Dying Tt Save Your Colon? Changing the Way We Look at Ulcerative Colitis

Treatment options for mesalamine-refractory ulcerative colitis (UC) include chronic immunosuppressive medications or colectomy surgery. Current treatment paradigms presume the patients\u27 foremost desire is to avoid surgery and therefore view surgery as a consequence of medication failure. However, immunosuppressive therapy may not be ideal for all patients due to unclear durable efficacy and potential lethal serious adverse events (SAEs). We sought to quantify UC patients\u27 risk tolerance of chronic immunosuppression to avoid colectomy. We first conducted a meta-analysis of all-cause and cause-specific mortality in both Crohn\u27s disease (CD) and UC, and examined the effect of study design on this outcome. We found elevated all-cause and cause-specific mortality in both UC and CD including colorectal-, pulmonary- and non-alcoholic liver disease-related relative mortality. We further found little evidence that study design impacted all-cause relative mortality summary estimates. We next conducted a study examining the reliability of the 6-Point Mayo score, a simple two-item non-invasive non-physician driven index, for measuring UC disease activity. We found the 6-Point Mayo to strongly correlate with more extensive disease assessment tools, with a similar sensitivity, specificity and ROC area under the curve for patient-defined clinical remission. With these insights, we conducted a discrete choice experiment to quantify the UC patients\u27 mean maximum acceptable risk for life-threatening SAEs associated with immunosuppressant therapy to avoid colectomy surgery with various outcomes. We found that UC patient tolerance for medical and surgical risks do not conform to conventional preference-elicitation methodology assumptions. UC patients were willing to accept very high levels of fatal SAEs to avoid an ostomy. However, if a durable medication-induced remission could not be achieved, patients were equally satisfied with J-pouch surgery. Several important clinical phenotypes impacted patient risk tolerances. This is the first empirical demonstration that UC patients view a well-functioning J-pouch as equivalent to mild clinical disease. It further demonstrates that patients value medication efficacy and suggests that clinical remission, rather than response, be the preferred outcome for therapy trials and treatment algorithms. Our findings underline the need for rigorous methodologies to accurately measure patient-preferences; and suggest potential avenues to enhance UC patient autonomy and facilitate shared decision-making

Impact of SARS-CoV-2 Vaccination on Inflammatory Bowel Disease Activity and Development of Vaccine-Related Adverse Events: Results From PREVENT-COVID

Severe acute respiratory syndrome coronavirus 2 vaccination is recommended for all individuals with inflammatory bowel disease (IBD), including those on immunosuppressive therapies; however, little is known about vaccine safety and efficacy in these patients or the impact of vaccination on IBD disease course.We evaluated coronavirus disease 2019 (COVID-19) vaccine–related adverse events (AEs) and the effect of vaccination on IBD disease course among participants in the PREVENT-COVID (Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID) study, a prospective, observational cohort study. Localized and systemic reactions were assessed via questionnaire. Disease flare was defined by worsening IBD symptoms and change in IBD medications. Outcomes were stratified by vaccine type and IBD medication classes.A total of 3316 individuals with IBD received at least 1 COVID-19 vaccine. Injection site tenderness (68%) and fatigue (46% dose 1, 68% dose 2) were the most commonly reported localized and systemic AEs after vaccination. Severe localized and systemic vaccine-related AEs were rare. The mRNA-1273 vaccine was associated with significantly greater severe AEs at dose 2 (localized 4% vs 2%, systemic 15% vs 10%; P < .001 for both). Prior COVID-19 infection, female sex, and vaccine type were associated with severe systemic reactions to dose 1, while age <50 years, female sex, vaccine type, and antitumor necrosis factor and vedolizumab use were associated with severe systemic reactions to dose 2. Overall rates (2%) of IBD flare were low following vaccination.Our findings provide reassurance that the severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with IBD, which may help to combat vaccine hesitancy and increase vaccine confidence.The severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with inflammatory bowel disease (IBD). Severe localized and systemic vaccine-related adverse events were rare, and rates of IBD flare were low (2%) following severe acute respiratory syndrome coronavirus 2 vaccination in a cohort of 3316 participants with IBD

Low Rates of Breakthrough COVID-19 Infection After SARS-CoV-2 Vaccination in Patients With Inflammatory Bowel Disease

We demonstrate low rates of breakthrough coronavirus disease 2019 (COVID-19) infection and mild course of illness following severe acute respiratory syndrome coronavirus 2 vaccination in a large cohort of inflammatory bowel disease patients. Residence in southern United States and lower median anti-receptor binding antibody level were associated with development of COVID-19

Dying to save your colon? Changing the way we look at ulcerative colitis

Treatment options for mesalamine-refractory ulcerative colitis (UC) include chronic immunosuppressive medications or colectomy surgery. Current treatment paradigms presume the patients\u27 foremost desire is to avoid surgery and therefore view surgery as a consequence of medication failure. However, immunosuppressive therapy may not be ideal for all patients due to unclear durable efficacy and potential lethal serious adverse events (SAEs). We sought to quantify UC patients\u27 risk tolerance of chronic immunosuppression to avoid colectomy. We first conducted a meta-analysis of all-cause and cause-specific mortality in both Crohn\u27s disease (CD) and UC, and examined the effect of study design on this outcome. We found elevated all-cause and cause-specific mortality in both UC and CD including colorectal-, pulmonary- and non-alcoholic liver disease-related relative mortality. We further found little evidence that study design impacted all-cause relative mortality summary estimates. We next conducted a study examining the reliability of the 6-Point Mayo score, a simple two-item non-invasive non-physician driven index, for measuring UC disease activity. We found the 6-Point Mayo to strongly correlate with more extensive disease assessment tools, with a similar sensitivity, specificity and ROC area under the curve for patient-defined clinical remission. With these insights, we conducted a discrete choice experiment to quantify the UC patients\u27 mean maximum acceptable risk for life-threatening SAEs associated with immunosuppressant therapy to avoid colectomy surgery with various outcomes. We found that UC patient tolerance for medical and surgical risks do not conform to conventional preference-elicitation methodology assumptions. UC patients were willing to accept very high levels of fatal SAEs to avoid an ostomy. However, if a durable medication-induced remission could not be achieved, patients were equally satisfied with J-pouch surgery. Several important clinical phenotypes impacted patient risk tolerances. This is the first empirical demonstration that UC patients view a well-functioning J-pouch as equivalent to mild clinical disease. It further demonstrates that patients value medication efficacy and suggests that clinical remission, rather than response, be the preferred outcome for therapy trials and treatment algorithms. Our findings underline the need for rigorous methodologies to accurately measure patient-preferences; and suggest potential avenues to enhance UC patient autonomy and facilitate shared decision-making

Dying to save your colon? Changing the way we look at ulcerative colitis

Treatment options for mesalamine-refractory ulcerative colitis (UC) include chronic immunosuppressive medications or colectomy surgery. Current treatment paradigms presume the patients\u27 foremost desire is to avoid surgery and therefore view surgery as a consequence of medication failure. However, immunosuppressive therapy may not be ideal for all patients due to unclear durable efficacy and potential lethal serious adverse events (SAEs). We sought to quantify UC patients\u27 risk tolerance of chronic immunosuppression to avoid colectomy. We first conducted a meta-analysis of all-cause and cause-specific mortality in both Crohn\u27s disease (CD) and UC, and examined the effect of study design on this outcome. We found elevated all-cause and cause-specific mortality in both UC and CD including colorectal-, pulmonary- and non-alcoholic liver disease-related relative mortality. We further found little evidence that study design impacted all-cause relative mortality summary estimates. We next conducted a study examining the reliability of the 6-Point Mayo score, a simple two-item non-invasive non-physician driven index, for measuring UC disease activity. We found the 6-Point Mayo to strongly correlate with more extensive disease assessment tools, with a similar sensitivity, specificity and ROC area under the curve for patient-defined clinical remission. With these insights, we conducted a discrete choice experiment to quantify the UC patients\u27 mean maximum acceptable risk for life-threatening SAEs associated with immunosuppressant therapy to avoid colectomy surgery with various outcomes. We found that UC patient tolerance for medical and surgical risks do not conform to conventional preference-elicitation methodology assumptions. UC patients were willing to accept very high levels of fatal SAEs to avoid an ostomy. However, if a durable medication-induced remission could not be achieved, patients were equally satisfied with J-pouch surgery. Several important clinical phenotypes impacted patient risk tolerances. This is the first empirical demonstration that UC patients view a well-functioning J-pouch as equivalent to mild clinical disease. It further demonstrates that patients value medication efficacy and suggests that clinical remission, rather than response, be the preferred outcome for therapy trials and treatment algorithms. Our findings underline the need for rigorous methodologies to accurately measure patient-preferences; and suggest potential avenues to enhance UC patient autonomy and facilitate shared decision-making