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Article ; Online: Monoclonal Antibody for Patients with Covid-19.

Jaworski, Juan P

2021 Volume 384, Issue 12, Page(s) 1170–1171

MeSH term(s)	Antibodies, Monoclonal ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 ; Humans ; SARS-CoV-2
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Neutralizing ; Antibodies, Viral
Language	English
Publishing date	2021-02-03
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2100221
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Article ; Online: Prolonged viral pneumonia and high mortality in COVID-19 patients on anti-CD20 monoclonal antibody therapy.

Feuth, Eeva / Nieminen, Valtteri / Palomäki, Antti / Ranti, Juha / Sucksdorff, Marcus / Finnilä, Taru / Oksi, Jarmo / Vuorinen, Tytti / Feuth, Thijs

European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology

2024 Volume 43, Issue 4, Page(s) 723–734

Abstract: Purpose: In clinical practice, we observed an apparent overrepresentation of COVID-19 patients ... of COVID-19 in these patients.: Methods: All adult patients from Turku University Hospital, Turku ... hospitalized due to COVID-19. Patients with demyelinating disorder (n = 20) were youngest (median age 36.5 ...

Abstract	Purpose: In clinical practice, we observed an apparent overrepresentation of COVID-19 patients on anti-CD20 monoclonal antibody therapy. The aim of this study was to characterize the clinical picture of COVID-19 in these patients. Methods: All adult patients from Turku University Hospital, Turku, Finland, with COVID-19 diagnosis and/or positive SARS-CoV-2 PCR test result up to March 2023, and with anti-CD20 therapy within 12 months before COVID-19 were included. Data was retrospectively obtained from electronic patient records. Results: Ninety-eight patients were identified. 44/93 patients (47.3%) were hospitalized due to COVID-19. Patients with demyelinating disorder (n = 20) were youngest (median age 36.5 years, interquartile range 33-45 years), had less comorbidities, and were least likely to be hospitalized (2/20; 10.0%) or die (n = 0). COVID-19 mortality was 13.3% in the whole group, with age and male sex as independent risk factors. Persistent symptoms were documented in 33/94 patients (35.1%) alive by day 30, in 21/89 patients (23.6%) after 60 days, and in 15/85 after 90 days (17.6%), mostly in patients with haematological malignancy or connective tissue disease. Prolonged symptoms after 60 days predisposed to persistent radiological findings (odds ratio 64.0; 95% confidence interval 6.3-711; p < 0.0001) and persistently positive PCR (odds ratio 45.5, 95% confidence interval 4.0-535; p < 0.0001). Several patients displayed rapid response to late antiviral therapy. Conclusion: Anti-CD20 monoclonal antibody therapy is associated with high COVID-19 mortality and with a phenotype consistent with prolonged viral pneumonia. Our study provides rationale for retesting of immunocompromised patients with prolonged COVID-19 symptoms and considering antiviral therapy.
MeSH term(s)	Adult ; Humans ; Male ; Middle Aged ; COVID-19 ; SARS-CoV-2 ; COVID-19 Testing ; Retrospective Studies ; Pneumonia, Viral/diagnosis ; Antineoplastic Agents/therapeutic use ; Antibodies, Monoclonal/therapeutic use ; Antiviral Agents/therapeutic use
Chemical Substances	Antineoplastic Agents ; Antibodies, Monoclonal ; Antiviral Agents
Language	English
Publishing date	2024-02-15
Publishing country	Germany
Document type	Journal Article
ZDB-ID	603155-9
ISSN	1435-4373 ; 0934-9723 ; 0722-2211
ISSN (online)	1435-4373
ISSN	0934-9723 ; 0722-2211
DOI	10.1007/s10096-024-04776-0
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Article ; Online: Monoclonal Antibody for Patients with Covid-19. Reply.

Lundgren, Jens D / Lane, H Clifford / Neaton, James D

The New England journal of medicine

2021 Volume 384, Issue 12, Page(s) 1171

MeSH term(s)	Antibodies, Monoclonal ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 ; Humans ; SARS-CoV-2
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Neutralizing ; Antibodies, Viral
Language	English
Publishing date	2021-02-03
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2100221
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Article: Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19.

Zou, Jingrui / Jing, Fuyuan

Pharmaceuticals (Basel, Switzerland)

2022 Volume 15, Issue 12

Abstract: ... in COVID-19 patients. Disproportionality analyses were conducted using reporting odds ratio and information ... component to identify safety signals. About 10% of adverse events in COVID-19 patients were cardiovascular ... events may be considered for certain COVID-19 patients at risk when they are treated ...

Abstract	Little is known about cardiovascular safety profiles for monoclonal antibody products that received the FDA Emergency Use Authorization for COVID-19. In this study, data from the FDA Adverse Event Reporting System from the first quarter of 2020 to the second quarter of 2022 were used to investigate cardiovascular safety signals associated with seven monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, sotrovimab, tocilizumab, bebtelovimab, tixagevimab + cilgavimab) in COVID-19 patients. Disproportionality analyses were conducted using reporting odds ratio and information component to identify safety signals. About 10% of adverse events in COVID-19 patients were cardiovascular adverse events. Four monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, and bebtelovimab) were associated with higher reporting of hypertension. Tocilizumab was associated with higher reporting of cardiac failure and embolic and thrombotic event. Casirivimab + imdevimab and bamlanivimab were also associated with higher reporting of ischemic heart disease. No cardiovascular safety signals were identified for sotrovimab and tixagevimab + cilgavimab. The results indicate differential cardiovascular safety profiles in monoclonal antibodies. Careful monitoring of cardiovascular events may be considered for certain COVID-19 patients at risk when they are treated with monoclonal antibodies.
Language	English
Publishing date	2022-11-26
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2193542-7
ISSN	1424-8247
ISSN	1424-8247
DOI	10.3390/ph15121472
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Article ; Online: Administration of Monoclonal Antibody for COVID-19 in Patient Homes.

Malani, Anurag N / LaVasseur, Beth / Fair, Jason / Domeier, Robert / Vershum, Rita / Fowler, Robin / Collins, Curtis D

JAMA network open

2021 Volume 4, Issue 10, Page(s) e2129388

MeSH term(s)	Antibodies, Monoclonal/therapeutic use ; COVID-19/therapy ; Cohort Studies ; Female ; Home Care Services/statistics & numerical data ; Humans ; Immunologic Factors/therapeutic use ; Male ; Michigan ; Middle Aged ; SARS-CoV-2/immunology
Chemical Substances	Antibodies, Monoclonal ; Immunologic Factors
Language	English
Publishing date	2021-10-01
Publishing country	United States
Document type	Journal Article
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2021.29388
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Article ; Online: Evaluation of the tolerability of monoclonal antibody therapy for pregnant patients with COVID-19.

Magawa, Shoichi / Nii, Masafumi / Maki, Shintaro / Enomoto, Naosuke / Takakura, Sho / Maegawa, Yuka / Osato, Kazuhiro / Tanaka, Hiroaki / Kondo, Eiji / Ikeda, Tomoaki

The journal of obstetrics and gynaecology research

2022 Volume 48, Issue 9, Page(s) 2325–2333

Abstract: ... with COVID-19 in Japan and its impact on the neonate and process of delivery.: Methods: Eight cases ... of pregnancy complicated by COVID-19 and requiring hospitalization during the delta variant epidemic were ... the fever improved within 24 h, which suggests rapid improvement in patient condition. ...

Abstract	Aim: To evaluate the tolerability of casirivimab and imdevimab (CAS/IMB) therapy in pregnant women with COVID-19 in Japan and its impact on the neonate and process of delivery. Methods: Eight cases of pregnancy complicated by COVID-19 and requiring hospitalization during the delta variant epidemic were included. Gestational age, initial symptoms, pregnancy complications and outcome, severity of illness, blood test findings at the time of treatment initiation and on days 3-5 after administration, body temperature at administration, and 8, 24, and 48 h post-administration, delivery outcome, and neonatal findings were recorded. Ten pregnant women who required hospitalization at the same time and did not receive CAS/IMB were used as controls. Results: Of the eight cases, seven were mild, and one case was of moderate severity. Body temperature in the CAS/IMB group was significantly higher at 8 h post-administration than that at the time of administration. However, body temperature significantly reduced at 24 and 48 h post-administration in the CAS/IMB group compared with that in the control group. There were no apparent adverse events after CAS/IMB administration. Conclusions: Maternal administration of CAS/IMB was safe. Although it was difficult to evaluate the improvement in disease by blood test findings, the fever improved within 24 h, which suggests rapid improvement in patient condition.
MeSH term(s)	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; COVID-19/drug therapy ; Female ; Humans ; Infant, Newborn ; Pregnancy ; Pregnancy Complications, Infectious/drug therapy ; SARS-CoV-2
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; imdevimab (2Z3DQD2JHM) ; casirivimab (J0FI6WE1QN)
Language	English
Publishing date	2022-06-24
Publishing country	Australia
Document type	Journal Article
ZDB-ID	1327307-3
ISSN	1447-0756 ; 1341-8076
ISSN (online)	1447-0756
ISSN	1341-8076
DOI	10.1111/jog.15338
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Zs.A 1810: Show issues

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Article: The Treatment of COVID-19 With Monoclonal Antibody Therapy: Patient-Reported Outcomes.

Lamour, Daniella / Vafadari, Nika / Clayton, Lisa M / Solano, Joshua J / Hughes, Patrick G / Shih, Richard D / Alter, Scott M

Cureus

2022 Volume 14, Issue 9, Page(s) e29247

Abstract: ... by the US Food and Drug Administration (FDA) under emergency use authorization (EUA) in 2020. This study surveyed COVID-19 patients ... enrolled in the study. This included patients over 18 years of age with a confirmed positive COVID-19 test ... about their disease course and experience with monoclonal antibody treatment. Methods Patients who received ...

Abstract	Objective There have been many efforts to research and produce treatment modalities for COVID-19. Monoclonal antibodies have been one of the effective treatments since their approval by the US Food and Drug Administration (FDA) under emergency use authorization (EUA) in 2020. This study surveyed COVID-19 patients about their disease course and experience with monoclonal antibody treatment. Methods Patients who received monoclonal antibody treatment between February 12, 2021, and June 2, 2021, at a South Florida community hospital were enrolled in the study. This included patients over 18 years of age with a confirmed positive COVID-19 test result, with mild to moderate symptoms within 10 days of onset and identified as high risk for progression to severe disease. There were no exclusion criteria. After 30 days, patients were followed up via a structured telephone survey regarding subsequent emergency department (ED) visits for worsening COVID-19 symptoms, need for oxygenation, intubation, and death. Secondary outcomes were adverse effects and patient perceptions. Results Among the 119 patients who received monoclonal antibodies during the established time frame, 93 (78.1%) consented to participate in the telephone survey. Of these, 11.8% had a subsequent visit to the ED for worsening COVID-19 symptoms, 6.5% required oxygen, and 2.2% were admitted to the intensive care unit (ICU). There were no reported intubations or deaths. The vast majority (91.4%) would recommend monoclonal antibody treatment to others. Conclusion Patients who received monoclonal antibody therapy had low rates of subsequent ED visits and rarely required oxygen or ICU admission. The majority of patients would recommend treatment with monoclonal antibodies to others.
Language	English
Publishing date	2022-09-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2747273-5
ISSN	2168-8184
ISSN	2168-8184
DOI	10.7759/cureus.29247
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Article ; Online: Implementation and patient outcomes of a pediatric COVID-19 monoclonal antibody program.

Blind, Jill E / Sapko, Matt / Killough, Alex / Thornton, Hannah / Watson, Joshua R

Journal of the Pediatric Infectious Diseases Society

2022

Abstract: ... Results: A total of 182 patients ≤21 years old received a COVID-19 mAb infusion between November 27, 2020 ... Background: The severity and reach of the COVID-19 pandemic drove the development of various ... risk assessments when considering COVID-19 mAb therapies in children and adolescents due to limited data ...

Abstract	Background: The severity and reach of the COVID-19 pandemic drove the development of various therapeutic approaches to combat SARS-CoV-2, including several neutralizing monoclonal antibody (mAb) therapies. A January 2021 pediatric consensus statement opposed routine use and recommended individualized risk assessments when considering COVID-19 mAb therapies in children and adolescents due to limited data. This report describes the implementation of a mAb referral process and clinical outcomes of patients who received a mAb infusion in a pediatric hospital. Methods: We developed a tiered allocation system based on underlying medical conditions and incorporated it into a standardized COVID-19 mAb referral and approval process. Demographics and clinical data were collected on all patients who received mAb therapy for treatment or post-exposure prophylaxis. Data recorded included socio-demographics, qualifying underlying medical condition, clinical manifestations of infection, and overall course of treatment and disease. Results: A total of 182 patients ≤21 years old received a COVID-19 mAb infusion between November 27, 2020, and January 26, 2022. Patient age ranged from 10 months to 21 years, with a median age of 15 years. In total, 7 patients (4%) had suspected adverse reactions during the infusion, and 15 (8%) patients required a COVID-19-related visit within 30 days of the mAb infusion. Conclusion: A tiered allocation process may provide the framework for the stratification and efficient distribution of mAb therapies. Future research must focus on efficacy of these therapies in the pediatric population, standardized therapeutic prioritization, and the optimal timeframe for mAb delivery to prevent progression to severe disease.
Language	English
Publishing date	2022-10-06
Publishing country	England
Document type	Journal Article
ZDB-ID	2668791-4
ISSN	2048-7207 ; 2048-7193
ISSN (online)	2048-7207
ISSN	2048-7193
DOI	10.1093/jpids/piac107
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Article ; Online: Immune cell kinetics and antibody response in COVID-19 patients with low-count monoclonal B-cell lymphocytosis.

Oliva-Ariza, Guillermo / Fuentes-Herrero, Blanca / Lecrevisse, Quentin / Carbonell, Cristina / Pérez-Pons, Alba / Torres-Valle, Alba / Pozo, Julio / Martín-Oterino, José Ángel / González-López, Óscar / López-Bernús, Amparo / Bernal-Ribes, Marta / Belhassen-García, Moncef / Pérez-Escurza, Oihane / Pérez-Andrés, Martín / Vazquez, Lourdes / Hernández-Pérez, Guillermo / García Palomo, Francisco Javier / Leoz, Pilar / Costa-Alba, Pilar /

Pérez-Losada, Elena / Yeguas, Ana / Santos Sánchez, Miryam / García-Blázquez, Marta / Morán-Plata, F Javier / Damasceno, Daniela / Botafogo, Vitor / Muñoz-García, Noemí / Fluxa, Rafael / van Dongen, Jacques J M / Marcos, Miguel / Almeida, Julia / Orfao, Alberto

American journal of hematology

2023 Volume 98, Issue 12, Page(s) 1909–1922

Abstract: Low-count monoclonal B-cell lymphocytosis (MBL ...

Abstract	Low-count monoclonal B-cell lymphocytosis (MBL
MeSH term(s)	Humans ; Lymphocytosis ; B-Lymphocytes ; Leukemia, Lymphocytic, Chronic, B-Cell/diagnosis ; Antibody Formation ; COVID-19 ; SARS-CoV-2 ; Neoplasms, Plasma Cell ; Precancerous Conditions ; Antibodies, Viral
Chemical Substances	Antibodies, Viral
Language	English
Publishing date	2023-10-04
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	196767-8
ISSN	1096-8652 ; 0361-8609
ISSN (online)	1096-8652
ISSN	0361-8609
DOI	10.1002/ajh.27119
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Zs.A 1251: Show issues

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Article ; Online: Implementation of an Emergency Department-Embedded Infusion Center for the Administration of Monoclonal Antibody Therapy in Patients With Early COVID-19 Infection.

Graham, Julie / Ballejos, Christina / Jenkins, Danisha / Kelley, Christina

Journal of infusion nursing : the official publication of the Infusion Nurses Society

2023 Volume 45, Issue 1, Page(s) 41–48

Abstract: The coronavirus disease 2019 (COVID-19) pandemic has tested nurse staffing and other resources ... persons who are immunocompromised, and introducing COVID-19-positive individuals could threaten the safety ... requires a location where patients can receive specialized care and monitoring for a period of 2 hours ...

Abstract	The coronavirus disease 2019 (COVID-19) pandemic has tested nurse staffing and other resources necessary for lifesaving treatment. The emergency use authorization in November 2020 of bamlanivimab as monotherapy and casirivimab/imdevimab as combination therapy brought hope to many as an option for outpatients at risk for severe illness. However, logistical concerns were soon revealed, because safe administration requires a location where patients can receive specialized care and monitoring for a period of 2 hours. This type of therapy would normally be offered at an outpatient infusion center. These centers often serve persons who are immunocompromised, and introducing COVID-19-positive individuals could threaten the safety of this population. This article describes the deployment of an emergency department-embedded infusion center set up for the purpose of supporting community members and providers electing for this treatment option.
MeSH term(s)	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Antibodies, Neutralizing ; COVID-19 ; Emergency Service, Hospital ; Humans ; SARS-CoV-2
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Antibodies, Neutralizing ; imdevimab (2Z3DQD2JHM) ; bamlanivimab (45I6OFJ8QH) ; casirivimab (J0FI6WE1QN)
Language	English
Publishing date	2023-02-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	2192558-6
ISSN	1539-0667 ; 1533-1458
ISSN (online)	1539-0667
ISSN	1533-1458
DOI	10.1097/NAN.0000000000000453
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