Eligibility criteria for pediatric patients who may benefit from anti SARS-CoV-2 monoclonal antibody therapy administration: an Italian inter-society consensus statement

Marcello Lanari; Elisabetta Venturini; Luca Pierantoni; Giacomo Stera; Guido Castelli Gattinara; Susanna Maria Roberta Esposito; Silvia Favilli; Emilio Franzoni; Eleonora Fusco; Paolo Lionetti; Claudio Maffeis; Gianluigi Marseglia; Laura Massella; Fabio Midulla; Alberto Zanobini; Marco Zecca; Alberto Villani; Annamaria Staiano; Luisa Galli; Other Collaborators

doi:10.1186/s13052-021-01187-1

Eligibility criteria for pediatric patients who may benefit from anti SARS-CoV-2 monoclonal antibody therapy administration: an Italian inter-society consensus statement

Ital J Pediatr. 2022 Jan 12;48(1):7. doi: 10.1186/s13052-021-01187-1.

Authors

Marcello Lanari^{1

2}, Elisabetta Venturini³, Luca Pierantoni¹, Giacomo Stera⁴, Guido Castelli Gattinara⁵, Susanna Maria Roberta Esposito⁶, Silvia Favilli⁷, Emilio Franzoni⁸, Eleonora Fusco⁹, Paolo Lionetti¹⁰, Claudio Maffeis¹¹, Gianluigi Marseglia¹², Laura Massella¹³, Fabio Midulla¹⁴, Alberto Zanobini², Marco Zecca¹⁵, Alberto Villani¹⁶, Annamaria Staiano¹⁷, Luisa Galli^{18

19}; Other Collaborators

Collaborators

Other Collaborators:
Francesco Blasi, Angelo Di Giorgio, Daniele Donà, Amelia Licari, Massimo Martinelli, Antonio Mastrangelo, Michele Miraglia Del Giudice, Giangiacomo Nicolini, Fabrizio Pugliese, Pasquale Striano, Giuliana Valerio

Affiliations

¹ Pediatric Emergency Unit, Scientific Institute for Research and Healthcare (IRCCS), Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
² Italian Association of Children's Hospital (AOPI), Rome, Italy.
³ Infectious Diseases Unit, Meyer Children's University Hospital, Florence, Italy.
⁴ Postgraduate School of Pediatrics, University of Bologna, Bologna, Italy.
⁵ Institute of Child Health, Ospedale Bambino Gesù - IRCCS, Rome, Italy.
⁶ Pediatric Clinic, Pietro Barilla Children's Hospital, Department of Medicine and Surgery, University of Parma, Parma, Italy.
⁷ Cardiology Unit, Meyer Children's University Hospital, Florence, Italy.
⁸ Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
⁹ Postgraduate School of Pediatrics, University of Florence, Meyer Children's Hospital, Florence, Italy.
¹⁰ Gastroenterology Unit, NEUROFARBA Department, University of Florence, Meyer Children's Hospital, Florence, Italy.
¹¹ Pediatric Clinic B, Mother and Child Hospital, Department of Surgery, Dentistry, Paediatrics, and Gynaecology, University of Verona, Verona, Italy.
¹² Department of Pediatrics, University of Pavia, San Matteo Foundation IRCCS Policlinico, Pavia, Italy.
¹³ Division of Nephrology, Department of Pediatric Subspecialties, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
¹⁴ Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Rome, Italy.
¹⁵ Pediatric Hematology/Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
¹⁶ General Pediatrics Unit, Pediatric Emergency and General Pediatrics Department, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
¹⁷ Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II", Naples, Italy.
¹⁸ Infectious Diseases Unit, Meyer Children's University Hospital, Florence, Italy. [email protected].
¹⁹ Department of Health Sciences, University of Florence, Florence, Italy. [email protected].

Abstract

The fast diffusion of the SARS-CoV-2 pandemic have called for an equally rapid evolution of the therapeutic options.The Human recombinant monoclonal antibodies (mAbs) have recently been approved by the Food and Drug Administration (FDA) and by the Italian Medicines Agency (AIFA) in subjects aged ≥12 with SARS-CoV-2 infection and specific risk factors.Currently the indications are specific for the use of two different mAbs combination: Bamlanivimab+Etesevimab (produced by Eli Lilly) and Casirivimab+Imdevimab (produced by Regeneron).These drugs have shown favorable effects in adult patients in the initial phase of infection, whereas to date few data are available on their use in children.AIFA criteria derived from the existing literature which reports an increased risk of severe COVID-19 in children with comorbidities. However, the studies analyzing the determinants for progression to severe disease are mainly monocentric, with limited numbers and reporting mostly generic risk categories.Thus, the Italian Society of Pediatrics invited its affiliated Scientific Societies to produce a Consensus document based on the revision of the criteria proposed by AIFA in light of the most recent literature and experts' agreement.This Consensus tries to detail which patients actually have the risk to develop severe disease, analyzing the most common comorbidities in children, in order to detail the indications for mAbs administration and to guide the clinicians in identifying eligible patients.

Keywords: Adolescents; COVID19; Monoclonal antibody; Risk factors.

Publication types

Review

MeSH terms

Adolescent
Age Factors
Antibodies, Monoclonal / therapeutic use*
Antibodies, Monoclonal, Humanized / therapeutic use*
Antibodies, Neutralizing / therapeutic use*
Antiviral Agents / therapeutic use*
COVID-19 / complications
COVID-19 Drug Treatment*
Child
Consensus
Drug Combinations
Humans
Italy
Patient Selection*
Risk Factors
Societies, Medical

Substances

Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Antibodies, Neutralizing
Antiviral Agents
Drug Combinations
bamlanivimab and etesevimab drug combination
casirivimab and imdevimab drug combination