scholarly journals 526. Implementation of Use of Monoclonal Antibody Therapy in a Large Academic Center for the Outpatient Treatment of Covid-19: Impact on 30 Day Hospitalization Rates, ED Visits and Death

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S364-S364
Author(s):  
Azra Bhimani ◽  
Vinay Srinivasan ◽  
Stacey Weinstein ◽  
Nathan Clemons ◽  
Quanna Batiste ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibody ◽  
Treatment Failure ◽  
Real World ◽  
Hospital Admissions ◽  
Antibody Therapy ◽  
Outpatient Setting ◽  
Hospitalized Patients ◽  
Monoclonal Antibody Therapy ◽  
Ed Visits

Abstract Background Monoclonal Antibody Therapy (MAbs) has been shown to reduce rates of ED visits and hospitalizations in patients at risk for severe Covid-19 infection in clinical trials. Since November, three Mabs received emergency use authorization: Bamlanivimab (Bam), Bamlanivimab/Etesevimab (Bam/Ete) and Casirivimab/Imdevimab (Casi/imdevi). We describe here the real-world effectiveness of implementing early MAb therapy in the outpatient setting for individuals with Covid-19 at high risk of progression. Methods We examined the records of 808 UCLA Health patients with a confirmed positive SARS-CoV2 PCR test who were either referred for outpatient Mab therapy or received Mab treatment in the emergency department (ED) between December 10, 2020, and May 3, 2021. The primary outcome of our analysis was the combined 30-day incidence of emergency department visits, hospitalizations, or death following the date of referral. SARS-CoV2 isolates of hospitalized patients who had received Mabs were sequenced to determine the presence of variants. Results Of 808 patients, 383 were referred for treatment but did not receive treatment, 109 received Mabs in the ED and 316 patients were treated in an outpatient setting. Composite 30-day mortality, ED visits and hospital admissions were significantly reduced in the combination therapy group (Bam/Ete or Cas/Imd) compared with monotherapy (Bam alone) or no treatment groups (aHR 0.16, 95% CI .038, .67). Significant factors associated with the composite outcome included: history of lung disease (HR 4.46, 95% CI 2.89-6.90), cardiovascular disease (HR 1.87, 95% CI 1.12-3.12), kidney disease (HR 2.04, 95% CI 1.27-3.25), and immunocompromised state (HR 3.24, 95% CI 1.02-10.26) as well as high social vulnerability index (HR 1.87, 95% CI 1.13-3.10). Over one-third of hospitalized patients who had received Mabs were confirmed to have the California variant (B.1.427/29) (Figure 1). Figure 1. Covid-19 MAB Treatment Failure Lineages Conclusion Our data show that in a real-world setting, combination monoclonal antibody therapy, not monotherapy, significantly reduced ED visits and hospital admissions, likely due to the presence of the California variants. High socioeconomic vulnerability and certain medical conditions increased risk of treatment failure. Disclosures Omai Garner, PhD, D(ABMM), Beckman Coulter (Scientific Research Study Investigator)

scholarly journals 553. Outcomes in Patients Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection After Treatment with Monoclonal Antibody Therapy (MAT) in the Outpatient Setting

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S379-S379
Author(s):  
Courtney Nichols ◽  
Mark Lustberg ◽  
Mohammad Mahdee Sobhanie ◽  
Joy Lehman ◽  
Erica E Reed ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Research Study ◽  
Hospital Admissions ◽  
Antibody Therapy ◽  
Scientific Research ◽  
Outpatient Setting ◽  
Control Group ◽  
Monoclonal Antibody Therapy ◽  
Study Investigator ◽  
And Control

Abstract Background Monoclonal antibody therapy (MAT) was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with positive SARS-CoV-2 viral testing and at high risk for progression to severe COVID-19 with up to 10 days of symptoms. This study assessed the impact of MAT on COVID-19-related ER visits, admissions, and mortality for patients diagnosed with COVID-19. Methods This was a single-center, retrospective study at The Ohio State University Wexner Medical Center to compare COVID-19-related ER visits, admissions, and mortality at 30 days after receiving MAT in the outpatient setting with either bamlanivimab or casirivimab-imdevimab in adult patients diagnosed with SARS-CoV-2 between November 16, 2020 and February 2, 2021. Outcomes in patients who received MAT were compared to those of a control group of patients diagnosed with COVID-19 in the outpatient setting from May 16, 2020 through November 15, 2020 who would have qualified for MAT through EUA criteria had it been available. Statistical analysis used logistic regression analysis with backward selection to determine the odds ratios (OR) and the 95% confidence interval to evaluate the relationship between patient clinical characteristics and outcomes. Results This study cohort included 1,944 patients, including 943 who received MAT and 1,001 in the control group. The MAT group included 658 who received bamlanivimab and 285 who received casirivimab-imdevimab. Patients who received MAT compared to the control group had a lower rate of COVID-19 related ER visits (3.3% vs 7.4%, p = < 0.0001) and hospital admissions (4.0% vs 7.8%, p = < 0.0001). No statistically significant difference was seen in mortality between the MAT group (0.5%) and control group (1.1%, p = 0.17). After accounting for potential confounders, the difference between the monoclonal antibody and control groups remained significant for ER visits and hospital admissions as reflected in the table. Conclusion Patients who received MAT for COVID-19 in the outpatient setting had a lower rate of COVID-19-related 30 day ER visits and hospitalizations compared to those who did not receive MAT, adjusting for potential confounders. Disclosures Mohammad Mahdee Sobhanie, M.D., Regeneron (Scientific Research Study Investigator)Regeneron (Scientific Research Study Investigator, Was a sub-investigator for Regeneron 2066 and 2069) Carlos Malvestutto, M.D., Lilly (Scientific Research Study Investigator)Regeneron Inc. (Scientific Research Study Investigator)ViiV Healthcare (Advisor or Review Panel member)

scholarly journals 31 Emergency Department-Based Monoclonal Antibody Therapy for Patients With Mild to Moderate COVID-19

2021 ◽  
Vol 78 (2) ◽  
pp. S15
Author(s):  
C. Lim ◽  
E. Eiting ◽  
A. O'Neill ◽  
R. Farraj ◽  
S. Koshy ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibody ◽  
Antibody Therapy ◽  
Monoclonal Antibody Therapy

scholarly journals 535. Comparison of Outcomes in Patients Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection After Monoclonal Antibody Therapy (MAT) with Bamlamivimab or Casirivimab-Imdevimab

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S369-S369
Author(s):  
Courtney Nichols ◽  
Mark Lustberg ◽  
Mohammad Mahdee Sobhanie ◽  
Joy Lehman ◽  
Erica E Reed ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Research Study ◽  
Hospital Admissions ◽  
Antibody Therapy ◽  
Scientific Research ◽  
Panel Member ◽  
Monoclonal Antibody Therapy ◽  
Study Investigator ◽  
Increased Risk ◽  
Significant Difference

Abstract Background Limited options currently exist for treatment of patients diagnosed with symptomatic coronavirus 2019 (COVID-19). Monoclonal antibody therapy (MAT) has been investigated as a therapeutic option for symptomatic COVID-19 patients in the outpatient setting at high-risk for progression to severe disease based on emergency use authorization (EUA) criteria. No published studies have compared outcomes for patients treated with different MAT for COVID-19. Methods This was a single-center, retrospective cohort study at The Ohio State University Wexner Medical Center to compare COVID-19-related emergency room (ER) visits, admissions, and mortality at 30 days after MAT infusion for adult patients with symptomatic SARS-CoV-2 between November 16, 2020 and February 2, 2021 who received bamlanivimab versus those who received casirivimab-imdevimab. Statistical analysis used logistic regression analysis to determine the odds ratio (OR) to evaluate the relationship between patient characteristics, MAT, and outcomes. Results The cohort included 943 patients with SARS-CoV-2 who received MAT, including 658 patients who received bamlanivimab and 285 who received casirivimab-imdevimab. Outcome results between patients who received bamlanivimab and casirivimab-imdevimab showed no statistically significant difference seen in the number of COVID-19 related ER visits (3.2% vs 3.5%, p = 0.80), hospital admissions (4.6% vs 2.8%, p = 0.21), or mortality (0.5% vs 0.7%, p = 0.63). Multivariate analysis showed no statistically significant difference in outcomes between the groups when accounting for potential confounders. As reflected in the Table, chronic lymphocytic leukemia (CLL), gender, and asthma were associated with increased COVID-19 related ER visit within 30 days of infusion and age, chronic obstructive pulmonary disease, CLL, and lupus were associated with increased risk for COVID-19 related admission within 30 days of infusion. Age and obesity with body mass index greater than 35 mg/kg2 were associated with increased risk for COVID-19 related mortality at 30 days. Conclusion COVID-19 related outcomes were similar when comparing patients with COVID-19 treated with bamlanivimab versus those treated with casirivimab-imdevimab. Disclosures Mohammad Mahdee Sobhanie, M.D., Regeneron (Scientific Research Study Investigator)Regeneron (Scientific Research Study Investigator, Was a sub-investigator for Regeneron 2066 and 2069) Carlos Malvestutto, M.D., Lilly (Scientific Research Study Investigator)Regeneron Inc. (Scientific Research Study Investigator)ViiV Healthcare (Advisor or Review Panel member)

scholarly journals The Efficacy of Bamlanivimab in Reducing Emergency Department Visits and Hospitalizations in a Real-World Setting

2021 ◽  
Author(s):  
Douglas S Corwin ◽  
Peter T Ender ◽  
Nitasa Sahu ◽  
Ryan A Durgham ◽  
Dennis M McGorry ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibody ◽  
High Risk ◽  
Real World ◽  
Hospital Admissions ◽  
Emergency Department Visits ◽  
Spike Protein ◽  
Ambulatory Treatment ◽  
Real World Setting ◽  
Antibody Targeting

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.

scholarly journals Emergency department use of monoclonal antibody therapy in high risk COVID positive patients

2021 ◽  
Vol 10 (2) ◽  
pp. 38
Author(s):  
Andrew R. Barbera ◽  
Kayla Wilson ◽  
James D. Melton III ◽  
Fred Blind ◽  
Donna M. Bhisitkul ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibody ◽  
High Risk ◽  
Large Scale ◽  
Best Practice ◽  
Antibody Therapy ◽  
Monoclonal Antibody Therapy ◽  
Regional Health ◽  
Staff Members ◽  
Medical Centers

Background: There have been many perceived barriers to the implementation of the mass use of monoclonal antibody therapy following the Food and Drug Administration’s Emergency Use Authorization in November 2020. These barriers include identifying eligible patients, physical resources including trained staff members, space, and materials for the administration away from others to reduce transmission, and cost of the resources. However, Lakeland Regional Health was able to create a safe and efficient protocol to administer Bamlanivimab in the treatment of high risk COVID positive patients and initiate this proposed pathway within 24 hours of receipt of the first shipment of medication.Methods: Critical to the development and success of this protocol was a multi-disciplinary approach focused on identifying and utilizing preexisting resources to ensure safe and efficient administration of this treatment to as many eligible patients as possible. Another crucial aspect was the utilization of the emergency department providers for identifying high risk eligible patients and as a safe and effective treatment setting.Results: This article is intended to demonstrate a best practice pathway to identify and administer Bamlanivimab, or similar treatments, and will not discuss outcomes or efficacy of the medication. To date Lakeland Regional Health has successfully treated over 1,000 high risk COVID-19 positive patients within our community.Conclusions: By identifying and utilizing similar resources and pathways available at individual medical centers, it is possible to safely and efficiently treat high risk COVID positive patients with monoclonal antibody therapy on a large scale.

scholarly journals Real-world clinical outcomes of treatment with casirivimab-imdevimab among patients with mild-to-moderate coronavirus disease 2019 during the Delta variant pandemic

2021 ◽  
Author(s):  
Yasuhito Suzuki ◽  
Yoko Shibata ◽  
Hiroyuki Minemura ◽  
Takehumi Nikaido ◽  
Yoshinori Tanino ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Real World ◽  
Odds Ratio ◽  
Antibody Therapy ◽  
Multivariate Logistic Regression Analysis ◽  
Monoclonal Antibody Therapy ◽  
Independent Factor ◽  
Multivariate Logistic Regression ◽  
Neutralizing Monoclonal Antibody ◽  
History Of

Background: Mutations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may reduce the efficacy of neutralizing monoclonal antibody therapy against coronavirus disease 2019 (COVID-19). We here evaluated the efficacy of casirivimab-imdevimab in patients with mild-to-moderate COVID-19 during the Delta variant surge in Fukushima Prefecture, Japan. Methods: We enrolled 949 patients with mild-to-moderate COVID-19 who were admitted to hospital between July 24, 2021 and September 30, 2021. Clinical deterioration after admission was compared between casirivimab-imdevimab users (n = 314) and non-users (n = 635). Results: The casirivimab-imdevimab users were older (P < 0.0001), had higher body temperature (≥ 38 degree) (P < 0.0001) and greater rates of history of cigarette smoking (P = 0.0068), hypertension (P = 0.0004), obesity (P < 0.0001), and dyslipidemia (P < 0.0001) than the non-users. Multivariate logistic regression analysis demonstrated that receiving casirivimab-imdevimab was an independent factor for preventing deterioration (odds ratio 0.448; 95% confidence interval 0.263 to 0.763; P = 0.0023). Furthermore, in 222 patients who were selected from each group after matching on the propensity score, deterioration was significantly lower among those receiving casirivimab-imdevimab compared to those not receiving casirivimab-imdevimab (7.66% vs 14.0%; p = 0.021). Conclusion: This real-world study demonstrates that casirivimab-imdevimab contributes to the prevention of deterioration in COVID-19 patients after hospitalization during a Delta variant surge.

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