scholarly journals Real-World Effectiveness and Tolerability of Monoclonal Antibodies for Ambulatory Patients with Early COVID-19

Author(s):  
Brandon J Webb ◽  
Whitney Buckel ◽  
Todd Vento ◽  
Allison M Butler ◽  
Nancy Grisel ◽  
...  

Importance: Interventions to reduce hospitalization of patients with COVID-19 are urgently needed. Randomized trials for efficacy suggest that anti-SARS-CoV2 neutralizing monoclonal antibodies (MAb) may reduce medically-attended visits and hospitalization but effectiveness has not been confirmed in a real-world setting. Objective: Estimate the effectiveness of MAb infusion in a real-world cohort of ambulatory patients with early symptomatic COVID-19 at high risk for hospitalization. Design: Quasi-experimental observational cohort study using target trial emulation and causal inference methodology in pre-and post-implementation groups. Setting: Infusion centers and urgent care clinics within an integrated healthcare system in the United States Participants: 13,534 high-risk adult outpatients with symptomatic, laboratory-confirmed COVID-19 within 7 days of symptom onset. Exposures: A single intravenous infusion of either bamlanivimab 700 mg or casirivimab/imdevimab 1200 mg/1200 mg. Main Outcomes and Measures: The primary outcome was emergency department visit or hospitalization within 14 days of positive test. Patients who received MAb infusion were compared to contemporaneous controls using inverse probability of treatment weighting, and to a pre-implementation cohort using propensity-weighted interrupted time series analysis. An exploratory analysis compared effectiveness of casirivimab/imdevimab and bamlanivimab. Results: 7404 patients who would have been MAb-eligible were identified in a pre-implementation cohort (July 1-November 27, 2020). In the post-implementation period (November 28, 2020-January 28, 2021), 594 received MAb treatment and 5536 MAb-eligible patients did not. Among Mab recipients, 479 (80.6%) received bamlanivimab and 115 (19.4%) casirivimab/imdevimab. The primary outcome occurred in 75 (12.6%) MAb recipients, 1018 (18.4%) contemporaneous controls, and 1525 (20.6%) patients in the pre-implementation cohort. MAb treatment was associated with fewer subsequent emergency department visits and hospitalizations (odds ratio estimating the average treatment effect 0.69, 95% CI 0.60-0.79). After implementation, propensity-weighted probability of emergency department visit or hospitalization decreased by 0.7% per day (95% CI 0.03-0.10%, p<0.001). Overall, 7 (1.2%) MAb patients experienced an adverse event; two (0.3%) were considered serious. In the exploratory analysis, the effect of casirivimab/imdevimab versus bamlanivimab was not significant (OR 0.52, 95% CI 0.17-1.63, p=0.26). Conclusions and Relevance: MAb treatment of high-risk ambulatory patients with early COVID-19 was well-tolerated and effective at preventing the need for subsequent medically-attended care.

Author(s):  
Brandon J Webb ◽  
Whitney Buckel ◽  
Todd Vento ◽  
Allison M Butler ◽  
Nancy Grisel ◽  
...  

Abstract Background Neutralizing monoclonal antibodies (MAb) are a promising therapy for early COVID-19, but effectiveness has not been confirmed in a real-world setting. Methods In this quasi-experimental pre-/post-implementation study, we estimated the effectiveness of MAb treatment within 7 days of symptom onset in high-risk ambulatory adults with COVID-19. The primary outcome was a composite of emergency department visit or hospitalization within 14 days of positive test. Secondary outcomes included adverse events and 14-day mortality. The average treatment effect in the treated for MAb therapy was estimated using inverse probability of treatment weighting and the impact of MAb implementation using propensity-weighted interrupted time series analysis. Results Pre-implementation (July-November, 2020), 7404 qualifying patients were identified. Post-implementation (December 2020-January 2021), 594 patients received MAb treatment and 5536 did not. The primary outcome occurred in 75 (12.6%) MAb recipients, 1018 (18.4%) contemporaneous controls and 1525 (20.6%) historical controls. MAb treatment was associated with decreased likelihood of emergency care or hospitalization, odds ratio 0.69 (95% CI 0.60-0.79). After implementation, the weighted probability that a given patient would require an emergency department visit or hospitalization decreased significantly (0.7% per day, 95% CI 0.03%-0.10%). Mortality was 0.2% (n=1) in the MAb group compared to 1.0% (n=71) and 1.0% (n=57) in pre- and post-implementation controls, respectively. Adverse events occurred in 7 (1.2%); 2 (0.3%) were considered serious. Conclusions MAb treatment of high-risk ambulatory patients with early COVID-19 was well-tolerated and likely effective at preventing the need for subsequent emergency department or hospital care.


Author(s):  
Douglas S Corwin ◽  
Peter T Ender ◽  
Nitasa Sahu ◽  
Ryan A Durgham ◽  
Dennis M McGorry ◽  
...  

Abstract Bamlanivimab, a monoclonal antibody targeting the spike protein of SARS-CoV-2, is available for ambulatory treatment of COVID-19. This real-world study confirms the efficacy of bamlanivimab in reducing hospital admissions and emergency department visits among high-risk outpatients with mild to moderate COVID-19 illness and reveals a trend toward improved mortality.


Author(s):  
Pinaki Mukherji ◽  
Dana Libov

This chapter presents 3 cases of vomiting in children and explores less common diagnoses not to be missed by the astute clinician. The first case of a child with recurrent progressive vomiting has unusual lab abnormalities which leads to the final diagnosis of an inborn error of metabolism. The second case presents a child with several Emergency Department visits for vomiting and a skin finding leads to a final diagnosis of non-accidental trauma. The final case reviews a vomiting child with electrolyte abnormalities and an abnormal radiograph, leading to a diagnosis of malrotation with volvulus. Each case gives the clinician key pearls to distinguish these high risk cases from everyday gastroenteritis.


2019 ◽  
pp. 082585971986906
Author(s):  
Debbie Selby ◽  
Anita Chakraborty ◽  
Audrey Kim ◽  
Jeff Myers

Background: Emergency department visits or readmission to hospital are common particularly among those with advanced illness. Little prospective data exist on early outcomes specifically for patients seen by a palliative care consult service during their acute care admission, who are subsequently discharged home. Methods: This study followed 62 oncology patients who had had a palliative care consult during their admission to acute care with weekly phone calls postdischarge for 4 weeks. Events recorded included death, readmission, emergency department visits, and admission to a palliative care unit. Results: By the end of the study, 32 (52%) of 62 had had at least 1 event, (readmission, emergency department visit, or death), with the majority of these occurring in the first 2 weeks postdischarge. The overall 4-week death rate was 14 (22.6%) of 62. Conclusions: These data suggest that the need for a palliative care consult identifies inpatients at very high risk for early deterioration and underlines the critical importance of advance care planning/goals-of-care discussions by the oncology and palliative care teams to ensure patients and families understand their disease process and have the opportunity to direct their care decisions.


Autism ◽  
2018 ◽  
Vol 23 (3) ◽  
pp. 566-573 ◽  
Author(s):  
Luther G Kalb ◽  
Elizabeth A Stuart ◽  
Roma A Vasa

This study examined differences in the rates of psychiatric-related emergency department visits among adolescents with autism spectrum disorder, adolescents with attention deficit hyperactivity disorder, and adolescents without autism spectrum disorder or attention deficit hyperactivity disorder. Additional outcomes included emergency department recidivism, probability of psychiatric hospitalization after the emergency department visit, and receipt of outpatient mental health services before and after the emergency department visit. Data came from privately insured adolescents, aged 12–17 years, with autism spectrum disorder (N = 46,323), attention deficit hyperactivity disorder (N = 408,066), and neither diagnosis (N = 2,330,332), enrolled in the 2010–2013 MarketScan Commercial Claims Database. Adolescents with autism spectrum disorder had an increased rate of psychiatric emergency department visits compared to adolescents with attention deficit hyperactivity disorder (IRR = 2.0, 95% confidence interval: 1.9, 2.1) and adolescents with neither diagnosis (IRR = 9.9, 95% confidence interval: 9.4, 10.4). Compared to the other groups, adolescents with autism spectrum disorder also had an increased probability of emergency department recidivism, psychiatric hospitalization after the emergency department visit, and receipt of outpatient care before and after the visit (all p < 0.001). Further research is required to understand whether these findings extend to youth with other neurodevelopmental disorders, particularly those who are publicly insured.


2016 ◽  
Vol 214 (1) ◽  
pp. S278
Author(s):  
Jean-Ju Sheen ◽  
Peter S. Bernstein ◽  
Brian Tu ◽  
Ying Liu ◽  
Desmond Sutton-Ramsey ◽  
...  

2020 ◽  
Vol 7 (1) ◽  
pp. e000357 ◽  
Author(s):  
Christopher F Bell ◽  
Julie Priest ◽  
Marni Stott-Miller ◽  
Hong Kan ◽  
Justyna Amelio ◽  
...  

ObjectiveTo examine the effects of belimumab initiation on healthcare resource utilisation (HCRU) and costs in SLE.MethodsThis retrospective observational cohort study used healthcare administrative claims data from the IBM MarketScan Commercial Claims and Encounters Database to identify patients with SLE billing codes who received ≥1 intravenous belimumab infusion between March 2011 and December 2015. The first belimumab administration was the ‘index date’. During the 6-month postindex period, nine belimumab infusions were recommended: three during the initiation period and six during the maintenance period. HCRU and cost data for inpatient admissions, emergency department visits, physician office visits, hospital-based outpatient visits, laboratory services, other outpatient services and outpatient pharmacy prescriptions were compared in the 6-month pre/postindex periods.ResultsOf the 1879 patients with SLE included, 43% received ≥3 intravenous initiation administrations. An average of 5.3 (SD: 2.4) of the nine recommended belimumab administrations were received within 6 months. In the 6-month preindex versus postindex periods, significant reductions were noted for inpatient hospitalisations (18% vs 9%, p<0.001; mean visits: 0.3 vs 0.14, p<0.001) and emergency department visits (40% vs 24%, p<0.001; mean visits; 3.53 vs 1.96, p<0.001). Mean total costs were higher in the 6-month postindex versus preindex period ($41 426 vs $29 270; p<0.001).ConclusionsIn this study of real-world intravenous belimumab for SLE, adherence to recommended infusion schedules was low. Outpatient healthcare and associated costs were higher in the 6 months after belimumab was initiated, although inpatient costs were lower. Reasons for non-adherence with belimumab and implications should be investigated.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040479
Author(s):  
Kacie Patterson ◽  
Rachel Davey ◽  
Richard Keegan ◽  
Theophile Niyonsenga ◽  
Itismita Mohanty ◽  
...  

IntroductionCardiac rehabilitation (CR) is recommended for secondary prevention of cardiovascular disease and reducing the risk of repeat cardiac events. Physical activity is a core component of CR; however, studies show that participants remain largely sedentary. Sedentary behaviour is an independent risk factor for all-cause mortality. Strategies to encourage sedentary behaviour change are needed. This study will explore the effectiveness and costs of a smartphone application (Vire) and an individualised online behaviour change program (ToDo-CR) in reducing sedentary behaviour, all-cause hospital admissions and emergency department visits over 12 months after commencing CR.Methods and analysisA multicentre, assessor-blind parallel randomised controlled trial will be conducted with 144 participants (18+ years). Participants will be recruited from three phase-II CR centres. They will be assessed on admission to CR and randomly assigned (1:1) to one of two groups: CR plus the ToDo-CR 6-month programme or usual care CR. Both groups will be re-assessed at 6 months and 12 months for the primary outcome of all-cause hospital admissions and presentations to the emergency department. Accelerometer-measured changes in sedentary behaviour and physical activity will also be assessed. Logistic regression models will be used for the primary outcome of hospital admissions and emergency department visits. Methods for repeated measures analysis will be used for all other outcomes. A cost-effectiveness analysis will be conducted to evaluate the effects of the intervention on the rates of hospital admissions and emergency department visits within the 12 months post commencing CR.Ethics and disseminationThis study received ethical approval from the Australian Capital Territory Health (2019.ETH.00162), Calvary Public Hospital Bruce (20–2019) and the University of Canberra (HREC-2325) Human Research Ethics Committees (HREC). Results will be disseminated through peer-reviewed academic journals. Results will be made available to participants on request.Trial registration numberACTRN12619001223123.


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