Pub Date : 2019-06-20DOI: 10.33590/emjgastroenterol/10310509
J. Fricker
Prof Ghosh presented data from the UNITI studies exploring ustekinumab in primary or secondary nonresponders to TNF agonists (UNITI-1) and conventional therapy failures (UNITI-2). The data demonstrate that ustekinumab shows higher efficacy in patients who have failed conventional therapy compared to those who have failed anti-TNF therapy. Further sub-studies showed similar efficacy for ustekinumab 90 mg every 8 weeks (q8w) and ustekinumab 90 mg every 12 weeks (q12w) subcutaneous (SC) regimens, except for in patients with high inflammatory burdens, who did better with q8w regimens. No new safety signals were identified for ustekinumab between Week 96 and Week 156, with overall rates of adverse events and serious adverse events being comparable to placebo. Rates of antibody formation remained low. Dr Raine described two case studies involving Crohn’s disease patients treated with ustekinumab. The first case described a female patient with luminal Crohn’s disease who had secondary nonresponse to an anti-TNF with signs of intestinal and systemic inflammation. The second case considered a patient with bio-naïve luminal Crohn’s disease who had a previous history of opportunistic infections (coughs, colds, and recurrent herpes simplex). Prof Armuzzi presented the results of the induction part of the UNIFI study, which randomised patients with moderate-to-severe ulcerative colitis (UC) to placebo, ustekinumab 130 mg, or a weight-tiered ustekinumab dose (˜6 mg/kg). Results showed clinical remission at Week 8 was 5.3% for placebo, 15.6% for ustekinumab 130 mg intravenous (IV) (p<0.001), and 15.5% for ustekinumab at ˜6 mg/kg IV (p<0.001). Furthermore, ustekinumab IV induced clinical response and endoscopic and mucosal healing, improved health related quality of life, and had an adverse event profile consistent with known safety profiles.
{"title":"IL-12/23 in IBD: Making the Best Use of Available Evidence","authors":"J. Fricker","doi":"10.33590/emjgastroenterol/10310509","DOIUrl":"https://doi.org/10.33590/emjgastroenterol/10310509","url":null,"abstract":"Prof Ghosh presented data from the UNITI studies exploring ustekinumab in primary or secondary nonresponders to TNF agonists (UNITI-1) and conventional therapy failures (UNITI-2). The data demonstrate that ustekinumab shows higher efficacy in patients who have failed conventional therapy compared to those who have failed anti-TNF therapy. Further sub-studies showed similar efficacy for ustekinumab 90 mg every 8 weeks (q8w) and ustekinumab 90 mg every 12 weeks (q12w) subcutaneous (SC) regimens, except for in patients with high inflammatory burdens, who did better with q8w regimens. No new safety signals were identified for ustekinumab between Week 96 and Week 156, with overall rates of adverse events and serious adverse events being comparable to placebo. Rates of antibody formation remained low.\u0000\u0000Dr Raine described two case studies involving Crohn’s disease patients treated with ustekinumab. The first case described a female patient with luminal Crohn’s disease who had secondary nonresponse to an anti-TNF with signs of intestinal and systemic inflammation.\u0000\u0000The second case considered a patient with bio-naïve luminal Crohn’s disease who had a previous history of opportunistic infections (coughs, colds, and recurrent herpes simplex).\u0000\u0000Prof Armuzzi presented the results of the induction part of the UNIFI study, which randomised patients with moderate-to-severe ulcerative colitis (UC) to placebo, ustekinumab 130 mg, or a weight-tiered ustekinumab dose (˜6 mg/kg). Results showed clinical remission at Week 8 was 5.3% for placebo, 15.6% for ustekinumab 130 mg intravenous (IV) (p<0.001), and 15.5% for ustekinumab at ˜6 mg/kg IV (p<0.001). Furthermore, ustekinumab IV induced clinical response and endoscopic and mucosal healing, improved health related quality of life, and had an adverse event profile consistent with known safety profiles.","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79017197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The emergence of anti-TNF biosimilars has had significant implications for the biologic treatment of inflammatory bowel disease (IBD). Significant cost savings provide an incentive for healthcare providers to encourage the prescription of biosimilars instead of reference products. However, patients may have concerns about the switching process, the reason for the switch, or the biosimilar itself, and it is important for healthcare professionals (HCP) to take these into account to enable an informed, shared treatment decision. The aim of this symposium was to understand treatment of IBD from the patient’s perspective, especially when switching treatment to a biosimilar product. Beginning with a review of the current and future treatment landscapes, the implications of the increasing availability of biosimilars were discussed. The role of HCP in communicating information about the switch was explored by the multidisciplinary faculty who also compared switching practices at their own treatment centres and shared best practices. Alongside videos of interviews with patients who had undergone a switch to a biosimilar, a patient advocacy perspective was provided by Ms Luisa Avedano, CEO, the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA).
{"title":"The IBD Pathway: From a Patient Perspective","authors":"M. Barker, Rugina Ali","doi":"10.33590/emj/10310701","DOIUrl":"https://doi.org/10.33590/emj/10310701","url":null,"abstract":"The emergence of anti-TNF biosimilars has had significant implications for the biologic treatment of inflammatory bowel disease (IBD). Significant cost savings provide an incentive for healthcare providers to encourage the prescription of biosimilars instead of reference products. However, patients may have concerns about the switching process, the reason for the switch, or the biosimilar itself, and it is important for healthcare professionals (HCP) to take these into account to enable an informed, shared treatment decision.\u0000\u0000The aim of this symposium was to understand treatment of IBD from the patient’s perspective, especially when switching treatment to a biosimilar product. Beginning with a review of the current and future treatment landscapes, the implications of the increasing availability of biosimilars were discussed. The role of HCP in communicating information about the switch was explored by the multidisciplinary faculty who also compared switching practices at their own treatment centres and shared best practices. Alongside videos of interviews with patients who had undergone a switch to a biosimilar, a patient advocacy perspective was provided by Ms Luisa Avedano, CEO, the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA).","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86976236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-04-29DOI: 10.33590/emjgastroenterol/10313455
Stephanie Gibson
The treatment landscape of ulcerative colitis (UC) is changing, with new treatment options becoming available and insights into disease management demonstrating the importance of a patient-centric approach. Induction and maintenance of long-term remission are important treatment goals. However, some of the current treatment options often have limited efficacy, which may be coupled with an unfavourable safety profile, such as an increased risk of infection. A multiphase approach to disease management, which includes induction and maintenance of remission through close monitoring, is a viable clinical strategy. Selecting an appropriate first-line therapy is a crucial part of this strategy, as options are sometimes limited for patients who have failed anti-tumour necrosis factor (TNF) therapy. The integrin antagonist, vedolizumab, has demonstrated effective induction and maintenance of clinical remission in both anti-TNF-naïve and anti-TNF-failure patients, with no increase in infection risks. Therefore, vedolizumab should be considered for inducing and maintaining remission as part of a patient-centric disease management programme. The development of simplified monitoring systems that provide an indication of endoscopic activity will also aid patients in taking charge of their disease management. In conclusion, putting our patients at the centre of a proactive model of disease management can help prevent complications in the long-term, and selecting suitable first-line therapies is an important step in this process.
{"title":"Management of Ulcerative Colitis: Putting Patients at the Centre","authors":"Stephanie Gibson","doi":"10.33590/emjgastroenterol/10313455","DOIUrl":"https://doi.org/10.33590/emjgastroenterol/10313455","url":null,"abstract":"The treatment landscape of ulcerative colitis (UC) is changing, with new treatment options becoming available and insights into disease management demonstrating the importance of a patient-centric approach. Induction and maintenance of long-term remission are important treatment goals. However, some of the current treatment options often have limited efficacy, which may be coupled with an unfavourable safety profile, such as an increased risk of infection. A multiphase approach to disease management, which includes induction and maintenance of remission through close monitoring, is a viable clinical strategy. Selecting an appropriate first-line therapy is a crucial part of this strategy, as options are sometimes limited for patients who have failed anti-tumour necrosis factor (TNF) therapy. The integrin antagonist, vedolizumab, has demonstrated effective induction and maintenance of clinical remission in both anti-TNF-naïve and anti-TNF-failure patients, with no increase in infection risks. Therefore, vedolizumab should be considered for inducing and maintaining remission as part of a patient-centric disease management programme. The development of simplified monitoring systems that provide an indication of endoscopic activity will also aid patients in taking charge of their disease management. In conclusion, putting our patients at the centre of a proactive model of disease management can help prevent complications in the long-term, and selecting suitable first-line therapies is an important step in this process.","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84667511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-01DOI: 10.33590/emjgastroenterol/10314820
J. Coker
Treatment advances in inflammatory bowel disease (IBD), as well as the development of new biomarkers and technologies to enhance monitoring of the disease and response to treatment, are providing new possibilities in the management of ulcerative colitis (UC) and Crohn’s disease (CD). Awareness of the impact of IBD on patients beyond clinical endpoints is also increasing, including the prevalence and extent of extra-intestinal manifestations, psychological issues, and nutritional deficiencies. This means that the role of physicians in IBD is more important than ever, with continuous investigation required for every patient and a wealth of considerations to take into account when deciding on the most suitable treatment approach to undertake. For this article, the European Medical Journal conducted a series of interviews with five key opinion leaders from across Europe, each with a wealth of experience and expertise in managing IBD, to gain their perspectives on a range of topics in this area. From the UK, we spoke to Dr Ian Arnott, Consultant Gastroenterologist, Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK; from Spain, Dr Manuel Barreiro-de Acosta, Gastroenterology Department, Inflammatory Bowel Disease Unit, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain; from Germany, Prof Eduard Stange, Internal Medicine I – Gastroenterology, Hepatology and Infectious diseases, University of Tübingen, Tübingen, Germany; from Italy, Prof Antonio Tursi, Gastroenterology Service, Azienda Sanitaria Locale Barletta Andria Trani, Andria, Italy; and from France, Prof Frank Ruemmele, Professor of Paediatrics, Medical Faculty of the Université Sorbonne, Hôpital Necker Enfants Malades, Assistance Publique – Hôpitaux de Paris, Paris, France. The article begins by discussing monitoring of treatment response and detection of extra-intestinal manifestations, followed by considerations in making treatment decisions before outlining novel therapy options in both UC and CD. Optimal use of anti-TNF therapy, the impact and challenge of psychological issues in IBD, and nutrition and diet in this disease are also explored.
{"title":"Key Considerations in the Management of Inflammatory Bowel Disease: Interviews with Key Opinion Leaders","authors":"J. Coker","doi":"10.33590/emjgastroenterol/10314820","DOIUrl":"https://doi.org/10.33590/emjgastroenterol/10314820","url":null,"abstract":"Treatment advances in inflammatory bowel disease (IBD), as well as the development of new biomarkers and technologies to enhance monitoring of the disease and response to treatment, are providing new possibilities in the management of ulcerative colitis (UC) and Crohn’s disease (CD). Awareness of the impact of IBD on patients beyond clinical endpoints is also increasing, including the prevalence and extent of extra-intestinal manifestations, psychological issues, and nutritional deficiencies. This means that the role of physicians in IBD is more important than ever, with continuous investigation required for every patient and a wealth of considerations to take into account when deciding on the most suitable treatment approach to undertake. For this article, the European Medical Journal conducted a series of interviews with five key opinion leaders from across Europe, each with a wealth of experience and expertise in managing IBD, to gain their perspectives on a range of topics in this area. From the UK, we spoke to Dr Ian Arnott, Consultant Gastroenterologist, Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK; from Spain, Dr Manuel Barreiro-de Acosta, Gastroenterology Department, Inflammatory Bowel Disease Unit, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain; from Germany, Prof Eduard Stange, Internal Medicine I – Gastroenterology, Hepatology and Infectious diseases, University of Tübingen, Tübingen, Germany; from Italy, Prof Antonio Tursi, Gastroenterology Service, Azienda Sanitaria Locale Barletta Andria Trani, Andria, Italy; and from France, Prof Frank Ruemmele, Professor of Paediatrics, Medical Faculty of the Université Sorbonne, Hôpital Necker Enfants Malades, Assistance Publique – Hôpitaux de Paris, Paris, France. The article begins by discussing monitoring of treatment response and detection of extra-intestinal manifestations, followed by considerations in making treatment decisions before outlining novel therapy options in both UC and CD. Optimal use of anti-TNF therapy, the impact and challenge of psychological issues in IBD, and nutrition and diet in this disease are also explored.","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78739990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-12-11DOI: 10.33590/emjgastroenterol/10313657
H. Saul
The objectives of the symposium were to raise awareness of the importance of treating early, setting treatment goals, and using enhanced clinical monitoring in inflammatory bowel disease (IBD). The progressive nature of Crohn’s disease (CD) leading to bowel damage is well-established, but, according to Prof Peyrin-Biroulet, there may be a window of opportunity early in the disease when progression can be prevented through early diagnosis coupled with early intervention. The same approach should be adopted for the treatment of ulcerative colitis (UC), which he noted is frequently undertreated. UC is also progressive and the overall disability associated with UC is similar to CD. Prof Colombel described the treat to target (T2T), with tight control (TC), approach in IBD. The target is a composite endpoint of clinical and endoscopic remission, determined and agreed upon with the patient. In this approach, the disease is continuously monitored and treatment modified until the target is reached with the primary aim of blocking disease progression. The CALM study1 demonstrated that a significantly higher proportion of patients in the TC arm achieved mucosal healing at 1 year compared to patients with a conventional treatment management. In order to illustrate the benefits of early diagnosis, Prof Panaccione presented two cases from clinical practice who exhibited similar symptoms at disease onset. The first case took 3 years to present; her treatment was managed conventionally and escalated according to symptoms with no assessment of biomarkers. She had recurrent symptoms and eventually required ileocaecal resection. By contrast, in the second case, diagnosis occurred within 4 months of symptom onset, and biomarkers were assessed. Biological treatment was initiated at the second consultation and optimised with a TC approach. The treatments in both cases were similar; however, conventional management resulted in disease progression and the T2T approach with TC resulted in asymptomatic, full disease control. Prof Louis emphasised that good communication between physicians and patients results in the development of goals that are both relevant and meaningful to patients. Patient-reported outcomes (PRO) are increasingly included in clinical trials and required by regulatory agencies. Prof Louis described how tools such as the IBD Disk, which was developed in partnership with patients, can highlight issues that impact the patient’s life and therefore aid in optimal communication between physicians and patients.
{"title":"Are We Ready to Change the Course of Inflammatory Bowel Disease?","authors":"H. Saul","doi":"10.33590/emjgastroenterol/10313657","DOIUrl":"https://doi.org/10.33590/emjgastroenterol/10313657","url":null,"abstract":"The objectives of the symposium were to raise awareness of the importance of treating early, setting treatment goals, and using enhanced clinical monitoring in inflammatory bowel disease (IBD). The progressive nature of Crohn’s disease (CD) leading to bowel damage is well-established, but, according to Prof Peyrin-Biroulet, there may be a window of opportunity early in the disease when progression can be prevented through early diagnosis coupled with early intervention. The same approach should be adopted for the treatment of ulcerative colitis (UC), which he noted is frequently undertreated. UC is also progressive and the overall disability associated with UC is similar to CD.\u0000\u0000Prof Colombel described the treat to target (T2T), with tight control (TC), approach in IBD. The target is a composite endpoint of clinical and endoscopic remission, determined and agreed upon with the patient. In this approach, the disease is continuously monitored and treatment modified until the target is reached with the primary aim of blocking disease progression. The CALM study1 demonstrated that a significantly higher proportion of patients in the TC arm achieved mucosal healing at 1 year compared to patients with a conventional treatment management. In order to illustrate the benefits of early diagnosis, Prof Panaccione presented two cases from clinical practice who exhibited similar symptoms at disease onset. The first case took 3 years to present; her treatment was managed conventionally and escalated according to symptoms with no assessment of biomarkers. She had recurrent symptoms and eventually required ileocaecal resection. By contrast, in the second case, diagnosis occurred within 4 months of symptom onset, and biomarkers were assessed. Biological treatment was initiated at the second consultation and optimised with a TC approach. The treatments in both cases were similar; however, conventional management resulted in disease progression and the T2T approach with TC resulted in asymptomatic, full disease control.\u0000\u0000Prof Louis emphasised that good communication between physicians and patients results in the development of goals that are both relevant and meaningful to patients. Patient-reported outcomes (PRO) are increasingly included in clinical trials and required by regulatory agencies. Prof Louis described how tools such as the IBD Disk, which was developed in partnership with patients, can highlight issues that impact the patient’s life and therefore aid in optimal communication between physicians and patients.","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"47 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77764007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-12-11DOI: 10.33590/emjgastroenterol/10311869
I. O'Neill
The epidemiology of diverticular disease (DD) is changing, with an increasing prevalence in younger patients from Europe and the USA, and changing disease patterns also seen in Asian populations. This epidemiological shift has substantial implications for disease management policy and healthcare costs. Most (75–80%) patients with diverticulosis never develop symptoms. Around 5% develop acute diverticulitis or other complications, while 10–15% develop symptomatic uncomplicated DD (SUDD) with symptoms resembling irritable bowel syndrome (IBS). However, most available guidelines highlight the importance of diverticulitis, with less emphasis on and often limited discussion about SUDD and its management. Recent data suggest an important relationship between gut microbiota and DD, including SUDD. In healthy individuals, the gut microbiota exists in harmony (eubiosis); in individuals with disease, quantitative and qualitative changes in microbial diversity (dysbiosis) may adversely influence colonic metabolism and homeostasis. Addressing this imbalance and restoring a healthier microbiota via eubiotic or probiotic therapy may be of value. In SUDD, clinical benefit has been seen with the use of rifaximin, which acts by multiple mechanisms: direct antibiotic activity, a modulatory eubiotic effect with an increase in muco-protective Lactobacillus and Bifidobacterium organisms, and anti-inflammatory effects, among others. Clinical studies have demonstrated symptom improvement and reduction in complications in patients with SUDD, with a favourable safety and tolerability profile and no evidence of microbial resistance. Evidence for other agents in DD is less robust. Mesalamine is not effective at preventing recurrence of acute diverticulitis, although it may provide some symptom improvement. At present, there is insufficient evidence to recommend the use of probiotics in SUDD symptom management.
{"title":"A Worldwide Perspective on Diagnosis and Management of Diverticular Disease: Understanding Similarities and Differences","authors":"I. O'Neill","doi":"10.33590/emjgastroenterol/10311869","DOIUrl":"https://doi.org/10.33590/emjgastroenterol/10311869","url":null,"abstract":"The epidemiology of diverticular disease (DD) is changing, with an increasing prevalence in younger patients from Europe and the USA, and changing disease patterns also seen in Asian populations. This epidemiological shift has substantial implications for disease management policy and healthcare costs. Most (75–80%) patients with diverticulosis never develop symptoms. Around 5% develop acute diverticulitis or other complications, while 10–15% develop symptomatic uncomplicated DD (SUDD) with symptoms resembling irritable bowel syndrome (IBS). However, most available guidelines highlight the importance of diverticulitis, with less emphasis on and often limited discussion about SUDD and its management. Recent data suggest an important relationship between gut microbiota and DD, including SUDD. In healthy individuals, the gut microbiota exists in harmony (eubiosis); in individuals with disease, quantitative and qualitative changes in microbial diversity (dysbiosis) may adversely influence colonic metabolism and homeostasis. Addressing this imbalance and restoring a healthier microbiota via eubiotic or probiotic therapy may be of value. In SUDD, clinical benefit has been seen with the use of rifaximin, which acts by multiple mechanisms: direct antibiotic activity, a modulatory eubiotic effect with an increase in muco-protective Lactobacillus and Bifidobacterium organisms, and anti-inflammatory effects, among others. Clinical studies have demonstrated symptom improvement and reduction in complications in patients with SUDD, with a favourable safety and tolerability profile and no evidence of microbial resistance. Evidence for other agents in DD is less robust. Mesalamine is not effective at preventing recurrence of acute diverticulitis, although it may provide some symptom improvement. At present, there is insufficient evidence to recommend the use of probiotics in SUDD symptom management.","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"132 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85756471","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-12-11DOI: 10.33590/emjgastroenterol/10314260
S. Reed
Despite the fact that the treatment armamentarium for inflammatory bowel diseases (IBD) is growing, unmet medical needs remain. These needs are driven, at least in part, by restricted access to biologics, which means that patients who would benefit from these agents will not receive them. This symposium explored approaches to improve IBD care, evaluating both the potential of novel therapies and the role of optimised treatment using the treat-to-target concept and careful evaluation of use of the right drug at the right time. The reality for clinicians is that selecting the best treatment needs to take into account the best medical option, patient preferences, and cost, which is one of the main barriers limiting access to biologic treatment. In this regard, biosimilars could serve the patient community by facilitating increased access, including use in early intervention to avoid disease progression. Education around biosimilars is essential to ensure patient acceptance of these agents and maximise the opportunity that they provide.
{"title":"The Emerging Treatment Landscape of Inflammatory Bowel Disease: Role of Innovator Biologics and Biosimilars","authors":"S. Reed","doi":"10.33590/emjgastroenterol/10314260","DOIUrl":"https://doi.org/10.33590/emjgastroenterol/10314260","url":null,"abstract":"Despite the fact that the treatment armamentarium for inflammatory bowel diseases (IBD) is growing, unmet medical needs remain. These needs are driven, at least in part, by restricted access to biologics, which means that patients who would benefit from these agents will not receive them. This symposium explored approaches to improve IBD care, evaluating both the potential of novel therapies and the role of optimised treatment using the treat-to-target concept and careful evaluation of use of the right drug at the right time. The reality for clinicians is that selecting the best treatment needs to take into account the best medical option, patient preferences, and cost, which is one of the main barriers limiting access to biologic treatment. In this regard, biosimilars could serve the patient community by facilitating increased access, including use in early intervention to avoid disease progression. Education around biosimilars is essential to ensure patient acceptance of these agents and maximise the opportunity that they provide.","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77744046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mena Mikhail, George Crowley, Syed Hissam Haider, Arul Veerappan, Rachel Lam, Angela Talusan, Emily Clementi, Dean Ostrofsky, Sophia Kwon, Anna Nolan
The prevalence of non-cardiac chest pain (NCCP) ranges from 13-33%. A majority of those presenting with a chief complaint of chest pain are found to have a diagnosis of NCCP. Aerodigestive diseases are a cause of NCCP, and billions of dollars are spent annually on the treatment of NCCP. Furthermore, NCCP can cause significant psychological stress. NCCP is commonly diagnosed when patients have chest pain despite a normal cardiac evaluation. The leading cause of NCCP is gastro-oesophageal reflux disease (GORD). GORD should be suspected in patients who report a history of acid regurgitation, cough, dysphagia, and bloating. Another common cause of NCCP is obstructive airway disease (OAD). A thorough history and review of the symptoms should be performed for those with suspected NCCP, especially because of the contributing end organs. It is known that environmental exposures can commonly cause GORD and OAD; however, NCCP has not been fully explored in the context of environmental exposure. Patients with a history of exposure to particulate matter can develop environmental-exposure-associated GORD and coexisting OAD. This narrative review aims to provide a practical overview of NCCP, its causes, their relation to environmental exposure, and associated biomarkers. The authors used a PubMed search that spanned 2003-2018 to accomplish this. Additionally, this review provides a broad overview of biomarkers of GORD-associated NCCP and OAD-associated NCCP due to environmental exposure.
{"title":"Non-Cardiac Chest Pain: A Review of Environmental Exposure-Associated Comorbidities and Biomarkers.","authors":"Mena Mikhail, George Crowley, Syed Hissam Haider, Arul Veerappan, Rachel Lam, Angela Talusan, Emily Clementi, Dean Ostrofsky, Sophia Kwon, Anna Nolan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The prevalence of non-cardiac chest pain (NCCP) ranges from 13-33%. A majority of those presenting with a chief complaint of chest pain are found to have a diagnosis of NCCP. Aerodigestive diseases are a cause of NCCP, and billions of dollars are spent annually on the treatment of NCCP. Furthermore, NCCP can cause significant psychological stress. NCCP is commonly diagnosed when patients have chest pain despite a normal cardiac evaluation. The leading cause of NCCP is gastro-oesophageal reflux disease (GORD). GORD should be suspected in patients who report a history of acid regurgitation, cough, dysphagia, and bloating. Another common cause of NCCP is obstructive airway disease (OAD). A thorough history and review of the symptoms should be performed for those with suspected NCCP, especially because of the contributing end organs. It is known that environmental exposures can commonly cause GORD and OAD; however, NCCP has not been fully explored in the context of environmental exposure. Patients with a history of exposure to particulate matter can develop environmental-exposure-associated GORD and coexisting OAD. This narrative review aims to provide a practical overview of NCCP, its causes, their relation to environmental exposure, and associated biomarkers. The authors used a PubMed search that spanned 2003-2018 to accomplish this. Additionally, this review provides a broad overview of biomarkers of GORD-associated NCCP and OAD-associated NCCP due to environmental exposure.</p>","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"7 1","pages":"103-112"},"PeriodicalIF":0.0,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6375490/pdf/nihms-1010168.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36964322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-12-01DOI: 10.33590/emjgastroenterol/10313895
Mena Mikhail, G. Crowley, S. Haider, A. Veerappan, R. Lam, A. Talusan, Emily A. Clementi, D. Ostrofsky, Sophia Kwon, A. Nolan
The prevalence of non-cardiac chest pain (NCCP) ranges from 13-33%. A majority of those presenting with a chief complaint of chest pain are found to have a diagnosis of NCCP. Aerodigestive diseases are a cause of NCCP, and billions of dollars are spent annually on the treatment of NCCP. Furthermore, NCCP can cause significant psychological stress. NCCP is commonly diagnosed when patients have chest pain despite a normal cardiac evaluation. The leading cause of NCCP is gastro-oesophageal reflux disease (GORD). GORD should be suspected in patients who report a history of acid regurgitation, cough, dysphagia, and bloating. Another common cause of NCCP is obstructive airway disease (OAD). A thorough history and review of the symptoms should be performed for those with suspected NCCP, especially because of the contributing end organs. It is known that environmental exposures can commonly cause GORD and OAD; however, NCCP has not been fully explored in the context of environmental exposure. Patients with a history of exposure to particulate matter can develop environmental-exposure-associated GORD and coexisting OAD. This narrative review aims to provide a practical overview of NCCP, its causes, their relation to environmental exposure, and associated biomarkers. The authors used a PubMed search that spanned 2003-2018 to accomplish this. Additionally, this review provides a broad overview of biomarkers of GORD-associated NCCP and OAD-associated NCCP due to environmental exposure.
{"title":"Non-Cardiac Chest Pain: A Review of Environmental Exposure-Associated Comorbidities and Biomarkers.","authors":"Mena Mikhail, G. Crowley, S. Haider, A. Veerappan, R. Lam, A. Talusan, Emily A. Clementi, D. Ostrofsky, Sophia Kwon, A. Nolan","doi":"10.33590/emjgastroenterol/10313895","DOIUrl":"https://doi.org/10.33590/emjgastroenterol/10313895","url":null,"abstract":"The prevalence of non-cardiac chest pain (NCCP) ranges from 13-33%. A majority of those presenting with a chief complaint of chest pain are found to have a diagnosis of NCCP. Aerodigestive diseases are a cause of NCCP, and billions of dollars are spent annually on the treatment of NCCP. Furthermore, NCCP can cause significant psychological stress. NCCP is commonly diagnosed when patients have chest pain despite a normal cardiac evaluation. The leading cause of NCCP is gastro-oesophageal reflux disease (GORD). GORD should be suspected in patients who report a history of acid regurgitation, cough, dysphagia, and bloating. Another common cause of NCCP is obstructive airway disease (OAD). A thorough history and review of the symptoms should be performed for those with suspected NCCP, especially because of the contributing end organs. It is known that environmental exposures can commonly cause GORD and OAD; however, NCCP has not been fully explored in the context of environmental exposure. Patients with a history of exposure to particulate matter can develop environmental-exposure-associated GORD and coexisting OAD. This narrative review aims to provide a practical overview of NCCP, its causes, their relation to environmental exposure, and associated biomarkers. The authors used a PubMed search that spanned 2003-2018 to accomplish this. Additionally, this review provides a broad overview of biomarkers of GORD-associated NCCP and OAD-associated NCCP due to environmental exposure.","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"17 1","pages":"103-112"},"PeriodicalIF":0.0,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80622519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Shiani, S. Lipka, B. Wolk, H. Pinkas, Ambuj Kumar, Angel Alsi-na, N. Kemmer, Alexandra Turner, P. Brady
Introduction: Magnetic resonance cholangiopancreatography (MRCP) is an important diagnostic tool in evaluating patients with biliary laboratory abnormalities after orthotopic liver transplant (OLT) to determine the need for more invasive procedures, such as endoscopic retrograde cholangiopancreatography (ERCP), which can deliver therapeutic interventions. The aim of this study was to determine the diagnostic accuracy of MRCP findings using ERCP as the gold standard in a group of post-OLT patients. Methods: A retrospective review of 273 patients who underwent OLT at the University of South Florida and Tampa General Hospital, Tampa, Florida, USA, from January 2012–April 2015 was performed. A total of 52 patients who had a MRCP and underwent a subsequent ERCP were studied. Presence of anastomotic stricture, common bile duct dilation >0.7 mm, bile leak, stone, intrahepatic stricture, or extrahepatic stricture on either modality was recorded. SPSS statistical analysis software (version 22 for Windows, SPSS Inc., Chicago, Illinois, USA) was used to calculate diagnostic accuracy. Results: The mean age of the population examined was 54.5±10.5 years; 73% of the patients were male (38 of 52). Overall agreement between the two procedures ranged from 71–96%. The sensitivity, specificity, and positive and negative predictive values of MRCP for anastomotic strictures were 77%, 59%, 79%, and 56%, respectively. The sensitivity, specificity, and positive and negative predictive values of MRCP for common bile duct dilation of >0.7 mm were 64%, 95%, 82%, and 88%, respectively. Conclusion: Despite significant improvement in the technology to better visualise the biliary system on MRCP, this study found that MRCP does not appear to be sensitive or specific in this chosen population. ERCP should be considered to confirm all positive MRCP findings, and in normal MRCP cases if there are other clinical data suggesting biliary abnormalities.
{"title":"Diagnostic Accuracy of Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography Findings in the Postorthotopic Liver Transplant Population","authors":"A. Shiani, S. Lipka, B. Wolk, H. Pinkas, Ambuj Kumar, Angel Alsi-na, N. Kemmer, Alexandra Turner, P. Brady","doi":"10.33590/emj/10311915","DOIUrl":"https://doi.org/10.33590/emj/10311915","url":null,"abstract":"Introduction: Magnetic resonance cholangiopancreatography (MRCP) is an important diagnostic tool in evaluating patients with biliary laboratory abnormalities after orthotopic liver transplant (OLT) to determine the need for more invasive procedures, such as endoscopic retrograde cholangiopancreatography (ERCP), which can deliver therapeutic interventions. The aim of this study was to determine the diagnostic accuracy of MRCP findings using ERCP as the gold standard in a group of post-OLT patients.\u0000\u0000Methods: A retrospective review of 273 patients who underwent OLT at the University of South Florida and Tampa General Hospital, Tampa, Florida, USA, from January 2012–April 2015 was performed. A total of 52 patients who had a MRCP and underwent a subsequent ERCP were studied. Presence of anastomotic stricture, common bile duct dilation >0.7 mm, bile leak, stone, intrahepatic stricture, or extrahepatic stricture on either modality was recorded. SPSS statistical analysis software (version 22 for Windows, SPSS Inc., Chicago, Illinois, USA) was used to calculate diagnostic accuracy.\u0000\u0000Results: The mean age of the population examined was 54.5±10.5 years; 73% of the patients were male (38 of 52). Overall agreement between the two procedures ranged from 71–96%. The sensitivity, specificity, and positive and negative predictive values of MRCP for anastomotic strictures were 77%, 59%, 79%, and 56%, respectively. The sensitivity, specificity, and positive and negative predictive values of MRCP for common bile duct dilation of >0.7 mm were 64%, 95%, 82%, and 88%, respectively.\u0000\u0000Conclusion: Despite significant improvement in the technology to better visualise the biliary system on MRCP, this study found that MRCP does not appear to be sensitive or specific in this chosen population. ERCP should be considered to confirm all positive MRCP findings, and in normal MRCP cases if there are other clinical data suggesting biliary abnormalities.","PeriodicalId":92504,"journal":{"name":"EMJ. Gastroenterology","volume":"70 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85744334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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