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Background & Aims We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice. Methods A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist–naive and –exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately. Results A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist–naive and −exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist−treated patients. However, in TNF-antagonist−naive patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754). Conclusions Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist−naive patients.

Gastroenterologists have long been spearheading the care of patients with various forms of liver disease. The diagnosis and management of liver disease has traditionally been a combination of clinical, laboratory, and imaging findings coupled with percutaneous and intravascular procedures with endoscopy largely limited to screening for and therapy of esophageal and gastric varices. As the applications of diagnostic and therapeutic endoscopic ultrasound (EUS) have evolved, it has found a particular niche within hepatology now coined endo-hepatology. Here we discuss several EUS-guided procedures such as liver biopsy, shear wave elastography, direct portal pressure measurement, paracentesis, as well as EUS-guided therapies for variceal hemorrhage.

Background Patients with Inflammatory bowel disease (IBD) remain highly concerned that either their disease or medications-namely, biologics-may increase the risk of severe coronavirus-2019 (COVID-19). We aimed to assess the safety of biologics in Inflammatory bowel disease (IBD) patients with COVID-19. Methods We systematically reviewed multiple databases to find relevant articles reporting the effect of biologics on "severe" COVID-19 in IBD patients. Those in the form of case series (> 10 patients), case-control, and cohort studies were included. Severe COVID-19 was defined as intensive care unit (ICU) admission, mechanical ventilation, and/or mortality. Pooled analysis with multivariate regression was performed. Results A total of 12 studies with 2681 patients were included. The proportion of females was (48.3%, 95% confidence interval (CI) 47.0-49.5%). The proportion of UC patients was (44.8%, 95% CI 41.0-48.5%). Overall, in IBD patients, the need for mechanical ventilation, intensive care unit (ICU) admission, and mortality was 5.1%, 6.1%, and 4.5%, respectively. Use of biologics did not show a moderating effect on mechanical ventilation (p = 0.68), ICU admission (p = 0.27), or mortality (p = 0.20). Conclusions Our findings advocate for the continued biologic therapy in IBD patients during the COVID-19 pandemic. Nevertheless, the incidence, severity, and outcomes related to COVID-19 in IBD patients' needs to be reassessed as data continues to emerge.

Background and Aims Rates of obesity are rising in patients with inflammatory bowel disease [IBD]. We conducted a US population-based study to determine the effects of obesity on outcomes in hospitalised patients with IBD. Methods We searched the Nationwide Readmissions Database 2016-2017 to identify all adult patients hospitalised for IBD, using ICD-10 codes. We compared obese (body mass index [BMI] ≥ 30) vs non-obese [BMI Results We identified 143 190 patients with IBD, of whom 9.1% were obese. Obesity was independently associated with higher all-cause readmission at 30 days {18% vs 13% (adjusted odds ratio [aOR] 1.16, p = 0.005)} and 90 days (29% vs 21% [aOR 1.27, p Conclusions Obesity in IBD appears to be associated with increased early readmission, characterised by a higher burden, despite the introduction of weight-based therapeutics. Prevention of obesity should be a focus in the treatment of IBD to decrease readmission and health care burden.

Background Infliximab is a weight-based prescription for multiple autoimmune diseases and is dispensed only in single-use, 100mg vials. We aim to compute the quantity of infliximab waste at our site and in an ideal world where weight-based prescribing practices are followed. We estimate hypothetical waste reduction and cost-savings if a smaller vial is dispensed. We also surveyed gastroenterologists to study prescription rounding practices for infliximab. Methods A pre-existing registry of 426 inflammatory bowel disease patients identified 112 individuals who had received a total of 1003 infliximab administrations from December 2013 to May 2019. We calculated infliximab wastage per administration for the real world and an ideal (weight-based) world. Analysis of potential waste reduction and cost-savings was computed with the hypothetical creation of 50 and 25mg vials. Infliximab-prescribing gastroenterologists completed an online survey, determining reasons for rounding of weight-based prescription, rounding practices, and biosimilar use. Results At our site, the total value of infliximab wasted was between $112738.08 and $243209.50. Utilizing 50 and 25mg vials would reduce this waste by 92.2% and 99.4%, respectively. If prescriber guidelines were followed precisely, the total value of waste was between $132781.08 and $286448.19. Utilizing 50 and 25mg vials would reduce waste by 50.39% and 75.34%, respectively. The physician survey revealed that 68.1% rounded doses while only 31.9% prescribed exact weight-based doses. Conclusions Infliximab-prescribing gastroenterologists considered reducing drug waste as a common reason in their rounding practices. Our analysis demonstrates significant waste reduction and cost-savings are possible with the introduction of 50 and 25mg vials.

Fatigue is a burdensome, multidimensional, and multifactorial symptom that is associated with a wide array of chronic illnesses, specifically occurring in nearly 50% of patients with inflammatory bowel disease (IBD). Although common, given its subjective nature, physicians often under-recognize and undertreat this debilitating symptom. There are multiple etiologies that can contribute to fatigue in patients with IBD, including disease activity, anemia, medications, psychosomatic symptoms, and alterations to the gut-brain axis. The management of fatigue in IBD can be challenging, as it is often times multifaceted. In this review, we summarize the available tools for the diagnosis and measurement of fatigue, discuss etiologies, and make recommendations for their management. We identify knowledge gaps for the workup and treatment of fatigue and propose an algorithm to aid physicians in the evaluation and management of fatigue in this unique population. However, future research is needed to address several areas of knowledge deficits and improve the management of fatigue in IBD.

Background Vedolizumab effectiveness estimates immediately after Food and Drug Administration (FDA) approval for ulcerative colitis (UC) and Crohn’s disease (CD) are limited by use in refractory populations. We aimed to compare treatment patterns and outcomes of vedolizumab in 2 time frames after FDA approval. Methods We used 2 data sets for time trend analysis, an academic multicenter vedolizumab consortium (VICTORY) and the Truven MarketScan database, and 2 time periods, May 2014–June 2015 (Era 1) and July 2015–June 2017 (Era 2). VICTORY cumulative 12-month clinical remission, corticosteroid-free remission, and mucosal healing rates, and Truven 12-month hospitalization and surgery rates, were compared between Eras 1 and 2 using time-to-event analyses. Results A total of 3661 vedolizumab-treated patients were included (n = 1087 VICTORY, n = 2574 Truven). In both cohorts, CD and UC patients treated during Era 2 were more likely to be biologic naïve. Compared with Era 1, Era 2 CD patients in the VICTORY consortium had higher rates of clinical remission (31% vs 40%, P = 0.03) and mucosal healing (42% vs 58%, P < 0.01). These trends were not observed for UC. In the Truven database, UC patients treated during Era 2 had lower rates of inflammatory bowel disease–related hospitalization (22.4% vs 9.6%, P < 0.001) and surgery (17.2% vs 9.4%, P = 0.008), which was not observed for CD. Conclusion Since FDA approval, remission and mucosal healing rates have increased for vedolizumab-treated CD patients, and vedolizumab-treated UC patients have had fewer hospitalizations and surgeries. This is likely due to differences between patient populations treated immediately after drug approval and those treated later., There has been a shift in utilization of vedolizumab in both Crohn’s disease and ulcerative colitis toward earlier use in the treatment sequencing algorithm. This shift in utilization is associated with improvements in response and disease outcomes.

Although still not approved at the federal level for medical or adult recreational use, cannabis has been approved in the United States (USA) by individual states for both of these purposes. A total of 15 states now regulate cannabis for adult use and 36 states for medical use. In more recent years, cannabis has gained popularity for the treatment of chronic conditions, inflammatory bowel disease (IBD) being one of them. However, the exact role of cannabis in the treatment of IBD remains uncertain. While cannabis may help in some instances with symptom management, it has not been proven to help with inflammation or to fundamentally correct underlying disease processes. Additionally, along with the perceived symptom benefits of cannabis come concerning issues like dosing inconsistencies, dependence, and cannabinoid hyperemesis syndrome. In this review article, we explore the nuanced relationship between cannabis and the treatment of IBD by summarizing the current research. We also use clinical vignettes to discuss the more practical considerations surrounding its use.

Background Ulcerative colitis (UC) flares often result in prolonged hospitalization and considerable mortality. Nevertheless, large-scale analyses evaluating the frequency and characteristics of hospital readmissions for UC remain limited. We aimed to examine these clinical outcomes in a nationwide cohort of patients hospitalized with UC. Methods We queried the 2017 Nationwide Readmission Database using ICD-10-CM codes to identify all adult patients admitted for UC. Outcomes including mortality, readmission rates, predictors of readmission and mortality, and healthcare usage were assessed. Multivariate analysis was used to adjust for potential confounders. Results From the 31,063 patients hospitalized for UC, 17.38% were readmitted within 30 days and 28.51% in 90 days. UC accounted for 28.17% and 29.82% of readmissions at 30 and 90 days, respectively. Compared to index admission, 30- and 90-day readmissions were characterized by significantly higher mortality (0.42% vs 1.99% and 1.65%, respectively), longer hospital stays (5.05 vs 6.62 and 6.04 days, respectively), and increased hospital cost ($49,999 vs $62,288 and $59,698, respectively) (all P < 0.01). Numerous factors, including chronic steroid use [hazard ratio (HR) 1.35] and opioid use (HR 1.6, were independently associated with increased 30-day readmission (P < 0.01). Numerous factors, including anxiety (HR 1.21) and venous thromboembolism (HR 5.39), were independently associated with increased 30-day mortality (P < 0.01). Conclusions In a large cohort of patients hospitalized for UC, we found that readmission is associated with higher mortality and more lengthy/costly admissions. Additionally, we found independent associations for readmission and mortality that may help identify patients who can benefit from close postdischarge follow-up.

Patients with inflammatory bowel disease (IBD) have an increased risk of venous thrombotic events. The impact IBD has on arterial thrombosis is not well characterized. We aimed to identify the impact of IBD on hospital outcomes in patients admitted for acute ischemic stroke (AIS). This is a retrospective cohort study utilizing the 2017 National Inpatient Sample. We identified all adult patients with a principal diagnosis of AIS and compared those with a concurrent diagnosis of IBD to those without—subgrouped by ulcerative colitis (UC) and Crohn’s disease (CD). Outcomes were mortality and healthcare usage among IBD patients with AIS. Multivariate analysis was used to control for confounders. Analyses were performed using STATA. Five hundred twenty-four thousand and forty-five patients were admitted for AIS in 2017; of them 2200 (0.41%) had a concurrent diagnosis of IBD. The presence of IBD did not significantly affect in-hospital mortality (4.09% vs. 4.01%) among patients admitted for AIS [OR 1.07 95% CI: 0.65–1.76], with similar findings upon subgroup analysis of UC [OR 0.91, 95% CI: 0.39–2.09] and CD [OR 1.17, 95% CI: 0.62–2.19]. Mean hospital length of stay and charges/costs in AIS were similar irrespective of IBD. UC and CD do not appear to be associated with a higher risk of mortality or increased healthcare usage in AIS. AIS risk assessment in patients with IBD is important but should be done in a similar fashion to the general population.

Background & Aims This study compared the effectiveness of the Specific Carbohydrate Diet (SCD) to the Mediterranean diet (MD) as treatment for Crohn's disease (CD) with mild to moderate symptoms. Methods Adult patients with CD and with mild-to-moderate symptoms were randomly assigned 1:1 to consume the MD or SCD for 12 weeks. For the first 6 weeks, participants received prepared meals and snacks according to their assigned diet. After 6 weeks, participants were instructed to follow the diet independently. The primary outcome was symptomatic remission at week 6. Key secondary outcomes at week 6 included fecal calprotectin (FC) response (FC 50% among those with baseline FC >250 μg/g) and C-reactive protein (CRP) response (high-sensitivity CRP 50% reduction from baseline among those with high-sensitivity CRP >5 mg/L). Results The study randomized 194 patients, and 191 were included in the efficacy analyses. The percentage of participants who achieved symptomatic remission at week 6 was not superior with the SCD (SCD, 46.5%; MD, 43.5%; P = .77). FC response was achieved in 8 of 23 participants (34.8%) with the SCD and in 4 of 13 participants (30.8%) with the MD (P = .83). CRP response was achieved in 2 of 37 participants (5.4%) with the SCD and in 1 of 28 participants (3.6%) with the MD (P = .68). Conclusions The SCD was not superior to the MD to achieve symptomatic remission, FC response, and CRP response. CRP response was uncommon. Given these results, the greater ease of following the MD and other health benefits associated with the MD, the MD may be preferred to the SCD for most patients with CD with mild to moderate symptoms. ClinicalTrials.gov Identifier: NCT03058679

Healthcare maintenance in inflammatory bowel disease refers to the ongoing health promotion and preventive care that are implemented while managing patients with this chronic illness. In addition to consolidating information about ongoing conventional treatments, queries should involve the domains of complementary medicine and quality of life given the complex nature of this disease. These patients are particularly at increased risk for infection, malignancy, malnutrition, mental illness, and bone disease. Despite its importance, these services are not delivered at the same rates when compared to the general population. Uncertainty around “ownership” of the patient by the primary care provider, anxiety surrounding safety of health maintenance interventions such as vaccination among immunosuppressed populations, and reimbursement concerns contribute to this gap in care. This chapter aims to be a useful primer, for primary care physicians and gastroenterologists, on the value of healthcare maintenance interventions. In addition, we will highlight practical strategies to enable implementation into practice.

The Inflammatory Bowel Disease (IBD) population, which may require treatment with immunosuppressive medications, may be uniquely vulnerable to COVID-19 infection. In fact, there is some evidence these medications may inhibit the cytokine storm that is theorized to cause a rapid decline seen in COVID-19. In addition, the digestive symptoms of COVID-19 can be difficult to distinguish from the activation of IBD. We present an interesting case of a Crohn’s patient inadvertently administering anti-cytokine therapy during the pre-symptomatic period of COVID-19 infection. Immune suppression during early infection with SARS-COV2 risks a poor immune response to the virus and could theoretically result in a more severe course of infection.

Data regarding hospitalization outcomes in patients with inflammatory bowel disease (IBD) with respect to hospital teaching status are largely unknown. We aimed to investigate the impact of hospital teaching status on IBD hospitalization outcomes. In this retrospective analysis, we queried the 2016 and 2017 National Inpatient Sample (NIS) databases using the International Classification of Diseases 10th revision (ICD-10) coding system. All adult patients with a principal diagnosis of IBD were included. We stratified the IBD group into ulcerative colitis (UC), Crohn’s disease (CD), and complicated IBD. Our primary outcome was mortality. Statistical analysis was performed using STATA, version 16.0. Of the 189,950 adult patients with IBD, the majority were admitted to teaching hospitals (70.9%). There was no significant difference in mortality based upon hospital teaching status (aOR 1.18, p = 0.48); however, these patients had an increased mean length of stay (adjusted coefficient: 0.82, p

Studies examining the mortality risk of inflammatory bowel disease (IBD) have yielded conflicting results, and most do not account for recent advancements made in the treatment of Crohn’s disease (CD) and ulcerative colitis (UC). We aim to assess the overall, premature, and cause-specific mortality in IBD patients over a 17-year time period and to evaluate any differences since the introduction of biologic therapy. A death record case–control study was performed to explore the odds of premature death (before age 65) and all-cause mortality among those with IBD. Cases consisted of IBD patients (1,129 with CD and 841 with UC) who died in New York State (NYS) from 1993 to 2010. Controls (n = 7880) were matched 4:1 on the basis of sex and zip code from those who died in NYS in the same time frame, without an IBD diagnosis. Compared with matched controls, those with CD (OR 1.56, CI 95% 1.34–1.82), but not UC (OR 0.72, CI 95% 0.59–0.89), were more likely to die prematurely. Both those with UC and CD were more likely to die from a gastrointestinal cause (CD OR 15.28, 95% CI 12.11–19.27; UC OR 14.02, 95% CI 10.76–18.26). There was no difference in the cause or age of death before and after the introduction of anti-TNF agents in those with IBD. Both CD and UC cases were more likely to die of a gastrointestinal etiology, and CD patients were more likely to die prematurely. There was no significant difference in the premature death, average age of death, and cause of death in this IBD population after the availability of anti-TNF therapy.

The COVID-19 pandemic seemingly is peaking now in New York City and has triggered significant changes to the standard management of gastrointestinal diseases. Priorities such as minimizing viral transmission, preserving personal protective equipment, and freeing hospital beds have driven unconventional approaches to managing gastroenterology (GI) patients. Conversion of endoscopy units to COVID units and redeployment of GI fellows and faculty has profoundly changed the profile of most GI services. Meanwhile, consult and procedural volumes have been reduced drastically. In this review, we share our collective experiences regarding how we have changed our practice of medicine in response to the COVID surge. Although we review our management of specific consults and conditions, the overarching theme focuses primarily on noninvasive measures and maximizing medical therapies. Endoscopic procedures have been reserved for those timely interventions that are most likely to be therapeutic. The role of multidisciplinary discussion, although always important, now has become critical. The support of our faculty and trainees remains essential. Local leadership can encourage well-being by frequent team check-ins and by fostering trainee development through remote learning. Advancing a clear vision and a transparent process for how to organize and triage care in the recovery phase will allow for a smooth transition to our new normal.

Background We quantified loss of response (LOR) to vedolizumab (VDZ) in clinical practice and assessed the effectiveness of VDZ dose intensification for managing LOR. Methods Retrospective review (May 2014–December 2016) of a prospectively maintained inflammatory bowel disease (IBD) registry. Kaplan-Meier estimates were used to determine rates of LOR to VDZ . Independent predictors of LOR were identified using univariate and multivariable Cox proportional hazard regression. Success of recapturing response (>50% reduction in symptoms from baseline) and remission (complete resolution of symptoms) after dose intensification was quantified. Results Cumulative rates for VDZ LOR were 20% at 6 months and 35% at 12 months, with slightly lower rates in Crohn’s disease than in ulcerative colitis (6 months 15% vs 18% and 12 months 30% vs 39%, P = 0.03). On multivariable analysis, LOR to a tumor necrosis factor (TNF) antagonist before VDZ use was associated with an increased risk for LOR to VDZ [hazard ratio (HR) 1.93; 95% confidence interval (CI) 1.25–2.97] in all patients. For Crohn’s disease patients specifically, higher baseline C-reactive protein concentration was associated with increased risk for LOR to VDZ (HR 1.01 per mg/dL increase, 95% CI 1.01–1.02). Shortening of VDZ infusion interval from 8 to every 4 or 6 weeks recaptured response in 49% and remission in 18% of patients. Conclusions LOR to a TNF antagonist before VDZ use and higher baseline C-reactive protein are important predictors of VDZ LOR. Treatment response can be recaptured in almost half of these patients with VDZ infusion interval shortening.

Background Crohn's disease (CD) following bariatric surgery has been previously described. It is not clear whether the clinical entity is due to rapid metabolism of fat, change in the bacterial milieu of the bowel, the loss of defense mechanisms of the stomach, or even a coincidence. Objectives To present observations which might serve to sort out these various etiologies. Design We present 5 cases of colitis, ileocolitis or enteritis, some with fistula formation, with clinical onset following bariatric surgery and add these to the 7 cases previously identified as CD reported elsewhere. We provide the clinical features of these 12 cases to reconcile with causative mechanisms. Limitations It remains possible that the onset of CD (or other inflammatory bowel disease) precedes the bariatric surgery which then accelerates the clinical manifestations described. Furthermore, without controls the association could remain a coincidence. Conclusions We review the evidence for release of proinflammatory cells and cytokines contained in fat following the bariatric surgery, and also consider the roles that the surgical resection of stomach and shortening of the bowel may also bring about this syndrome. The earlier onset is more likely due to surgical loss of defenses of the stomach and the later onset to a metabolic alteration of the presurgical obesity, involving fat metabolism, and/or the microbiome. The role of characteristic creeping fat of CD is also addressed.

Introduction: Successful recovery from the COVID-19 pandemic relies on widespread vaccine acceptance. While uptake has improved over recent months, hesitancy and skepticism persist, including in populations who could most benefit from vaccination such as the elderly, chronically ill or those on immunosuppressants. This survey study aims to characterize attributes that correlate and possibly determine vaccine intent or hesitancy among our IBD population. Methods: Subjects were invited to participate in a web-based survey using a patient database from an academic IBD clinic. Survey questions covered disease history, medications, changes to medications and disease management during the COVID-19 pandemic, as well as social, economic, and household characteristics. Positive vaccine intent was defined as having either received a COVID-19 vaccine or planning to do so when it would become available for the participant's age group. Vaccine hesitancy was defined as not having received any portion of a COVID-19 vaccine and not intending to do so. Chi square and logistic binomial regression analysis was performed using SPSS. Results: Of 609 patients invited, 278 (45.6%) completed the survey. 234 (84.2%) had positive vaccine intent;44 (15.8%) were vaccine hesitant. Significant factors are highlighted in Table 1 and were almost exclusively socio-economic. Positive vaccine intent associated variables included college education or above (OR 2.5, p .026), annual income over $150,000 (OR 3.295, p .015), Democratic affiliation (OR 7.193, p

INTRODUCTION: Gastric pneumatosis, the presence of intramural gas in the stomach, is a rare but alarming radiographic finding Gastric emphysema (GE) and emphysematous gastritis remain the two most important differential diagnoses of gastric pneumatosis, both differing vastly in their management and prognosis Due to these differences, it is essential to reach an accurate clinical diagnosis early Here we describe the case of a young male with GE due to severe gastroparesis from uncontrolled diabetes CASE DESCRIPTION/METHODS: A 36 year-old COVID-19 positive male with a history of uncontrolled Type 1 Diabetes, Hepatitis C, and Hirschsprung disease presented with generalized weakness, fatigue, polyuria, and polydipsia for two days Laboratory work revealed diabetic ketoacidosis which improved with intravenous (IV) fluids and insulin However, his course was complicated by persistent nausea, inability to tolerate oral diet, abdominal distension, and worsening leukocytosis Computed Tomography (CT) of the abdomen demonstrated a markedly distended stomach containing air and undigested food, air in the gastric wall, gas and thrombus in the left portal vein, and pancolitis He remained afebrile, hemodynamically stable with negative blood cultures and was initially treated conservatively with fluconazole and piperacillin-tazobactam, nasogastric suction and supportive care Repeat CT of the abdomen two days later showed improvement in gastric pneumatosis and portal venous gas Subsequent EGD revealed retained gastric contents, an open pylorus, and large necroticappearing ulcerations extending most of the lesser curvature and fundus of the stomach These findings were consistent with GE, likely a chronic issue from longstanding gastroparesis However microvascular thrombi related to COVID remain on the differential as there is a known propensity for a procoagulable state in these patients DISCUSSION: GE can be due to an increase in intraluminal pressure or mucosal injury that leads to intramural gas formation In our patient, we suspect his GE was due to uncontrolled diabetes, causing severe gastroparesis and gastric wall distention GE is benign and managed with observation and conservative treatment Comparatively emphysematous gastritis is often associated with systemic toxicity, is potentially fatal, and often requires more aggressive therapy including surgery As in the majority of GE cases, our patient's symptoms improved with conservative treatment and follow-up imaging revealed interval improvement

INTRODUCTION: COVID-19 is now a global pandemic and immunosuppression is widely suspected to be a risk factor for more severe outcomes We present a worst-case scenario of COVID-19 establishing itself at the time of maintenance administration of anti-TNF therapy in a patient CASE DESCRIPTION/METHODS: The patient is a 60-year-old female with a history of Rheumatoid Arthritis, Systemic Lupus Erythematosus, and ileocolonic inflammatory Crohn's disease in remission on weekly adalimumab and methotrexate She presented to the emergency department (ED) with one day of fevers and generalized myalgias and was discharged home with a diagnosis of influenza-like illness She was asked to quarantine pending COVID-19 test results, which returned positive three days later Her last dose of adalimumab was administered 5 days prior and methotrexate 7 days prior The next day she developed gastrointestinal symptoms including diarrhea, nausea, emesis, and abdominal cramping, not consistent with her usual Crohn's flares She also noted new onset shortness of breath and returned to the ED Vitals were Tmax 101 1F, BP 152/80, HR 109, RR 17, O2 Sat 99% on room air CT scan of chest and abdomen revealed patchy lung consolidations, and colitis in the proximal sigmoid colon Clostridium difficile stool test was negative, fecal calprotectin was normal at 19 She was treated with our COVID-19 hospitalization protocol, which consisted of hydroxychloroquine, azithromycin, and ascorbic acid Supplemental oxygen was required for two days She defervesced after day 4 of hospitalization and was discharged after day 5 DISCUSSION: This case provides some of the details in regard to timing of infection and administration of immunosuppressive therapy Theoretically, immunosuppressed inflammatory bowel disease (IBD) patients are at the highest risk for morbidity and mortality from COVID-19 SARSCoV- 2 has an average incubation period of five days, we estimate our patient administered adalimumab and methotrexate during the pre-symptomatic post infection period (Figure 2) Although we expected her condition would deteriorate, within two days she improved with interventions recently shown to have no benefit in the treatment of COVID-19 We hypothesize that the adalimumab may have interfered with COVID-19's aberrant immune response, leading to a less severe disease course We are hopeful this case and additional outcomes studies will help clarify concerns about immunosuppressed populations during the pandemic

Background Direct comparisons are lacking between vedolizumab and tumour necrosis factor (TNF)-antagonist therapy in Crohn's disease (CD). Aim To compare safety and effectiveness of vedolizumab and TNF-antagonist therapy in adult CD patients. Methods Retrospective observational cohort (May 2014-December 2017) propensity score-weighted comparison of vedolizumab vs TNF-antagonist therapy (infliximab, adalimumab, certolizumab) in CD. Propensity scores were weighted for age, prior treatments, disease complications, extent and severity, steroid dependence, and concomitant immunosuppressive drug use. The primary outcome was comparative risk for infections or non-infectious serious adverse events (requiring antibiotics, antivirals, antifungals, hospitalisation, or treatment discontinuation, or resulting in death). Secondary comparative effectiveness outcomes were clinical remission (resolution of CD-related symptoms), steroid-free clinical remission and endoscopic remission (absence of ulcers/erosions). Results We included 1266 patients (n = 659 vedolizumab). Rates of non-infectious serious adverse events (odds ratio [OR] 0.072, 95% confidence interval [CI] 0.012-0.242), but not serious infections (OR 1.183, 95% CI 0.786-1.795), were significantly lower with vedolizumab vs TNF-antagonist therapy. Safety comparisons for non-infectious serious adverse events remained significant after adjusting for differences in duration of exposure. No significant difference was observed between vedolizumab and TNF-antagonist therapy for clinical remission (hazard ratio [HR] 0.932, 95% CI 0.707-1.228), steroid-free clinical remission (HR 1.250, 95% CI 0.677-2.310) or endoscopic remission (HR 0.827, 95% CI 0.595-1.151). TNF-antagonist therapy was associated with higher treatment persistence compared with vedolizumab. Conclusions There was a lower risk of non-infectious serious adverse events, but not serious infections, with vedolizumab vs TNF-antagonist therapy, with no significant difference for achieving disease remission.

We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD).Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively.We included 212 patients with moderate-severe CD (median age 34 years; 40% male; 90% tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25-53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35%, 63%, and 26%, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95% confidence interval (CI): 0.20-0.81), smoking history (HR 0.47; 95% CI: 0.25-0.89), active perianal disease (HR 0.49; 95% CI: 0.27-0.88), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95% CI: 0.12-0.73), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF).VDZ is a safe and effective treatment option for moderate-severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.

Background & aimsWe created and validated a clinical decision support tool (CDST) to predict outcomes of vedolizumab therapy for ulcerative colitis (UC).MethodsWe performed logistic regression analyses of data from the GEMINI 1 trial, from 620 patients with UC who received vedolizumab induction and maintenance therapy (derivation cohort), to identify factors associated with corticosteroid-free remission (full Mayo score of 2 or less, no subscore above 1). We used these factors to develop a model to predict outcomes of treatment, which we called the vedolizumab CDST. We evaluated the correlation between exposure and efficacy. We validated the CDST in using data from 199 patients treated with vedolizumab in routine practice in the United States from May 2014 through December2017.ResultsAbsence of exposure to a tumor necrosis factor (TNF) antagonist (+3 points), disease duration of 2 y or more (+3 points), baseline endoscopic activity (moderate vs severe) (+2 points), and baseline albumin concentration (+0.65 points per 1 g/L) were independently associated with corticosteroid-free remission during vedolizumab therapy. Patients in the derivation and validation cohorts were assigned to groups of low (CDST score, 26 points or less), intermediate (CDST score, 27-32 points), or high (CDST score, 33 points or more) probability of vedolizumab response. We observed a statistically significant linear relationship between probability group and efficacy (area under the receiver operating characteristic curve, 0.65), as well as drug exposure (P < .001) in the derivation cohort. In the validation cohort, a cutoff value of 26 points identified patients who did not respond to vedolizumab with high sensitivity (93%); only the low and intermediate probability groups benefited from reducing intervals of vedolizumab administration due to lack of response (P = .02). The vedolizumab CDST did not identify patients with corticosteroid-free remission during TNF antagonist therapy.ConclusionsWe used data from a trial of patients with UC to develop a scoring system, called the CDST, which identified patients most likely to enter corticosteroid-free remission during vedolizumab therapy, but not anti-TNF therapy. We validated the vedolizumab CDST in a separate cohort of patients in clinical practice. The CDST identified patients most likely to benefited from reducing intervals of vedolizumab administration due to lack of initial response. ClinicalTrials.gov no: NCT00783718.

Background Clostridium difficile infection (CDI) is common in patients with inflammatory bowel disease (IBD), often leading to diagnostic confusion and delays in IBD therapy escalation. This study sought to assess outcomes after CDI in IBD patients exposed to new or escalated immunosuppressive therapy. Methods This multicenter retrospective cohort study included IBD patients with documented CDI at 4 academic medical centers. Data were abstracted from clinical databases at each institution. Outcomes at 30 and 90 days were compared between patients undergoing new or intensified immunosuppressive therapy and those without therapy escalation. Continuous variables were compared using t tests, and proportions using chi-square tests. Multivariable logistic regression was used to determine the association of individual variables with severe outcomes (including death, sepsis, and/or colectomy) within 90 days. Secondary outcomes included CDI recurrence, rehospitalization, worsening of IBD, and severe outcomes within 30 days. Results A total of 207 adult patients with IBD and CDI were included, of whom 62 underwent escalation to biologic or corticosteroid therapy (median time to escalation, 13 days). Severe outcomes within 90 days occurred in 21 (15.6%) nonescalated and 1 (1.8%) therapy-escalated patients. Serum albumin 2.2 mg/dL, intensive care unit admission, hypotension, and comorbid disease were associated with severe outcomes. Likelihood of severe outcomes was decreased in patients undergoing escalation of IBD therapy after CDI (adjusted odds ratio [aOR], 0.12) and increased among patients aged >65 years (aOR, 4.55). Conclusions Therapy escalation for IBD within 90 days of CDI was not associated with worse clinical outcomes. Initiation of immunosuppression for active IBD may therefore be appropriate in carefully selected patients after treatment of CDI.

Patients with ulcerative colitis, a high-risk group for the development of colon cancer, undergo colonoscopy more frequently than the general population. This increase in endoscopic evaluation also exposes these patients to an increased risk of complications, including iatrogenic perforation. Our survey study aims to determine factors that affect the management choices for iatrogenic perforations for ulcerative colitis patients in remission and identify areas of consensus among general gastroenterologists, inflammatory bowel disease specialists, and colorectal surgeons. An anonymous, cross-sectional survey was performed using an online platform. A matrix questionnaire posed five clinical scenarios with six management options for an iatrogenic perforation in ulcerative colitis patients with varying disease distribution, disease activity, and maintenance regimens. One hundred thirty-eight general gastroenterologists, 35 inflammatory bowel disease specialists, and 174 colorectal surgeons responded to the survey; 47, 41, and 23%, respectively, answered they did not feel comfortable managing perforations in ulcerative colitis patients in remission. We found the greatest concordance among gastroenterologists and colorectal surgeons in cases of perforation in ulcerative colitis with a history of dysplasia; the majority of respondents chose staged total proctocolectomy with ileal pouch anal anastomosis. We found discordance in decision making for ulcerative colitis in remission without dysplasia, with perforation occurring in colitis involved and uninvolved areas. Our survey revealed that a significant fraction of gastroenterologists and colorectal surgeons are uncomfortable managing iatrogenic colonic perforations in ulcerative colitis patients. We have identified knowledge and practice gaps in defining the optimal management of iatrogenic perforations in ulcerative colitis patients.

There is significant interest among patients and providers in using cannabis (marijuana) and its derivatives to treat a number of chronic illnesses, including inflammatory bowel disease. Despite the Schedule I classification of cannabis by the federal government, state governments have sought ways to make cannabis available for specific medical conditions, and some states have legalized cannabis outright. This white paper summarizes the preclinical data, clinical data, safety data, and the regulatory landscape as they apply to medical cannabis use in inflammatory bowel disease. Animal models of cannabinoid chemistry and physiology give evidence of anti-inflammatory, antidiarrheal, and nociceptive-limiting properties. Human studies have found benefit in controlling symptoms and improving quality of life, but no studies have established true disease modification given the absent improvement in biomarker profiles or endoscopic healing. Finally, this review describes the legal, regulatory, and practical hurdles to studying the risks and benefits of medical cannabis in the United States. 10.1093/ibd/izy319_video1 izy319.video1 5852852028001

Background & Aims As more treatment options for inflammatory bowel diseases become available, it is important to identify patients most likely to respond to different therapies. We created and validated a scoring system to identify patients with Crohn’s disease (CD) who respond to vedolizumab. Methods We collected data from the GEMINI 2 phase 3 trial of patients with active CD treated with vedolizumab for 26 weeks (n = 814) and performed logistic regression analysis to identify factors associated with clinical, steroid-free, and durable remission (derivation set). We used these data to develop a clinical decision support tool, which we validated using data from 366 participants in a separate clinical practice observational cohort of patients with active CD treated with vedolizumab for 26 weeks (the VICTORY cohort). We evaluated the ability of this tool to identify patients in clinical remission or corticosteroid-free remission, or those with mucosal healing (MH), clinical remission with MH, or corticosteroid-free remission with MH after vedolizumab therapy using receiver operating characteristic area under the curve (AUC) analyses. The primary outcome was to develop and validate a list of factors associated with achieving remission by vedolizumab in patients with active CD. Results In the derivation analysis, we identified absence of previous treatment with a tumor necrosis factor antagonist (+3 points), absence of prior bowel surgery (+2 points), absence of prior fistulizing disease (+2 points), baseline level of albumin (+0.4 points per g/L), and baseline concentration of C-reactive protein (reduction of 0.5 points for values between 3.0 and 10.0 mg/L and 3.0 points for values >10.0 mg/L) as factors associated with remission. In the validation set, our model identified patients in clinical remission with an AUC of 0.67, patients in corticosteroid-free remission with an AUC of 0.66, patients with MH with an AUC of 0.72, patients in clinical remission with MH with an AUC of 0.73, and patients in corticosteroid-free clinical remission with MH with an AUC of 0.75. A cutoff value of 13 points identified patients in clinical remission after vedolizumab therapy with 92% sensitivity, patients in corticosteroid-free remission with 94% sensitivity, patients with MH with 98% sensitivity, patients with clinical remission and MH with 100% sensitivity, and patients with corticosteroid-free clinical remission with MH with 100% sensitivity. Conclusions We developed and validated a scoring system to identify patients with CD most likely to respond to 26 weeks of vedolizumab therapy. Further studies are needed to optimize its accuracy in select populations and determine its cost-effectiveness.