Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents

被引：45

作者：

Wolf, Joshua ^{[1
,2
]}

Abzug, Mark J. ^{[3
,4
]}

Wattier, Rachel L. ^{[5
]}

Sue, Paul K. ^{[6
]}

Vora, Surabhi B. ^{[7
,8
]}

Zachariah, Philip ^{[9
]}

Dulek, Daniel E. ^{[10
,11
]}

Waghmare, Alpana ^{[7
,8
,12
]}

Olivero, Rosemary ^{[13
]}

Downes, Kevin J. ^{[14
]}

James, Scott H. ^{[15
]}

Pinninti, Swetha G. ^{[15
]}

Yarbrough, April ^{[16
]}

Aldrich, Margaret L. ^{[17
]}

MacBrayne, Christine E. ^{[18
]}

Soma, Vijaya L. ^{[19
,20
]}

Grapentine, Steven P. ^{[21
]}

Oliveira, Carlos R. ^{[22
]}

Hayes, Molly ^{[23
]}

Kimberlin, David W. ^{[15
]}

Jones, Sarah B. ^{[24
]}

Bio, Laura L. ^{[25
]}

Morton, Theodore H. ^{[1
]}

Hankins, Jane S. ^{[26
]}

Maron, Gabriela M. ^{[1
]}

Timberlake, Kathryn ^{[27
]}

Young, Jennifer L. ^{[28
]}

Orscheln, Rachel C. ^{[29
,30
]}

Schwenk, Hayden T. ^{[31
,32
]}

Goldman, David L. ^{[17
]}

Groves, Helen E. ^{[33
]}

Huskins, W. Charles ^{[34
]}

Rajapakse, Nipunie S. ^{[34
]}

Lamb, Gabriella S. ^{[35
]}

Tribble, Alison C. ^{[36
,37
]}

Lloyd, Elizabeth C. ^{[36
,37
]}

Hersh, Adam L. ^{[38
,39
]}

Thorell, Emily A. ^{[38
,39
]}

Ratner, Adam J. ^{[19
,20
,40
]}

Chiotos, Kathleen ^{[14
,41
]}

Nakamura, Mari M. ^{[35
,42
]}

机构：

[1] St Jude Childrens Res Hosp, Dept Infect Dis, 262 Danny Thomas Pl,MS 320, Memphis, TN 38105 USA

[2] Univ Tennessee, Dept Pediat, Hlth Sci Ctr, Memphis, TN USA

[3] Univ Colorado, Dept Pediat, Div Infect Dis, Sch Med, Aurora, CO USA

[4] Childrens Hosp Colorado, Aurora, CO USA

[5] Univ Calif San Francisco, Dept Pediat, Div Infect Dis & Global Hlth, San Francisco, CA USA

[6] Univ Texas Southwestern Med Ctr Dallas, Dept Pediat, Div Pediat Infect Dis, Dallas, TX USA

[7] Univ Washington, Dept Pediat, Div Pediat Infect Dis, Seattle, WA 98195 USA

[8] Childrens Hosp, Seattle, WA USA

[9] Columbia Univ, Dept Pediat, Div Infect Dis, New York, NY USA

[10] Vanderbilt Univ, Dept Pediat, Div Infect Dis, Nashville, TN USA

[11] Monroe Carell Jr Childrens Hosp, Nashville, TN USA

[12] Fred Hutchinson Canc Res Ctr, Vaccine & Infect Dis Div, Seattle, WA USA

[13] Helen DeVos Childrens Hosp Spectrum Hlth, Michigan State Coll Human Med, Dept Pediat & Human Dev, Sect Infect Dis, Grand Rapids, MI USA

[14] Childrens Hosp Philadelphia, Dept Pediat, Div Infect Dis, Philadelphia, PA USA

[15] Univ Alabama Birmingham, Dept Pediat, Div Pediat Infect Dis, Birmingham, AL USA

[16] Childrens Alabama, Dept Pharm, Birmingham, AL USA

[17] Childrens Hosp Montefiore, Dept Pediat, Div Infect Dis, New York, NY USA

[18] Childrens Hosp Colorado, Dept Pharm, Aurora, CO USA

[19] NYU, Dept Pediat, Div Infect Dis, Grossman Sch Med, New York, NY USA

[20] Hassenfeld Childrens Hosp, New York, NY USA

[21] Univ Calif San Francisco, Dept Pharm, Benioff Childrens Hosp, San Francisco, CA USA

[22] Yale Univ, Sch Med, Dept Pediat, Div Infect Dis & Global Hlth, New Haven, CT 06510 USA

[23] Childrens Hosp Philadelphia, Antimicrobial Stewardship Program, Philadelphia, PA 19104 USA

[24] Boston Childrens Hosp, Dept Pharm, Boston, MA USA

[25] Lucile Packard Childrens Hosp Stanford, Dept Pharm, Palo Alto, CA USA

[26] St Jude Childrens Res Hosp, Dept Hematol, Memphis, TN 38105 USA

[27] Hosp Sick Children, Dept Pharm, Toronto, ON, Canada

[28] St Louis Childrens Hosp, Dept Pharm, St Louis, MO USA

[29] Washington Univ, Div Infect Dis, Dept Pediat, St Louis, MO USA

[30] St Louis Childrens Hosp, St Louis, MO 63178 USA

[31] Stanford Univ, Dept Pediat, Sch Med, Div Infect Dis, Stanford, CA USA

[32] Lucile Packard Childrens Hosp, Stanford, CA USA

[33] Hosp Sick Children, Dept Pediat, Div Infect Dis, Toronto, ON, Canada

[34] Mayo Clin, Coll Med & Sci, Div Pediat Infect Dis, Dept Pediat & Adolescent Med, Rochester, MN USA

[35] Boston Childrens Hosp, Dept Pediat, Div Infect Dis, Boston, MA USA

[36] Univ Michigan, Dept Pediat, Div Infect Dis, Ann Arbor, MI USA

[37] CS Mott Childrens Hosp, Ann Arbor, MI USA

[38] Univ Utah, Dept Pediat, Div Infect Dis, Salt Lake City, UT USA

[39] Primary Childrens Med Ctr, Salt Lake City, UT USA

[40] NYU, Dept Microbiol, Grossman Sch Med, New York, NY 10016 USA

[41] Childrens Hosp Philadelphia, Dept Anesthesia & Crit Care Med, Div Crit Care Med, Philadelphia, PA USA

[42] Boston Childrens Hosp, Antimicrobial Stewardship Program, Boston, MA USA

来源：

JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY | 2021年 / 10卷 / 05期

关键词：

bamlanivimab; casirivimab; COVID-19; imdevimab; pediatric; SICKLE-CELL-DISEASE; UNITED-STATES; COVID-19; OBESITY; ASTHMA;

D O I：

10.1093/jpids/piaa175

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Background. In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (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 the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

引用

页码：629 / 634

页数：6

共 67 条

[1]

Al-Hebshi A, 2020, PEDIATR BLOOD CANCER, V67

[2]

[Anonymous], 2020, WEEKLY UPDATES SELEC

[3]

[Anonymous], [No title captured]

[4]

Appiah-Kubi A, 2020, BRIT J HAEMATOL, V190, P221

[5] Prognosis of patients with sickle cell disease and COVID-19: a French experience [J].

Arlet, Jean-Benoit ;

de Luna, Gonzalo ;

Khimoud, Djamal ;

Odievre, Marie-Helene ;

de Montalembert, Marione ;

Joseph, Laure ;

Chantalat-Auger, Christelle ;

Flamarion, Edouard ;

Bartolucci, Pablo ;

Lionnet, Francois ;

Monnier, Sebastien ;

Guillaumat, Cecile ;

Santin, Aline .

LANCET HAEMATOLOGY, 2020, 7 (09) :E632-E634

[6] Hospital Admission in Children and Adolescents With COVID-19 Early Results From a National Survey Conducted by the German Society for Pediatric Infectious Diseases (DGPI) [J].

Armann, Jakob Peter ;

Diffloth, Natalie ;

Simon, Arne ;

Doenhardt, Maren ;

Hufnagel, Markus ;

Trotter, Andreas ;

Schneider, Dominik ;

Huebner, Johannes ;

Berner, Reinhard .

DEUTSCHES ARZTEBLATT INTERNATIONAL, 2020, 117 (21) :373-374

[7] Assessment of 135 794 Pediatric Patients Tested for Severe Acute Respiratory Syndrome Coronavirus 2 Across the United States [J].

Bailey, L. Charles ;

Razzaghi, Hanieh ;

Burrows, Evanette K. ;

Bunnell, H. Timothy ;

Camacho, Peter E. F. ;

Christakis, Dimitri A. ;

Eckrich, Daniel ;

Kitzmiller, Melody ;

Lin, Simon M. ;

Magnusen, Brianna C. ;

Newland, Jason ;

Pajor, Nathan M. ;

Ranade, Daksha ;

Rao, Suchitra ;

Sofela, Olamiji ;

Zahner, Janet ;

Bruno, Cortney ;

Forrest, Christopher B. .

JAMA PEDIATRICS, 2021, 175 (02) :176-184

[8]

Bellino S, 2020, PEDIATRICS, V146

[9]

Bhimraj A, Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19 Infection

[10] Coronavirus Disease 2019 in Children - United States, February 12-April 2, 2020 [J].

Bialek, Stephanie ;

Gierke, Ryan ;

Hughes, Michelle ;

McNamara, Lucy A. ;

Pilishvili, Tamara ;

Skoff, Tami .

MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT, 2020, 69 (14) :422-426

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