The impact of COVID-19 monoclonal antibodies on clinical outcomes: A retrospective cohort study
Nagler, Arielle R; Horwitz, Leora I; Jones, Simon; Petrilli, Christopher M; Iturrate, Eduardo; Lighter, Jennifer L; Phillips, Michael; Bosworth, Brian P; Polsky, Bruce; Volpicelli, Frank M; Dapkins, Isaac; Viswanathan, Anand; FranÃ§ois, Fritz; Kalkut, Gary
DISCLAIMER/CONCLUSIONS:In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE/OBJECTIVE:Despite progress in the treatment of coronavirus disease 2019 (COVID-19), including the development of monoclonal antibodies (mAbs), more clinical data to support the use of mAbs in outpatients with COVID-19 is needed. This study is designed to determine the impact of bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab on clinical outcomes within 30 days of COVID-19 diagnosis. METHODS:A retrospective cohort study was conducted at a single academic medical center with 3 campuses in Manhattan, Brooklyn, and Long Island, NY. Patients 12 years of age or older who tested positive for COVID-19 or were treated with a COVID-19-specific therapy, including COVID-19 mAb therapies, at the study site between November 24, 2020, and May 15, 2021, were included. The primary outcomes included rates of emergency department (ED) visit, inpatient admission, intensive care unit (ICU) admission, or death within 30 days from the date of COVID-19 diagnosis. RESULTS:A total of 1,344 mAb-treated patients were propensity matched to 1,344 patients with COVID-19 patients who were not treated with mAb therapy. Within 30 days of diagnosis, among the patients who received mAb therapy, 101 (7.5%) presented to the ED and 79 (5.9%) were admitted. Among the patients who did not receive mAb therapy, 165 (12.3%) presented to the ED and 156 (11.6%) were admitted (relative risk [RR], 0.61 [95% CI, 0.50-0.75] and 0.51 [95% CI, 0.40-0.64], respectively). Four mAb patients (0.3%) and 2.64 control patients (0.2%) were admitted to the ICU (RR, 01.51; 95% CI, 0.45-5.09). Six mAb-treated patients (0.4%) and 3.37 controls (0.3%) died and/or were admitted to hospice (RR, 1.61; 95% CI, 0.54-4.83). mAb therapy in ambulatory patients with COVID-19 decreases the risk of ED presentation and hospital admission within 30 days of diagnosis.
Gastrostomy tubes in patients with COVID-19: Reduction of in-hospital mortality with a multidisciplinary team-based approach [Meeting Abstract]
Saltiel, J; Lee, B; Tran, J; Kumar, V; Grendell, J; Goodman, A; Petrilli, C; Bosworth, B; Latorre, M
Introduction: Critically-ill patients with COVID-19 often require long-term enteral access due to prolonged ventilator support and slow recovery from neurologic injury. The outcomes of hospitalized patients with SARS-CoV-2 who received gastrostomy tubes (GTs) are unknown and limited guidance exists on how to safely triage GT placement in this population. The Enteral Access Team (EAT) is a multidisciplinary team led by an attending gastroenterologist (GI) hospitalist with advanced practice providers who collaborate with Palliative Care, Geriatrics, Speech-Language Pathology, and Nutrition to reduce unnecessary feeding tube placements at the end-of-life. The EAT reviews the appropriateness of GT placement and triages each case to the indicated procedural service. The EAT's multidisciplinary approach was applied for patients with COVID-19.
Method(s): We performed a retrospective study of 135 hospitalized patients with positive PCR tests for SARS-CoV-2 who received GTs between 3/2020 and 4/2021. The GTs were placed by 3 services (gastroenterology, interventional radiology and surgery) at 3 hospitals within 1 health system in New York. One of the hospitals employed the multidisciplinary EAT approach to its triage of GT placement. Outcomes were compared between the EAT site and control sites where GT placement was decided through direct consultation by the primary team with one of the procedural services.
Result(s): Demographics for the two groups, including overall numbers of COVID-19 admissions, can be seen in Table 1. At the EAT site (n =43) 5% of patients expired prior to discharge following GT placement compared with 25% at the control sites (P <0.05). Patients at the EAT site were older with a mean age of 70 years compared to the control sites with a mean age of 63 years (P=0.01). There was no significant difference in the percentage of COVID-19 patients who received GTs, length-ofstay, or time from gastrostomy to discharge or death. Multivariable analysis showed the odds of in hospital mortality were 10.1 times greater with the standard workflow than with the EAT workflow (OR 10.1, [95% CI: 1.7-60.6], P <0.05).
Conclusion(s): The EAT's novel multidisciplinary team-based approach helps to appropriately select hospitalized patients with SARs-CoV-2 for long-term enteral access leading to reduced in-hospital mortality following GT placement. Additionally, this approach may help to mediate the national shortage of GTs and reduce the risk of exposure to providers involved in GT placement
Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials
Rolston, Vineet S; Kimmel, Jessica; Popov, Violeta; Bosworth, Brian P; Hudesman, David; Malter, Lisa B; Hong, Simon; Chang, Shannon
GOALS AND BACKGROUND/OBJECTIVE:Ustekinumab (UST) is a monoclonal antibody inhibitor of IL-12/IL-23 approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). We conducted a meta-analysis to compare rates of adverse events (AEs) in randomized controlled trials (RCTs) of UST for all indications. STUDY/METHODS:A systematic search was performed of MEDLINE, Embase, and PubMed databases through November 2019. Study inclusion included RCTs comparing UST to placebo or other biologics in patients aged 18Â years or older with a diagnosis of an autoimmune condition. RESULTS:Thirty RCTs with 16,068 patients were included in our analysis. Nine thousand six hundred and twenty-six subjects were included in the UST vs placebo analysis. There was no significant difference in serious or mild/moderate AEs between UST and placebo with an OR of 0.83 (95% CI 0.66, 1.05) and 1.08 (95% CI 0.99, 1.18), respectively, over a median follow-up time of 16Â weeks. In a sub-analysis of CD and UC trials, no difference in serious or mild/moderate AEs in UST versus placebo was seen. CONCLUSIONS:UST was not associated with an increase in short-term risk of AEs.
From the American Epicenter: Coronavirus Disease 2019 in Patients with Inflammatory Bowel Disease in the New York City Metropolitan Area
Axelrad, Jordan E; Malter, Lisa; Hong, Simon; Chang, Shannon; Bosworth, Brian; Hudesman, David
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.
The COVID-19 Army: Experiences From the Deployment of Non-Hospitalist Physician Volunteers During the COVID-19 Pandemic
Hauck, Kevin D; Hochman, Katherine A; Pochapin, Mark B; Zabar, Sondra R; Wilhite, Jeffrey A; Glynn, Gretchen; Bosworth, Brian P
OBJECTIVE:New York City was the epicenter of the outbreak of the 2019 coronavirus disease (COVID-19) pandemic in the United States. As a large, quaternary care medical center, NYU Langone Medical Center was one of many New York medical centers that experienced an unprecedented influx of patients during this time. Clinical leadership effectively identified, oriented, and rapidly deployed a "COVID Army," consisting of non-hospitalist physicians, to meet the needs of the patient influx. We share feedback from our providers on our processes and offer specific recommendations for systems experiencing a similar influx in the current and future pandemics. METHODS:To assess the experiences and perceived readiness of these physicians (n = 183), we distributed a 32-item survey between March and June of 2020. Thematic analyses and response rates were examined to develop results. RESULTS:Responses highlighted varying experiences and attitudes of our frontline physicians during an emerging pandemic. Thematic analyses revealed a series of lessons learned, including the need to (1) provide orientations, (2) clarify roles/workflow, (3) balance team workload, (4) keep teams updated on evolving policies, (5) make team members feel valued, and (6) ensure they have necessary tools available. CONCLUSIONS:Lessons from our deployment and assessment are scalable at other institutions.
A Case-Based Approach to Constipation in Primary Care [Case Report]
Snell, David B; Faruqui, Saamia; Bosworth, Brian P
Primary care physicians frequently evaluate patients with constipation. The history is crucial in uncovering warning symptoms and signs that warrant colonoscopy. Particular elements in the history and rectal examination also can provide clues regarding the underlying etiology. Regardless of etiology, lifestyle modifications, fiber, and laxatives are first-line therapies. Patients who fail first-line therapies can be offered second-line treatments and/or referred for testing of defecatory function. In those with severely refractory symptoms, referrals to a gastroenterologist and a surgeon should be considered.
Experiences from the deployment of non-hospitalist physician volunteers during the 2020 covid pandemic [Meeting Abstract]
Hauck, K; Hochman, K; Pochapin, M; Zabar, S; Wilhite, J; Glynn, G; Bosworth, B
BACKGROUND: New York City was the epicenter of the COVID pandemic in the US during early 2020. NYU Langone Medical Center was one of many New York medical centers that experienced an unprecedented influx of patients. During the onset of the pandemic, clinic leadership identified, oriented, and rapidly deployed a COVID Army, consisting of non-hospitalist physicians, to meet the needs of this patient influx. Orientation and training included an hour-long session with an emphasis on the inpatient electronic medical record system and a plan for at the elbow assistance from senior hospitalists. Here, we share feedback from our providers on our capacity building process and use information gathered to offer specific lessons learned in planning for workforce mobilization.
METHOD(S): A 32-item survey was distributed from March-June of 2020 in order to assess the experiences of these ancillary physicians, all of which were NYU Langone providers. Items included a mix of Likert and open-ended questions on demographics and attitudes toward experiences on the COVID team.
RESULT(S): All 272 volunteers received a survey. 67% (n=183) responded. 84 (46%) were from the Department of Medicine, the remainder were primarily from surgical, pediatrics or obstetrics/gynecology. Respondents worked in combination ambulatory/inpatient practices (n=94; 52%) or outpatient only (n=85; 47%) (Mean years in practice: 7.18). 76% felt that the number of patients they were in charge of felt Just Right (average: 7). 10% rated the experience as challenging (n=17). On their perception of support and training, 94% and 63% rated the support and training they received as somewhat or very effective, respectively. 89% (n=99) and 96% (n=107) of supplemental attendings felt valued and valuable to their team, respectively. 87% of respondents identified as being willing to volunteer again. In review of open-ended feedback, we identified a series of themes surrounding areas for improvement. These include the need to 1) invest time into orientations, including training on EHR use, (2) clarify roles and workflow within each team up front, (3) balance team workload if possible, (4) keep teams updated on evolving policies and recommendations, (5) make team members feel valued and supported, and (6) ensure they have the right tools available.
CONCLUSION(S): Given what we have learned from our survey, the continued waxing and waning of community infection, and the unknown length and extent of the COVID pandemic, we recommend providing transparent leadership, frequent communication, and an educational series to ensure everyone is learning together. In addition, clarity is essential, and it is important to be specific in defining the exact roles of ancillary physicians. It is our hope that the lessons learned from our needs assessment can be applied to other hospitals currently in the throes of a surge of COVID inpatients. LEARNING OBJECTIVE #1: Identify best practices for preparing an ancillary workforce for patient surge. LEARNING OBJECTIVE #2: Understand tools for quality patient care
Collaborating Across Private, Public, Community, and Federal Hospital Systems: Lessons Learned from the Covid-19 Pandemic Response in NYC
Schaye, Verity E; Reich, Jenna A; Bosworth, Brian P; Stern, David T; Volpicelli, Frank; Shapiro, Neil M; Hauck, Kevin D; Fagan, Ian M; Villagomez, Seagram M; Uppl, Amit; et al
Inflammatory Bowel Disease Is Not Associated with Severe Outcomes of COVID-19: A Cohort Study from the United States Epicenter [Meeting Abstract]
Hong, S; Malter, L; Bosworth, B P; Chang, S; Hudesman, D P; Axelrad, J E
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
A clinical and radiographic model to predict surgery for acute small bowel obstruction in Crohn's disease
Lowe, Sarina C; Ream, Justin; Hudesman, David; Malter, Lisa; Bosworth, Brian; Xia, Yuhe; Zhong, Hua; Dane, Bari; Megibow, Alec; Chang, Shannon
PURPOSE/OBJECTIVE:For more than half of Crohn's disease patients, strictures will cause bowel obstructions that require surgery within 10Â 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 6Â 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.