Early Monoclonal Antibody Administration Can Reduce Both Hospitalizations and Mortality in High-Risk Outpatients With Coronavirus Disease 2019 (COVID-19)

Jenks, Jeffrey D.; Aslam, Saima; Horton, Lucy E; Logan, Cathy; Taremi, Mahnaz; Vaida, Florin; Ritter, Michele; Bharti, Ajay; Law, Nancy; Bordeaux, Kathleen; Guerrero, Claudia; Paddock, Diana; Bautista, Joseph; Medrano-Fernández, Alejandra; Arend, Sarah; Williams, Mackenzie; Vega, Marvin Ochoa; Montilla, C.

doi:10.1093/cid/ciab522

Cited by 18 publications

(26 citation statements)

References 1 publication

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“…Our findings are in agreement with two randomized controlled trials 7 , 9 and three retrospective studies. 8 , 10 , 11 However, efficacy in transplant recipients was not explicitly analyzed in the clinical trials 7 , 9 and one retrospective report. 10 Kumar et al 8 included 109 immunocompromised patients in their study but did not specify how many were OTR.…”

Section: Discussionmentioning

confidence: 99%

“… 8 , 10 , 11 However, efficacy in transplant recipients was not explicitly analyzed in the clinical trials 7 , 9 and one retrospective report. 10 Kumar et al 8 included 109 immunocompromised patients in their study but did not specify how many were OTR. Del Bello et al recently reported improved outcomes in 16 OTR who were treated with mAbs compared to 32 historical controls without multivariate or time‐to‐event analyses.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, despite study limitations, our conclusions are well‐aligned with those of two randomized, double‐blinded, placebo‐controlled clinical trials, 7 , 9 and two large retrospective studies with concurrent controls. 8 , 10 …”

Section: Discussionmentioning

confidence: 99%

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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

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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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

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“…Multiple studies demonstrate the e cacy of monoclonal antibodies (mAb) in preventing progression of COVID-19 when administered to high-risk patients early in disease presentation. [1][2][3][4][5][6] A study by Cooper and colleagues evaluated nearly 3000 patients with coronavirus disease 2019 (COVID-19) who received mAb therapies in Houston, TX. 7 Compared to a propensity-matched control cohort, mAb-treated patients had signi cantly lower rates of hospitalization at 14-and 28-days and decreased mortality at 28-days postinfusion.…”

Section: Introductionmentioning

confidence: 99%

A Real-World Assessment of Unvaccinated And Vaccinated Patients With Coronavirus Disease 2019 (COVID-19) Treated With Monoclonal Antibodies During The Delta Wave

Guo

Cowman

Chang

et al. 2022

Preprint

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Background: Monoclonal antibodies (mAb) prevent COVID-19 progression during early disease presentation. We aimed to compare the mAb treatment outcomes among vaccinated and unvaccinated patients during Delta wave and assess the feasibility of implementing stricter eligibility criteria given mAb scarcity in New York City.Methods: We conducted a retrospective observational study of casirivimab/imdevimab recipients with mild-to-moderate COVID-19 infection in an emergency department or outpatient infusion center (July 1 – August 20, 2021). The outcome was all-cause hospital admission within 30 days post-treatment between vaccinated vs. unvaccinated patients during Delta surge in the Bronx, NY. Results: A total of 250 patients received casirivimab/imdevimab (162 unvaccinated vs. 88 vaccinated). The median age was 39 years for unvaccinated patients, and 52 years for vaccinated patients (p<0.0001). The median number of EUA criteria met was 1 for unvaccinated and 2 for vaccinated patients (p<0.0001). Overall, 6% (15/250) of patients were admitted within 30 days post-treatment. Eleven unvaccinated patients (7%) were admitted (all-cause) within 30-days compared to 4 (5%) of vaccinated patients (p=0.48).Conclusions: All-cause 30-day admission was not statistically different between vaccinated and unvaccinated patients. With limited federal allocation of therapies, programs must prioritize patients at highest risk of hospitalization and death regardless of vaccination status.

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“…All three regimens were given EUA by the U.S. FDA for the treatment of non-hospitalized patients with mild to moderate COVID-19 infection who are at high risk for progression to severe disease. Although COVID-19 positive patients receiving bamlanivimab early after the onset of the symptoms as an outpatient had lower 30-day hospitalization [54] as well as those with high risk (elderly, African American, Native American, and/ or Hispanic/Latino ethnicity, obese, and co-morbidities including hypertension, diabetes, coronary artery disease, chronic lung diseases, CKD, immunosuppressed) receiving casirivimab/imdevimab or bamlanivimab showed a reduction in 30-day hospitalization and COVID-19-related mortality [55], the EUA for bamlanivimab and bamlanivimab/etesevimab have since been withdrawn due to concerns for reduced efficacy with the emergence of SARS-CoV-2 viral variants [56][57][58].…”

Section: Monoclonal Antibodiesmentioning

confidence: 99%

Kidney Transplantation during the COVID-19 Pandemic: From Past through Present Time of Emerging Vaccine

Jittirat¹,

Eguchi²,

Tanphaichitr³

et al. 2021

OBM ICM

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The novel coronavirus disease 2019 (COVID-19) pandemic has significantly impacted kidney transplantation worldwide. The rate of kidney transplantation decreased during the peak of the COVID-19 pandemic, especially living donor kidney transplantation. Kidney transplant recipients are at high risk of developing severe complications from COVID-19 due to underlying comorbidities and immunosuppressed status. Management of immunosuppression, including the induction therapy and maintenance immunosuppressive regimen, has been modified at many transplant centers during the pandemic. In severe acute respiratory virus syndrome coronavirus 2 (SARS-CoV-2) infected kidney transplant recipients, the immunosuppression is usually reduced. The acute rejection treatment is usually individualized based on the risks and benefits. Several COVID-19 therapies have received emergency use authorization to prevent the progression of COVID-19 severity. Use of oral antiviral therapies is faced with challenges in terms of drug-drug interaction, drug efficacy, and lack of data in the transplant population. For COVID-19 prophylaxis in kidney transplant recipients, the effectiveness of COVID-19 vaccines is lower compared to the general population. Pre-exposure prophylaxis with a long-acting antibody combination may be an adjunct strategy for vaccination in kidney transplant recipients or those for whom COVID-19 vaccination is not contraindicated. Post-exposure prophylaxis remains to be studied. Further studies are necessary to establish standard guidelines of immunosuppressive management in kidney transplant recipients diagnosed with COVID-19 and to better understand the outcomes and adverse drug reactions of the therapeutic and prophylactic modalities including vaccination in this high-risk population.

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Early Monoclonal Antibody Administration Can Reduce Both Hospitalizations and Mortality in High-Risk Outpatients With Coronavirus Disease 2019 (COVID-19)

Cited by 18 publications

References 1 publication

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

A Real-World Assessment of Unvaccinated And Vaccinated Patients With Coronavirus Disease 2019 (COVID-19) Treated With Monoclonal Antibodies During The Delta Wave

Kidney Transplantation during the COVID-19 Pandemic: From Past through Present Time of Emerging Vaccine

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