scholarly journals Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents

2021 ◽  
Author(s):  
Joshua Wolf ◽  
Mark J Abzug ◽  
Rachel L Wattier ◽  
Paul K Sue ◽  
Surabhi B Vora ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
High Risk ◽  
Infectious Diseases ◽  
Children And Adolescents ◽  
Severe Disease ◽  
Antibody Therapy ◽  
Pediatric Intensive Care ◽  
Risk Groups ◽  
Monoclonal Antibody Therapy ◽  
Routine Administration

Abstract Background In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for two novel virus-neutralizing monoclonal antibody therapies, bamlanivimab, and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate COVID-19 in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products. Methods A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion. Results The course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis. Conclusions Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence, and ensure implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

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.

Cell Surface Targets for Monoclonal Antibody Therapy in Lymphoid Neoplasms of Children and Adolescents.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4544-4544
Author(s):  
Mark Lones ◽  
Ivan Kirov
Keyword(s):  
Monoclonal Antibody ◽  
Cell Surface ◽  
Children And Adolescents ◽  
Burkitt Lymphoma ◽  
Antibody Therapy ◽  
Surface Antigens ◽  
Monoclonal Antibody Therapy ◽  
Cell Surface Antigens ◽  
Lymphoid Neoplasms ◽  
Hla Dr

Abstract Recently, monoclonal antibodies have become available for treatment of lymphoid neoplasms in adults, but have not been studied in children and adolescents. These monoclonal antibodies are directed against cell surface antigens CD20 (Rituximab, Ibritumomab-Tiuxetan, Tositumomab), CD22 (Epratuzumab), CD52 (CAMPATH-1H), HLA-DR Beta-chain (Hu1D10), CD23 (IDEC-152), and CD33 (Gemtuzumab Ozogamicin). The objective of this study is to identify cell surface targets eligible for monoclonal antibody therapy in lymphoid neoplasms of children and adolescents. This is a retrospective analysis of lymphoid neoplasms evaluated by flow cytometry immunophenotyping at a single institution from January 2002 to July 2004. All patients were less than 21 years old at primary diagnosis. Flow cytometry immunophenotyping employed a 3-color method. Fluorochrome-conjugated monoclonal antibodies were utilized to detect cell surface antigens: CD20, CD22, CD23 (Becton-Dickinson), and CD52 (CALTAG) conjugated with PE; HLA-DR and CD33 (Becton-Dickinson) conjugated with FITC. For this study, a cell surface antigen was interpreted as positive when neoplastic cells exhibited moderate or bright intensity staining, or interpreted as negative when staining was dim or absent. A total of 95 patients are included in this study. Demographic data: Age <1 to 20 years (median 7); Male=52, Female=43. Diagnoses included: Precursor-B Acute Lymphoblastic Leukemia (Pre-B ALL) = 80, Precursor-T Acute Lymphoblastic Leukemia or Precursor-T Lymphoblastic Lymphoma (Pre-T ALL/LBL) = 11, Burkitt Lymphoma = 4. Total specimens = 105 (primary diagnosis = 82, relapse = 23). Immunophenotyping results for the number of specimens tested are in the Table. Table 1 Diagnosis CD20 CD22 CD52 HLA-DR CD23 CD33 Pre-B ALL 32/86 (37%) 90/90 (100%) 53/57 (93%) 87/87 (100%) 0/15 (0%) 4/90 (4%) Pre-T ALL/LBL 0/11 (0%) 0/11 (0%) 9/10 (90%) 2/11 (18%) 0/5 (0%) 0/11 (0%) Burkitt Lymphoma 4/4 (100%) 4/4 (100%) 3/3 (100%) 3/3 (100%) 0/2 (0%) 0/3 (0%) CD22 was positive (usually bright intensity) in all Pre-B ALL and Burkitt Lymphoma specimens. CD20 was positive in all Burkitt Lymphoma (bright intensity) and in a subset of Pre-B ALL (usually moderate intensity) specimens. CD22 and CD20 were negative in Pre-T ALL/LBL specimens. In a subset, CD52 was positive (moderate to bright intensity) in nearly all specimens. HLA-DR was positive (moderate to bright intensity) in all Pre-B ALL and Burkitt Lymphoma specimens. In a subset, CD23 was negative in all specimens. Also, CD33 was negative in nearly all specimens. In conclusion, lymphoid neoplasms in children and adolescents have cell surface antigens that are eligible targets for currently available monoclonal antibody therapy. Patients with Pre-B ALL are candidates for therapy directed to CD22, CD52, HLA-DR, and a subset to CD20, but not to CD23 or CD33. Patients with Burkitt Lymphoma are eligible for therapy to CD20, CD22, CD52, and HLA-DR, but not CD23 or CD33. Patients with Pre-T ALL/LBL are eligible for therapy to CD52, but not CD20, CD22, HLA-DR, CD23 or CD33. These results indicate that future clinical therapeutic trials can be designed for children and adolescents with lymphoid neoplasms to evaluate monoclonal antibody therapy directed to CD20, CD22, CD52, or HLA-DR, employing single or multiple antibodies as a new modality, in addition to chemotherapy.

scholarly journals Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19

2021 ◽  
Vol 12 ◽  
pp. 215013272110192
Author(s):  
Dennis M. Bierle ◽  
Ravindra Ganesh ◽  
Caroline G. Wilker ◽  
Sara N. Hanson ◽  
Darcie E. Moehnke ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
High Risk ◽  
Clinical Outcomes ◽  
Antibody Therapy ◽  
Cultural Factors ◽  
Monoclonal Antibody Therapy ◽  
Antibody Treatment ◽  
Medical Comorbidities ◽  
Monoclonal Antibody Treatment ◽  
Social And Cultural Factors

Background The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal antibody therapies are not established. This study aimed to identify factors impacting the decision to consent for monoclonal antibody therapies and assess the differences in clinical outcomes of patients who accepted compared to those who declined these therapies. Methods This retrospective cohort study enrolled 2820 adult patients who were offered monoclonal antibody therapies, bamlanivimab and casirivimab-imdevimab, for COVID-19 at Mayo Clinic in the Midwest between 11/19/2020 and 12/31/2020. The primary endpoint is the decision to accept or decline monoclonal antibody treatment. Secondary endpoints were patient-level factors that could have impacted the decision to accept treatment (age, gender, race, ethnicity, primary language spoken, and medical comorbidities). The main clinical endpoint was hospitalization within 28 days of COVID-19 diagnosis. Results 59.1% (n = 1669) chose to accept monoclonal antibody therapy, and 40.9% (n = 1151) chose to decline the offer for treatment. Patients were more likely to accept treatment if they were non-Hispanic White, English speaking, identified a spouse or life partner, had a religious affiliation, and possessed more medical comorbidities. Overall, 28-day hospitalization rate was 2.6% (n = 72/2820) and was higher among those who declined (3.3%) than those who accepted monoclonal antibody therapy (2.0%; Rate Ratio = 0.62, 95% Confidence Interval, 0.39-0.98). Conclusions Despite having more comorbidities, patients who accepted monoclonal antibody treatments had a lower rate of hospitalization compared to patients who declined treatment. Several social and cultural factors were associated with the decision to decline therapy, including race, language, ethnicity, and lack of social support. These findings can inform public health efforts to reduce social disparities in the treatment of COVID-19 and increase utilization of monoclonal antibody therapies in high risk populations.

scholarly journals 549. Monoclonal Antibody Therapy for COVID-19 Infection in Michigan: The Flint Experience

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S376-S377
Author(s):  
Mariam Younas ◽  
Danielle Osterholzer ◽  
Brandon R Flues ◽  
Carlos Rios-Bedoya ◽  
Philip McDonald ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
High Risk ◽  
Mortality Rate ◽  
Medical Center ◽  
Demographic Data ◽  
Severe Disease ◽  
Antibody Therapy ◽  
Hospitalization Rate ◽  
P Value ◽  
Underserved Area

Abstract Background Bamlanivimab (BAM), a neutralizing IgG1 monoclonal antibody (mAb), received emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for treatment of mild to moderate COVID-19 infection in patients 12 years of age and older weighing at least 40 kg at high risk for progressive and severe disease on Nov 10, 2020. The purpose of this study is to describe our experience with this treatment modality. Methods Hurley Medical Center (HMC), is a 443-bed inner city teaching hospital in Flint, MI. HMC administered its first BAM infusion on Nov 19, 2020. Through April 30, 2021, 407 patients with confirmed SARS-CoV-2 infection, received a mAb infusion. 62/407 patients received the combination mAb therapy of BAM + Etesevimab, as the EUA for BAM monotherapy was revoked on 04/16/21. We retrospectively collected basic demographic data and hospitalization to our facility within 14 days of receiving mAb therapy on these patients. Results During the 5.5 month study period, patients receiving mAb therapy at HMC had a mean age of 56 years (yrs) (± standard deviation) (± 15.4) and a mean Body Mass Index (BMI) of 34 kg/m² (± 8.5) (Tables 1,2). African Americans (AA) comprised 48% (194/407) (Table 3) and females comprised 54% (220/407) of the cohort. 6% (25/407) of the patients required hospitalization within 14 days of mAb infusion, had a mean age of 58 yrs (± 17) (p-value 0.62) and a mean BMI of 32 kg/m² (± 9) (p-value 0.33). Females and AA comprised 56% (14/25) and 48% (12/25) of this subgroup respectively (p-value 1.0). No deaths were reported within 30 days of infusion in this cohort. Conclusion Previously published reports cite a hospitalization rate in untreated high-risk COVID-19 infected patients of 9-15%. During the period of study, the county hospitalization rate and county mortality rate for all comers with COVID-19 was 6.6% and 2.7% respectively while our high risk cohort had a hospitalization rate of 6% and with no deaths reported. Our cohort had much lower rates of hospitalization and death than would be expected especially in a group which comprised of 48% AA in an underserved area. mAb therapy seems to have a protective effect with significant reduction in the hospitalization and mortality rate among high-risk patients with COVID-19 infection and should be prioritized for administration. Disclosures All Authors: No reported disclosures

scholarly journals Use of monoclonal antibody therapy for nosocomial SARS-CoV-2 infection in patients at high risk for severe COVID-19: experience from a tertiary-care hospital in Germany

Infection ◽  
2021 ◽  
Author(s):  
Johanna Koehler ◽  
Barbara Ritzer ◽  
Simon Weidlich ◽  
Friedemann Gebhardt ◽  
Chlodwig Kirchhoff ◽  
...  
Keyword(s):  
High Risk ◽  
Tertiary Care Hospital ◽  
Severe Disease ◽  
Treatment Options ◽  
Tertiary Care ◽  
Antibody Therapy ◽  
Additional Treatment ◽  
Care Hospital ◽  
Cross Sectional ◽  
Asymptomatic Patients

AbstractAdditional treatment options for coronavirus disease (COVID-19) are urgently needed, particularly for populations at high risk of severe disease. This cross-sectional, retrospective study characterized the outcomes of 43 patients with nosocomial severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection with and without treatment using monoclonal SARS-CoV-2 spike antibodies (bamlanivimab or casirivimab/imdevimab). Our results indicate that treatment with monoclonal antibodies results in a significant decrease in disease progression and mortality when used for asymptomatic patients with early SARS-CoV-2 infection.

scholarly journals Inhalation monoclonal antibody therapy: a new way to treat and manage respiratory infections

2021 ◽  
Author(s):  
Hilal Ahmad Parray ◽  
Shivangi Shukla ◽  
Reshma Perween ◽  
Ritika Khatri ◽  
Tripti Shrivastava ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Respiratory Infections ◽  
Antibody Therapy ◽  
Monoclonal Antibody Therapy
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