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

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.

Safety and Efficacy of Outpatient Treatments for COVID-19: Real-Life Data from a Regionwide Cohort of High-Risk Patients in Tuscany, Italy (the FEDERATE Cohort)

“…On the other hand, patients were excluded if they were: (i) hospitalized for reasons other than COVID-19 at the time of treatment, (ii) without a risk factor for severe COVID-19 according to AIFA criteria, and/or (iii) asymptomatic or suffering from a severe or critical disease. Children from a pediatric infectious diseases center were included, in light of a recent position paper by the Italian Society of Pediatrics recommending early treatment options for children at risk of COVID-19 progression [ 23 ].…”

Safety of Monoclonal Antibodies in Children Affected by SARS-CoV-2 Infection

“…Today, there are no approved clinical criteria for SARS-CoV-2 mAb administration under 12 years old and under 40 kg of body weight. Recently, the Italian Society of Pediatrics proposed pediatric criteria for the use of mAbs based on the available evidence from the scientific literature and experts' recommendations [26]. Besides this, the American Academy of Pediatrics first, and the Minnesota Department of Health afterward, issued a list of criteria for SARS-CoV-2 mAb indications in pediatric populations [23].…”

A Single-center Experience in Treating Young Children at High Risk For Severe COVID-19 With Sotrovimab

“…They were hospitalized to ensure clinical observation because they all fulfilled the criteria for high risk of progression to severe COVID-19 (Table 1 ) and they all met AIFA’s indications for treatment with sotrovimab, with the exception of age and weight. 5 None of them had received vaccination for SARS-CoV-2 (4 out 5 were less than 5 years old). As required by the hospital’s policy, off-label monoclonal antibodies (mAb) use for age and weight was prescribed after Hospital Drug Committee approval and once we obtained the informed parental consent.…”

“…Neurological symptoms may appear throughout the course of KD, ptosis is very rare, as only 5 cases have been published previously. [2][3][4][5] It seems to be a late complication that appears between the second and fourth week from the onset of symptoms. In none of the cases, ptosis was remitted after immunoglobulins administration.…”