Faculty Bibliography

BACKGROUND:We aimed to characterize patients with inflammatory bowel disease (IBD) and novel coronavirus disease 2019 (COVID-19). METHODS:We performed a case series of patients with IBD and confirmed or highly suspected COVID-19 to assess rates of severe outcomes. RESULTS:We identified 83 patients with IBD with confirmed (54%) or highly suspected (46%) COVID-19. The overall hospitalization rate was 6%, generally comprising patients with active Crohn's disease or older men with comorbidities, and 1 patient expired. DISCUSSION/CONCLUSIONS:In this series of patients with IBD, severe outcomes of COVID-19 were rare and comparable to similarly aged individuals in the general population.

Background: Ustekinumab has been recently approved for the treatment of moderately to severely active ulcerative colitis (UC). The registry trials for ustekinumab in UC demonstrated efficacy and safety, but data on real-world outcomes are limited. We describe the effectiveness and safety of ustekinumab in patients with UC from 2 US tertiary inflammatory bowel disease centers. Methods: Patients with moderately to severely active UC treated with ustekinumab at NYU Langone Health (New York, New York) and University of Chicago Medical Center (Chicago, Illinois) between January 2016 and March 2020 were retrospectively included. The primary outcome was clinical remission at 3 and 12 months, defined as a partial Mayo score of ≤2, with a combined rectal bleeding and stool frequency subscore of ≤1. Results: Sixty-six UC patients were included. Ninety-two percent of patients had prior exposure to biologics or tofacitinib. Forty-three percent and 45% of patients achieved clinical remission by 3 and 12 months, respectively. Anti-TNF nonresponse and endoscopic Mayo score of 3 were negative predictors of clinical remission. Thirty-three percent of those followed for a year achieved concurrent endoscopic and histologic healing, which was significantly associated with lower partial Mayo score (P < 0.01) and lower stool frequency (P = 0.02). Serious adverse events occurred in 4 (6%) patients (3 UC exacerbations, 1 vasculitis). Conclusions: In this cohort of mostly biologic-refractory UC patients, treatment with ustekinumab achieved remission in nearly half of them at 12 months, and was associated with an overall favorable safety profile. These results are modestly better than the pivotal trials.

INTRODUCTION: The outbreak of novel severe acute respiratory virus syndrome coronavirus 2 (SARS-CoV 2), the causative virus of coronavirus disease 2019 (COVID-19), has become a global pandemic. In the United States, cases exceed 2 million, with the New York City (NYC) metropolitan area at the epicenter. Patients with inflammatory bowel disease (IBD) are generally considered higher risk of infection due to immunosuppressive therapies, however, data are lacking regarding outcomes of COVID-19 in patients with IBD compared to the general population. We aim to investigate the impact of IBD on COVID-19 outcomes.
METHOD(S): We prospectively collected data on all patients with IBD [Crohn's disease (CD), ulcerative colitis (UC)] with confirmed or highly suspected COVID-19 (fever and/or close contact plus respiratory symptoms) and all non-IBD patients with confirmed COVID-19 from March 3 to May 10, 2020 at an academic medical center in NYC. Patient demographics, co-morbidities, and medication history were recorded. The endpoints were severe outcomes of COVID-19, including hospitalization, ventilator requirement, ICU admission and death. Adjusted analyses were performed for predictors of a composite endpoint of ventilator, ICU and death.
RESULT(S): We identified 83 patients with IBD [CD (n = 56, 67%) or UC (n = 27, 33%)] with confirmed or suspected COVID-19 and 8277 non-IBD patients with confirmed COVID-19 (Table 1). IBD patients had a lower median age (34 vs. 53 years; P < 0.001) and a higher proportion of Caucasians (69% vs. 41%; P < 0.001). IBD patients were less likely to have any co-morbidity (29% vs. 52%; P < 0.001), and had higher rates of immunomodulator (IMM) or biologic use. IBD patients with confirmed COVID-19 had lower rates of hospitalizations (14% vs. 51%; P < 0.001) and ICU admissions (2% vs. 13%; P = 0.04; Table 2). On multivariable analysis restricted to confirmed COVID-19, the presence of IBD was not associated with severe outcomes (OR 0.55, 95% CI 0.12-2.44, P = 0.43). Age, male gender, number of comorbidities, thiopurine and steroid use were significant predictors of severe COVID-19 outcomes, while TNF-antagonists had a protective effect (Table 3).
CONCLUSION(S): In this large cohort study, IBD was not a risk factor for severe outcomes of COVID-19. Age, co-morbidities, and exposure to thiopurines and steroids were associated with severe outcomes of COVID-19. TNF-antagonists may be protective from severe outcomes of COVID-19, but this requires further study

INTRODUCTION: Ustekinumab has been recently approved for the treatment of moderately to severely active ulcerative colitis (UC). The registry trials for ustekinumab in UC demonstrated efficacy and safety, but data on the effectiveness and safety in the real world are limited. We describe the effectiveness and safety of ustekinumab in patients with UC from two US tertiary IBD centers.
METHOD(S): Patients with moderately to severely active UC treated with ustekinumab at NYU Langone Medical Center (New York, NY) and University of Chicago Medical Center (Chicago, IL) between January 2016 and March 2020 were retrospectively included. The primary outcome was clinical remission at 3 and 12 months, defined as a partial Mayo score of 2, with a combined rectal bleeding and stool frequency subscore of #1.
RESULT(S): Sixty-six UC patients were included (Table 1). 61% of patients had extensive colitis and overall mean total Mayo score was 6.5 +/- 2.4. 92% of patients had prior exposure to biologics or tofacitinib. 43% and 45% of patients achieved clinical remission by 3 and 12 months, respectively (Figure 1). Anti-TNF non-response and endoscopic Mayo score of 3 were negative predictors of clinical remission at 3 months (Table 2). At 1 year, 50% of patients achieved endoscopic remission and 33% achieved mucosal and histo-endoscopic healing. The achievement of histo-endoscopic healing was significantly associated with lower partial Mayo score (0.5 +/- 0.6 vs. 3.5 +/- 1.7; P < 0.01) and lower stool frequency (0.3 +/- 0.5 vs. 1.4 +/- 0.7; P = 0.02). Serious adverse events occurred in 4 (6%) patients (3 UC exacerbations, 1 vasculitis).
CONCLUSION(S): In this cohort of mostly biologic-refractory UC patients, treatment with usteki-numab achieved remission in nearly half of them at 12 months, and was associated with an overall favorable safety profile. These results are modestly better than the pivotal trials

PURPOSE/OBJECTIVE:For more than half of Crohn's disease patients, strictures will cause bowel obstructions that require surgery within 10 years of their initial diagnosis. This study utilizes computed tomography imaging and clinical data obtained at the initial emergency room visit to create a prediction model for progression to surgery in Crohn's disease patients with acute small bowel obstructions. METHODS:A retrospective chart review was performed for patients who presented to the emergency room with an ICD-10 diagnosis for Crohn's disease and visit diagnosis of small bowel obstruction. Two expert abdominal radiologists evaluated the CT scans for bowel wall thickness, maximal and minimal luminal diameters, length of diseased segment, passage of oral contrast, evidence of penetrating disease, bowel wall hyperenhancement or stratification, presence of a comb sign, fat hypertrophy, and small bowel feces sign. The primary outcome was progression to surgery within 6 months of presentation. The secondary outcome was time to readmission. RESULTS:Forty patients met the inclusion criteria, with 78% receiving medical treatment alone and 22% undergoing surgery within 6 months of presentation to the emergency room. Multivariable analysis produced a model with an AUC of 92% (95% CI 0.82-1.00), 78% sensitivity, and 97% specificity, using gender, body mass index, and the radiographic features of segment length, penetrating disease, and bowel wall hyperenhancement. CONCLUSIONS:The model demonstrates that routine clinical and radiographic data from an emergency room visit can predict progression to surgery, and has the potential to risk stratify patients, guide management in the acute setting, and predict readmission.

BACKGROUND:As treatments, management strategies, and the role of advanced practice providers (APPs) have evolved in recent years, the Crohn's & Colitis Foundation sought to understand the educational and resource needs of clinicians caring for patients with inflammatory bowel diseases (IBDs). The aim of this study was to describe the self-identified IBD knowledge and resource gaps of clinicians to inform the development of future programming. METHODS:A survey containing 19 questions created by the foundation's Professional Education Committee, a subset of its National Scientific Advisory Committee, was conducted from September 7, 2018 to October 15, 2018. Responses were included from providers if they were currently seeing any IBD patients in a clinical setting. The foundation distributed the survey by email and various social media channels to encourage a diverse response. The survey included questions on comfort levels around diagnosis, treatment, and management of patients with IBD, in addition to preferences and utilization of educational resources. The × 2 test was used to evaluate significant differences among respondents in the various domains surveyed. RESULTS:There were 197 eligible responses, of which 75% were from MD/Dos, followed by 25% APN/PA/RN/MSN/PhD/other; and 70% of respondents provide care for adult patients. The amount of time in practice was divided evenly among respondents. Fifty-seven percent of respondents practice in an academic/university setting, and approximately 75% indicated that ≥21% of their practice consisted of patients with IBD. Forty-four percent and 46% of respondents reported access to IBD based mental health providers and social workers in their practice, respectively. Seventy-two percent reported access to radiologists, 69% had access to dietitians, and 62% had access to advance practice providers. The areas of greatest educational need were prescribing medical cannabis (if approved locally) for pain management (62%); caring for patients with prior malignancy (35%); caring for pregnant patients and family planning (33%); caring for elderly patients (30%); and therapy decisions, including use of JAK inhibitors (29%), drug holidays (25%), and use of biosimilars (24%). More than 50% of respondents stated they do not participate in shared decision-making, citing time as the most common limiting factor. The majority of providers cited live education as their preferred learning format, and they wish to earn continuing medical education (CME) hours. CONCLUSION/CONCLUSIONS:This survey helped identify current IBD educational needs in our professional community. With a rapidly changing treatment landscape and an increase in the diversity of providers delivering care, additional opportunities to keep abreast of practice changes are critical to providing comprehensive, quality care in IBD. Our survey demonstrated that shared decision-making is underutilized in practice due to a need for resources that aid in its efficient integration into practice. Based on our results, a focus on creating live learning opportunities that offer CME are needed in the areas of therapeutic decision-making and treating IBD in special subsets (eg, prior malignancy, pregnancy, elderly).

INTRODUCTION: Cytomegalovirus (CMV) primarily affects immunocompromised patients, and has multiple manifestations in the gastrointestinal (GI) tract. The incidence of CMV-related GI disease has decreased since the advent of antiretroviral therapy (ART) for HIV. This, along with varied and nonspecific symptoms, makes it difficult to diagnose. CASE DESCRIPTION/METHODS: We report a 34-year-old man with AIDS (CD4 count 114 cells/muL) on ART presenting with five days of fevers. He was admitted to the ICU for sepsis and stabilized. His course was complicated by pulmonary embolism, recurrent fevers, and development of biopsy proven pyoderma gangrenosum. He also reported odynophagia, and was empirically treated for candida esophagitis with fluconazole. On hospital day 37, he developed massive hematochezia. An urgent esophagogastroduodenoscopy (EGD) did not reveal the source of bleeding, but showed a 5-cm linear esophageal scar, which appeared to be a healing tear. Sigmoidoscopy revealed a solitary rectal ulcer with a visible vessel, which was clipped for hemostasis. His bleeding resolved. The patient's odynophagia persisted, significantly limiting his ability to tolerate oral intake. Repeat EGD revealed a large, cratered, non-bleeding esophageal ulcer which was biopsied. The same day, the patient developed hematochezia; repeat sigmoidoscopy showed a deeply cratered rectal ulcer with a visible vessel successfully treated with hemostatic clips. Esophageal biopsies returned positive for CMV; valganciclovir was initiated. His odynophagia improved after starting treatment and he had no further GI bleeding. Given the clinical response, the rectal ulcers were presumed to be due to CMV, making this a case of extensive CMV-related GI disease. DISCUSSION: This is a case of extensive CMV-related GI disease which eluded diagnosis during a prolonged and complicated hospitalization. CMV-related GI disease has varied presentations, most commonly affecting the esophagus, but has also been noted to manifest with gastritis, duodenitis, pancreatitis, and colitis. The most common endoscopic findings for esophageal involvement are discrete, shallow, punched-out ulcers surrounded by normal appearing mucosa. Clinical manifestations of colonic CMV include abdominal pain and diarrhea, while discrete ulceration causing bleeding is less commonly reported. This case highlights the importance of a high index of suspicion for CMV in immunocompromised patients with multiple, unexplained GI symptoms to avoid a delay in diagnosis and management. (Figure Presented)

INTRODUCTION: Familial dysautonomia (FD) is a progressive neurogenetic disease with carrier rate as high as 1 in 18 persons in European Jews of Polish origin. Clinical hallmarks include cardiovascular instability, spinal deformities, renal dysfunction, alacrima, ataxia, and impaired nociception. Physical or emotional stress may elicit autonomic crises characterized by hypertension and vomiting. Despite profound sensory deficits, GI perturbations are frequently reported by FD patients. While the incidence of inflammatory bowel disease (IBD) and FD is unknown, concurrence is underreported given increased frequency of both diseases in Ashkenazi Jews. CASE DESCRIPTION/METHODS: We report a 33-year-old female with FD and ulcerative colitis who presented with one week of abdominal pain and bloody diarrhea. She had been maintained on balsalazide. Colonoscopy one year prior revealed endoscopic and histologic remission. On physical examination, her abdomen was tender in the lower quadrants. A CT scan revealed pancolitis. Stool studies resulted negative. Her CRP was 58.4 mg/L and albumin was 2.4 g/dL. A flexible sigmoidoscopy noted Mayo endoscopic score 3 in the rectum and CMV staining was negative. The patient was started on IV steroids. Her hospital course was complicated by ileus, parainfluenza infection, and MSSA bacteremia with a pacemaker lead vegetation, requiring extraction. Lack of optimal clinical response to treatment on hospital day five led to consideration of alternative treatments with careful attention to her underlying FD. A subtotal colectomy with end ileostomy was unfavorable due to concern for volume loss. Infliximab and cyclosporine were opposed due to infection risk and later exhibiting possible nephrotoxicity. During this discussion the patient improved enough to be transitioned to oral steroids with a plan to initiate vedolizumab as an outpatient. On recent colonoscopy she had achieved mucosal healing. DISCUSSION: This is the first case of UC in a FD patient reported. Given myriad GI symptoms in the later diagnosis it can be hard to distinguish disease-related from treatment-related events. Due to the gut-specificity of vedolizumab, infection risk is considerably reduced compared to that of other biologics and is the most favorable option in the setting of underlying FD. This case highlights the difficulty encountered when treating IBD in the setting of systemic illness and underscores the need to carefully consider management options to enhance patient outcomes. (Figure Presented)

Education in inflammatory bowel disease (IBD) varies widely between categorical gastroenterology (GI) programs and is largely related to the presence of expert clinicians, patient population, and the presence of an IBD center. The treatment of IBD is becoming increasingly complex at a rapid pace, widening this educational divide. This manuscript outlines all the current US educational offerings in IBD for GI fellows, including how to obtain supplemental education during the 3-year training period and beyond. It reviews how to assess trainee knowledge in the field of IBD and proposes 8 clinically anchored, entrustable professional activities that should help prioritize important aspects of IBD management to incorporate during categorical GI training.

BACKGROUND: According to the 2017 American College of Gastroenterology (AGA) guidelines, therapeutic drug monitoring (TDM) of drug trough concentrations and anti-drug antibodies is recommended to optimize treatment with anti-tumor necrosis factor (TNF) agents and thiopurines1. Specifically, the AGA conditionally recommends reactive TDM in patients with active symptoms of inflammatory bowel disease (IBD) while on anti-TNF agents, as such testing is crucial for differentiating between mechanistic, non-immune mediated pharmacokinetic and immune-mediated pharmacokinetic drug failure, and allows providers to appropriately tailor treatment regimens. As such algorithms for monitoring therapies in IBD have evolved, it has become incumbent on physicians caring for these patients to develop techniques to engage in patient-centered care using the technique of shared decision making. Gastroenterology (GI) trainees may not be well versed in navigating these complex interpersonal skills. The Observed Structured Clinical Examination (OSCE) is a well-validated method of assessing core competencies of communication and professionalism. While it is traditionally used at the undergraduate medical education level, it has been used at the graduate level to address disease-specific competencies. Here, we discuss the use of an OSCE to assess the performance of GI fellows in engaging in shared decision-making on the topic of TDM for a patient with complex IBD refractory to treatment.
METHOD(S): Eleven second-year gastroenterology fellows from 4 GI fellowship programs participated in a 4 station OSCE. Previously validated OSCE checklists were used to assess the fellows' performance in IBD-specific cases, one of which will be discussed here. In the "Therapeutic Drug Monitoring" case, the objective for the fellows was to discuss the indications for infliximab trough and antibody testing and how results of this testing would impact treatment based on the AGA guidelines. Checklists were scored on a 3 and 5-point Likert Scale by the Standardized Patient (SP), mapped to the appropriate ACGME milestones by a GI medical educator and normalized on a scale from 0 to 9. Post-OSCE, the fellows were surveyed to assess their perspective on their performance as well as the exam's educational value.
RESULT(S): 6 ACGME milestones were assessed in this OSCE. Scores ranged from mean of 5.85 to 7.88. Fellows scored lowest on gathering and synthesizing essential and accurate information to define each patient's clinical problem(s) (PC1, mean score 5.85) with an average score of 5.85. They scored highest for overall clinical knowledge (MK1, mean score 7.88). Overall, 9/10 (90%) of fellows would be recommended for their interpersonal skills, but only 4/10 (40%) were deemed effective in their communication skills. The majority of fellows noted improvement in their understanding of when to use and how to interpret TDM after the exercise. CONCLUSION(S): This OSCE was designed to assess clinical and communication skills for gastroenterology surrounding the complex clinical arena of therapeutic drug monitoring utilizing crucial communication skills. The results suggest weaker performance linked to gathering and synthesizing clinical information, with stronger performance in clinical knowledge, developing management plans and various communication skills. This OSCE feedback and assessment can be used to develop targeted educational interventions to strengthen clinical and communication skills for providers