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Crohn Disease: HELP
Articles from Maryland
Based on 200 articles published since 2008

These are the 200 published articles about Crohn Disease that originated from Maryland during 2008-2019.
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4 · 5 · 6 · 7 · 8
1 Guideline Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. 2015

Pennazio, Marco / Spada, Cristiano / Eliakim, Rami / Keuchel, Martin / May, Andrea / Mulder, Chris J / Rondonotti, Emanuele / Adler, Samuel N / Albert, Joerg / Baltes, Peter / Barbaro, Federico / Cellier, Christophe / Charton, Jean Pierre / Delvaux, Michel / Despott, Edward J / Domagk, Dirk / Klein, Amir / McAlindon, Mark / Rosa, Bruno / Rowse, Georgina / Sanders, David S / Saurin, Jean Christophe / Sidhu, Reena / Dumonceau, Jean-Marc / Hassan, Cesare / Gralnek, Ian M. ·Division of Gastroenterology, San Giovanni Battista University Teaching Hospital, Turin, Italy. · Digestive Endoscopy Unit, Catholic University, Rome, Italy. · Department of Gastroenterology, Chaim Sheba Medical Center, Sackler School of Medicine, Tel-Aviv University Tel-Hashomer, Israel. · Klinik für Innere Medizin, Bethesda Krankenhaus Bergedorf, Hamburg, Germany. · Department of Medicine II, Sana Klinikum, Offenbach, Germany. · Department of Gastroenterology and Hepatology, VU University Medical Centre, Amsterdam, The Netherlands. · Gastroenterology Unit, Ospedale Valduce, Como, Italy. · Division of Gastroenterology, Shaare Zedek Medical Center, Jerusalem, Israel. · Department of Medicine I, Johann Wolfgang Goethe University Frankfurt, Frankfurt, Germany. · Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Service d'Hépato-gastro-entérologie, Paris, France. · Medizinische Klinik, Evangelisches Krankenhaus, Düsseldorf, Germany. · Department of Hepato-Gastroenterology, Nouvel Hôpital Civil, University Hospital of Strasbourg, Strasbourg, France. · Royal Free Unit for Endoscopy and Centre for Gastroenterology, The Royal Free Hospital and University College London, London, UK. · Department of Medicine B, University of Münster, Münster, Germany. · Institute of Gastroenterology and Liver Diseases, Ha'emek Medical Center Afula, Israel, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology Haifa, Israel. · Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. · Gastroenterology Department, Centro Hospitalar do Alto Ave, Guimarães, Portugal. · Clinical Psychology Unit, Department of Psychology, University of Sheffield. · Centre Hospitalier Lyon Sud, Pierre Bénite, Lyon, France. · Gedyt Endoscopy Center, Buenos Aires, Argentina. ·Endoscopy · Pubmed #25826168.

ABSTRACT: This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). The Guideline was also reviewed and endorsed by the British Society of Gastroenterology (BSG). It addresses the roles of small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders. Main recommendations 1 ESGE recommends small-bowel video capsule endoscopy as the first-line investigation in patients with obscure gastrointestinal bleeding (strong recommendation, moderate quality evidence). 2 In patients with overt obscure gastrointestinal bleeding, ESGE recommends performing small-bowel capsule endoscopy as soon as possible after the bleeding episode, optimally within 14 days, in order to maximize the diagnostic yield (strong recommendation, moderate quality evidence). 3 ESGE does not recommend the routine performance of second-look endoscopy prior to small-bowel capsule endoscopy; however whether to perform second-look endoscopy before capsule endoscopy in patients with obscure gastrointestinal bleeding or iron-deficiency anaemia should be decided on a case-by-case basis (strong recommendation, low quality evidence). 4 In patients with positive findings at small-bowel capsule endoscopy, ESGE recommends device-assisted enteroscopy to confirm and possibly treat lesions identified by capsule endoscopy (strong recommendation, high quality evidence). 5 ESGE recommends ileocolonoscopy as the first endoscopic examination for investigating patients with suspected Crohn's disease (strong recommendation, high quality evidence). In patients with suspected Crohn's disease and negative ileocolonoscopy findings, ESGE recommends small-bowel capsule endoscopy as the initial diagnostic modality for investigating the small bowel, in the absence of obstructive symptoms or known stenosis (strong recommendation, moderate quality evidence).ESGE does not recommend routine small-bowel imaging or the use of the PillCam patency capsule prior to capsule endoscopy in these patients (strong recommendation, low quality evidence). In the presence of obstructive symptoms or known stenosis, ESGE recommends that dedicated small bowel cross-sectional imaging modalities such as magnetic resonance enterography/enteroclysis or computed tomography enterography/enteroclysis should be used first (strong recommendation, low quality evidence). 6 In patients with established Crohn's disease, based on ileocolonoscopy findings, ESGE recommends dedicated cross-sectional imaging for small-bowel evaluation since this has the potential to assess extent and location of any Crohn's disease lesions, to identify strictures, and to assess for extraluminal disease (strong recommendation, low quality evidence). In patients with unremarkable or nondiagnostic findings from such cross-sectional imaging of the small bowel, ESGE recommends small-bowel capsule endoscopy as a subsequent investigation, if deemed to influence patient management (strong recommendation, low quality evidence). When capsule endoscopy is indicated, ESGE recommends use of the PillCam patency capsule to confirm functional patency of the small bowel (strong recommendation, low quality evidence). 7 ESGE strongly recommends against the use of small-bowel capsule endoscopy for suspected coeliac disease but suggests that capsule endoscopy could be used in patients unwilling or unable to undergo conventional endoscopy (strong recommendation, low quality evidence).

2 Guideline Guidelines for imaging of Crohn's perianal fistulizing disease. 2015

Ong, Eugene M W / Ghazi, Leyla J / Schwartz, David A / Mortelé, Koenraad J / Anonymous470823. ·*Department of Radiology, Division of Clinical MRI, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts; †Division of Gastroenterology and Hepatology, University of Maryland School of Medicine, Baltimore, Maryland; and ‡Department of Gastroenterology and Hepatology, Vanderbilt University, Nashville, Tennessee. ·Inflamm Bowel Dis · Pubmed #25751067.

ABSTRACT: -- No abstract --

3 Guideline Guidelines for the multidisciplinary management of Crohn's perianal fistulas: summary statement. 2015

Schwartz, David A / Ghazi, Leyla J / Regueiro, Miguel / Fichera, Alessandro / Zoccali, Marco / Ong, Eugene M W / Mortelé, Koenraad J / Anonymous460823. ·*Department of Gastroenterology and Hepatology, Vanderbilt University, Nashville, Tennessee; †Department of Gastroenterology and Hepatology, University of Maryland Medical Center, Baltimore, Maryland; ‡University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; §Division of General Surgery, Department of Surgery, University of Washington Medical Center, Seattle, Washington; ‖Department of Surgery, Weill Medical College of Cornell University, New York, New York; and ¶Division of Clinical MRI, Department of Radiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. ·Inflamm Bowel Dis · Pubmed #25751066.

ABSTRACT: -- No abstract --

4 Guideline Refractory inflammatory bowel disease in children. 2008

Oliva-Hemker, M / Escher, J C / Moore, D / Dubinksy, M / Hildebrand, H / Koda, Y K L / Murch, S / Sandhu, B / Seo, J K / Tanzi, M N / Warner, B / Anonymous5690604. ·Division of Pediatric Gastroenterology and Nutrition, Johns Hopkins University School of Medicine, Baltimore, MD 21287-2631, USA. moliva@jhmi.edu ·J Pediatr Gastroenterol Nutr · Pubmed #18664886.

ABSTRACT: -- No abstract --

5 Editorial Circulating Endothelial Progenitor Cells in Crohn's Disease: An EPiC in the Making? 2017

Dietrich, Catharine / Singh, Shree Ram. ·Stem Cell Regulation and Animal Aging Section, Basic Research Laboratory, National Cancer Institute, NIH, Frederick, MD, 21702, USA. · Stem Cell Regulation and Animal Aging Section, Basic Research Laboratory, National Cancer Institute, NIH, Frederick, MD, 21702, USA. singhshr@mail.nih.gov. ·Dig Dis Sci · Pubmed #28078527.

ABSTRACT: -- No abstract --

6 Editorial Editorial: serologic microbial associated markers to predict Crohn's disease behaviour - authors' reply. 2016

Colombel, J-F / Riddle, M S / Murray, J A. ·Icahn School of Medicine at Mount Sinai, New York, NY, USA. jean-frederic.colombel@mssm.edu. · Naval Medical Research Center, Silver Spring, MD, USA. · Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA. ·Aliment Pharmacol Ther · Pubmed #27375094.

ABSTRACT: -- No abstract --

7 Editorial Shifting Away From Estrogen-Containing Oral Contraceptives in Crohn's Disease. 2016

Long, Millie D / Hutfless, Susan. ·Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: millie_long@med.unc.edu. · Gastrointestinal Epidemiology Research Center, Division of Gastroenterology & Hepatology, Johns Hopkins University, Baltimore, Maryland; Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland. ·Gastroenterology · Pubmed #27138980.

ABSTRACT: -- No abstract --

8 Editorial Editorial: UV exposure and IBD--should more be done to demonstrate an association before trying to find its mechanism? Authors' reply. 2014

Limketkai, B N / Hutfless, S M. ·Harvey M. and Lyn P. Meyerhoff Inflammatory Bowel Disease Center, Division of Gastroenterology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Division of Gastroenterology & Hepatology, Stanford University School of Medicine, Stanford, CA, USA. berkeley.limketkai@gmail.com. ·Aliment Pharmacol Ther · Pubmed #25123386.

ABSTRACT: -- No abstract --

9 Editorial Radiating disparity in IBD. 2014

Flasar, Mark / Patil, Seema. ·Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, 100 North Greene Street, Lower Level, Baltimore, MD, 21201, USA, mflasar@medicine.umaryland.edu. ·Dig Dis Sci · Pubmed #24318801.

ABSTRACT: -- No abstract --

10 Editorial Editorial: Can stenosis in ileal Crohn's disease be prevented by current therapy? 2013

Limketkai, Berkeley N / Bayless, Theodore M. ·Harvey M. and Lyn P. Meyerhoff IBD Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. ·Am J Gastroenterol · Pubmed #24192948.

ABSTRACT: Diagnostic delay is common with Crohn's disease (CD), especially with ileitis. Recent data show that diagnostic delay is associated with an increased risk of bowel stenosis and intestinal surgery. It is nonetheless unclear whether early diagnosis and treatment can truly prevent CD stenosis. Available cohort studies suggest that CD stricture formation occurs over a fixed time course. Current therapies have also not been shown to reduce the risk of ileal stenosis or rates of surgery, and there are no available therapies to reverse existing fibrosis. Development of medications that target fibrosis is an important area of research.

11 Review Nutritional Interventions in the Patient with Inflammatory Bowel Disease. 2018

Limketkai, Berkeley N / Wolf, Andrea / Parian, Alyssa M. ·Division of Gastroenterology and Hepatology, Stanford University School of Medicine, 300 Pasteur Drive, Alway M211, Stanford, CA 94305, USA. Electronic address: berkeley.limketkai@gmail.com. · Department of Clinical Nutrition, Stanford Health Care, Stanford, 300 Pasteur Drive, Palo Alto, CA 94305, USA. · Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, 1800 Orleans Street, Baltimore, MD 21287, USA. ·Gastroenterol Clin North Am · Pubmed #29413010.

ABSTRACT: Nutritional strategies have been explored as primary or adjunct therapies for inflammatory bowel disease (IBD). Exclusive enteral nutrition is effective for the induction of remission in Crohn disease and is recommended as a first-line therapy for children. Dietary strategies focus on adjusting the ratio of consumed nutrients that are proinflammatory or antiinflammatory. Treatments with dietary supplements focus on the antiinflammatory effects of the individual supplements (eg, curcumin, omega-3 fatty acids, vitamin D) or their positive effects on the intestinal microbiome (eg, prebiotics, probiotics). This article discusses the role of diets and dietary supplements in the treatment of IBD.

12 Review Optimization of biologic therapy in Crohn's disease. 2018

Razvi, Mohammed / Lazarev, Mark. ·a Division of Gastroenterology and Hepatology, Department of Medicine , Johns Hopkins Hospital , Baltimore , MD , USA. ·Expert Opin Biol Ther · Pubmed #29191059.

ABSTRACT: INTRODUCTION: Crohn's disease (CD) is a manifestation of inflammatory bowel disease (IBD), which can result in significant morbidity. Biologic therapy with anti-TNF medication has been effective in treating inflammation and reducing complications in CD. It is important for clinicians to have better knowledge of the various biologic therapies including mechanisms of action and optimization strategies. AREAS COVERED: The review describes optimization of biologic therapy in CD including different mechanisms of loss of response, therapeutic drug monitoring in CD, clinical implications and management strategies which utilize drug monitoring, and areas of future development and research in optimization of biologic therapy. EXPERT OPINION: Achieving adequate levels of the drug (antibody unbound) is one of the most important determinants of attaining clinical remission and mucosal healing. Drug level is also critical in determining if a patient requires combination therapy with an immunomodulator. Certain populations, including those with active perianal disease, may require higher serum levels to achieve healing or closure. Treat to target level is an algorithm that is not universally accepted and more data is need. Additionally, there are numerous assays that don't always correlate, especially regarding measuring anti-drug antibodies.

13 Review Surgical care of the pediatric Crohn's disease patient. 2017

Stewart, Dylan. ·Department of Surgery, Johns Hopkins School of Medicine, Johns Hopkins Children's Center, 1800 Orleans St, Bloomberg Suite 7335, Baltimore, MD 21287. Electronic address: dstewart@jhmi.edu. ·Semin Pediatr Surg · Pubmed #29126506.

ABSTRACT: Despite the significant advances in the medical management of inflammatory bowel disease over the last decade, surgery continues to play a major role in the management of pediatric Crohn's disease (CD). While adult and pediatric Crohn's disease may share many clinical characteristics, pediatric Crohn's patients often have a more aggressive phenotype, and the operative care given by the pediatric surgeon to the newly diagnosed Crohn's patient is very different in nature to the surgical needs of adult patients after decades of disease progression. Children also have the unique surgical indication of growth failure to consider in the overall clinical decision making. While surgery is never curative in CD, it has the ability to transform the disease process in children, and appropriately timed operations may have tremendous impact on a child's physical and mental maturation. This monograph aims to address the surgical care of Crohn's disease in general, with a specific emphasis on the surgical treatment of small intestinal and ileocecal involvement.

14 Review Medical versus surgical management of penetrating Crohn's disease: the current situation and future perspectives. 2017

Patil, Seema A / Cross, Raymond K. ·a University of Maryland School of Medicine , Department of Medicine, Division of Gastroenterology and Hepatology , Baltimore , United States. ·Expert Rev Gastroenterol Hepatol · Pubmed #28633544.

ABSTRACT: INTRODUCTION: The development of penetrating Crohn's disease (CD) occurs in up to 50% of patients over the course of their lifetime. While the presentation of these complications, including free perforation, intra-abdominal abscess, and enteric fistula, are usually obvious, the management can require a nuanced approach, with distinct short and long-term approaches. Areas covered: This review discusses medical and surgical methods of treating these complications, including the role of percutaneous drainage of abscesses, the implications of a stricture associated with a fistula, and the efficacy of postoperative anti-TNF therapy in preventing recurrence after surgical treatment. Expert commentary: An approach to the management of these complications that begins with control of sepsis, including broad-spectrum antibiotics, bowel rest, and nutritional support is proposed. The next appropriate step is a diagnostic evaluation to determine the utility of medical versus surgical therapy, considering the presence of a stricture and prior immunosuppressive therapy. Postoperative anti-TNF therapy, a highly effective method to prevent recurrence, should be considered in many cases.

15 Review Genital and reproductive organ complications of Crohn disease: technical considerations as it relates to perianal disease, imaging features, and implications on management. 2017

Kammann, Steven / Menias, Christine / Hara, Amy / Moshiri, Mariam / Siegel, Cary / Safar, Bashar / Brandes, Steven / Shaaban, Akram / Sandrasegaran, Kumar. ·Department of Radiology, Dartmouth-Hitchcock Medical Center, 100 Hitchcock Way, Manchester, NH, 03104, USA. Steven.e.Kammann@hitchcock.org. · Department of Radiology, Mayo Clinic-Arizona, 13400 E. Shea Blvd., Scottsdale, AZ, 85259, USA. · Department of Radiology, University of Washington Medical Center, 1959 NE Pacific St., Seattle, WA, 98195, USA. · Mallinkrodt Institute of Radiology, 510 S Kingshighway Blvd, St. Louis, MO, 63110, USA. · Department of Surgery, John Hopkins School of Medicine, 600 N. Wolfe Street, Sheikh Zayed Tower, Baltimore, MD, 21287, USA. · Department of Urology, Columbia University Medical Center, 161 Fort Washington Avenue, 11thFloor, New York, NY, 10032, USA. · Department of Radiology, University Hospital Radiology, University of Utah, 50 N Medical Dr., Salt Lake City, UT, 84132, USA. · Department of Radiology, Indiana University, 550 N. University Blvd. Rm 0663, Indianapolis, IN, 46202, USA. ·Abdom Radiol (NY) · Pubmed #28194515.

ABSTRACT: OBJECTIVE: A relatively large proportion of patients with Crohn disease (CD) develop complications including abscess formation, stricture, and penetrating disease. A subset of patients will have genital and reproductive organ involvement of CD, resulting in significant morbidity. These special circumstances create unique management challenges that must be tailored to the activity, location, and extent of disease. Familiarity with the epidemiology, pathogenesis, imaging features, and treatment strategies for patients with genital CD can aid imaging diagnoses and guide appropriate patient management. The purpose of this study is to illustrate the spectrum of CD in the genital tract and reproductive organs and discuss the complex management strategies in these patients as it relates to imaging. CONCLUSION: Given the impact on patient outcome and treatment planning, familiarity with the epidemiology, pathogenesis, imaging features, and treatment of patients with genital Crohn disease can aid radiologic diagnoses and guide appropriate patient management.

16 Review Central Endoscopy Reading in Inflammatory Bowel Diseases. 2016

Panés, Julián / Feagan, Brian G / Hussain, Fez / Levesque, Barrett G / Travis, Simon P. ·Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain jpanes@clinic.cat. · Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada. · Quintiles Immunology and Internal Medicine, Medical Strategy & Science, Rockville, MD, USA. · Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA. · Translational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK. ·J Crohns Colitis · Pubmed #27604978.

ABSTRACT: Endoscopic assessment of the presence and severity of endoscopic lesions has become an essential part of clinical trials in ulcerative colitis and Crohn's disease, for both patient eligibility and outcome measures. Variability in lesion interpretation between and within observers and the potential bias of local investigators in patient assessment have long been recognized. This variability can be reduced, although not completely removed, by independent evaluation of the examinations by experienced off-site (central) readers, properly trained in regard to lesion definition and identification, that should be removed from direct patient contact and blinded to any other clinical or study data. Adding endoscopic demonstration of active disease to eligibility criteria has the potential to reduce placebo response rates, whereas in outcome assessment it has the potential to provide a more precise estimation of the treatment effect, increasing the efficiency of the study. Central endoscopy reading is still at the beginning of its development, and the paradigms of central reading need refinement in terms of the number of readers, the process by which a final score is assigned, the selection and sequence of central readers, and the endoscopic indices of choice.

17 Review Racial and Ethnic Minorities with Inflammatory Bowel Disease in the United States: A Systematic Review of Disease Characteristics and Differences. 2016

Afzali, Anita / Cross, Raymond K. ·*Department of Medicine, Division of Gastroenterology, Harborview Medical Center, University of Washington, Seattle, Washington; University of Washington Inflammatory Bowel Disease Program; and†Department of Medicine, Division of Gastroenterology and Hepatology, University of Maryland, Baltimore, Maryland; University of Maryland Inflammatory Bowel Disease Program. ·Inflamm Bowel Dis · Pubmed #27379446.

ABSTRACT: BACKGROUND: Inflammatory bowel disease (IBD) has predominantly affected whites, particularly Ashkenazi Jews. Over the last 2 decades, IBD has "emerged" in minorities. Differences in natural history and disease characteristics have been suggested. The objective of this systematic review is to summarize these differences in studies from the United States. METHODS: A structured search was performed within the Medline database through PubMed, EMBASE, and Cochrane databases. Published studies of genetics, pathogenesis, prevalence or incidence, disease location and behavior, extraintestinal manifestations, disparities and access to care in patients with IBD who are of African American, Asian, and Hispanic descent living in the United States were eligible. RESULTS: A total of 47 studies were included for African Americans (n = 20,054), Hispanics (n = 10,762), and Asians (n = 2668). The incidence and prevalence of IBD is increasing among minorities. There is less of a genetic influence in the pathogenesis of IBD among African Americans; however, novel variants have been identified. There is a predilection for pancolonic ulcerative colitis among Hispanics and Asians. Crohn's disease-related hospitalizations are increasing in Asians, whereas African Americans are more likely to use the emergency department. No major differences are seen in disease location and behavior, upper gastrointestinal tract, and perianal involvement and extraintestinal manifestations among races and ethnic groups. Medication utilization seems to be similar. Differences in surgery are likely explained by health insurance status. CONCLUSIONS: Future prospective studies are needed to fully characterize disease characteristics and treatment response among minorities. With novel IBD therapies in the pipeline, enrollment in clinical trials should emphasize increased representation of all races and ethnic groups.

18 Review Pharmacodynamic assessment of vedolizumab for the treatment of ulcerative colitis. 2016

McLean, Leon P / Cross, Raymond K. ·a Department of Medicine, Division of Gastroenterology and Hepatology , University of Maryland , Baltimore , MD , USA. ·Expert Opin Drug Metab Toxicol · Pubmed #27096357.

ABSTRACT: INTRODUCTION: Vedolizumab is an anti-integrin approved for the treatment of Crohn's disease and ulcerative colitis. By binding the α4β7-integrin heterodimer, vedolizumab blocks leukocyte translocation into gastrointestinal tissue. AREAS COVERED: This review discusses the chemistry, pharmacologic properties, clinical efficacy, and safety of vedolizumab in ulcerative colitis. Other medications available for the treatment of ulcerative colitis are also discussed. EXPERT OPINION: Vedolizumab is a promising new agent for the treatment of ulcerative colitis. Its mechanism of action differs from TNF-α inhibitors and immune suppressants, allowing it to be used in cases of TNF-α inhibitor failure or non-response, or as a first-line biologic drug. Available safety data suggests that vedolizumab is not associated with an increased risk of infection or malignancy; however, additional post-marketing data are required to confirm these initial reports. Vedolizumab is likely to be used in growing numbers of patients over the coming years.

19 Review Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling. 2016

Mehrotra, Nitin / Bhattaram, Atul / Earp, Justin C / Florian, Jeffry / Krudys, Kevin / Lee, Jee Eun / Lee, Joo Yeon / Liu, Jiang / Mulugeta, Yeruk / Yu, Jingyu / Zhao, Ping / Sinha, Vikram. ·Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland nitin.mehrotra@fda.hhs.gov. · Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. ·Drug Metab Dispos · Pubmed #27079249.

ABSTRACT: Dose selection is one of the key decisions made during drug development in pediatrics. There are regulatory initiatives that promote the use of model-based drug development in pediatrics. Pharmacometrics or quantitative clinical pharmacology enables development of models that can describe factors affecting pharmacokinetics and/or pharmacodynamics in pediatric patients. This manuscript describes some examples in which pharmacometric analysis was used to support approval and labeling in pediatrics. In particular, the role of pharmacokinetic (PK) comparison of pediatric PK to adults and utilization of dose/exposure-response analysis for dose selection are highlighted. Dose selection for esomeprazole in pediatrics was based on PK matching to adults, whereas for adalimumab, exposure-response, PK, efficacy, and safety data together were useful to recommend doses for pediatric Crohn's disease. For vigabatrin, demonstration of similar dose-response between pediatrics and adults allowed for selection of a pediatric dose. Based on model-based pharmacokinetic simulations and safety data from darunavir pediatric clinical studies with a twice-daily regimen, different once-daily dosing regimens for treatment-naïve human immunodeficiency virus 1-infected pediatric subjects 3 to <12 years of age were evaluated. The role of physiologically based pharmacokinetic modeling (PBPK) in predicting pediatric PK is rapidly evolving. However, regulatory review experiences and an understanding of the state of science indicate that there is a lack of established predictive performance of PBPK in pediatric PK prediction. Moving forward, pharmacometrics will continue to play a key role in pediatric drug development contributing toward decisions pertaining to dose selection, trial designs, and assessing disease similarity to adults to support extrapolation of efficacy.

20 Review Integrin antagonists as potential therapeutic options for the treatment of Crohn's disease. 2016

McLean, Leon P / Cross, Raymond K. ·a Department of Medicine, Division of Gastroenterology and Hepatology , University of Maryland, Baltimore , Baltimore , MD , USA. ·Expert Opin Investig Drugs · Pubmed #26822204.

ABSTRACT: INTRODUCTION: Anti-integrin therapy for the treatment of patients with Crohn's disease is rapidly evolving. Two agents, natalizumab and vedolizumab, are approved by the United States Food and Drug Administration for the treatment of Crohn's disease, with vedolizumab the primary anti-integrin used due to a more favorable safety profile. Several other anti-integrins are in various stages of development. AREAS COVERED: This review discusses the current state of anti-integrin therapy as well as suggestions for positioning of these agents in clinical practice. Emerging anti-integrin therapies, their underlying mechanisms of action, and available safety and clinical data are also reviewed. EXPERT OPINION: Anti-integrins are effective for the treatment of Crohn's disease, even in patients refractory to other therapies. Their use should be considered in patients with Crohn's disease who do not respond to, develop non-response to, or have contraindications to anti-TNF therapy. Anti-integrin therapies can be offered as a first biologic therapy, in particular for older patients, patients with concurrent multiple sclerosis (natalizumab only), and in patients with contraindications to anti-TNF therapy. In patients with more severe symptoms, providers should consider co-induction with corticosteroids if possible to hasten remission.

21 Review Short Bowel Syndrome and Intestinal Failure in Crohn's Disease. 2016

Limketkai, Berkeley N / Parian, Alyssa M / Shah, Neha D / Colombel, Jean-Frédéric. ·*Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California; †Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland; and ‡Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York. ·Inflamm Bowel Dis · Pubmed #26818425.

ABSTRACT: Crohn's disease is a chronic and progressive inflammatory disorder of the gastrointestinal tract. Despite the availability of powerful immunosuppressants, many patients with Crohn's disease still require one or more intestinal resections throughout the course of their disease. Multiple resections and a progressive reduction in bowel length can lead to the development of short bowel syndrome, a form of intestinal failure that compromises fluid, electrolyte, and nutrient absorption. The pathophysiology of short bowel syndrome involves a reduction in intestinal surface area, alteration in the enteric hormonal feedback, dysmotility, and related comorbidities. Most patients will initially require parenteral nutrition as a primary or supplemental source of nutrition, although several patients may eventually wean off nutrition support depending on the residual gut anatomy and adherence to medical and nutritional interventions. Available surgical treatments focus on reducing motility, lengthening the native small bowel, or small bowel transplantation. Care of these complex patients with short bowel syndrome requires a multidisciplinary approach of physicians, dietitians, and nurses to provide optimal intestinal rehabilitation, nutritional support, and improvement in quality of life.

22 Review Dietary Supplement Therapies for Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis. 2016

Parian, Alyssa / Limketkai, Berkeley N. ·Johns Hopkins School of Medicine, Department of Gastroenterology 4940 Eastern Avenue, ABuilding 502, Baltimore, MD 21224, USA. alyssaparian@gmail.com. ·Curr Pharm Des · Pubmed #26561079.

ABSTRACT: Inflammatory bowel disease (IBD) including ulcerative colitis and Crohn's disease are chronic relapsing and remitting chronic diseases for which there is no cure. The treatment of IBD frequently requires immunosuppressive and biologic therapies which carry an increased risk of infections and possible malignancy. There is a continued search for safer and more natural therapies in the treatment of IBD. This review aims to summarize the most current literature on the use of dietary supplements for the treatment of IBD. Specifically, the efficacy and adverse effects of vitamin D, fish oil, probiotics, prebiotics, curcumin, Boswellia serrata, aloe vera and cannabis sativa are reviewed.

23 Review The Intestinal Microbiota in Inflammatory Bowel Disease. 2015

Becker, Christoph / Neurath, Markus F / Wirtz, Stefan. ·Christoph Becker, PhD, is associated professor, Markus F. Neurath, MD, is director, and Stefan Wirtz, PhD, is senior scientist at the Department of Medicine 1 at the Friedrich-Alexander University Erlangen-Nuremberg in Erlangen, Germany. ·ILAR J · Pubmed #26323629.

ABSTRACT: The intestinal microbiota has important metabolic and host-protective functions. Conversely to these beneficial functions, the intestinal microbiota is thought to play a central role in the etiopathogenesis of inflammatory bowel disease (IBD; Crohn's disease and ulcerative colitis), a chronic inflammation of the gut mucosa. Genetic screens and studies in experimental mouse models have clearly demonstrated that IBD can develop due to excessive translocation of bacteria into the bowel wall or dysregulated handling of bacteria in genetically susceptible hosts. In healthy individuals, the microbiota is efficiently separated from the mucosal immune system of the gut by the gut barrier, a single layer of highly specialized epithelial cells, some of which are equipped with innate immune functions to prevent or control access of bacterial antigens to the mucosal immune cells. It is currently unclear whether the composition of the microbial flora or individual bacterial strains or pathogens induces or supports the pathogenesis of IBD. Further research will be necessary to carefully dissect the contribution of individual bacterial species to this disease and to ascertain whether specific modulation of the intestinal microbiome may represent a valuable further option for future therapeutic strategies.

24 Review Quantitative measurements in capsule endoscopy. 2015

Keuchel, M / Kurniawan, N / Baltes, P / Bandorski, D / Koulaouzidis, A. ·Clinic for Internal Medicine, Bethesda Krankenhaus Bergedorf, Glindersweg 80, 21029 Hamburg, Germany. Electronic address: keuchel@bkb.info. · Clinic for Internal Medicine, Bethesda Krankenhaus Bergedorf, Glindersweg 80, 21029 Hamburg, Germany. · Kerckhoff Klinik, Bad Nauheim, Germany. · Endoscopy Unit, The Royal Infirmary of Edinburgh, UK. ·Comput Biol Med · Pubmed #26299419.

ABSTRACT: This review summarizes several approaches for quantitative measurement in capsule endoscopy. Video capsule endoscopy (VCE) typically provides wireless imaging of small bowel. Currently, a variety of quantitative measurements are implemented in commercially available hardware/software. The majority is proprietary and hence undisclosed algorithms. Measurement of amount of luminal contamination allows calculating scores from whole VCE studies. Other scores express the severity of small bowel lesions in Crohn׳s disease or the degree of villous atrophy in celiac disease. Image processing with numerous algorithms of textural and color feature extraction is further in the research focuses for automated image analysis. These tools aim to select single images with relevant lesions as blood, ulcers, polyps and tumors or to omit images showing only luminal contamination. Analysis of motility pattern, size measurement and determination of capsule localization are additional topics. Non-visual wireless capsules transmitting data acquired with specific sensors from the gastrointestinal (GI) tract are available for clinical routine. This includes pH measurement in the esophagus for the diagnosis of acid gastro-esophageal reflux. A wireless motility capsule provides GI motility analysis on the basis of pH, pressure, and temperature measurement. Electromagnetically tracking of another motility capsule allows visualization of motility. However, measurement of substances by GI capsules is of great interest but still at an early stage of development.

25 Review Safety of vedolizumab in the treatment of Crohn's disease and ulcerative colitis. 2015

Hagan, Matilda / Cross, Raymond K. ·a 1 University of Maryland, Division of Gastroenterology and Hepatology, Department of Medicine , 100 North Greene Street, Lower Level, Baltimore, MD 21201, USA rcross@medicine.umaryland.edu. ·Expert Opin Drug Saf · Pubmed #26138111.

ABSTRACT: INTRODUCTION: Vedolizumab is the latest FDA-approved anti-integrin therapy for treatment of moderate-to-severe inflammatory bowel disease (IBD). The safety and efficacy of vedolizumab have been studied in short-term clinical trials. AREAS COVERED: This paper reviews the safety profile of vedolizumab compared with other biologics. It also highlights the mechanism of action of the medication. We discuss the current position of vedolizumab in our current algorithm for IBD management and comment on future prospects of the drug. EXPERT OPINION: Vedolizumab appears to be a safe and effective option in the treatment of moderate-to-severe IBD in the short term. Long-term observational studies and post-marketing safety data are needed to ascertain the long-term efficacy and side effect profile.