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

Bierle, Dennis M.; Ganesh, Ravindra; Wilker, Caroline G.; Hanson, Sara N; Moehnke, Darcie E; Jackson, Tammy A.; Ramar, Priya; Rosedahl, Jordan; Philpot, Lindsey M.; Razonable, Raymund R.

doi:10.1177/21501327211019282

Cited by 43 publications

(42 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Black race and Hispanic ethnicity were strongly associated with hospitalization or ER visit and these patients were the minority in the group receiving mAbs. The latter finding agrees with a recent large‐scale report, which, nevertheless, included mostly White non‐Hispanic patients 24 . It is possible that novel therapeutics for COVID‐19 are less accessible to patients who identify as minorities 25 …”

Section: Discussionsupporting

confidence: 89%

“…Higher complexity favors the acceptance of investigational treatments. 24 However, because of a higher degree of medical complexity, Black or Hispanic patients can present frequently with severe disease, which may have prompted a lower threshold for hospital admission over outpatient management with mAbs. More than half of Black (54.5%) or Hispanic (58.5%) patients who were not given mAbs when mAbs were available had symptoms for >10 days or required hospital admission (Table S2 ).…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Use of anti-spike monoclonal antibodies in kidney transplant recipients with COVID-19: Efficacy, ethnic and racial disparities

Klein

Hardesty

Vieira

et al. 2022

American Journal of Transplantation

View full text Add to dashboard Cite

Organ transplant recipients may not mount an adequate immune response to COVID‐19 infection and therefore may benefit greatly from passive immunization with anti‐spike monoclonal antibodies (mAbs), which have been shown to decrease hospitalization rates in the general outpatient population. We evaluated the efficacy of mAb therapy in decreasing hospitalizations or emergency room (ER) visits among kidney transplant recipients (KTR) with COVID‐19. We identified KTR with COVID‐19 between March 1, 2020 and April 30, 2021. Patients were excluded if they had multi‐organ transplant or hospital‐acquired COVID‐19. We studied 95 KTR; 20 received mAb. mAb administration was associated with a significant decrease in hospitalizations or ER visits (15% vs. 76%, p < 0.001). This association remained significant after adjustment for potential confounders, and analysis of mAb administration as a time‐dependent variable, with day of symptom onset as day 1 (adjusted HR 0.216, p = 0.04). Black or Hispanic patients were less likely to receive mAb and more likely to be admitted to the hospital or visit the ER. In our KTR population, mAb therapy for COVID‐19 may have helped decrease hospitalizations and ER visits. Healthcare inequities, including access to investigational treatments, have been exacerbated by the COVID‐19 pandemic. Antiviral mAbs are a promising therapeutic modality, especially for immunocompromised patients.

show abstract

Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Use of anti-spike monoclonal antibodies in kidney transplant recipients with COVID-19: Efficacy, ethnic and racial disparities

Klein

Hardesty

Vieira

et al. 2022

American Journal of Transplantation

View full text Add to dashboard Cite

show abstract

“…reasons might include hesitancy about receiving treatment; a previous study found patients who were non-Hispanic White and English-speaking accepted mAb treatment more often than did those who were non-White and Hispanic (6).…”

Section: Discussionmentioning

confidence: 99%

Racial and Ethnic Disparities in Receipt of Medications for Treatment of COVID-19 — United States, March 2020–August 2021

Wiltz¹,

Feehan²,

Molinari³

et al. 2022

MMWR Morb. Mortal. Wkly. Rep.

110

View full text Add to dashboard Cite

On January 14, 2022, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr).The COVID-19 pandemic has magnified longstanding health care and social inequities, resulting in disproportionately high COVID-19-associated illness and death among members of racial and ethnic minority groups (1). Equitable use of effective medications (2) could reduce disparities in these severe outcomes (3). Monoclonal antibody (mAb) therapies against SARS-CoV-2, the virus that causes COVID-19, initially received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) in November 2020. mAbs are typically administered in an outpatient setting via intravenous infusion or subcutaneous injection and can prevent progression of COVID-19 if given after a positive SARS-CoV-2 test result or for postexposure prophylaxis in patients at high risk for severe illness. † Dexamethasone, a commonly used steroid, and remdesivir, an antiviral drug that received EUA from FDA in May 2020, are used in inpatient settings and help prevent COVID-19 progression § (2). No large-scale studies have yet examined the use of mAb by race and ethnicity. Using COVID-19 patient electronic health record data from 41 U.S. health care systems that participated in the PCORnet, the National Patient-Centered Clinical Research Network, ¶ this study assessed receipt of medications for COVID-19 treatment by race (White, Black, Asian, and Other races [including American Indian or Alaska Native, Native Hawaiian or Other * These authors contributed equally to this report. † Fact sheets for healthcare providers for FDA emergency use authorization are available from https://www.fda.gov/media/145611/download for REGEN-COV (casirivimab and imdevimab) and https://www.fda.gov/ media/145802/download for bamlanivimab and etesevimab. The SARS-CoV-2 B.1.1.529 (Omicron) variant is not neutralized by bamlanivimab and etesevimab or casirivimab and imdevimab, the mAb-based COVID-19 treatments that were most frequently prescribed before the emergence of Omicron. § https://www.covid19treatmentguidelines.nih.gov/management/ clinical-management/ ¶ PCORnet is a national network-of-networks developed to conduct patientcentered outcomes research. The PCORnet infrastructure supports large-scale studies using its distributed data network.

show abstract

“…This data confirms that timely and early administration of monoclonal antibodies is associated with a significantly lower risk of hospitalization. The providers should be aware of and address any possible disparities involving underrepresented populations when providing these potentially lifesaving options [35,42].…”

Section: Anti-sars-cov-2 Monoclonal Antibody In Solid Organ Transplan...mentioning

confidence: 99%

COVID-19 and Solid Organ Transplantation: Role of Anti-SARS-CoV-2 Monoclonal Antibodies

Dhand

Razonable

2022

Curr Transpl Rep

Self Cite

View full text Add to dashboard Cite

Purpose of Review Solid organ transplant recipients (SOTRs) are ideal candidates for early treatment or prevention of coronavirus disease 2019 (COVID-19) using anti-SARS-CoV-2 monoclonal antibodies because of multiple underlying medical conditions, chronic immune-suppression, sub-optimal immunogenic response to vaccination, and evolving epidemiological risks. In this article, we review pertinent challenges regarding the management of COVID-19 in SOTRs, describe the role of active and passive immunity in the treatment and prevention of COVID-19, and review real-world data regarding the use of anti-SARS-CoV-2 monoclonal antibodies in SOTRs. Recent Findings The use of an anti-SARS-CoV-2 monoclonal antibody in high-risk solid organ transplant recipients is associated with a reduction in the risk of hospitalization, need for intensive care, and death related to COVID-19. Overall, the early experiences from a diverse population of solid organ transplant recipients who were treated with anti-spike monoclonal antibodies are encouraging with no reported acute graft injury, severe adverse events, or deaths related to COVID-19. Summary Anti-SARS-CoV-2 antibodies are currently authorized for treatment of mild-moderate COVID-19 and post-exposure prophylaxis, including in SOTRs. Potential future uses include pre-exposure prophylaxis in certain high-risk persons and synergistic use along with emerging oral treatment options. Successful timely administration of anti-SARS-CoV-2 monoclonal antibodies requires a multidisciplinary team approach, effective communication between patients and providers, awareness of circulating viral variants, acknowledgement of various biases affecting treatment, and close monitoring for efficacy and tolerability.

show abstract

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

Cited by 43 publications

References 20 publications

Use of anti-spike monoclonal antibodies in kidney transplant recipients with COVID-19: Efficacy, ethnic and racial disparities

Use of anti-spike monoclonal antibodies in kidney transplant recipients with COVID-19: Efficacy, ethnic and racial disparities

Racial and Ethnic Disparities in Receipt of Medications for Treatment of COVID-19 — United States, March 2020–August 2021

COVID-19 and Solid Organ Transplantation: Role of Anti-SARS-CoV-2 Monoclonal Antibodies

Contact Info

Product

Resources

About