene Modesto, Séverine Vermeire, Silvio Danese, Siew C Ng, Kenneth K Kwok, Nana Koram, Thomas V Jones,

<h4>Background</h4>Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Post-marketing surveillance (PMS) is an important part of monitoring adverse events (AEs).<h4>Aims</h4>To report an analysis of PMS case safety reports for tofacitinib in patients with UC METHODS: Worldwide tofacitinib PMS reports received in the Pfizer safety ... Read more >>

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

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Burden of comorbid anxiety and depression in patients with inflammatory bowel disease: a systematic literature review.

Marla C Dubinsky, Iris Dotan, David T Rubin, Mark Bernauer, Dipen Patel, Raymond Cheung, Irene Modesto, Mark Latymer, Laurie Keefer,

<h4>Introduction</h4>Patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, often have comorbid anxiety and depression that affects their quality of life (QoL) and management of their IBD.<h4>Areas covered</h4>A systematic literature review (SLR) was conducted to identify articles and conference abstracts on comorbid anxiety and depression in IBD ... Read more >>

Expert Rev Gastroenterol Hepatol (Expert review of gastroenterology & hepatology)
[2021, 15(9):985-997]

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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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COVID-19 Outcomes Among Racial and Ethnic Minority Individuals With Inflammatory Bowel Disease in the United States.

Manasi Agrawal, Erica J Brenner, Joyce Wing Yan Mak, Xian Zhang, Gilaad G Kaplan, Siew C Ng, Walter Reinisch, Flavio Steinwurz, James D Lewis, Michele Kissous-Hunt, Irene Modesto, Ryan C Ungaro, Jean-Frederic Colombel, Michael D Kappelman,

The coronavirus disease 2019 (COVID-19) has affected more than 29 million people and led to more than 542,000 deaths in the United States.<sup>1</sup> Older age, comorbidities, and racial and ethnic minority status are associated with severe COVID-19.<sup>2</sup> Among patients with inflammatory bowel disease (IBD), racial and ethnic minorities have worse ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2021, 19(10):2210-2213.e3]

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Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis.

David T Rubin, Walter Reinisch, Thomas Greuter, Paulo G Kotze, Marcia Pinheiro, Rajiv Mundayat, Eric Maller, Marc Fellmann, Nervin Lawendy, Irene Modesto, Stephan R Vavricka, Gary R Lichtenstein,

<h4>Introduction</h4>Extraintestinal manifestations (EIMs) in patients with ulcerative colitis (UC) are common. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC. We evaluated the efficacy of tofacitinib in patients with EIMs, and the impact of tofacitinib on EIMs in patients with UC in the OCTAVE clinical ... Read more >>

Therap Adv Gastroenterol (Therapeutic advances in gastroenterology)
[2021, 14:17562848211005708]

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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]

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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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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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Characteristics and Outcomes of IBD Patients with COVID-19 on Tofacitinib Therapy in the SECURE-IBD Registry.

Manasi Agrawal, Erica J Brenner, Xian Zhang, Irene Modesto, John Woolcott, Ryan C Ungaro, Jean-Frederic Colombel, Michael D Kappelman,

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, 27(4):585-589]

Cited: 8 times

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Cost-effectiveness of tofacitinib compared with infliximab, adalimumab, golimumab, vedolizumab and ustekinumab for the treatment of moderate to severe ulcerative colitis in Germany.

Aditya Sardesai, Axel Dignass, Peter Quon, Sandra Milev, Joseph C Cappelleri, Agnes Kisser, Irene Modesto, Puza P Sharma,

<h4>Objectives</h4>Tofacitinib is an oral, small molecule Janus kinase (JAK) inhibitor for the treatment of ulcerative colitis (UC). This study assessed the cost-effectiveness of tofacitinib versus other available treatments for patients with moderate to severe UC following an inadequate response to conventional treatment and who are either naïve to or have ... Read more >>

J Med Econ (Journal of medical economics)
[2021, 24(1):279-290]

Cited: 0 times

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Inhibitors of the Janus Kinases: A New Oral Treatment Option for Ulcerative Colitis.

Irene Modesto,

J Clin Gastroenterol (Journal of clinical gastroenterology)
[2020, 54(10):911]

Cited: 0 times

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Living with Ulcerative Colitis Study (LUCY) in England: a retrospective study evaluating healthcare resource utilisation and direct healthcare costs of postoperative care in ulcerative colitis.

Matthew J Brookes, John Waller, Joseph C Cappelleri, Irene Modesto, Marco D DiBonaventura, Natalie Bohm, Ruth Mokgokong, Olivia Massey, Robert Wood, Danielle Bargo,

<h4>Objective</h4>Ulcerative colitis (UC) is a lifelong, relapsing-remitting disease. Patients non-responsive to pharmacological treatment may require a colectomy. We estimated pre-colectomy and post-colectomy healthcare resource utilisation (HCRU) and costs in England.<h4>Design/method</h4>A retrospective, longitudinal cohort study indexing adult patients with UC undergoing colectomy (2009-2015), using linked Clinical Practice Research Datalink/Hospital Episode Statistics ... Read more >>

BMJ Open Gastroenterol (BMJ open gastroenterology)
[2020, 7(1):]

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Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments.

Klaus Gottlieb, Marco Daperno, Keith Usiskin, Bruce E Sands, Harris Ahmad, Colin W Howden, William Karnes, Young S Oh, Irene Modesto, Colleen Marano, Ryan William Stidham, Walter Reinisch,

Central reading, that is, independent, off-site, blinded review or reading of imaging endpoints, has been identified as a crucial component in the conduct and analysis of inflammatory bowel disease clinical trials. Central reading is the final step in a workflow that has many parts, all of which can be improved. ... Read more >>

Gut (Gut)
[2021, 70(2):418-426]

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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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Comment on: "Retrospective Claims Analysis Indirectly Comparing Medication Adherence and Persistence Between Intravenous Biologics and Oral Small-Molecule Therapies in Inflammatory Bowel Diseases".

John Woolcott, Joseph C Cappelleri, Puza Sharma, Irene Modesto,

Adv Ther (Advances in therapy)
[2020, 37(4):1694-1696]

Cited: 0 times

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Living with ulcerative colitis in Germany: a retrospective analysis of dose escalation, concomitant treatment use and healthcare costs.

Axel Dignass, John Waller, Joseph C Cappelleri, Irene Modesto, Agnes Kisser, Lena Dietz, Marco DiBonaventura, Robert Wood, Melanie May, Berit Libutzki, Danielle Bargo,

<b>Aims:</b> To investigate treatment of moderate-to-severe ulcerative colitis (UC) using real-world German health insurance claims data.<b>Materials and methods:</b> A retrospective, longitudinal cohort study was conducted from a German statutory health insurance database for adult patients with UC indexed on biologic therapy initiation (2013-2015). Anonymized data were evaluated for 12 months prior ... Read more >>

J Med Econ (Journal of medical economics)
[2020, 23(4):415-427]

Cited: 2 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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Mesalazine for the treatment of inflammatory bowel disease.

Valeria Criscuoli, Irene Modesto, Ambrogio Orlando, Mario Cottone,

<h4>Introduction</h4>Ulcerative colitis (UC) and Crohn's disease (CD) represent a chronic inflammatory condition of the bowel that often require lifelong medical therapy for the induction and maintenance of the remission. Mesalazine therapies are available both as oral delayed-release and sustained-release formulation, topical formulations and as prodrug.<h4>Areas covered</h4>Available literature regarding mesalazine is ... Read more >>

Expert Opin Pharmacother (Expert opinion on pharmacotherapy)
[2013, 14(12):1669-1678]

Cited: 6 times

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Methodology for high-quality studies on course and prognosis of inflammatory bowel disease.

Irene Modesto, Giovanni Perricone, Ambrogio Orlando, Mario Cottone,

Inflammatory bowel diseases (IBDs) are characterized by a chronic course with an alternation of relapses and remissions. Questions about prognosis are important for the patient who wants to know how the disease will affect his/her life and also for clinicians to make management decisions. Correct selection of the patients is ... Read more >>

World J Gastroenterol (World journal of gastroenterology)
[2012, 18(29):3800-3805]

Cited: 1 time

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The role of portal vein thrombosis in the clinical course of inflammatory bowel diseases: report on three cases and review of the literature.

Emanuele Sinagra, Emma Aragona, Claudia Romano, Simonetta Maisano, Ambrogio Orlando, Roberto Virdone, Lorenzo Tesè, Irene Modesto, Valeria Criscuoli, Mario Cottone,

Inflammatory bowel diseases are associated with an increased risk of vascular complications. The most important are arterial and venous thromboembolisms, which are considered as specific extraintestinal manifestations of inflammatory bowel diseases. Among venous thromboembolism events, portal vein thrombosis has been described in inflammatory bowel diseases. We report three cases of ... Read more >>

Gastroenterol Res Pract (Gastroenterology research and practice)
[2012, 2012:916428]

Cited: 6 times

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Is 5-ASA still the treatment of choice for ulcerative colitis?

Mario Cottone, Sara Renna, Irene Modesto, Ambrogio Orlando,

5-Amino-salacylic acid (5-ASA) is up to now the treatment of choice in the induction and maintenance of remission of mild-to-moderate ulcerative colitis (UC). Sulfasalazine, despite similar efficacy, is hampered by more side effects, but in presence of peripheral arthopaties it remains the treatment of choice. The new delayed release MMX ... Read more >>

Curr Drug Targets (Current drug targets)
[2011, 12(10):1396-1405]

Cited: 9 times

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The role of CARD15 mutations and smoking in the course of Crohn's disease in a Mediterranean area.

Maria Concetta Renda, Ambrogio Orlando, Giuseppe Civitavecchia, Valeria Criscuoli, Aurelio Maggio, Filippo Mocciaro, Francesca Rossi, Daniela Scimeca, Irene Modesto, Lorenzo Oliva, Mario Cottone,

<h4>Aim</h4>To evaluate the role of CARD15 mutations and smoking in the main events of Crohn's disease (CD).<h4>Patients and methods</h4>A total of 182 patients with CD were included in a prospective study in order to evaluate the role of CARD15 mutations and smoking in the main outcomes of disease course: first ... Read more >>

Am J Gastroenterol (The American journal of gastroenterology)
[2008, 103(3):649-655]

Cited: 16 times

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Meta-analysis of the placebo rates of clinical relapse and severe endoscopic recurrence in postoperative Crohn's disease.

Sara Renna, Calogero Cammà, Irene Modesto, Giuseppe Cabibbo, Giuseppe Cabibbo, Daniela Scimeca, Giuseppe Civitavecchia, Filippo Mocciaro, Ambrogio Orlando, Marco Enea, Mario Cottone,

<h4>Backgrounds & aims</h4>The benefit of therapy for prevention of postoperative recurrence of Crohn's disease (CD) is limited. Clinical relapse and severe endoscopic recurrence are the main outcomes in the evaluation of trials on prevention of recurrence. The aim of this meta-analysis was to focus on knowledge of the placebo rates ... Read more >>

Gastroenterology (Gastroenterology)
[2008, 135(5):1500-1509]

Cited: 51 times

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Leukocytapheresis in patients with moderate-severe steroid-dependant ulcerative colitis: clinical response without endoscopic response.

Irene Modesto, Daniela Scimeca, Ambrogio Orlando, Mario Cottone,

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2006, 12(10):1009-1010]

Cited: 0 times

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Infliximab and ulcerative colitis.

Mario Cottone, Filippo Mocciaro, Irene Modesto,

Tumour necrosis factor (TNF)-alpha is an inflammatory cytokine that plays a main role in the inflammatory process underlying inflammatory bowel disease (IBD). Despite the fact that the cytokine profiles associated with ulcerative colitis (UC) and Crohn's disease (CD) are classically considered different (a Th2 pattern in UC and a Th1 ... Read more >>

Expert Opin Biol Ther (Expert opinion on biological therapy)
[2006, 6(4):401-408]

Cited: 8 times

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